Trial Outcomes & Findings for Ofatumumab Plus Bendamustine in Frontline and Relapsed Chronic Lymphocytic Leukaemia (CLL) (NCT NCT01520922)

NCT ID: NCT01520922

Last Updated: 2017-01-19

Results Overview

OR is defined as the number of participants achieving an objective response (complete response \[CR\], CR with incomplete bone marrow recovery \[CRi\], partial response \[PR\], and nodular PR \[nPR\]), after 3 cycles, after 6 cycles, and after the last dose of ofatumumab and bendamustine treatment. CR (all the criteria at least 2 months after last treatment): no lymphadenopathy (Ly)/ hepatomegaly/ splenomegaly/ constitutional symptoms; neutrophils \>1500 per microliter (µL), platelets (PL) \>100,000/µL, hemoglobin (Hb) \>11 grams/deciliter (g/dL), lymphocytes (LC) \<4000/µL, bone marrow (BM) sample must be normocellular for age, \<30% LC, no lymphoid nodule. CRi: CR criteria, persistent anemia/thrombocytopenia/neutropenia unrelated to CLL but related to drug toxicity. PR: \>=50% decrease in LC, Ly, size of liver and spleen and at least one of the following results: PL \>100,000/µL or 50% improvement over Baseline (BL), Hb \>11 g/dL or 50% improvement over BL, LC \<4000/µL. nPR: persistent nodules BM.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

99 participants

Primary outcome timeframe

From the start of study treatment until 3 months after the last dose of study treatment

Results posted on

2017-01-19

Participant Flow

Participants (par.) who met eligibility criteria at Screening were then allocated to one of the following populations: par. with previously untreated CLL or par. with relapsed CLL. A total of 99 par. were enrolled and 97 par. entered the treatment period. Study results do not include the 2 par. that were not treated in this study

Participant milestones

Participant milestones
Measure	Ofatumumab + Bendamustine 90 mg/m^2 Participants with previously untreated CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 90 mg/m\^2 on Days 1 and 2 of each cycle (6 cycles).	Ofatumumab + Bendamustine 70 mg/m^2 Participants with relapsed CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 70 mg/m\^2 on Days 1 and 2 of each cycle (6 cycles).
Treatment Phase STARTED	44	53
Treatment Phase COMPLETED	39	45
Treatment Phase NOT COMPLETED	5	8
Follow up STARTED	44	45
Follow up COMPLETED	44	44
Follow up NOT COMPLETED	0	1
Survival Follow-up STARTED	21	40
Survival Follow-up COMPLETED	20	40
Survival Follow-up NOT COMPLETED	1	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Ofatumumab + Bendamustine 90 mg/m^2 Participants with previously untreated CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 90 mg/m\^2 on Days 1 and 2 of each cycle (6 cycles).	Ofatumumab + Bendamustine 70 mg/m^2 Participants with relapsed CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 70 mg/m\^2 on Days 1 and 2 of each cycle (6 cycles).
Treatment Phase Physician Decision	2	1
Treatment Phase Progression	0	2
Treatment Phase Adverse Event	3	5
Follow up Lost to Follow-up	0	1
Survival Follow-up Withdrawal by Subject	1	0

Baseline Characteristics

Ofatumumab Plus Bendamustine in Frontline and Relapsed Chronic Lymphocytic Leukaemia (CLL)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ofatumumab + Bendamustine 90 mg/m^2 n=44 Participants Participants with previously untreated CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 90 mg/m\^2 on Days 1 and 2 of each cycle (6 cycles).	Ofatumumab + Bendamustine 70 mg/m^2 n=53 Participants Participants with relapsed CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 70 mg/m\^2 on Days 1 and 2 of each cycle (6 cycles).	Total n=97 Participants Total of all reporting groups
Age, Continuous	63.2 Years STANDARD_DEVIATION 10.11 • n=93 Participants	66.5 Years STANDARD_DEVIATION 9.28 • n=4 Participants	65.0 Years STANDARD_DEVIATION 9.76 • n=27 Participants
Gender Female	15 Participants n=93 Participants	17 Participants n=4 Participants	32 Participants n=27 Participants
Gender Male	29 Participants n=93 Participants	36 Participants n=4 Participants	65 Participants n=27 Participants
Race/Ethnicity, Customized White - White/Caucasian/European Heritage	42 Participants n=93 Participants	53 Participants n=4 Participants	95 Participants n=27 Participants
Race/Ethnicity, Customized White - Arabic/North African Heritage	1 Participants n=93 Participants	0 Participants n=4 Participants	1 Participants n=27 Participants
Race/Ethnicity, Customized African American/African Heritage	1 Participants n=93 Participants	0 Participants n=4 Participants	1 Participants n=27 Participants

PRIMARY outcome

Timeframe: From the start of study treatment until 3 months after the last dose of study treatment

Population: As-treated subjects (ATS) Population: all participants who received at least one dose of both study drugs (ofatumumab and bendamustine). OR was measured using the International Workshop for CLL (IWCLL) updated National Cancer Institute-sponsored Working Group (NCI-WG) guidelines 2008. The 95% exact binomial confidence interval is for CR+CRi+nPR+PR.

