Trial Outcomes & Findings for A Phase I/II, Open-label Study of Ofatumumab Added to Chlorambucil in Previously Untreated Japanese Patients With Chronic Lymphocytic Leukemia (NCT NCT01563055)

NCT ID: NCT01563055

Last Updated: 2015-08-10

Results Overview

Tolerability of ofatumumab in combination with chlorambucil was evaluated based on the number of participants who developed toxicity requiring discontinuation from study treatment during Cycle 1. The treatment was considered tolerable when 0 of 3 participants, or \<=2 of 6 participants developed toxicity which required discontinuation of study treatment during Cycle 1. The toxicity requiring discontinuation was determined based on the pre-defined withdrawal criteria.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 10 participants
• Primary outcome timeframe: From start of treatment through Cycle 1 (Week 4)
• Results posted on: 2015-08-10

Participant Flow

This study consisted of two parts. In part A of the study, the eligible participants (par.) were enrolled to assess the tolerability of ofatumumab with chlorambucil. After confirmation of the tolerability, Part B of the study was initiated. The total number of participants in Part A and Part B was 10.

Participant milestones

Measure	Ofatumumab + Chlorambucil Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams \[mg\]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m\^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up \[FU\] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
Overall Study STARTED	10
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Phase I/II, Open-label Study of Ofatumumab Added to Chlorambucil in Previously Untreated Japanese Patients With Chronic Lymphocytic Leukemia

Baseline characteristics by cohort

Measure	Ofatumumab + Chlorambucil n=10 Participants Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams \[mg\]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m\^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up \[FU\] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
Age, Continuous	71.5 Years STANDARD_DEVIATION 10.38 • n=5 Participants
Age, Customized <65 years	1 Participants n=5 Participants
Age, Customized >=65 years	9 Participants n=5 Participants
Age, Customized >=75 years	4 Participants n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants
Race/Ethnicity, Customized Asian - Japanese Heritage	10 Participants n=5 Participants

PRIMARY outcome

Timeframe: From start of treatment through Cycle 1 (Week 4)

Population: All Subjects Population: all participants who received at least one dose of investigational product.

Tolerability of ofatumumab in combination with chlorambucil was evaluated based on the number of participants who developed toxicity requiring discontinuation from study treatment during Cycle 1. The treatment was considered tolerable when 0 of 3 participants, or <=2 of 6 participants developed toxicity which required discontinuation of study treatment during Cycle 1. The toxicity requiring discontinuation was determined based on the pre-defined withdrawal criteria.

Outcome measures

Measure

Ofatumumab + Chlorambucil n=3 Participants Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams \[mg\]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m\^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up \[FU\] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).

Number of Participants Who Developed Toxicity Requiring Discontinuation From Study Treatment During Cycle 1

0 Participants

PRIMARY outcome

Timeframe: From start of treatment until disease progression or death (up to Week 62.3)

Population: All Subjects Population

Response evaluated as per International Workshop for Chronic Lymphocytic Leukemia (IWCLL) National Cancer Institute-sponsored Working Group (NCI-WG) Guidelines, 2008. Overall response rate (ORR) is defined as percentage of par. achieving complete remission (CR), nodular partial remission (nPR), CR-incomplete (CRi) or PR. CR (>=2 months after last treatment): lymphocytes (LC) <4000 per microliter (μL), no lymphadenopathy (Ly)>1.5 cm/hepatomegaly/splenomegaly/constitutional symptoms; neutrophils (N)>1500/µL, platelets (PL)>100,000/µL, hemoglobin (Hb)>11 grams/deciliter (g/dL), bone marrow (BM) sample must be normocellular for age,<30% LC, no lymphoid nodule (LN). PR:>=50% decrease in LC, Ly, size of liver and spleen; and at least one of these: N>1500/μL, PL>100,000/µL or 50% improvement over Baseline (BL), Hb>11 g/dL or 50% improvement over BL. nPR: persistent nodules BM. CRi: CR criteria, persistent anemia/thrombocytopenia/neutropenia unrelated to CLL but related to drug toxicity.

Outcome measures

Measure	Ofatumumab + Chlorambucil n=10 Participants Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams \[mg\]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m\^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up \[FU\] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
Number of Participants With Overall Response, as Assessed by the Independent Review Committee (IRC) With CT, IRC and Investigator IRC Assessed, CRi	0 Participants
Number of Participants With Overall Response, as Assessed by the Independent Review Committee (IRC) With CT, IRC and Investigator IRC Assessed, nPR	1 Participants
Number of Participants With Overall Response, as Assessed by the Independent Review Committee (IRC) With CT, IRC and Investigator IRC Assessed, PR	5 Participants
Number of Participants With Overall Response, as Assessed by the Independent Review Committee (IRC) With CT, IRC and Investigator Investigator Assessed, CR	1 Participants
Number of Participants With Overall Response, as Assessed by the Independent Review Committee (IRC) With CT, IRC and Investigator Investigator Assessed, CRi	0 Participants
Number of Participants With Overall Response, as Assessed by the Independent Review Committee (IRC) With CT, IRC and Investigator IRC with CT Assessed, CR	0 Participants
Number of Participants With Overall Response, as Assessed by the Independent Review Committee (IRC) With CT, IRC and Investigator IRC with CT Assessed, CRi	0 Participants
Number of Participants With Overall Response, as Assessed by the Independent Review Committee (IRC) With CT, IRC and Investigator IRC with CT Assessed, nPR	0 Participants
Number of Participants With Overall Response, as Assessed by the Independent Review Committee (IRC) With CT, IRC and Investigator IRC with CT Assessed, PR	5 Participants
Number of Participants With Overall Response, as Assessed by the Independent Review Committee (IRC) With CT, IRC and Investigator IRC Assessed, CR	1 Participants
Number of Participants With Overall Response, as Assessed by the Independent Review Committee (IRC) With CT, IRC and Investigator Investigator Assessed, nPR	0 Participants
Number of Participants With Overall Response, as Assessed by the Independent Review Committee (IRC) With CT, IRC and Investigator Investigator Assessed, PR	6 Participants

SECONDARY outcome

Timeframe: From start of treatment until disease progression or death (up to Week 62.3)

Population: All Subjects Population

Response was determined according to the IWCLL updated NCI-WG guidelines, 2008. According to the guidelines, CR (all the criteria at least 2 months after last treatment): peripheral blood lymphocytes below < 4,000/μL, no Ly > 1.5 cm/ hepatomegaly/ splenomegaly/ constitutional symptoms; Neu >1500 /µL, PL >100,000/µL, Hb >11 g/dL, BM sample must be normocellular for age, <30% lymphocytes, no LN. PR: >=50% decrease in peripheral blood lymphocytes, Ly, size of liver and spleen; and blood count showing at least one of the following results: Neu>1500/μL, PL >100,000/µL or 50% improvement over BL, Hb >11 g/dL or 50% improvement over BL. No increase in LN and no new LN.

Outcome measures

Measure	Ofatumumab + Chlorambucil n=10 Participants Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams \[mg\]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m\^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up \[FU\] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
Number of Participants With CR, as Assessed by the IRC, IRC With CT, and the Investigator IRC with CT Assessed, CR	0 Participants
Number of Participants With CR, as Assessed by the IRC, IRC With CT, and the Investigator IRC Assessed, CR	1 Participants
Number of Participants With CR, as Assessed by the IRC, IRC With CT, and the Investigator Investigator Assessed, CR	1 Participants

SECONDARY outcome

Timeframe: From start of treatment until disease progression or death (up to Week 62.3)

Population: All Subjects Population. Only participants who progressed or died were analyzed.

Progression free survival is defined as the time from start of treatment until disease progression (PD) or death due to any cause. PD was determined by the IRC or investigator according to the definitions of response in the IWCLL updated NCI-WG guidelines, 2008. According to the guidelines, PD is characterized by at least one of the following: lymphadenopathy (appearance of any new lesion such as enlarged lymph nodes (>1.5 centimeter [cm]), spleen or liver or other infiltrates or an increase by 50% or more in the greatest diameter of any previous site); an increase by 50% or more in the previously noted enlargement of the liver or spleen; an increase by 50% or more in the numbers of blood lymphocytes with at least 5000 per microliter B-lymphocytes; transformation to a more aggressive histology; or occurrence of cytopenia attributable to chronic lymphocytic leukemia. PFS was censored at the last visit with adequate assessment for participants who were alive and had not progressed.

Outcome measures

Measure	Ofatumumab + Chlorambucil n=10 Participants Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams \[mg\]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m\^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up \[FU\] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
Progression-free Survival (PFS), as Assessed by the IRC and the Investigator IRC Assessed, Response, n=1	NA Weeks Interval 6.1 to No PFS could be determined because only one progression or death was observed in the participants, and other 9 participants were censored for analysis Not enough events to estimate upper limit of confidence interval
Progression-free Survival (PFS), as Assessed by the IRC and the Investigator Investigator Assessed, Response, n=1	NA Weeks Interval 16.1 to No PFS could be determined because only one progression or death was observed in the participants, and other 9 participants were censored for analysis Not enough events to estimate upper limit of confidence interval

SECONDARY outcome

Timeframe: From start of treatment until death (up to Week 62.3

Population: All Subjects Population

Overall survival is defined as time from start of treatment until death due to any cause. For participants who did not die, time to death was censored at the time of the last date of contact.

Outcome measures

Measure

Ofatumumab + Chlorambucil n=10 Participants Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams \[mg\]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m\^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up \[FU\] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).

Overall Survival

NA Weeks All participants were alive at the time of the last follow-up and thus were censored for the analysis

SECONDARY outcome

Timeframe: From start of treatment until the first response (CR/CRi/nPR/PR) (up to Week 62.3)

Population: All Subjects Population. Only those participants classified as responders (CR, CRi, PR, nPR) were evaluated.

Time to response is defined as the time from start of treatment until the first response (CR/CRi/nPR/PR). Response was determined according to the IWCLL updated NCI-WG guidelines, 2008. This analysis only included participants who had a response while in the study, there was no censoring.

Outcome measures

Measure

Ofatumumab + Chlorambucil n=7 Participants Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams \[mg\]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m\^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up \[FU\] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).

Time to Response, as Assessed by the IRC

4.1 Weeks Interval 4.1 to 6.1

SECONDARY outcome

Timeframe: From initial response (CR/CRi/nPR/PR) until disease progression or death (up to Week 62.3)

Population: All Subjects Population. Only those participants classified as responders (CR, CRi, PR, nPR) were evaluated.

Duration of response is defined as the time from the first documented evidence of CR, CRi, nPR or PR until the first documented sign of PD or death in participants with CR, CRi, nPR or PR. For participants who did not progress or die, duration of response was censored on the date of last assessment.

Outcome measures

Measure

Ofatumumab + Chlorambucil n=7 Participants Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams \[mg\]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m\^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up \[FU\] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).

Duration of Response, as Assessed by the IRC

NA Weeks The duration of response could not be assessed because no progression was observed in any of the participants.

SECONDARY outcome

Timeframe: From start of treatment until the first administration of the next CLL therapy (up to Week 62.3)

Population: All Subjects Population. Only those participants who received next CLL therapy were evaluated.

Time to next CLL therapy is defined as the time from start of treatment until the first administration of the next CLL treatment other than chlorambucil administrations scheduled in this study. Time to next CLL therapy was restricted to the subgroup of the population who receive a next CLL therapy after experiencing disease progression.

Outcome measures

Measure

Ofatumumab + Chlorambucil n=1 Participants Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams \[mg\]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m\^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up \[FU\] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).

Time to Next Chronic Lymphocytic Leukemia (CLL) Therapy

11.4 Weeks No 95% CI were available because only one participant received the next CLL therapy.

SECONDARY outcome

Timeframe: Baseline, C2-D29, C3-D57, C4-D85, C5-D113, C6-D141, C7-D169, C8-D197, C9 -D225, FU 1-PDFU 1 (28 days post Day 1 of Last Cycle), FU 85-PDFU 85 (84 days after FU-1), and FU 169-PDFU 169 (168 days after FU-1)

Population: All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the All Subjects Population.