Outcome measures

Outcome measures
Measure	Ofatumumab + Bendamustine 90 mg/m^2 n=44 Participants Participants with previously untreated CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 90 mg/m\^2 on Days 1 and 2 of each cycle (6 cycles).	Ofatumumab + Bendamustine 70 mg/m^2 n=53 Participants Participants with relapsed CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 70 mg/m\^2 on Days 1 and 2 of each cycle (6 cycles).
Number of Participants With Overall Response (OR), as Assessed by the Investigator CR	19 Participants	6 Participants
Number of Participants With Overall Response (OR), as Assessed by the Investigator CRi	2 Participants	2 Participants
Number of Participants With Overall Response (OR), as Assessed by the Investigator nPR	4 Participants	8 Participants
Number of Participants With Overall Response (OR), as Assessed by the Investigator PR	17 Participants	23 Participants

SECONDARY outcome

Timeframe: From the start of study treatment until 3 months after the last dose of study treatment

Population: ATS Population. OR was measured using the International Workshop for CLL (IWCLL) updated National Cancer Institute-sponsored Working Group (NCI-WG) guidelines 2008.

Outcome measures

Outcome measures
Measure	Ofatumumab + Bendamustine 90 mg/m^2 n=44 Participants Participants with previously untreated CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 90 mg/m\^2 on Days 1 and 2 of each cycle (6 cycles).	Ofatumumab + Bendamustine 70 mg/m^2 n=53 Participants Participants with relapsed CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 70 mg/m\^2 on Days 1 and 2 of each cycle (6 cycles).
Number of Participants With Overall Response (OR) With Computed Tomography (CT) Scan (CT Scan) Assessment, as Assessed by the Investigator CRi	1 Participants	2 Participants
Number of Participants With Overall Response (OR) With Computed Tomography (CT) Scan (CT Scan) Assessment, as Assessed by the Investigator CR	12 Participants	5 Participants
Number of Participants With Overall Response (OR) With Computed Tomography (CT) Scan (CT Scan) Assessment, as Assessed by the Investigator nPR	2 Participants	6 Participants
Number of Participants With Overall Response (OR) With Computed Tomography (CT) Scan (CT Scan) Assessment, as Assessed by the Investigator PR	22 Participants	24 Participants

SECONDARY outcome

Timeframe: From the start of study treatment until 3 months after the last dose of study treatment

Population: ATS Population

Response was determined according to the IWCLL updated NCI-WG guidelines 2008. CR requires all of the following criteria at least 2 months after the last treatment: no lymphadenopathy (Ly)/ hepatomegaly/ splenomegaly/ constitutional symptoms; neutrophils \>1500/µL, platelets (PL) \>100,000/µL, hemoglobin (Hb) \>11.0 g/dL, lymphocytes (LC) \<4000/µL, bone marrow (BM) sample must be normocellular for age, \<30% LC, no lymphoid nodule.

Outcome measures

Outcome measures
Measure	Ofatumumab + Bendamustine 90 mg/m^2 n=44 Participants Participants with previously untreated CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 90 mg/m\^2 on Days 1 and 2 of each cycle (6 cycles).	Ofatumumab + Bendamustine 70 mg/m^2 n=53 Participants Participants with relapsed CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 70 mg/m\^2 on Days 1 and 2 of each cycle (6 cycles).
Number of Participants With Complete Response (CR) With and Without a CT Scan Assessment After the Last Dose of Study Treatment, as Assessed by the Investigator CR without CT scan assessment	19 Participants	6 Participants
Number of Participants With Complete Response (CR) With and Without a CT Scan Assessment After the Last Dose of Study Treatment, as Assessed by the Investigator CR with CT scan assessment	12 Participants	5 Participants

SECONDARY outcome

Timeframe: From the start of study treatment to the first response (CR, CRi, nPR, or PR) (up to 3 Month Follow-up (F/U) visit)

Population: ATS Population. Only participants who had a response (CR, CRi, nPR, or PR) were evaluated.

Time to response is defined as time from date of the first administration of study treatment to the first response (CR, CRi, nPR, or PR). Response was determined according to the IWCLL updated NCI-WG guidelines 2008. CR: all of the following criteria at least 2 months after last treatment: no lymphadenopathy (Ly)/ hepatomegaly/ splenomegaly/ constitutional symptoms; neutrophils \>1500 per microliter (µL), platelets (PL) \>100,000/µL, hemoglobin (Hb) \>11.0 grams/deciliter (g/dL), lymphocytes (LC) \<4000/µL, bone marrow (BM) sample must be normocellular for age, \<30% LC, no lymphoid nodule. CRi: CR criteria, persistent anemia/ thrombocytopenia/ neutropenia unrelated to CLL but related to drug toxicity. nPR: persistent nodules BM. PR: \>=50% decrease in LC, Ly, size of liver and spleen and at least one of the following results: PL \>100,000/µL or 50% improvement over Baseline (BL), Hb \>11.0 g/dL or 50% improvement over BL, LC \<4000/µL.