The number of participants with no B-symptoms (no night sweat [without signs of infection], no unexplained, unintentional weight loss >= 10% within the previous 6 months, no recurrent, unexplained fever of greater than 38 degrees celcius for 2 weeks and no extreme fatigue) and the number of participants with at least one of the B-symptoms are summarized by assessment time. The presence of the B-symptoms was assessed at Baseline, Day 1 of each treatment cycle and follow-up (FU). Baseline was the last pre-dose assessment performed at Cycle (C) 1-Day (D) 1.

Outcome measures

Measure	Ofatumumab + Chlorambucil n=10 Participants Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams \[mg\]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m\^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up \[FU\] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
Number of Participants With no B-symptoms (Constitutional Symptoms) and With at Least One B-symptom (Constitutional Symptoms) at the Indicated Time Points Cycle 9-Day 225, With at least one B-symptom, n=2	0 Participants
Number of Participants With no B-symptoms (Constitutional Symptoms) and With at Least One B-symptom (Constitutional Symptoms) at the Indicated Time Points Baseline, With no B-symptom, n=10	9 Participants
Number of Participants With no B-symptoms (Constitutional Symptoms) and With at Least One B-symptom (Constitutional Symptoms) at the Indicated Time Points Baseline, With at least one B-symptom, n=10	1 Participants
Number of Participants With no B-symptoms (Constitutional Symptoms) and With at Least One B-symptom (Constitutional Symptoms) at the Indicated Time Points Cycle 2-Day 29, With no B-symptom, n=8	8 Participants
Number of Participants With no B-symptoms (Constitutional Symptoms) and With at Least One B-symptom (Constitutional Symptoms) at the Indicated Time Points Cycle 2-Day 29, With at least one B-symptom, n=8	0 Participants
Number of Participants With no B-symptoms (Constitutional Symptoms) and With at Least One B-symptom (Constitutional Symptoms) at the Indicated Time Points Cycle 3-Day 57, With no B-symptom, n=8	8 Participants
Number of Participants With no B-symptoms (Constitutional Symptoms) and With at Least One B-symptom (Constitutional Symptoms) at the Indicated Time Points Cycle 3-Day 57, With at least one B-symptom, n=8	0 Participants
Number of Participants With no B-symptoms (Constitutional Symptoms) and With at Least One B-symptom (Constitutional Symptoms) at the Indicated Time Points Cycle 4-Day 85, With no B-symptom, n=7	7 Participants
Number of Participants With no B-symptoms (Constitutional Symptoms) and With at Least One B-symptom (Constitutional Symptoms) at the Indicated Time Points Cycle 4-Day 85, With at least one B-symptom, n=7	0 Participants
Number of Participants With no B-symptoms (Constitutional Symptoms) and With at Least One B-symptom (Constitutional Symptoms) at the Indicated Time Points Cycle 5-Day 113, With no B-symptom, n=7	7 Participants
Number of Participants With no B-symptoms (Constitutional Symptoms) and With at Least One B-symptom (Constitutional Symptoms) at the Indicated Time Points Cycle 5-Day 113, With at least one B-symptom, n=7	0 Participants
Number of Participants With no B-symptoms (Constitutional Symptoms) and With at Least One B-symptom (Constitutional Symptoms) at the Indicated Time Points Cycle 6-Day 141, With no B-symptom, n=7	7 Participants
Number of Participants With no B-symptoms (Constitutional Symptoms) and With at Least One B-symptom (Constitutional Symptoms) at the Indicated Time Points Cycle 6-Day 141, With at least one B-symptom, n=7	0 Participants
Number of Participants With no B-symptoms (Constitutional Symptoms) and With at Least One B-symptom (Constitutional Symptoms) at the Indicated Time Points Cycle 7-Day 169, With no B-symptom, n=2	2 Participants
Number of Participants With no B-symptoms (Constitutional Symptoms) and With at Least One B-symptom (Constitutional Symptoms) at the Indicated Time Points Cycle 7-Day 169, With at least one B-symptom, n=2	0 Participants
Number of Participants With no B-symptoms (Constitutional Symptoms) and With at Least One B-symptom (Constitutional Symptoms) at the Indicated Time Points Cycle 8-Day 197, With no B-symptom, n=2	2 Participants
Number of Participants With no B-symptoms (Constitutional Symptoms) and With at Least One B-symptom (Constitutional Symptoms) at the Indicated Time Points Cycle 8-Day 197, With at least one B-symptom, n=2	0 Participants
Number of Participants With no B-symptoms (Constitutional Symptoms) and With at Least One B-symptom (Constitutional Symptoms) at the Indicated Time Points Cycle 9-Day 225, With no B-symptom, n=2	2 Participants
Number of Participants With no B-symptoms (Constitutional Symptoms) and With at Least One B-symptom (Constitutional Symptoms) at the Indicated Time Points FU 1-PDFU 1, With no B-symptom, n=9	9 Participants
Number of Participants With no B-symptoms (Constitutional Symptoms) and With at Least One B-symptom (Constitutional Symptoms) at the Indicated Time Points FU 1-PDFU 1, With at least one B-symptom, n=9	0 Participants
Number of Participants With no B-symptoms (Constitutional Symptoms) and With at Least One B-symptom (Constitutional Symptoms) at the Indicated Time Points FU 85-PDFU 85, With no B-symptom, n=9	9 Participants
Number of Participants With no B-symptoms (Constitutional Symptoms) and With at Least One B-symptom (Constitutional Symptoms) at the Indicated Time Points FU 85-PDFU 85, With at least one B-symptom, n=9	0 Participants
Number of Participants With no B-symptoms (Constitutional Symptoms) and With at Least One B-symptom (Constitutional Symptoms) at the Indicated Time Points FU 169-PDFU 169, With no B-symptom, n=8	8 Participants
Number of Participants With no B-symptoms (Constitutional Symptoms) and With at Least One B-symptom (Constitutional Symptoms) at the Indicated Time Points FU 169-PDFU 169, With at least one B-symptom, n=8	0 Participants

SECONDARY outcome

Timeframe: Baseline, C2-D29, C3-D57, C4-D85, C5-D113, C6-D141, C7-D169, C8-D197, C9 -D225, FU 1-PDFU 1 (28 days post Day 1 of Last Cycle), FU 85-PDFU 85 (84 days after FU-1), and FU 169-PDFU 169 (168 days after FU-1)

Population: All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the All Subjects population.

ECOG PS is a scale to assess disease progression, extent to which disease affects the daily living abilities and determines appropriate treatment and prognosis. It is scored on a scale of 0 to 5 as, 0 (fully active), 1 (restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature), 2 (ambulatory and capable of all self cares but unable to carry out any work activities, up and about > 50% of waking hours), 3 (capable of only limited self cares, confined to bed or chair > 50% of waking hours), 4 (completely disabled, cannot carry on any self cares, totally confined to bed or chair), 5 (death). Improvement is defined as decrease from Baseline by at least one step on the ECOG performance status scale (yes/no). Baseline was the last pre-dose assessment performed on Cycle 1-Day 1(C1-D1). When C1-D1 was missing, the last assessment performed prior to pre-dose C1-D1 was used. It was performed on Day 1 of each cycle and follow-up (FU).

Outcome measures

Measure	Ofatumumab + Chlorambucil n=10 Participants Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams \[mg\]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m\^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up \[FU\] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
Number of Participants With Improvement in Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) Cycle 6-Day 141, Deteriorated, n=7	1 Participants
Number of Participants With Improvement in Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) Cycle 7-Day 169, No change, n=2	2 Participants
Number of Participants With Improvement in Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) Cycle 7-Day 169, Deteriorated, n=2	0 Participants
Number of Participants With Improvement in Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) Cycle 8-Day 197, Improved, n=2	0 Participants
Number of Participants With Improvement in Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) Cycle 8-Day 197, No change, n=2	2 Participants
Number of Participants With Improvement in Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) Cycle 8-Day 197, Deteriorated, n=2	0 Participants
Number of Participants With Improvement in Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) Cycle 9-Day 225, Improved, n=2	0 Participants
Number of Participants With Improvement in Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) Cycle 9-Day 225, Deteriorated, n=2	0 Participants
Number of Participants With Improvement in Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) FU 1-PDFU 1, Improved, n=9	0 Participants
Number of Participants With Improvement in Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) FU 1-PDFU 1, No change, n=9	9 Participants
Number of Participants With Improvement in Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) Cycle 2-Day 29, Improved, n=8	0 Participants
Number of Participants With Improvement in Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) Cycle 2-Day 29, No change, n=8	8 Participants
Number of Participants With Improvement in Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) Cycle 2-Day 29, Deteriorated, n=8	0 Participants
Number of Participants With Improvement in Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) Cycle 3-Day 57, Improved, n=8	0 Participants
Number of Participants With Improvement in Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) Cycle 3-Day 57, No change, n=8	8 Participants
Number of Participants With Improvement in Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) Cycle 3-Day 57, Deteriorated, n=8	0 Participants
Number of Participants With Improvement in Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) Cycle 4-Day 85, Improved, n=7	0 Participants
Number of Participants With Improvement in Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) Cycle 4-Day 85, No change, n=7	7 Participants
Number of Participants With Improvement in Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) Cycle 4-Day 85, Deteriorated, n=7	0 Participants
Number of Participants With Improvement in Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) Cycle 5-Day 113, Improved, n=7	0 Participants
Number of Participants With Improvement in Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) Cycle 5-Day 113, No change, n=7	7 Participants
Number of Participants With Improvement in Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) Cycle 5-Day 113, Deteriorated, n=7	0 Participants
Number of Participants With Improvement in Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) Cycle 6-Day 141, Improved, n=7	0 Participants
Number of Participants With Improvement in Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) Cycle 6-Day 141, No change, n=7	6 Participants
Number of Participants With Improvement in Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) Cycle 7-Day 169, Improved, n=2	0 Participants
Number of Participants With Improvement in Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) Cycle 9-Day 225, No change, n=2	2 Participants
Number of Participants With Improvement in Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) FU 1-PDFU 1, Deteriorated, n=9	0 Participants
Number of Participants With Improvement in Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) FU 85-PDFU 85, Improved, n=9	0 Participants
Number of Participants With Improvement in Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) FU 85-PDFU 85, No change, n=9	8 Participants
Number of Participants With Improvement in Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) FU 85-PDFU 85, Deteriorated, n=9	1 Participants
Number of Participants With Improvement in Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) FU 169-PDFU 169, Improved, n=8	0 Participants
Number of Participants With Improvement in Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) FU 169-PDFU 169, No change, n=8	8 Participants
Number of Participants With Improvement in Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) FU 169-PDFU 169, Deteriorated, n=8	0 Participants

SECONDARY outcome

Timeframe: From start of treatment until follow-up for survival (up to Week 62.3)

Population: All Subjects Population

An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, or important medical events that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed.

Outcome measures

Measure	Ofatumumab + Chlorambucil n=10 Participants Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams \[mg\]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m\^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up \[FU\] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE) Any AE	10 Participants
Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE) Any SAE	2 Participants

SECONDARY outcome

Timeframe: From start of treatment until follow-up for survival (up to Week 62.3)

Population: All Subjects Population

Adverse events were graded according to the National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE) grade, version 4.03 (1=mild; 2=moderate; 3=severe; 4=life-threatening/disabling; 5=death). AEs not in the list of CTCAE were graded at discretion of the investigator.

Outcome measures

Measure	Ofatumumab + Chlorambucil n=10 Participants Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams \[mg\]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m\^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up \[FU\] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
Number of Participants With AEs of Maximum Severity Any AE Grade 1	0 Participants
Number of Participants With AEs of Maximum Severity Any AE Grade 2	4 Participants
Number of Participants With AEs of Maximum Severity Any AE Grade 3	5 Participants
Number of Participants With AEs of Maximum Severity Any AE Grade 4	1 Participants
Number of Participants With AEs of Maximum Severity Any AE Grade 5	0 Participants

SECONDARY outcome

Timeframe: From start of treatment until follow-up for survival (up to Week 62.3)

Population: All Subjects Population

Adverse events were graded according to the National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE) grade, version 4.03 (1=mild; 2=moderate; 3=severe; 4=life-threatening/disabling; 5=death). AEs not in the list of CTCAE were graded at discretion of the investigator. Myelosuppression is defined as the decrease in the ability of the bone marrow to produce blood cells. Participants with Grade (G)3 or G4 adverse event of infection and myelosuppression (anemia, neutropenia, and thrombocytopenia) are presented. Also presented are number of participants with autoimmune hemolytic anemia (AIHA). AIHA is a disease where the body's immune system fails to recognize red blood cells as "self" and begins destroying these red blood cells.

Outcome measures

Measure	Ofatumumab + Chlorambucil n=10 Participants Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams \[mg\]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m\^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up \[FU\] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
Number of Participants With the Indicated Grade 3 or Grade 4 Adverse Events Infections, G3	0 Participants
Number of Participants With the Indicated Grade 3 or Grade 4 Adverse Events Infections, G4	0 Participants
Number of Participants With the Indicated Grade 3 or Grade 4 Adverse Events Thrombocytopenia, G3	2 Participants
Number of Participants With the Indicated Grade 3 or Grade 4 Adverse Events Thrombocytopenia, G4	0 Participants
Number of Participants With the Indicated Grade 3 or Grade 4 Adverse Events Neutropenia, G3	2 Participants
Number of Participants With the Indicated Grade 3 or Grade 4 Adverse Events Neutropenia, G4	1 Participants
Number of Participants With the Indicated Grade 3 or Grade 4 Adverse Events Anemia, G3	0 Participants
Number of Participants With the Indicated Grade 3 or Grade 4 Adverse Events Anemia, G4	0 Participants
Number of Participants With the Indicated Grade 3 or Grade 4 Adverse Events Autoimmune Hematologic Complication	0 Participants

SECONDARY outcome

Timeframe: Screening, Cycle 4-Day 85, FU 1-PDFU 1 (28 days post Day 1 of Last Cycle), and FU 169-PDFU 169 (168 days after FU-1)

Population: All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the All Subjects Population.

HAHA are indicators of immunogenicity induced by ofatumumab. Blood samples were taken from participants at Screening, Cycle 4-Day 85, FU 1-PDFU 1, and FU 169-PDFU 169. The presence of HAHA in human serum was determined using a validated electrochemiluminescent assay in a multi-tier assay format. The results are presented as participants with HAHA results as positive, negative or confirmation required.

Outcome measures

Measure	Ofatumumab + Chlorambucil n=10 Participants Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams \[mg\]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m\^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up \[FU\] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
Number of Participants With the Indicated Results for Human Anti-human Antibody (HAHA) at the Indicated Time Points Cycle 4-Day 85, Negative, n=7	7 Participants
Number of Participants With the Indicated Results for Human Anti-human Antibody (HAHA) at the Indicated Time Points FU 1-PDFU 1, Confirmation required, n=10	0 Participants
Number of Participants With the Indicated Results for Human Anti-human Antibody (HAHA) at the Indicated Time Points FU 169-PDFU 169, Positive, n=8	0 Participants
Number of Participants With the Indicated Results for Human Anti-human Antibody (HAHA) at the Indicated Time Points Screening, Positive, n=10	1 Participants
Number of Participants With the Indicated Results for Human Anti-human Antibody (HAHA) at the Indicated Time Points Screening, Negative, n=10	9 Participants
Number of Participants With the Indicated Results for Human Anti-human Antibody (HAHA) at the Indicated Time Points Screening, Confirmation required, n=10	0 Participants
Number of Participants With the Indicated Results for Human Anti-human Antibody (HAHA) at the Indicated Time Points Cycle 4-Day 85, Positive, n=7	0 Participants
Number of Participants With the Indicated Results for Human Anti-human Antibody (HAHA) at the Indicated Time Points Cycle 4-Day 85, Confirmation required, n=7	0 Participants
Number of Participants With the Indicated Results for Human Anti-human Antibody (HAHA) at the Indicated Time Points FU 1-PDFU 1, Positive, n=10	0 Participants
Number of Participants With the Indicated Results for Human Anti-human Antibody (HAHA) at the Indicated Time Points FU 1-PDFU 1, Negative, n=10	10 Participants
Number of Participants With the Indicated Results for Human Anti-human Antibody (HAHA) at the Indicated Time Points FU 169-PDFU 169, Negative, n=8	8 Participants
Number of Participants With the Indicated Results for Human Anti-human Antibody (HAHA) at the Indicated Time Points FU 169-PDFU 169, Confirmation required, n=8	0 Participants

SECONDARY outcome

Timeframe: Baseline (Cycle 1-Day 1), FU 1-PDFU 1 (28 days post Day 1 of Last Cycle), and FU 169-PDFU 169 (168 days after FU-1)

Population: All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the All Subjects population.

Immunoglobulins, or antibodies, are large proteins used by the immune system to identify and neutralize foreign particles such as bacteria and viruses. Their normal blood levels indicate proper immune status. Low levels indicate immuno-suppression. IgA, IgG, and IgM were measured in the blood samples of the participants. Baseline IgA, IgG, and IgM values are the last pre-dose assessment values performed on Cycle 1-Day 1. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Immunoglobulins were measured at Cycle 1-Day 1, FU 1-PDFU 1, and FU 169-PDFU 169 for participants in CR, PR, and stable disease (SD).

Outcome measures

Measure	Ofatumumab + Chlorambucil n=10 Participants Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams \[mg\]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m\^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up \[FU\] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
Mean Change From Baseline in the Immunoglobulins (Ig) Antibodies IgA, IgG, and IgM at the Indicated Time Points IgA, FU 1-PDFU 1, n=10	0.111 Grams per liter Standard Deviation 0.2816
Mean Change From Baseline in the Immunoglobulins (Ig) Antibodies IgA, IgG, and IgM at the Indicated Time Points IgA, FU 169-PDFU 169, n=8	0.326 Grams per liter Standard Deviation 0.4172
Mean Change From Baseline in the Immunoglobulins (Ig) Antibodies IgA, IgG, and IgM at the Indicated Time Points IgG, FU 1-PDFU 1, n=10	-0.025 Grams per liter Standard Deviation 1.4555
Mean Change From Baseline in the Immunoglobulins (Ig) Antibodies IgA, IgG, and IgM at the Indicated Time Points IgG, FU 169-PDFU 169, n=8	0.611 Grams per liter Standard Deviation 1.0636
Mean Change From Baseline in the Immunoglobulins (Ig) Antibodies IgA, IgG, and IgM at the Indicated Time Points IgM, FU 1-PDFU 1, n=10	-0.053 Grams per liter Standard Deviation 0.1466
Mean Change From Baseline in the Immunoglobulins (Ig) Antibodies IgA, IgG, and IgM at the Indicated Time Points IgM, FU 169-PDFU 169, n=8	-0.045 Grams per liter Standard Deviation 0.1466

SECONDARY outcome

Timeframe: FU 85-PDFU 85 (84 days after FU-1)

Population: All Subjects Population. Only those participants who were positive and negative for MRD were analyzed.

MRD refers to small number of leukemic cells that remain in the participant's body during treatment or after treatment in participants who achieved a confirmed complete remission. MRD assessment in bone marrow aspiration sample was perfrmed by flow cytometry (cluster of differentiation [CD]5, CD19, CD20, CD23). The absence of MRD was defined as less than one CLL cell per 10,000 leukocytes. The number of participants who were positive and negative for MRD are presented.

Outcome measures

Measure	Ofatumumab + Chlorambucil n=8 Participants Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams \[mg\]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m\^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up \[FU\] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
Number of Participants Who Were Positive or Negative for Minimal Residual Disease (MRD), as Assessed by IRC With CT Positive	4 Participants
Number of Participants Who Were Positive or Negative for Minimal Residual Disease (MRD), as Assessed by IRC With CT Negative	4 Participants

SECONDARY outcome

Timeframe: Baseline, C1-D15, C2-D29, C2-D43, C3-D57, C4-D85, C5-D113, C6-D141, C7-D169, C8-D197, C9-D225, FU 1-PDFU 1 (28 days post Day 1 of Last Cycle), FU 85-PDFU 85 (84 days after FU-1), and FU 169-PDFU 169 (168 days after FU-1)

Population: All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the All Subjects population.

CD5+CD19+ cells were counted in peripheral blood by flow cytometry. Baseline CD5+CD19+ and CD5-CD19+ cell count value is the last pre-dose assessment values performed on Cycle 1-Day 1. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. B-cell monitoring (CD5+CD19+ and CD5-CD19+) was performed at Cycle 1 (Day 1, Day 15) and Cycle 2 (Day 29, Day 43), on Day 1 of Cycle 3, 4, 5, 6, 9 and 12 (Day 57, Day 85, Day 113, Day 141, Day 225, Day 309), 28 days after the first day of the last treatment cycle (FU 1-PDFU 1) for all participants depending on the number of cycles administered, and 84 and 168 days after the day of FU 1-PDFU 1 for participants in CR, PR, and SD.

Outcome measures

Measure	Ofatumumab + Chlorambucil n=10 Participants Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams \[mg\]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m\^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up \[FU\] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
Change From Baseline in CD5+CD19+ and CD5-CD19+ Cell Counts at the Indicated Time Points CD5+CD19+, Cycle 1-Day 15, n=8	-71066.50 Cells per microliter Standard Deviation 114877.018
Change From Baseline in CD5+CD19+ and CD5-CD19+ Cell Counts at the Indicated Time Points CD5+CD19+, Cycle 2-Day 29, n=8	-50441.25 Cells per microliter Standard Deviation 56969.080
Change From Baseline in CD5+CD19+ and CD5-CD19+ Cell Counts at the Indicated Time Points CD5+CD19+, Cycle 2-Day 43, n=8	-36755.88 Cells per microliter Standard Deviation 36719.313
Change From Baseline in CD5+CD19+ and CD5-CD19+ Cell Counts at the Indicated Time Points CD5+CD19+, Cycle 3-Day 57, n=8	-31823.50 Cells per microliter Standard Deviation 37479.968
Change From Baseline in CD5+CD19+ and CD5-CD19+ Cell Counts at the Indicated Time Points CD5+CD19+, Cycle 4-Day 85, n=7	-35679.00 Cells per microliter Standard Deviation 39379.825
Change From Baseline in CD5+CD19+ and CD5-CD19+ Cell Counts at the Indicated Time Points CD5+CD19+, Cycle 5-Day 113, n=7	-35754.71 Cells per microliter Standard Deviation 39502.575
Change From Baseline in CD5+CD19+ and CD5-CD19+ Cell Counts at the Indicated Time Points CD5+CD19+, Cycle 6-Day 141, n=7	-35791.43 Cells per microliter Standard Deviation 39535.868
Change From Baseline in CD5+CD19+ and CD5-CD19+ Cell Counts at the Indicated Time Points CD5+CD19+, Cycle 7-Day 169, n=2	-61591.00 Cells per microliter Standard Deviation 19469.478
Change From Baseline in CD5+CD19+ and CD5-CD19+ Cell Counts at the Indicated Time Points CD5+CD19+, Cycle 8-Day 197, n=2	-61589.00 Cells per microliter Standard Deviation 19473.721
Change From Baseline in CD5+CD19+ and CD5-CD19+ Cell Counts at the Indicated Time Points CD5+CD19+, Cycle 9-Day 225, n=2	-61591.00 Cells per microliter Standard Deviation 19470.892
Change From Baseline in CD5+CD19+ and CD5-CD19+ Cell Counts at the Indicated Time Points CD5+CD19+, FU 1-PDFU 1, n=10	-59868.20 Cells per microliter Standard Deviation 96360.514
Change From Baseline in CD5+CD19+ and CD5-CD19+ Cell Counts at the Indicated Time Points CD5+CD19+, FU 85-PDFU 85, n=9	-31370.78 Cells per microliter Standard Deviation 36239.779
Change From Baseline in CD5+CD19+ and CD5-CD19+ Cell Counts at the Indicated Time Points CD5+CD19+, FU 169- PDFU 169, n=8	-31270.25 Cells per microliter Standard Deviation 38733.484
Change From Baseline in CD5+CD19+ and CD5-CD19+ Cell Counts at the Indicated Time Points CD19+CD5-, Cycle 1-Day 15, n=8	-6752.50 Cells per microliter Standard Deviation 14473.357
Change From Baseline in CD5+CD19+ and CD5-CD19+ Cell Counts at the Indicated Time Points CD19+CD5-, Cycle 2-Day 29, n=8	-6616.13 Cells per microliter Standard Deviation 14070.593
Change From Baseline in CD5+CD19+ and CD5-CD19+ Cell Counts at the Indicated Time Points CD19+CD5-, Cycle 2-Day 43, n=8	-6044.00 Cells per microliter Standard Deviation 12496.749
Change From Baseline in CD5+CD19+ and CD5-CD19+ Cell Counts at the Indicated Time Points CD19+CD5-, Cycle 3-Day 57, n=8	-2867.13 Cells per microliter Standard Deviation 4561.234
Change From Baseline in CD5+CD19+ and CD5-CD19+ Cell Counts at the Indicated Time Points CD19+CD5-, Cycle 4-Day 85, n=7	-1792.57 Cells per microliter Standard Deviation 3669.425
Change From Baseline in CD5+CD19+ and CD5-CD19+ Cell Counts at the Indicated Time Points CD19+CD5-, Cycle 5-Day 113, n=7	-1792.43 Cells per microliter Standard Deviation 3668.705
Change From Baseline in CD5+CD19+ and CD5-CD19+ Cell Counts at the Indicated Time Points CD19+CD5-, Cycle 6-Day 141, n=7	-1794.14 Cells per microliter Standard Deviation 3668.713
Change From Baseline in CD5+CD19+ and CD5-CD19+ Cell Counts at the Indicated Time Points CD19+CD5-, Cycle 7-Day 169, n=2	-362.50 Cells per microliter Standard Deviation 64.347
Change From Baseline in CD5+CD19+ and CD5-CD19+ Cell Counts at the Indicated Time Points CD19+CD5-, Cycle 8-Day 197, n=2	-362.00 Cells per microliter Standard Deviation 63.640
Change From Baseline in CD5+CD19+ and CD5-CD19+ Cell Counts at the Indicated Time Points CD19+CD5-, Cycle 9-Day 225, n=2	-362.00 Cells per microliter Standard Deviation 63.640
Change From Baseline in CD5+CD19+ and CD5-CD19+ Cell Counts at the Indicated Time Points CD19+CD5-, FU 1-PDFU 1, n=10	-7534.40 Cells per microliter Standard Deviation 13238.650
Change From Baseline in CD5+CD19+ and CD5-CD19+ Cell Counts at the Indicated Time Points CD19+CD5-, FU 85-PDFU 85, n=9	-3911.67 Cells per microliter Standard Deviation 6060.974
Change From Baseline in CD5+CD19+ and CD5-CD19+ Cell Counts at the Indicated Time Points CD19+CD5-, FU 169-PDFU 169, n=8	-2170.38 Cells per microliter Standard Deviation 3568.904