Outcome measures

Outcome measures
Measure	Ofatumumab + Bendamustine 90 mg/m^2 n=43 Participants Participants with previously untreated CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 90 mg/m\^2 on Days 1 and 2 of each cycle (6 cycles).	Ofatumumab + Bendamustine 70 mg/m^2 n=47 Participants Participants with relapsed CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 70 mg/m\^2 on Days 1 and 2 of each cycle (6 cycles).
Investigator-assessed Kaplan-meier Estimates of Time to Response	0.95 Months Interval 0.95 to 1.02	1.08 Months Interval 0.95 to 1.87

SECONDARY outcome

Timeframe: From time of initial response (CR, CRi, nPR, or PR) to disease progression or death, whichever came first (up to 3 years after the last doseof study treatment)

Population: ATS Population. Only participants with an initial response (CR, CRi, nPR, or PR) with PD or death were assessed for duration of response.

The duration of response is defined as the time from the initial response (CR, CRi, nPR, or PR) to the first documented sign of disease progression (PD) or death due to any cause. PD requires at least one of the following: new lesion or increase by \>=50% from Baseline in lymphocytes (LC) with at least 5000B-lymphocytes per microliter (5.0 x 10\^9/L), lymphadenopathy (Ly), size of liver and spleen, platelets (PL) \>= 50% decrease from Baseline, or to \<100,000/uL secondary to CLL, hemoglobin (Hb) decrease of \>2 g/dL from Baseline or to \<10 g/dL secondary to CLL, CLL- transformation, cytopenia after treatment. Response was determined according to the IWCLL updated NCI-WG guidelines 2008.

Outcome measures

Outcome measures
Measure	Ofatumumab + Bendamustine 90 mg/m^2 n=20 Participants Participants with previously untreated CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 90 mg/m\^2 on Days 1 and 2 of each cycle (6 cycles).	Ofatumumab + Bendamustine 70 mg/m^2 n=35 Participants Participants with relapsed CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 70 mg/m\^2 on Days 1 and 2 of each cycle (6 cycles).
Investigator-assessed Kaplan-meier Estimates of Duration of Response	35.15 Months Interval 33.05 to 37.13	21.75 Months Interval 14.75 to 26.41

SECONDARY outcome

Timeframe: From the start of study treatment until earliest date of disease progression or death (up to 3 years after the last dose of study treatment)

Population: All Treated Subjects' (ATS) population. N= Progression or Death

PFS is defined as the interval of time between the date of the first administration of study treatment and the earlier of the date of disease progression (PD) and the date of death due to any cause. PD requires at least one of the following:new lesion or increase by \>=50% from BL in LC, Ly, size of liver and spleen, PL \>= 50% decrease from BL, or to \<100,000/uL secondary to CLL, Hb decrease of \>2 g/dL from BL or to \<10 g/dL secondary to CLL, CLL- transformation. Response was determined according to the IWCLL updated NCI-WG guidelines 2008. Participants who have neither progressed or died at the time of analysis were censored at the date of the last adequate assessment. If there was more than 1 scheduled visit missed, PFS is censored at the last adequate assessment of response. An adequate assessment is defined as an assessment where the investigator determined a response of CR, CRi, nPR, PR, or stable disease (SD).

Outcome measures

Outcome measures
Measure	Ofatumumab + Bendamustine 90 mg/m^2 n=20 Participants Participants with previously untreated CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 90 mg/m\^2 on Days 1 and 2 of each cycle (6 cycles).	Ofatumumab + Bendamustine 70 mg/m^2 n=39 Participants Participants with relapsed CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 70 mg/m\^2 on Days 1 and 2 of each cycle (6 cycles).
Investigator-assessed of Kaplan-meier Estimates of Progression-free Survival (PFS)	36.07 Months Interval 34.0 to 38.05	22.54 Months Interval 14.0 to 27.33

SECONDARY outcome

Timeframe: From the start of study treatment to the date of death due to any cause (up to 3 years after the last dose of study treatment)

Population: All treated subjects. N= Death

OS is defined as the interval of time between the date of the first administration of study treatment and the date of death due to any cause. For participants who did not die, time of death was censored at the date of last contact.

Outcome measures

Outcome measures
Measure	Ofatumumab + Bendamustine 90 mg/m^2 n=3 Participants Participants with previously untreated CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 90 mg/m\^2 on Days 1 and 2 of each cycle (6 cycles).	Ofatumumab + Bendamustine 70 mg/m^2 n=23 Participants Participants with relapsed CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 70 mg/m\^2 on Days 1 and 2 of each cycle (6 cycles).
Investigator-assessed Kaplan-meier Estimates of Overall Survival	NA Months Median was not available because over 50% of the all treated subjects were alive.	NA Months Median was not available because over 50% of the all treated subjects were alive.