SECONDARY outcome

Timeframe: Cycle 1-Day 1

Population: All Subjects Population

Beta-2-microglobulin is a protein present on the surface of most cells. Higher levels indicate a poor prognosis of CLL. Beta-2 microglobulin was measured at Cycle 1-Day 1.

Outcome measures

Measure

Ofatumumab + Chlorambucil n=10 Participants Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams \[mg\]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m\^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up \[FU\] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).

Beta-2 Microglobulin at Cycle 1-Day 1

301.442 Nanomoles per liter (NMOL/L) Standard Deviation 157.5521

SECONDARY outcome

Timeframe: Cycle 1-Day 1 and Cycle 4-Day 85

Population: All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the All Subjects pPopulation.

The CH50 is the serum complement to lyse 50% of sensitized red blood cells; it is a marker of complement activation. A high CH50 level suggests evidence for complement activation, whereas a low CH50 level suggests lack of complement activation. Peripheral blood samples were collected for analysis at Cycle 1-Day 1 and Cycle 4-Day 85.

Outcome measures

Measure	Ofatumumab + Chlorambucil n=10 Participants Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams \[mg\]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m\^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up \[FU\] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
Complement (CH50) at Cycle 1-Day 1 and Cycle 4-Day 85 Cycle 1-Day 1, n=10	42.63 Kilo units per liter (KU/L) Standard Deviation 4.549
Complement (CH50) at Cycle 1-Day 1 and Cycle 4-Day 85 Cycle 4-Day 85, n=7	39.80 Kilo units per liter (KU/L) Standard Deviation 5.791

SECONDARY outcome

Timeframe: Cycle 1-Day 1 and Cycle 3-Day 57

Population: PK Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the PK Population.

Maximum (peak) plasma drug concentration of ofatumumab was determined at Cycle 1-Day 1 and Cycle 3-Day 57. Samples were collected at Cycle 1-Day 1 (pre-dose, end of infusion, 10 min, 1hr, 2 hr, 24 hr, 72 hr, 120 hr), and Cycle 3-Day 57 (pre-dose, end of infusion, 10 min, 1 hr, 2 hr, 24 hr, 72 hr, 120 hr, 168 hr).

Outcome measures

Measure	Ofatumumab + Chlorambucil n=6 Participants Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams \[mg\]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m\^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up \[FU\] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
Maximum (Peak) Plasma Concentration (Cmax) of Ofatumumab Cycle 1-Day 1, n=6	59.4051 Micrograms/milliliter (µg/mL) Interval 43.125 to 81.831
Maximum (Peak) Plasma Concentration (Cmax) of Ofatumumab Cycle 3-Day 57, n=5	296.1851 Micrograms/milliliter (µg/mL) Interval 197.449 to 444.295

SECONDARY outcome

Timeframe: Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 57

Population: PK Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the PK Population.

Cmax of serum chlorambucil was assesed at Cycle 1-Day 1, Cycle 1-Day 4 and Cycle 3-Day 57. In each sampling, blood samples were collected at pre-dose, and 15 min, 30 min, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, and 10 hr.

Outcome measures

Measure	Ofatumumab + Chlorambucil n=6 Participants Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams \[mg\]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m\^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up \[FU\] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
Cmax of Serum Chlorambucil Cycle 1-Day 1, n=6	412.1241 ng/mL Interval 307.431 to 552.469
Cmax of Serum Chlorambucil Cycle 1-Day 4, n=6	388.1516 ng/mL Interval 338.065 to 445.659
Cmax of Serum Chlorambucil Cycle 3-Day 57, n=5	420.9367 ng/mL Interval 198.124 to 894.326

SECONDARY outcome

Timeframe: Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 57

Population: PK Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the PK Population.

Cmax of chlorambucil metabolite phenyl acetic acid mustard was assesed at Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 57. In each sampling, blood samples were collected at pre-dose, and 15 min, 30 min, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, and 10 hr.

Outcome measures

Measure	Ofatumumab + Chlorambucil n=6 Participants Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams \[mg\]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m\^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up \[FU\] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
Cmax of Serum Phenyl Acetic Acid Mustard Cycle 1-Day 1, n=6	237.3587 ng/mL Interval 158.718 to 354.965
Cmax of Serum Phenyl Acetic Acid Mustard Cycle 1-Day 4, n=6	215.5603 ng/mL Interval 117.594 to 395.14
Cmax of Serum Phenyl Acetic Acid Mustard Cycle 3-Day 57, n=5	226.2480 ng/mL Interval 170.174 to 300.799

SECONDARY outcome

Timeframe: Cycle 1-Day 8, Cycle 2-Day 29, Cycle 3-Day 57, Cycle 4-Day 85, Cycle 5-Day 113, and Cycle 6-Day 141

Population: PK Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the PK Population.

Minimum plasma drug concentration of ofatumumab was determined at Cycle 1-Day 8, Cycle 2-Day 29, Cycle 3-Day 57, Cycle 4-Day 85, Cycle 5-Day 113, and Cycle 6-Day 141. Samples were collected at Cycle 1-Day 1 (pre-dose, end of infusion, 10 min, 1hr, 2 hr, 24 hr, 72 hr, 120 hr), Cycle 2-Day 29 (pre-dose), Cycle 3-Day 57 (pre-dose, end of infusion, 10 min, 1 hr, 2 hr, 24 hr, 72 hr, 120 hr, 168 hr), Cycle 4-Day 85 (pre-dose, 30 min post end of infusion), Cycle 5-Day 113 (pre-dose and end of infusion) and Cycle 6-Day 141 (pre-dose and end of infusion).

Outcome measures

Measure	Ofatumumab + Chlorambucil n=6 Participants Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams \[mg\]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m\^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up \[FU\] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
Minimum Plasma Concentration (Cmin) of Ofatumumab Cycle 6-Day 141, n=4	82.9519 Micrograms/milliliter (µg/mL) Interval 25.286 to 272.123
Minimum Plasma Concentration (Cmin) of Ofatumumab Cycle 1-Day 8, n=6	1.8693 Micrograms/milliliter (µg/mL) Interval 0.002 to 1779.832
Minimum Plasma Concentration (Cmin) of Ofatumumab Cycle 2-Day 29, n=4	73.0911 Micrograms/milliliter (µg/mL) Interval 59.023 to 90.511
Minimum Plasma Concentration (Cmin) of Ofatumumab Cycle 3-Day 57, n=5	57.8542 Micrograms/milliliter (µg/mL) Interval 15.444 to 216.724
Minimum Plasma Concentration (Cmin) of Ofatumumab Cycle 4-Day 85, n=4	82.1944 Micrograms/milliliter (µg/mL) Interval 24.517 to 275.563
Minimum Plasma Concentration (Cmin) of Ofatumumab Cycle 5-Day 113, n=4	98.3353 Micrograms/milliliter (µg/mL) Interval 44.749 to 216.089

SECONDARY outcome

Timeframe: Cycle 1-Day 4 and Cycle 3-Day 57

Population: PK Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the PK Population.

Cmin of chlorambucil was assesed at Cycle 1-Day 4 and Cycle 3-Day 57. In each sampling, blood samples were collected at pre-dose, and 15 min, 30 min, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, and 10 hr.

Outcome measures

Measure	Ofatumumab + Chlorambucil n=6 Participants Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams \[mg\]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m\^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up \[FU\] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
Cmin of Chlorambucil Cycle 1-Day 4, n=6	NA ng/mL The Cmin value was non quantifiable (NQ) for all time points.
Cmin of Chlorambucil Cycle 3-Day 57, n=5	NA ng/mL The Cmin value was non quantifiable (NQ) for all time points.

SECONDARY outcome

Timeframe: Cycle 1-Day 4 and Cycle 3-Day 57

Population: PK Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the PK Population.

Cmin of chlorambucil metabolite phenyl acetic acid mustard was assesed at Cycle 1-Day 4 and Cycle 3-Day 57. Blood samples were collected at Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 57. In each sampling, blood samples were collected at pre-dose, and 15 min, 30 min, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, and 10 hr.

Outcome measures

Measure	Ofatumumab + Chlorambucil n=6 Participants Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams \[mg\]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m\^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up \[FU\] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
Cmin of Phenyl Acetic Acid Mustard Cycle 1-Day 4, n=6	NA ng/mL The Cmin value was non quantifiable (NQ) for all time points.
Cmin of Phenyl Acetic Acid Mustard Cycle 3-Day 57, n=5	NA ng/mL The Cmin value was non quantifiable (NQ) for all time points.

SECONDARY outcome

Timeframe: Cycle 1-Day 1

Population: PK Population

Plasma clearance is defined as the plasma volume which is totally cleared of drug per unit of time. Blood samples were collected at Cycle 1-Day1 (pre-dose, end of infusion, 10 min, 1hr, 2 hr, 24 hr, 72 hr, 120 hr).

Outcome measures

Measure

Ofatumumab + Chlorambucil n=6 Participants Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams \[mg\]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m\^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up \[FU\] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).

Total Plasma Clearance (CL) of Ofatumumab

172.64451 Milliliters/hour (mL/hr) Interval 46.4417 to 641.7962

SECONDARY outcome

Timeframe: Cycle 1-Day 1 and Cycle 3-Day 57

Population: PK Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the PK Population.

Area under the concentration time curve over the dosing interval (AUC[0-tau]) is a measure of drug exposure over time. AUC(0-tau) is defined as the area under the drug plasma/serum concentration-time curve from dosing to time tau, where tau is the length of the dosing interval of the drug. For ofatumumab it was assesed at Cycle 1-Day 1 and Cycle 3-Day 57. Samples were collected at Cycle 1-Day 1 (pre-dose, end of infusion, 10 min, 1 hr, 2 hr, 24 hr, 72 hr, 120 hr) and Cycle 3-Day 57 (pre-dose, end of infusion, 10 min, 1 hr, 2 hr, 24 hr, 72 hr, 120 hr, 168 hr).