SECONDARY outcome

Timeframe: From the start of study treatment to disease progression (up to 3 years after the last dose of study treatment)

Population: All treated subjects (ATS). This analysis includes patients who had progression.

Time to progression is defined as the time from the date of the first administration of study treatment to disease progression (PD). PD requires at least one of the following: new lesion or increase by \>=50% from Baseline in lymphocytes (LC) with at least 5000 B-lymphocytes per microliter (5.0 x 10\^9/L), lymphadenopathy (Ly), size of liver and spleen, platelets (PL) \>= 50% decrease from Baseline, or to \<100,000/uL secondary to CLL, hemoglobin (Hb) decrease of \>2 g/dL from Baseline or to \<10 g/dL secondary to CLL, CLL- transformation, cytopenia after treatment. Response was determined according to the IWCLL updated NCI-WG guidelines 2008.

Outcome measures

Outcome measures
Measure	Ofatumumab + Bendamustine 90 mg/m^2 n=19 Participants Participants with previously untreated CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 90 mg/m\^2 on Days 1 and 2 of each cycle (6 cycles).	Ofatumumab + Bendamustine 70 mg/m^2 n=35 Participants Participants with relapsed CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 70 mg/m\^2 on Days 1 and 2 of each cycle (6 cycles).
Investigator-Assessed Kaplan-Meier Estimates of Time to Progression	36.0 Months Interval 34.0 to 38.05	22.67 Months Interval 16.07 to 28.58

SECONDARY outcome

Timeframe: From the start of study treatment until the start of the next anti-CLL therapy (up to 3 years after the last dose of study treatment)

Population: ATS Population. Only participants that took anti-CLL therapy were evaluated.

Time to next therapy is defined as the time from the date of the first administration of study treatment until the start of the next anti-CLL therapy.

Outcome measures

Outcome measures
Measure	Ofatumumab + Bendamustine 90 mg/m^2 n=14 Participants Participants with previously untreated CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 90 mg/m\^2 on Days 1 and 2 of each cycle (6 cycles).	Ofatumumab + Bendamustine 70 mg/m^2 n=29 Participants Participants with relapsed CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 70 mg/m\^2 on Days 1 and 2 of each cycle (6 cycles).
Time to Next Therapy	31.18 Months Interval 17.25 to 37.03	16.82 Months Interval 11.6 to 25.36

SECONDARY outcome

Timeframe: From first dose of study medication to 60 days after the last dose of study medication (if the event is considered as an AE), or up to 3 years after the last dose of study treatment or until the time of the next anti-CLL therapy, if considered a SAE

Population: Safety Population: all participants who received at least one dose of any study treatment (ofatumumab or bendamustine).

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 is an event of possible drug-induced liver injury. Refer to the general Adverse AE/SAE module for a complete list of AEs and SAEs.

Outcome measures

Outcome measures
Measure	Ofatumumab + Bendamustine 90 mg/m^2 n=44 Participants Participants with previously untreated CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 90 mg/m\^2 on Days 1 and 2 of each cycle (6 cycles).	Ofatumumab + Bendamustine 70 mg/m^2 n=53 Participants Participants with relapsed CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 70 mg/m\^2 on Days 1 and 2 of each cycle (6 cycles).
Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE) Any AE	43 Participants	50 Participants
Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE) Any SAE	20 Participants	25 Participants

SECONDARY outcome

Timeframe: Baseline and end of study treatment (up to 30 months)

Population: Safety Population. Only those participants who were available at the indicated time points were analyzed.

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.

Outcome measures

Outcome measures
Measure	Ofatumumab + Bendamustine 90 mg/m^2 n=38 Participants Participants with previously untreated CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 90 mg/m\^2 on Days 1 and 2 of each cycle (6 cycles).	Ofatumumab + Bendamustine 70 mg/m^2 n=43 Participants Participants with relapsed CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 70 mg/m\^2 on Days 1 and 2 of each cycle (6 cycles).
Change From Baseline in the Immunoglobulin (Ig) Antibodies to End of Study Treatment IgA	0.0768 Gram per liter Standard Deviation 0.91109	0.0540 Gram per liter Standard Deviation 0.23643
Change From Baseline in the Immunoglobulin (Ig) Antibodies to End of Study Treatment IgM	-0.0490 Gram per liter Standard Deviation 0.29267	-0.0463 Gram per liter Standard Deviation 0.16294
Change From Baseline in the Immunoglobulin (Ig) Antibodies to End of Study Treatment IgG	-0.714 Gram per liter Standard Deviation 3.0614	-1.246 Gram per liter Standard Deviation 5.3194

SECONDARY outcome

Timeframe: Baseline, 3-Month Follow-up to 36-Month Follow-up (in 3 months interval)

Population: ATS Population. Only those participants with data available at the specified time points were analyzed (represented by n=X, X in the category titles).

CD5+ CD19+ cells were counted by flow cytometry. Flow cytometry is a technique for counting and examining microscopic particles with an electronic detection apparatus. Baseline 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.