Outcome measures

Measure	Ofatumumab + Chlorambucil n=6 Participants Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams \[mg\]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m\^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up \[FU\] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
Area Under the Drug Plasma Concentration-time Curve From Dosing to Time Tau (AUC[0-tau]) of Ofatumumab Cycle 1-Day 1, n=6	1438.65082 Hours*nanogram/milliliter (hr*ng/mL Interval 469.631 to 4407.112
Area Under the Drug Plasma Concentration-time Curve From Dosing to Time Tau (AUC[0-tau]) of Ofatumumab Cycle 3-Day 57, n=5	62463.2072 Hours*nanogram/milliliter (hr*ng/mL Interval 11630.9814 to 335453.399

SECONDARY outcome

Timeframe: Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 57

Population: PK population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the PK Population.

Area under the concentration time curve over the dosing interval (AUC[0-tau]) is a measure of drug exposure over time. AUC(0-tau) is defined as the area under the drug plasma/serum concentration-time curve from dosing to time tau, where tau is the length of the dosing interval of the drug. It was assesed at 1st (Cycle 1-Day 1), 4th (Cycle 1-Day 4), and 15th (Cycle 3-Day 57) chlorambucil administration. In each sampling, blood samples were collected at pre-dose, and 15 min, 30 min, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, and 10 hr.

Outcome measures

Measure	Ofatumumab + Chlorambucil n=6 Participants Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams \[mg\]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m\^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up \[FU\] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
AUC(0-tau) of Chlorambucil Cycle 1-Day 1, n=6	1191.17448 Hr*ng/mL Interval 871.1321 to 1628.7963
AUC(0-tau) of Chlorambucil Cycle 1-Day 4, n=6	1060.28140 Hr*ng/mL Interval 714.1802 to 1574.1077
AUC(0-tau) of Chlorambucil Cycle 3-Day 57, n=5	1259.26147 Hr*ng/mL Interval 662.4484 to 2393.7554

SECONDARY outcome

Timeframe: Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 57

Population: PK Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the PK Population.

Area under the concentration time curve over the dosing interval (AUC[0-tau]) is a measure of drug exposure over time. AUC(0-tau) is defined as the area under the drug plasma/serum concentration-time curve from dosing to time tau, where tau is the length of the dosing interval of the drug. It was assesed at 1st (Cycle 1-Day 1), 4th (Cycle 1-Day 4), and 15th (Cycle 3-Day 57) chlorambucil administration. In each sampling, blood samples were collected at pre-dose, and 15 min, 30 min, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, and 10 hr.

Outcome measures

Measure	Ofatumumab + Chlorambucil n=6 Participants Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams \[mg\]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m\^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up \[FU\] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
AUC(0-tau) of Phenyl Acetic Acid Mustard Cycle 3-Day 57, n=5	1038.87699 Hr*ng/mL Interval 799.7379 to 1349.5239
AUC(0-tau) of Phenyl Acetic Acid Mustard Cycle 1-Day 1, n=6	1076.06435 Hr*ng/mL Interval 727.9702 to 1590.6069
AUC(0-tau) of Phenyl Acetic Acid Mustard Cycle 1-Day 4, n=6	984.02359 Hr*ng/mL Interval 608.0939 to 1592.3568

SECONDARY outcome

Timeframe: Cycle 1-Day 1

Population: PK Population

The total AUC or AUC0-infinity is the area under the curve from time 0 extrapolated to infinite time. It was assesed on Cycle 1-Day 1. The samples were collected at Cycle 1-Day1 (pre-dose, end of infusion, 10 min, 1hr, 2 hr, 24 hr, 72 hr, 120 hr).

Outcome measures

Measure

Ofatumumab + Chlorambucil n=6 Participants Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams \[mg\]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m\^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up \[FU\] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).

Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC[0-infinity]) for Ofatumumab

1737.67475 Hr*ug/mL Interval 467.4381 to 6459.7075

SECONDARY outcome

Timeframe: Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 57

Population: PK Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the PK Population.

The total AUC or AUC0-infinity is the area under the curve from time 0 extrapolated to infinite time. It was assesed at Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 57. In each sampling, blood samples were collected at pre-dose, and 15 min, 30 min, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, and 10 hr.

Outcome measures

Measure	Ofatumumab + Chlorambucil n=6 Participants Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams \[mg\]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m\^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up \[FU\] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
AUC(0-infinity) for Chlorambucil Cycle 1-Day 1, n=6	1216.65216 Hr*ng/mL Interval 891.8548 to 1659.7349
AUC(0-infinity) for Chlorambucil Cycle 1-Day 4, n=6	1103.25854 Hr*ng/mL Interval 726.9103 to 1674.4561
AUC(0-infinity) for Chlorambucil Cycle 3-Day 57, n=5	1290.04709 Hr*ng/mL Interval 671.4967 to 2478.3764

SECONDARY outcome

Timeframe: Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 57

Population: PK Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the PK Population.

The total AUC or AUC(0-infinity) is the area under the curve from time 0 extrapolated to infinite time. It was assesed at Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 57. In each sampling, blood samples were collected at pre-dose, and 15 min, 30 min, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, and 10 hr.

Outcome measures

Measure	Ofatumumab + Chlorambucil n=6 Participants Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams \[mg\]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m\^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up \[FU\] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
AUC(0-infinity) for Phenyl Acetic Acid Mustard Cycle 1-Day 1, n=6	1212.98123 Hr*ng/mL Interval 853.1396 to 1724.5987
AUC(0-infinity) for Phenyl Acetic Acid Mustard Cycle 1-Day 4, n=6	1139.55544 Hr*ng/mL Interval 746.7799 to 1738.9147
AUC(0-infinity) for Phenyl Acetic Acid Mustard Cycle 3-Day 57, n=5	1181.43279 Hr*ng/mL Interval 829.6354 to 1682.4058

SECONDARY outcome

Timeframe: Cycle 1-Day 1

Population: PK Population

Volume of distribution at steady state (Vss) is defined as the distribution of a drug between plasma and the rest of the body at steady state. Samples were collected at Cycle 1-Day1 (pre-dose, end of infusion, 10 min, 1hr, 2 hr, 24 hr, 72 hr, 120 hr).

Outcome measures

Measure

Ofatumumab + Chlorambucil n=6 Participants Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams \[mg\]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m\^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up \[FU\] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).

Volume of Distribution at Steady State (Vss) of Ofatumumab

5731.24330 mL Interval 2746.3527 to 11960.2807

SECONDARY outcome

Timeframe: Cycle 1-Day 1 and Cycle 3-Day 57

Population: PK Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the PK Population.

t1/2 is the time required for the plasma concentration of ofatumumab to decrease by half. Samples were collected at Cycle 1-Day 1 (pre-dose, end of infusion, 10 min, 1hr, 2 hr, 24 hr, 72 hr, 120 hr) and Cycle 3-Day 57 (pre-dose, end of infusion, 10 min, 1 hr, 2 hr, 24 hr, 72 hr, 120 hr, 168 hr).

Outcome measures

Measure	Ofatumumab + Chlorambucil n=6 Participants Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams \[mg\]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m\^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up \[FU\] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
Plasma Half-life (t1/2) of Ofatumumab Cycle 1-Day 1, n=6	33.69818 hours Interval 5.3514 to 212.1989
Plasma Half-life (t1/2) of Ofatumumab Cycle 3-Day 57, n=5	259.94722 hours Interval 18.3504 to 3682.3409

SECONDARY outcome

Timeframe: Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 57

Population: PK Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the PK Population.

t1/2 is the time required for the serum concentration of chlorambucil to decrease by half. Blood samples for serum concentration of chlorambucil was collected at Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 57. In each sampling, blood samples were collected at pre-dose, and 15 min, 30 min, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, and 10 hr.

Outcome measures

Measure	Ofatumumab + Chlorambucil n=6 Participants Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams \[mg\]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m\^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up \[FU\] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
Plasma Half-life (t1/2) of Chlorambucil Cycle 1-Day 1, n=6	1.06879 hours Interval 0.804 to 1.4209
Plasma Half-life (t1/2) of Chlorambucil Cycle 1-Day 4, n=6	1.74766 hours Interval 1.2398 to 2.4636
Plasma Half-life (t1/2) of Chlorambucil Cycle 3-Day 57, n=5	1.38140 hours Interval 1.0619 to 1.7971

SECONDARY outcome

Timeframe: Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 57

Population: PK Population

t1/2 is the time required for the plasma/serum concentration of phenylacetic acid mustard to decrease by half. Blood samples for serum concentration of phenylacetic acid mustard was collected at Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 57. In each sampling, blood samples were collected at pre-dose, and 15 min, 30 min, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, and 10 hr.

Outcome measures

Measure	Ofatumumab + Chlorambucil n=6 Participants Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams \[mg\]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m\^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up \[FU\] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
Plasma Half-life (t1/2) of Phenyl Acetic Acid Mustard Cycle 1-Day 1, n=6	2.11378 hours Interval 1.7689 to 2.5258
Plasma Half-life (t1/2) of Phenyl Acetic Acid Mustard Cycle 1-Day 4, n=6	2.52918 hours Interval 2.0358 to 3.1421
Plasma Half-life (t1/2) of Phenyl Acetic Acid Mustard Cycle 3-Day 57, n=5	2.11552 hours Interval 1.311 to 3.4139

SECONDARY outcome

Timeframe: Cycle 1-Day 1 and Cycle 3-Day 57

Population: PK Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the PK Population.

Tmax is the time required for reaching maximum concentration of drug (Cmax). Samples were collected at Cycle 1-Day 1 (pre-dose, end of infusion, 10 min, 1hr, 2 hr, 24 hr, 72 hr, 120 hr) and Cycle 3-Day 57 (pre-dose, end of infusion, 10 min, 1 hr, 2 hr, 24 hr, 72 hr, 120 hr, 168 hr).

Outcome measures

Measure	Ofatumumab + Chlorambucil n=6 Participants Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams \[mg\]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m\^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up \[FU\] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
Time to Maximum Concentration (Tmax) of Ofatumumab Cycle 1-Day 1, n=6	7.5400 hours Interval 4.8 to 8.58
Time to Maximum Concentration (Tmax) of Ofatumumab Cycle 3-Day 57, n=5	5.3200 hours Interval 4.18 to 34.58

SECONDARY outcome

Timeframe: Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 57

Population: PK Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the PK Population.

Tmax is the time required for reaching maximum concentration of drug (Cmax). Blood samples were collected at Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 57. In each sampling, blood samples were collected at pre-dose, and 15 min, 30 min, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, and 10 hr.

Outcome measures

Measure	Ofatumumab + Chlorambucil n=6 Participants Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams \[mg\]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m\^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up \[FU\] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
Time to Maximum Concentration (Tmax) of Chlorambucil Cycle 1-Day 4, n=6	1.9850 hours Interval 0.47 to 4.15
Time to Maximum Concentration (Tmax) of Chlorambucil Cycle 1-Day 1, n=6	2.9850 hours Interval 1.53 to 6.0
Time to Maximum Concentration (Tmax) of Chlorambucil Cycle 3-Day 57, n=5	3.0000 hours Interval 1.45 to 3.98

SECONDARY outcome

Timeframe: Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 57

Population: PK Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the PK Population.

Tmax is the time required for reaching maximum concentration of drug (Cmax). Blood samples were collected at Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 57. In each sampling, blood samples were collected at pre-dose, and 15 min, 30 min, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, and 10 hr.

Outcome measures

Measure	Ofatumumab + Chlorambucil n=6 Participants Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams \[mg\]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m\^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up \[FU\] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
Time to Maximum Concentration (Tmax) of Phenyl Acetic Acid Mustard Cycle 1-Day 1, n=6	3.9600 hours Interval 2.03 to 6.0
Time to Maximum Concentration (Tmax) of Phenyl Acetic Acid Mustard Cycle 1-Day 4, n=6	3.4150 hours Interval 1.42 to 5.95
Time to Maximum Concentration (Tmax) of Phenyl Acetic Acid Mustard Cycle 3-Day 57, n=5	3.9200 hours Interval 1.97 to 5.93

SECONDARY outcome

Timeframe: Cycle 1-Day 1

Population: PK Population

MRTinf is the average amount of time that ofatumumab spends in the body. Samples were collected at Cycle 1-Day 1 (pre-dose, end of infusion, 10 min, 1hr, 2 hr, 24 hr, 72 hr, 120 hr).

Outcome measures

Measure

Ofatumumab + Chlorambucil n=6 Participants Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams \[mg\]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m\^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up \[FU\] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).

Mean Residence Time to Infinity (MRTinf) of Ofatumumab

33.19679 hours Interval 8.9888 to 122.6002

SECONDARY outcome

Timeframe: Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 57

Population: PK Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the PK Population.

MRTinf is the average amount of time that chlorambucil spends in the body. Blood samples were collected at Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 57. In each sampling, blood samples were collected at pre-dose, and 15 min, 30 min, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, and 10 hr.

Outcome measures

Measure	Ofatumumab + Chlorambucil n=6 Participants Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams \[mg\]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m\^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up \[FU\] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
Mean Residence Time Inf (MRTinf) of Chlorambucil Cycle 1-Day 1, n=6	3.63147 hours Interval 2.9689 to 4.4419
Mean Residence Time Inf (MRTinf) of Chlorambucil Cycle 1-Day 4, n=6	3.36698 hours Interval 2.3904 to 4.7426
Mean Residence Time Inf (MRTinf) of Chlorambucil Cycle 3-Day 57, n=5	3.46924 hours Interval 2.6156 to 4.6014

SECONDARY outcome

Timeframe: Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 57

Population: PK Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the PK Population.

MRTinf is the average amount of time that phenyl acetic acid mustard spends in the body. Blood samples were collected at Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 57. In each sampling, blood samples were collected at pre-dose, and 15 min, 30 min, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, and 10 hr.

Outcome measures

Measure	Ofatumumab + Chlorambucil n=6 Participants Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams \[mg\]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m\^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up \[FU\] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
Mean Residence Time Inf (MRTinf) of Phenyl Acetic Acid Mustard Cycle 1-Day 1, n=6	5.71852 hours Interval 4.8439 to 6.751
Mean Residence Time Inf (MRTinf) of Phenyl Acetic Acid Mustard Cycle 1-Day 4, n=6	5.62096 hours Interval 4.2681 to 7.4027
Mean Residence Time Inf (MRTinf) of Phenyl Acetic Acid Mustard Cycle 3-Day 57, n=5	5.58632 hours Interval 3.8972 to 8.0076

SECONDARY outcome

Timeframe: Cycle 1-Day 1

Population: PK Population

Vz for ofatumumab was calculated as a ratio of the amount of ofatumumab in the body during the terminal phase to the plasma concentration during the terminal phase. Samples were collected at Cycle 1-Day 1 (pre-dose, end of infusion, 10 min, 1hr, 2 hr, 24 hr, 72 hr, 120 hr).

Outcome measures

Measure

Ofatumumab + Chlorambucil n=6 Participants Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams \[mg\]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m\^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up \[FU\] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).

Volume of Distribution (Vz) of Ofatumumab

8393.31979 mL Interval 1691.3939 to 41650.745

SECONDARY outcome

Timeframe: Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 57

Population: PK Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the PK Population.

CL/F is defined as the apparent total clearance of the drug from plasma after oral administration of chlorambucil. It was assessed at Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 57. In each sampling, blood samples were collected at pre-dose, and 15 min, 30 min, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, and 10 hr.

Outcome measures

Measure	Ofatumumab + Chlorambucil n=6 Participants Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams \[mg\]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m\^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up \[FU\] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
Apparent Total Clearance of the Drug From Plasma (CL/F) for Chlorambucil Cycle 1-Day 4, n=6	9.06406 L/hr/m^2 Interval 5.9721 to 13.7569
Apparent Total Clearance of the Drug From Plasma (CL/F) for Chlorambucil Cycle 3-Day 57, n=5	7.75166 L/hr/m^2 Interval 4.0349 to 14.8921
Apparent Total Clearance of the Drug From Plasma (CL/F) for Chlorambucil Cycle 1-Day 1, n=6	8.21928 L/hr/m^2 Interval 6.0251 to 11.2126

SECONDARY outcome

Timeframe: Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 57

Population: PK Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the PK Population.

Vz/F of chlorambucil is defined as the apparent volume of distribution during terminal phase after non-intravenous (oral) administration of chlorambucil. It was assessed at Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 57. In each sampling, blood samples were collected at pre-dose, and 15 min, 30 min, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, and 10 hr.

Outcome measures

Measure	Ofatumumab + Chlorambucil n=6 Participants Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams \[mg\]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m\^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up \[FU\] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
Apparent Volume of Distribution During Terminal Phase (Vz/F) of Chlorambucil Cycle 1-Day 1, n=6	12.67367 L/m^2 Interval 8.2247 to 19.5291
Apparent Volume of Distribution During Terminal Phase (Vz/F) of Chlorambucil Cycle 1-Day 4, n=6	22.85356 L/m^2 Interval 14.929 to 34.9846
Apparent Volume of Distribution During Terminal Phase (Vz/F) of Chlorambucil Cycle 3-Day 57, n=5	15.44858 L/m^2 Interval 9.2556 to 25.7853

SECONDARY outcome

Timeframe: Cycle 1-Day 1

Population: PK Population

%AUC_extrap is defined as the area under the plasma concentration-time curve extrapolated from time t to infinity as a percentage of total AUC. Samples were collected at Cycle 1-Day 1 (pre-dose, end of infusion, 10 min, 1 hr, 2 hr, 24 hr, 72 hr, 120 hr).

Outcome measures

Measure

Ofatumumab + Chlorambucil n=6 Participants Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams \[mg\]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m\^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up \[FU\] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).

%AUC_extrap of Ofatumumab

3.99041 percentage of AUC after extrapolation Interval 0.4518 to 35.2433

SECONDARY outcome

Timeframe: Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 57

Population: PK Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the PK Population.

%AUC_extrap is defined as the area under the plasma concentration-time curve extrapolated from time t to infinity as a percentage of total AUC. It was assessed at Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 57. In each sampling, blood samples were collected at pre-dose, and 15 min, 30 min, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, and 10 hr.

Outcome measures

Measure	Ofatumumab + Chlorambucil n=6 Participants Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams \[mg\]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m\^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up \[FU\] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
%AUC_extrap of Chlorambucil Cycle 1-Day 1, n=6	1.51853 percentage of AUC after extrapolation Interval 0.6086 to 3.7891
%AUC_extrap of Chlorambucil Cycle 1-Day 4, n=6	3.20042 percentage of AUC after extrapolation Interval 1.5963 to 6.4164
%AUC_extrap of Chlorambucil Cycle 3-Day 57, n=5	2.01046 percentage of AUC after extrapolation Interval 0.8604 to 4.6978

SECONDARY outcome

Timeframe: Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 57

Population: PK Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the PK Population.

%AUC_extrap is defined as the area under the plasma concentration-time curve extrapolated from time t to infinity as a percentage of total AUC. It was assessed at Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 57. In each sampling, blood samples were collected at pre-dose, and 15 min, 30 min, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, and 10 hr.

Outcome measures

Measure	Ofatumumab + Chlorambucil n=6 Participants Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams \[mg\]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m\^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up \[FU\] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
%AUC_extrap of Phenyl Acetic Acid Mustard Cycle 1-Day 1, n=6	10.12009 percentage of AUC after extrapolation Interval 6.3465 to 16.1375
%AUC_extrap of Phenyl Acetic Acid Mustard Cycle 1-Day 4, n=6	11.57955 percentage of AUC after extrapolation Interval 5.9445 to 22.5564
%AUC_extrap of Phenyl Acetic Acid Mustard Cycle 3-Day 57, n=5	8.34549 percentage of AUC after extrapolation Interval 2.8229 to 24.6725

SECONDARY outcome

Timeframe: Cycle 1-Day 1 and Cycle 3-Day 57

Population: PK Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the PK Population.

AUC (0-t) represents the area under the concentration curve of ofatumumab in plasma from 0 to time t hours. AUC (0-t) was assessed at 168 hours and 672 hours post-dose.

Outcome measures

Measure	Ofatumumab + Chlorambucil n=6 Participants Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams \[mg\]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m\^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up \[FU\] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
AUC (0-t) of Ofatumumab AUC(0-168), Cycle 1-Day 1, n=6	1526.32835 hr*µg/mL Interval 523.9756 to 4446.158
AUC (0-t) of Ofatumumab AUC (0-672), Cycle 3-Day 57, n=5	58769.6326 hr*µg/mL Interval 11273.1942 to 306378.977

SECONDARY outcome

Timeframe: Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 57

Population: PK Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the PK Population.

AUC (0-t) represents the area under the concentration curve of chlorambucil in serum from 0 to time t hours. AUC (0-t) was assessed at 6 hours and 24 hours.

Outcome measures

Measure	Ofatumumab + Chlorambucil n=6 Participants Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams \[mg\]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m\^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up \[FU\] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
AUC (0-t) of Chlorambucil AUC(0-6), Cycle 1-Day 4, n=6	956.95261 hr*ng/mL Interval 688.0559 to 1330.9359
AUC (0-t) of Chlorambucil AUC(0-6), Cycle 3-Day 57, n=5	1139.48401 hr*ng/mL Interval 622.5013 to 2085.8169
AUC (0-t) of Chlorambucil AUC(0-24), Cycle 1-Day 1, n=6	1216.41085 hr*ng/mL Interval 891.5347 to 1659.6721
AUC (0-t) of Chlorambucil AUC(0-6), Cycle 1-Day 1, n=6	1069.26703 hr*ng/mL Interval 811.5607 to 1408.8064
AUC (0-t) of Chlorambucil AUC(0-24), Cycle 1-Day 4, n=6	1102.61367 hr*ng/mL Interval 726.5937 to 1673.2279
AUC (0-t) of Chlorambucil AUC(0-24), Cycle 3-Day 57, n=5	1289.89389 hr*ng/mL Interval 671.526 to 2477.6795

SECONDARY outcome

Timeframe: Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 57

Population: PK Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the PK Population.

AUC (0-t) represents the area under the concentration curve of phenyl acetic acid mustard in serum from 0 to time t hours. AUC (0-t) was assessed at 6 hours and 24 hours.

Outcome measures

Measure	Ofatumumab + Chlorambucil n=6 Participants Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams \[mg\]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m\^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up \[FU\] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
AUC (0-t) of Phenyl Acetic Acid Mustard AUC(0-6), Cycle 1-Day 1, n=6	755.55297 hr*ng/mL Interval 459.9461 to 1241.1461
AUC (0-t) of Phenyl Acetic Acid Mustard AUC(0-6), Cycle 1-Day 4, n=6	719.39401 hr*ng/mL Interval 388.9287 to 1330.6493
AUC (0-t) of Phenyl Acetic Acid Mustard AUC(0-6), Cycle 3-Day 57, n=5	743.47268 hr*ng/mL Interval 568.9947 to 971.4531
AUC (0-t) of Phenyl Acetic Acid Mustard AUC(0-24), Cycle 1-Day 1, n=6	1211.58911 hr*ng/mL Interval 850.9549 to 1725.06
AUC (0-t) of Phenyl Acetic Acid Mustard AUC(0-24), Cycle 1-Day 4, n=6	1134.84945 hr*ng/mL Interval 741.362 to 1737.1855
AUC (0-t) of Phenyl Acetic Acid Mustard AUC(0-24), Cycle 3-Day 57, n=5	1175.00443 hr*ng/mL Interval 831.9658 to 1659.4858

SECONDARY outcome

Timeframe: Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 57

Population: PK Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the PK Population.

Cmax/D is defined as the maximum plasma concentration (Cmax) per unit dose. It was assessed at Cycle 1-Day 1, Cycle 1-Day 4 and Cycle 3-Day 57. In each sampling, blood samples were collected at pre-dose, and 15 min, 30 min, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, and 10 hr.