Outcome measures

Outcome measures
Measure	Ofatumumab + Bendamustine 90 mg/m^2 n=44 Participants Participants with previously untreated CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 90 mg/m\^2 on Days 1 and 2 of each cycle (6 cycles).	Ofatumumab + Bendamustine 70 mg/m^2 n=53 Participants Participants with relapsed CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 70 mg/m\^2 on Days 1 and 2 of each cycle (6 cycles).
Change From Baseline in Cluster of Differentiation (CD) CD5+CD19+ Cell Counts up to 36 Months 6 month F/U - Baseline (n=30,28)	-61258.2 Cell per microliter Standard Deviation 42645.75 • Interval 0.0 to 899.0	-45630.4 Cell per microliter Standard Deviation 40130.68 • Interval 0.0 to 4452.0
Change From Baseline in Cluster of Differentiation (CD) CD5+CD19+ Cell Counts up to 36 Months 9 month F/U - Baseline (n=37,23)	-76688.7 Cell per microliter Standard Deviation 99375.55 • Interval 0.0 to 4055.0	-49527.3 Cell per microliter Standard Deviation 40728.82 • Interval 0.0 to 17282.0
Change From Baseline in Cluster of Differentiation (CD) CD5+CD19+ Cell Counts up to 36 Months 12 month F/U - Baseline (n=32,23)	-77884.8 Cell per microliter Standard Deviation 106795.41	-43994.3 Cell per microliter Standard Deviation 39165.64
Change From Baseline in Cluster of Differentiation (CD) CD5+CD19+ Cell Counts up to 36 Months 15 month F/U - Baseline (n=29,21)	-80997.6 Cell per microliter Standard Deviation 108950.32	-39985.6 Cell per microliter Standard Deviation 36456.16
Change From Baseline in Cluster of Differentiation (CD) CD5+CD19+ Cell Counts up to 36 Months 18 month F/U - Baseline (n=23,11)	-85837.7 Cell per microliter Standard Deviation 120525.82	-31229.5 Cell per microliter Standard Deviation 28486.65
Change From Baseline in Cluster of Differentiation (CD) CD5+CD19+ Cell Counts up to 36 Months 21 month F/U - Baseline (n=17,8)	-82180.6 Cell per microliter Standard Deviation 138188.36	-52665.1 Cell per microliter Standard Deviation 42250.59
Change From Baseline in Cluster of Differentiation (CD) CD5+CD19+ Cell Counts up to 36 Months 24 month F/U - Baseline (n=15,7)	-92850.6 Cell per microliter Standard Deviation 144547.27	-37969.3 Cell per microliter Standard Deviation 26444.26
Change From Baseline in Cluster of Differentiation (CD) CD5+CD19+ Cell Counts up to 36 Months 27 month F/U - Baseline (n=19, 6)	-82553.4 Cell per microliter Standard Deviation 129930.36	-24824.8 Cell per microliter Standard Deviation 23700.40
Change From Baseline in Cluster of Differentiation (CD) CD5+CD19+ Cell Counts up to 36 Months 30 month F/U - Baseline (n=15, 6)	-96903.7 Cell per microliter Standard Deviation 142080.38	-30938.0 Cell per microliter Standard Deviation 28108.70
Change From Baseline in Cluster of Differentiation (CD) CD5+CD19+ Cell Counts up to 36 Months 36 month F/U - Baseline (n=8, 4)	-52087.1 Cell per microliter Standard Deviation 35735.07	-30961.0 Cell per microliter Standard Deviation 25003.73
Change From Baseline in Cluster of Differentiation (CD) CD5+CD19+ Cell Counts up to 36 Months 3 month F/U - Baseline (n=32, 31)	-72622.5 Cell per microliter Standard Deviation 104175.69 • Interval 9882.0 to 600336.0	-40644.2 Cell per microliter Standard Deviation 36183.14 • Interval 2086.0 to 222187.0
Change From Baseline in Cluster of Differentiation (CD) CD5+CD19+ Cell Counts up to 36 Months 33 month F/U - Baseline (n=10, 3)	-65321.8 Cell per microliter Standard Deviation 40537.06	-38216.3 Cell per microliter Standard Deviation 24864.31

SECONDARY outcome

Timeframe: Baseline, 3-Month Follow-up to 36-Month Follow-up (in 3 months interval)

Population: Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n=X, X in the category titles).

CD5-CD19+ cells were counted by flow cytometry. Flow cytometry is a technique for counting and examining microscopic particles with an electronic detection apparatus. Baseline 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.

Outcome measures

Outcome measures
Measure	Ofatumumab + Bendamustine 90 mg/m^2 n=44 Participants Participants with previously untreated CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 90 mg/m\^2 on Days 1 and 2 of each cycle (6 cycles).	Ofatumumab + Bendamustine 70 mg/m^2 n=53 Participants Participants with relapsed CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 70 mg/m\^2 on Days 1 and 2 of each cycle (6 cycles).
Change From Baseline in Cluster of Differentiation (CD) CD5-CD19+ Cell Counts up to 36 Months 3 month F/U - Baseline (n= 32, 31)	-5800.8 Cell per microliter Standard Deviation 12693.09 • Interval 15.0 to 61395.0	-2052.4 Cell per microliter Standard Deviation 5243.64 • Interval 7.0 to 85179.0
Change From Baseline in Cluster of Differentiation (CD) CD5-CD19+ Cell Counts up to 36 Months 9 month F/U - Baseline (n= 37, 23)	-5969.7 Cell per microliter Standard Deviation 12277.21 • Interval 1.0 to 22.0	-2288.4 Cell per microliter Standard Deviation 5724.47 • Interval 1.0 to 159.0
Change From Baseline in Cluster of Differentiation (CD) CD5-CD19+ Cell Counts up to 36 Months 12 month F/U - Baseline (n= 32, 23)	-6756.8 Cell per microliter Standard Deviation 13009.04	-4656.3 Cell per microliter Standard Deviation 9087.98
Change From Baseline in Cluster of Differentiation (CD) CD5-CD19+ Cell Counts up to 36 Months 15 month F/U - Baseline (n= 29, 21)	-5323.6 Cell per microliter Standard Deviation 8727.91	-4256.2 Cell per microliter Standard Deviation 9145.23
Change From Baseline in Cluster of Differentiation (CD) CD5-CD19+ Cell Counts up to 36 Months 18 month F/U - Baseline (n= 23, 11)	-4677.9 Cell per microliter Standard Deviation 7677.12	-5043.6 Cell per microliter Standard Deviation 10927.98
Change From Baseline in Cluster of Differentiation (CD) CD5-CD19+ Cell Counts up to 36 Months 30 month F/U - Baseline (n= 15, 6)	-7673.6 Cell per microliter Standard Deviation 10238.82	-3964.3 Cell per microliter Standard Deviation 8918.40
Change From Baseline in Cluster of Differentiation (CD) CD5-CD19+ Cell Counts up to 36 Months 33 month F/U - Baseline (n= 10, 3)	-9511.2 Cell per microliter Standard Deviation 11834.25	-206.0 Cell per microliter Standard Deviation 215.84
Change From Baseline in Cluster of Differentiation (CD) CD5-CD19+ Cell Counts up to 36 Months 36 month F/U - Baseline (n= 8, 4)	-8430.1 Cell per microliter Standard Deviation 13019.82	-5693.0 Cell per microliter Standard Deviation 10969.00
Change From Baseline in Cluster of Differentiation (CD) CD5-CD19+ Cell Counts up to 36 Months 6 month F/U - Baseline (n= 30, 28)	-3921.1 Cell per microliter Standard Deviation 6959.20 • Interval 1.0 to 16.0	-3822.8 Cell per microliter Standard Deviation 8449.80 • Interval 0.0 to 625.0
Change From Baseline in Cluster of Differentiation (CD) CD5-CD19+ Cell Counts up to 36 Months 21 month F/U - Baseline (n= 17, 8)	-5224.2 Cell per microliter Standard Deviation 8477.84	-275.1 Cell per microliter Standard Deviation 449.28
Change From Baseline in Cluster of Differentiation (CD) CD5-CD19+ Cell Counts up to 36 Months 24 month F/U - Baseline (n= 15, 7)	-4522.7 Cell per microliter Standard Deviation 7562.59	-224.0 Cell per microliter Standard Deviation 447.47
Change From Baseline in Cluster of Differentiation (CD) CD5-CD19+ Cell Counts up to 36 Months 27 month F/U - Baseline (n= 19, 6)	-7259.0 Cell per microliter Standard Deviation 10162.96	-3870.5 Cell per microliter Standard Deviation 8960.80

SECONDARY outcome

Timeframe: 3 month follow up to the 36 Month Follow-up (in 3 month interval)

Population: ATS Population. Number of subjects who had CR with bone marrow confirmation are included. Only those participants with data available at the specified time points were analyzed.

MRD refers to small number of leukemic cells that remain in the participant during treatment or after treatment at the time the participant achieved a confirmed CR. MRD analysis was performed for the partcipants who were suspected of achieving a primary endpoint CR. Analysis of CD5+ CD19+ was performed on the bone marrow aspirate sample obtained no sooner than 2 months following the last dose of study treatment. MRD results were reported as negative or positive. The absence of MRD (negative MRD) is defined as less than one CLL cell per 10000 leukocytes.