Outcome measures

Measure	Ofatumumab + Chlorambucil n=6 Participants Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams \[mg\]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m\^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up \[FU\] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
Dose Normalized Cmax (Cmax/D) for Chlorambucil Cycle 1-Day 1, n=6	26.49755 ng/mL/mg Interval 17.9092 to 39.2044
Dose Normalized Cmax (Cmax/D) for Chlorambucil Cycle 1-Day 4, n=6	24.95624 ng/mL/mg Interval 21.0337 to 29.6103
Dose Normalized Cmax (Cmax/D) for Chlorambucil Cycle 3-Day 57, n=5	28.82981 ng/mL/mg Interval 15.058 to 55.1973

SECONDARY outcome

Timeframe: Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 57

Population: PK Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the PK Population.

Cmax/D is defined as the maximum plasma concentration (Cmax) per unit dose. It was assessed at Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 57. In each sampling, blood samples were collected at pre-dose, and 15 min, 30 min, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, and 10 hr.

Outcome measures

Measure	Ofatumumab + Chlorambucil n=6 Participants Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams \[mg\]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m\^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up \[FU\] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
Cmax/D for Phenyl Acetic Acid Mustard Cycle 1-Day 1, n=6	15.26100 ng/mL/mg Interval 9.5416 to 24.4087
Cmax/D for Phenyl Acetic Acid Mustard Cycle 1-Day 4, n=6	13.85946 ng/mL/mg Interval 7.0899 to 27.0926
Cmax/D for Phenyl Acetic Acid Mustard Cycle 3-Day 57, n=5	15.49565 ng/mL/mg Interval 12.5677 to 19.1057

SECONDARY outcome

Timeframe: Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 57

Population: PK Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the PK Population.

Dose adjusted AUC for the indicated time points were assessed at Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 57. In each sampling, blood samples were collected at pre-dose, and 15 min, 30 min, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, and 10 hr.

Outcome measures

Measure	Ofatumumab + Chlorambucil n=6 Participants Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams \[mg\]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m\^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up \[FU\] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
AUC (0-6)/D, AUC(0-24)/D, AUC (0-inf)/D, and AUC (0-tau)/D of Chlorambucil AUC(0-24)/D, Cycle 3-Day 57, n=5	88.34439 hr*ng/mL/mg Interval 46.169 to 169.0471
AUC (0-6)/D, AUC(0-24)/D, AUC (0-inf)/D, and AUC (0-tau)/D of Chlorambucil AUC(0-6)/D, Cycle 1-Day 1, n=6	68.74861 hr*ng/mL/mg Interval 50.626 to 93.3586
AUC (0-6)/D, AUC(0-24)/D, AUC (0-inf)/D, and AUC (0-tau)/D of Chlorambucil AUC(0-6)/D, Cycle 1-Day 4, n=6	61.52734 hr*ng/mL/mg Interval 45.5317 to 83.1424
AUC (0-6)/D, AUC(0-24)/D, AUC (0-inf)/D, and AUC (0-tau)/D of Chlorambucil AUC(0-6)/D, Cycle 3-Day 57, n=5	78.04287 hr*ng/mL/mg Interval 43.5278 to 139.9265
AUC (0-6)/D, AUC(0-24)/D, AUC (0-inf)/D, and AUC (0-tau)/D of Chlorambucil AUC(0-24)/D, Cycle 1-Day 1, n=6	78.20923 hr*ng/mL/mg Interval 56.3038 to 108.6371
AUC (0-6)/D, AUC(0-24)/D, AUC (0-inf)/D, and AUC (0-tau)/D of Chlorambucil AUC(0-24)/D, Cycle 1-Day 4, n=6	70.89263 hr*ng/mL/mg Interval 48.0841 to 104.5204
AUC (0-6)/D, AUC(0-24)/D, AUC (0-inf)/D, and AUC (0-tau)/D of Chlorambucil AUC(0-tau)/D, Cycle 1-Day 1, n=6	76.58665 hr*ng/mL/mg Interval 54.855 to 106.9276
AUC (0-6)/D, AUC(0-24)/D, AUC (0-inf)/D, and AUC (0-tau)/D of Chlorambucil AUC(0-tau)/D, Cycle 1-Day 4, n=6	68.17087 hr*ng/mL/mg Interval 47.2363 to 98.3834
AUC (0-6)/D, AUC(0-24)/D, AUC (0-inf)/D, and AUC (0-tau)/D of Chlorambucil AUC(0-tau)/D, Cycle 3-Day 57, n=5	86.24639 hr*ng/mL/mg Interval 45.5445 to 163.3224
AUC (0-6)/D, AUC(0-24)/D, AUC (0-inf)/D, and AUC (0-tau)/D of Chlorambucil AUC(0-inf)/D, Cycle 1-Day 1, n=6	78.22474 hr*ng/mL/mg Interval 56.328 to 108.6336
AUC (0-6)/D, AUC(0-24)/D, AUC (0-inf)/D, and AUC (0-tau)/D of Chlorambucil AUC(0-inf)/D, Cycle 1-Day 4, n=6	70.93409 hr*ng/mL/mg Interval 48.1052 to 104.5967
AUC (0-6)/D, AUC(0-24)/D, AUC (0-inf)/D, and AUC (0-tau)/D of Chlorambucil AUC(0-inf)/D, Cycle 3-Day 57, n=5	88.35489 hr*ng/mL/mg Interval 46.1675 to 169.0927

SECONDARY outcome

Timeframe: Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 57

Population: PK Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the PK Population.

Dose adjusted AUC for the indicated time points were assessed at Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 57. In each sampling, blood samples were collected at pre-dose, and 15 min, 30 min, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, and 10 hr.

Outcome measures

Measure	Ofatumumab + Chlorambucil n=6 Participants Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams \[mg\]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m\^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up \[FU\] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
AUC (0-6)/D, AUC(0-24)/D, AUC (0-inf)/D and AUC (0-tau)/D of Phenyl Acetic Acid Mustard AUC(0-6)/D, Cycle 1-Day 1, n=6	48.57834 hr*ng/mL/mg Interval 27.8596 to 84.7051
AUC (0-6)/D, AUC(0-24)/D, AUC (0-inf)/D and AUC (0-tau)/D of Phenyl Acetic Acid Mustard AUC(0-6)/D, Cycle 1-Day 4, n=6	46.25349 hr*ng/mL/mg Interval 23.9914 to 89.173
AUC (0-6)/D, AUC(0-24)/D, AUC (0-inf)/D and AUC (0-tau)/D of Phenyl Acetic Acid Mustard AUC(0-6)/D, Cycle 3-Day 57, n=5	50.92019 hr*ng/mL/mg Interval 42.0701 to 61.6321
AUC (0-6)/D, AUC(0-24)/D, AUC (0-inf)/D and AUC (0-tau)/D of Phenyl Acetic Acid Mustard AUC(0-24)/D, Cycle 1-Day 1, n=6	77.89921 hr*ng/mL/mg Interval 49.8974 to 121.6154
AUC (0-6)/D, AUC(0-24)/D, AUC (0-inf)/D and AUC (0-tau)/D of Phenyl Acetic Acid Mustard AUC(0-24)/D, Cycle 1-Day 4, n=6	72.96523 hr*ng/mL/mg Interval 44.3328 to 120.0899
AUC (0-6)/D, AUC(0-24)/D, AUC (0-inf)/D and AUC (0-tau)/D of Phenyl Acetic Acid Mustard AUC(0-24)/D, Cycle 3-Day 57, n=5	80.47565 hr*ng/mL/mg Interval 53.4597 to 121.1442
AUC (0-6)/D, AUC(0-24)/D, AUC (0-inf)/D and AUC (0-tau)/D of Phenyl Acetic Acid Mustard AUC(0-tau)/D, Cycle 1-Day 1, n=6	69.18564 hr*ng/mL/mg Interval 43.091 to 111.0825
AUC (0-6)/D, AUC(0-24)/D, AUC (0-inf)/D and AUC (0-tau)/D of Phenyl Acetic Acid Mustard AUC(0-tau)/D, Cycle 1-Day 4, n=6	63.26787 hr*ng/mL/mg Interval 36.8314 to 108.6797
AUC (0-6)/D, AUC(0-24)/D, AUC (0-inf)/D and AUC (0-tau)/D of Phenyl Acetic Acid Mustard AUC(0-tau)/D, Cycle 3-Day 57, n=5	71.15233 hr*ng/mL/mg Interval 53.3094 to 94.9674
AUC (0-6)/D, AUC(0-24)/D, AUC (0-inf)/D and AUC (0-tau)/D of Phenyl Acetic Acid Mustard AUC(0-inf)/D, Cycle 1-Day 1, n=6	77.98872 hr*ng/mL/mg Interval 50.0093 to 121.6221
AUC (0-6)/D, AUC(0-24)/D, AUC (0-inf)/D and AUC (0-tau)/D of Phenyl Acetic Acid Mustard AUC(0-inf)/D, Cycle 1-Day 4, n=6	73.26780 hr*ng/mL/mg Interval 44.6278 to 120.2876
AUC (0-6)/D, AUC(0-24)/D, AUC (0-inf)/D and AUC (0-tau)/D of Phenyl Acetic Acid Mustard AUC(0-inf)/D, Cycle 3-Day 57, n=5	80.91593 hr*ng/mL/mg Interval 53.1321 to 123.2284

Adverse Events

Ofatumumab+Chlorambucil

Serious events: 2 serious events

Other events: 10 other events

Deaths: 0 deaths

Serious adverse events

Measure	Ofatumumab+Chlorambucil n=10 participants at risk Participants with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams \[mg\]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28 day cycle in combination with chlorambucil 10 mg/meter squared (m\^2) orally on Days 1-7 of every 28 day cycle for a minimum of 3 cycles, until best overall response or a maximum of 12 cycles. After completion of the Treatment Phase (for participants in CR, PR or SD), survival and disease status assessment visits were performed 28 days after the first day of the last treatment cycle (Follow-up \[FU\] 1), 84 days, and 168 days after the day of FU 1 (FU 85 and FU 169, respectively). For participants experiencing disease progression during the Treatment Phase, the post progressive disease (PD) follow-up for safety assessments were performed 28 days after the first day of the last treatment cycle (PDFU 1). Subsequent follow-up was performed 8
Injury, poisoning and procedural complications Spinal compression fracture	10.0% 1/10 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until follow-up for survival (up to Week 62.3). SAEs and non-serious AEs are reported for members of the All Subjects Population, comprised of all participants who received at least one dose of investigational product.
Respiratory, thoracic and mediastinal disorders Hypoxia	10.0% 1/10 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until follow-up for survival (up to Week 62.3). SAEs and non-serious AEs are reported for members of the All Subjects Population, comprised of all participants who received at least one dose of investigational product.