Outcome measures

Outcome measures
Measure	Ofatumumab + Bendamustine 90 mg/m^2 n=16 Participants Participants with previously untreated CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 90 mg/m\^2 on Days 1 and 2 of each cycle (6 cycles).	Ofatumumab + Bendamustine 70 mg/m^2 n=4 Participants Participants with relapsed CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 70 mg/m\^2 on Days 1 and 2 of each cycle (6 cycles).
Number of Participants Who Were Negative or Positive for Minimal Residual Disease (MRD) and Achieved a Bone Marrow Biopsy Confirmed Complete Response (CR) up to 36-Month Follow-up 3 month F/U, MRD Positive (n=16 , 4)	7 Participants	4 Participants
Number of Participants Who Were Negative or Positive for Minimal Residual Disease (MRD) and Achieved a Bone Marrow Biopsy Confirmed Complete Response (CR) up to 36-Month Follow-up 3 month F/U, MRD Negative (n=16 , 4)	9 Participants	0 Participants
Number of Participants Who Were Negative or Positive for Minimal Residual Disease (MRD) and Achieved a Bone Marrow Biopsy Confirmed Complete Response (CR) up to 36-Month Follow-up 6 month F/U, MRD Positive (n=8 , 2)	1 Participants	1 Participants
Number of Participants Who Were Negative or Positive for Minimal Residual Disease (MRD) and Achieved a Bone Marrow Biopsy Confirmed Complete Response (CR) up to 36-Month Follow-up 9 month F/U, MRD Positive (n=11 , 2)	3 Participants	1 Participants
Number of Participants Who Were Negative or Positive for Minimal Residual Disease (MRD) and Achieved a Bone Marrow Biopsy Confirmed Complete Response (CR) up to 36-Month Follow-up 9 month F/U, MRD Negative (n=11 , 2)	8 Participants	1 Participants
Number of Participants Who Were Negative or Positive for Minimal Residual Disease (MRD) and Achieved a Bone Marrow Biopsy Confirmed Complete Response (CR) up to 36-Month Follow-up 12 month F/U, MRD Positive (n=9 , 2)	1 Participants	1 Participants
Number of Participants Who Were Negative or Positive for Minimal Residual Disease (MRD) and Achieved a Bone Marrow Biopsy Confirmed Complete Response (CR) up to 36-Month Follow-up 12 month F/U, MRD Negative (n=9 , 2)	8 Participants	1 Participants
Number of Participants Who Were Negative or Positive for Minimal Residual Disease (MRD) and Achieved a Bone Marrow Biopsy Confirmed Complete Response (CR) up to 36-Month Follow-up 15 month F/U, MRD Positive (n=9 , 2)	3 Participants	1 Participants
Number of Participants Who Were Negative or Positive for Minimal Residual Disease (MRD) and Achieved a Bone Marrow Biopsy Confirmed Complete Response (CR) up to 36-Month Follow-up 15 month F/U, MRD Negative (n=9 , 2)	6 Participants	1 Participants
Number of Participants Who Were Negative or Positive for Minimal Residual Disease (MRD) and Achieved a Bone Marrow Biopsy Confirmed Complete Response (CR) up to 36-Month Follow-up 24 month F/U, MRD Positive (n=6 , 1)	0 Participants	0 Participants
Number of Participants Who Were Negative or Positive for Minimal Residual Disease (MRD) and Achieved a Bone Marrow Biopsy Confirmed Complete Response (CR) up to 36-Month Follow-up 30 month F/U, MRD Positive (n=4 , 1)	1 Participants	0 Participants
Number of Participants Who Were Negative or Positive for Minimal Residual Disease (MRD) and Achieved a Bone Marrow Biopsy Confirmed Complete Response (CR) up to 36-Month Follow-up 33 month F/U, MRD Positive (n=4 , 1)	1 Participants	0 Participants
Number of Participants Who Were Negative or Positive for Minimal Residual Disease (MRD) and Achieved a Bone Marrow Biopsy Confirmed Complete Response (CR) up to 36-Month Follow-up 6 month F/U, MRD Negative (n=8 , 2)	7 Participants	1 Participants
Number of Participants Who Were Negative or Positive for Minimal Residual Disease (MRD) and Achieved a Bone Marrow Biopsy Confirmed Complete Response (CR) up to 36-Month Follow-up 18 month F/U, MRD Positive (n=6 , 1)	1 Participants	0 Participants
Number of Participants Who Were Negative or Positive for Minimal Residual Disease (MRD) and Achieved a Bone Marrow Biopsy Confirmed Complete Response (CR) up to 36-Month Follow-up 18 month F/U, MRD Negative (n=6 , 1)	5 Participants	1 Participants
Number of Participants Who Were Negative or Positive for Minimal Residual Disease (MRD) and Achieved a Bone Marrow Biopsy Confirmed Complete Response (CR) up to 36-Month Follow-up 21 month F/U, MRD Positive (n=7, 1)	2 Participants	0 Participants
Number of Participants Who Were Negative or Positive for Minimal Residual Disease (MRD) and Achieved a Bone Marrow Biopsy Confirmed Complete Response (CR) up to 36-Month Follow-up 21 month F/U, MRD Negative (n=7 , 1)	5 Participants	1 Participants
Number of Participants Who Were Negative or Positive for Minimal Residual Disease (MRD) and Achieved a Bone Marrow Biopsy Confirmed Complete Response (CR) up to 36-Month Follow-up 24 month F/U, MRD Negative (n=6 , 1)	6 Participants	1 Participants
Number of Participants Who Were Negative or Positive for Minimal Residual Disease (MRD) and Achieved a Bone Marrow Biopsy Confirmed Complete Response (CR) up to 36-Month Follow-up 27 month F/U, MRD Positive (n=3 , 1)	0 Participants	0 Participants
Number of Participants Who Were Negative or Positive for Minimal Residual Disease (MRD) and Achieved a Bone Marrow Biopsy Confirmed Complete Response (CR) up to 36-Month Follow-up 27 month F/U, MRD Negative (n=3 , 1)	3 Participants	1 Participants
Number of Participants Who Were Negative or Positive for Minimal Residual Disease (MRD) and Achieved a Bone Marrow Biopsy Confirmed Complete Response (CR) up to 36-Month Follow-up 30 month F/U, MRD Negative (n=4 , 1)	3 Participants	1 Participants
Number of Participants Who Were Negative or Positive for Minimal Residual Disease (MRD) and Achieved a Bone Marrow Biopsy Confirmed Complete Response (CR) up to 36-Month Follow-up 33 month F/U, MRD Negative (n=4 , 1)	3 Participants	1 Participants
Number of Participants Who Were Negative or Positive for Minimal Residual Disease (MRD) and Achieved a Bone Marrow Biopsy Confirmed Complete Response (CR) up to 36-Month Follow-up 36 month F/U, MRD Positive (n=2 , 1)	0 Participants	0 Participants
Number of Participants Who Were Negative or Positive for Minimal Residual Disease (MRD) and Achieved a Bone Marrow Biopsy Confirmed Complete Response (CR) up to 36-Month Follow-up 36 month F/U, MRD Negative (n=2 , 1)	2 Participants	1 Participants