Other adverse events

Measure	Ofatumumab+Chlorambucil n=10 participants at risk Participants with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams \[mg\]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28 day cycle in combination with chlorambucil 10 mg/meter squared (m\^2) orally on Days 1-7 of every 28 day cycle for a minimum of 3 cycles, until best overall response or a maximum of 12 cycles. After completion of the Treatment Phase (for participants in CR, PR or SD), survival and disease status assessment visits were performed 28 days after the first day of the last treatment cycle (Follow-up \[FU\] 1), 84 days, and 168 days after the day of FU 1 (FU 85 and FU 169, respectively). For participants experiencing disease progression during the Treatment Phase, the post progressive disease (PD) follow-up for safety assessments were performed 28 days after the first day of the last treatment cycle (PDFU 1). Subsequent follow-up was performed 8
Investigations White blood cell count decreased	50.0% 5/10 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until follow-up for survival (up to Week 62.3). SAEs and non-serious AEs are reported for members of the All Subjects Population, comprised of all participants who received at least one dose of investigational product.
Investigations Neutrophil count decreased	40.0% 4/10 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until follow-up for survival (up to Week 62.3). SAEs and non-serious AEs are reported for members of the All Subjects Population, comprised of all participants who received at least one dose of investigational product.
Investigations Platelet count decreased	30.0% 3/10 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until follow-up for survival (up to Week 62.3). SAEs and non-serious AEs are reported for members of the All Subjects Population, comprised of all participants who received at least one dose of investigational product.
Investigations Alanine aminotransferase increased	20.0% 2/10 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until follow-up for survival (up to Week 62.3). SAEs and non-serious AEs are reported for members of the All Subjects Population, comprised of all participants who received at least one dose of investigational product.
Investigations Aspartate aminotransferase increased	20.0% 2/10 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until follow-up for survival (up to Week 62.3). SAEs and non-serious AEs are reported for members of the All Subjects Population, comprised of all participants who received at least one dose of investigational product.
Investigations Weight decreased	20.0% 2/10 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until follow-up for survival (up to Week 62.3). SAEs and non-serious AEs are reported for members of the All Subjects Population, comprised of all participants who received at least one dose of investigational product.
Investigations Weight increased	20.0% 2/10 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until follow-up for survival (up to Week 62.3). SAEs and non-serious AEs are reported for members of the All Subjects Population, comprised of all participants who received at least one dose of investigational product.
Investigations Amylase increased	10.0% 1/10 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until follow-up for survival (up to Week 62.3). SAEs and non-serious AEs are reported for members of the All Subjects Population, comprised of all participants who received at least one dose of investigational product.
Investigations Beta 2 microglobulin increased	10.0% 1/10 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until follow-up for survival (up to Week 62.3). SAEs and non-serious AEs are reported for members of the All Subjects Population, comprised of all participants who received at least one dose of investigational product.
Investigations Blood bilirubin increased	10.0% 1/10 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until follow-up for survival (up to Week 62.3). SAEs and non-serious AEs are reported for members of the All Subjects Population, comprised of all participants who received at least one dose of investigational product.
Investigations Blood creatinine increased	10.0% 1/10 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until follow-up for survival (up to Week 62.3). SAEs and non-serious AEs are reported for members of the All Subjects Population, comprised of all participants who received at least one dose of investigational product.
Investigations Blood lactate dehydrogenase increased	10.0% 1/10 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until follow-up for survival (up to Week 62.3). SAEs and non-serious AEs are reported for members of the All Subjects Population, comprised of all participants who received at least one dose of investigational product.
Investigations Blood phosphorus increased	10.0% 1/10 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until follow-up for survival (up to Week 62.3). SAEs and non-serious AEs are reported for members of the All Subjects Population, comprised of all participants who received at least one dose of investigational product.
Investigations Blood potassium increased	10.0% 1/10 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until follow-up for survival (up to Week 62.3). SAEs and non-serious AEs are reported for members of the All Subjects Population, comprised of all participants who received at least one dose of investigational product.
Investigations Blood sodium decreased	10.0% 1/10 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until follow-up for survival (up to Week 62.3). SAEs and non-serious AEs are reported for members of the All Subjects Population, comprised of all participants who received at least one dose of investigational product.
Investigations Electrocardiogram ST segment depression	10.0% 1/10 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until follow-up for survival (up to Week 62.3). SAEs and non-serious AEs are reported for members of the All Subjects Population, comprised of all participants who received at least one dose of investigational product.
Investigations Haemoglobin decreased	10.0% 1/10 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until follow-up for survival (up to Week 62.3). SAEs and non-serious AEs are reported for members of the All Subjects Population, comprised of all participants who received at least one dose of investigational product.
Investigations Lymphocyte count decreased	10.0% 1/10 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until follow-up for survival (up to Week 62.3). SAEs and non-serious AEs are reported for members of the All Subjects Population, comprised of all participants who received at least one dose of investigational product.
Blood and lymphatic system disorders Thrombocytopenia	70.0% 7/10 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until follow-up for survival (up to Week 62.3). SAEs and non-serious AEs are reported for members of the All Subjects Population, comprised of all participants who received at least one dose of investigational product.
Blood and lymphatic system disorders Neutropenia	50.0% 5/10 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until follow-up for survival (up to Week 62.3). SAEs and non-serious AEs are reported for members of the All Subjects Population, comprised of all participants who received at least one dose of investigational product.
Blood and lymphatic system disorders Anaemia	30.0% 3/10 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until follow-up for survival (up to Week 62.3). SAEs and non-serious AEs are reported for members of the All Subjects Population, comprised of all participants who received at least one dose of investigational product.
Skin and subcutaneous tissue disorders Rash	60.0% 6/10 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until follow-up for survival (up to Week 62.3). SAEs and non-serious AEs are reported for members of the All Subjects Population, comprised of all participants who received at least one dose of investigational product.
Skin and subcutaneous tissue disorders Pruritus	30.0% 3/10 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until follow-up for survival (up to Week 62.3). SAEs and non-serious AEs are reported for members of the All Subjects Population, comprised of all participants who received at least one dose of investigational product.
Skin and subcutaneous tissue disorders Dermatitis acneiform	20.0% 2/10 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until follow-up for survival (up to Week 62.3). SAEs and non-serious AEs are reported for members of the All Subjects Population, comprised of all participants who received at least one dose of investigational product.
Skin and subcutaneous tissue disorders Rash maculo-papular	20.0% 2/10 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until follow-up for survival (up to Week 62.3). SAEs and non-serious AEs are reported for members of the All Subjects Population, comprised of all participants who received at least one dose of investigational product.
General disorders Fatigue	30.0% 3/10 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until follow-up for survival (up to Week 62.3). SAEs and non-serious AEs are reported for members of the All Subjects Population, comprised of all participants who received at least one dose of investigational product.
General disorders Pyrexia	30.0% 3/10 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until follow-up for survival (up to Week 62.3). SAEs and non-serious AEs are reported for members of the All Subjects Population, comprised of all participants who received at least one dose of investigational product.
General disorders Chills	20.0% 2/10 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until follow-up for survival (up to Week 62.3). SAEs and non-serious AEs are reported for members of the All Subjects Population, comprised of all participants who received at least one dose of investigational product.
General disorders Oedema	20.0% 2/10 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until follow-up for survival (up to Week 62.3). SAEs and non-serious AEs are reported for members of the All Subjects Population, comprised of all participants who received at least one dose of investigational product.
General disorders Chest discomfort	10.0% 1/10 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until follow-up for survival (up to Week 62.3). SAEs and non-serious AEs are reported for members of the All Subjects Population, comprised of all participants who received at least one dose of investigational product.
General disorders Malaise	10.0% 1/10 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until follow-up for survival (up to Week 62.3). SAEs and non-serious AEs are reported for members of the All Subjects Population, comprised of all participants who received at least one dose of investigational product.
Gastrointestinal disorders Nausea	50.0% 5/10 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until follow-up for survival (up to Week 62.3). SAEs and non-serious AEs are reported for members of the All Subjects Population, comprised of all participants who received at least one dose of investigational product.
Gastrointestinal disorders Constipation	20.0% 2/10 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until follow-up for survival (up to Week 62.3). SAEs and non-serious AEs are reported for members of the All Subjects Population, comprised of all participants who received at least one dose of investigational product.
Gastrointestinal disorders Abdominal pain upper	10.0% 1/10 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until follow-up for survival (up to Week 62.3). SAEs and non-serious AEs are reported for members of the All Subjects Population, comprised of all participants who received at least one dose of investigational product.
Gastrointestinal disorders Diarrhoea	10.0% 1/10 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until follow-up for survival (up to Week 62.3). SAEs and non-serious AEs are reported for members of the All Subjects Population, comprised of all participants who received at least one dose of investigational product.
Gastrointestinal disorders Enterocolitis	10.0% 1/10 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until follow-up for survival (up to Week 62.3). SAEs and non-serious AEs are reported for members of the All Subjects Population, comprised of all participants who received at least one dose of investigational product.
Gastrointestinal disorders Vomiting	10.0% 1/10 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until follow-up for survival (up to Week 62.3). SAEs and non-serious AEs are reported for members of the All Subjects Population, comprised of all participants who received at least one dose of investigational product.
Respiratory, thoracic and mediastinal disorders Dyspnoea	20.0% 2/10 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until follow-up for survival (up to Week 62.3). SAEs and non-serious AEs are reported for members of the All Subjects Population, comprised of all participants who received at least one dose of investigational product.
Respiratory, thoracic and mediastinal disorders Hypoxia	20.0% 2/10 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until follow-up for survival (up to Week 62.3). SAEs and non-serious AEs are reported for members of the All Subjects Population, comprised of all participants who received at least one dose of investigational product.
Respiratory, thoracic and mediastinal disorders Wheezing	10.0% 1/10 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until follow-up for survival (up to Week 62.3). SAEs and non-serious AEs are reported for members of the All Subjects Population, comprised of all participants who received at least one dose of investigational product.
Metabolism and nutrition disorders Decreased appetite	40.0% 4/10 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until follow-up for survival (up to Week 62.3). SAEs and non-serious AEs are reported for members of the All Subjects Population, comprised of all participants who received at least one dose of investigational product.
Musculoskeletal and connective tissue disorders Back pain	10.0% 1/10 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until follow-up for survival (up to Week 62.3). SAEs and non-serious AEs are reported for members of the All Subjects Population, comprised of all participants who received at least one dose of investigational product.
Musculoskeletal and connective tissue disorders Bone pain	10.0% 1/10 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until follow-up for survival (up to Week 62.3). SAEs and non-serious AEs are reported for members of the All Subjects Population, comprised of all participants who received at least one dose of investigational product.
Musculoskeletal and connective tissue disorders Neck pain	10.0% 1/10 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until follow-up for survival (up to Week 62.3). SAEs and non-serious AEs are reported for members of the All Subjects Population, comprised of all participants who received at least one dose of investigational product.
Musculoskeletal and connective tissue disorders Spinal column stenosis	10.0% 1/10 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until follow-up for survival (up to Week 62.3). SAEs and non-serious AEs are reported for members of the All Subjects Population, comprised of all participants who received at least one dose of investigational product.
Nervous system disorders Headache	20.0% 2/10 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until follow-up for survival (up to Week 62.3). SAEs and non-serious AEs are reported for members of the All Subjects Population, comprised of all participants who received at least one dose of investigational product.
Nervous system disorders Dizziness	10.0% 1/10 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until follow-up for survival (up to Week 62.3). SAEs and non-serious AEs are reported for members of the All Subjects Population, comprised of all participants who received at least one dose of investigational product.
Nervous system disorders Dysgeusia	10.0% 1/10 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until follow-up for survival (up to Week 62.3). SAEs and non-serious AEs are reported for members of the All Subjects Population, comprised of all participants who received at least one dose of investigational product.
Vascular disorders Hot flush	10.0% 1/10 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until follow-up for survival (up to Week 62.3). SAEs and non-serious AEs are reported for members of the All Subjects Population, comprised of all participants who received at least one dose of investigational product.
Vascular disorders Hypertension	10.0% 1/10 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until follow-up for survival (up to Week 62.3). SAEs and non-serious AEs are reported for members of the All Subjects Population, comprised of all participants who received at least one dose of investigational product.
Vascular disorders Hypotension	10.0% 1/10 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until follow-up for survival (up to Week 62.3). SAEs and non-serious AEs are reported for members of the All Subjects Population, comprised of all participants who received at least one dose of investigational product.
Infections and infestations Nasopharyngitis	20.0% 2/10 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until follow-up for survival (up to Week 62.3). SAEs and non-serious AEs are reported for members of the All Subjects Population, comprised of all participants who received at least one dose of investigational product.
Infections and infestations Herpes zoster	10.0% 1/10 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until follow-up for survival (up to Week 62.3). SAEs and non-serious AEs are reported for members of the All Subjects Population, comprised of all participants who received at least one dose of investigational product.
Infections and infestations Otitis media	10.0% 1/10 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until follow-up for survival (up to Week 62.3). SAEs and non-serious AEs are reported for members of the All Subjects Population, comprised of all participants who received at least one dose of investigational product.
Psychiatric disorders Insomnia	20.0% 2/10 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until follow-up for survival (up to Week 62.3). SAEs and non-serious AEs are reported for members of the All Subjects Population, comprised of all participants who received at least one dose of investigational product.
Cardiac disorders Palpitations	10.0% 1/10 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until follow-up for survival (up to Week 62.3). SAEs and non-serious AEs are reported for members of the All Subjects Population, comprised of all participants who received at least one dose of investigational product.
Hepatobiliary disorders Hepatic function abnormal	10.0% 1/10 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until follow-up for survival (up to Week 62.3). SAEs and non-serious AEs are reported for members of the All Subjects Population, comprised of all participants who received at least one dose of investigational product.

Additional Information

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• Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
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