SECONDARY outcome

Timeframe: From start of treatment until earliest date of disease progression or death (up to 3 years after the last dose of study treatment)

Population: Safety Population: All subjects who receive at least one dose of study medication.

Participants who received no transfusion and at least one transfusion during the study are presented. Participants who took any blood products are counted in this table.

Outcome measures

Outcome measures
Measure	Ofatumumab + Bendamustine 90 mg/m^2 n=44 Participants Participants with previously untreated CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 90 mg/m\^2 on Days 1 and 2 of each cycle (6 cycles).	Ofatumumab + Bendamustine 70 mg/m^2 n=53 Participants Participants with relapsed CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 70 mg/m\^2 on Days 1 and 2 of each cycle (6 cycles).
Number of Participants Who Received no Transfusion or at Least One Transfusion During the Study No transfusions	38 Participants	33 Participants
Number of Participants Who Received no Transfusion or at Least One Transfusion During the Study At least one transfusion	6 Participants	20 Participants

SECONDARY outcome

Population: Safety Population All subjects who receive at least one dose of study medication.

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. The number of participants diagnosed with AIHA are presented.

Outcome measures

Outcome measures
Measure	Ofatumumab + Bendamustine 90 mg/m^2 n=44 Participants Participants with previously untreated CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 90 mg/m\^2 on Days 1 and 2 of each cycle (6 cycles).	Ofatumumab + Bendamustine 70 mg/m^2 n=53 Participants Participants with relapsed CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 70 mg/m\^2 on Days 1 and 2 of each cycle (6 cycles).
Number of Participants With Autoimmune Hemolytic Anaemia (AIHA) Disease	0 Participants	1 Participants

SECONDARY outcome

Timeframe: From the first dose of study medication to 60 days after the last dose of study medication

Population: Safety Population

Participants with a Grade 3 or Grade 4 myelosuppression (anemia, neutropenia, and thrombocytopenia) are presented. Myelosuppression is defined as the decrease in the ability of the bone marrow to produce blood cells. AEs were graded according to NCI common terminology criteria for adverse events (CTCAE) grade, version 4.0 (1, mild; 2, moderate; 3, severe; 4, life-threatening/disabling; 5, death).

Outcome measures

Outcome measures
Measure	Ofatumumab + Bendamustine 90 mg/m^2 n=44 Participants Participants with previously untreated CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 90 mg/m\^2 on Days 1 and 2 of each cycle (6 cycles).	Ofatumumab + Bendamustine 70 mg/m^2 n=53 Participants Participants with relapsed CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 70 mg/m\^2 on Days 1 and 2 of each cycle (6 cycles).
Number of Participants With the Indicated Grade 3 or Grade 4 Myelosuppression (Anemia, Neutropenia, and Thrombocytopenia), as Assessed by the Investigator Neutropenia/Febrile neutropenia, Grade 3	8 Participants	27 Participants
Number of Participants With the Indicated Grade 3 or Grade 4 Myelosuppression (Anemia, Neutropenia, and Thrombocytopenia), as Assessed by the Investigator Neutropenia/Febrile Neutropenia, Grade 4	9 Participants	16 Participants
Number of Participants With the Indicated Grade 3 or Grade 4 Myelosuppression (Anemia, Neutropenia, and Thrombocytopenia), as Assessed by the Investigator Thrombocytopenia, Grade 3	1 Participants	2 Participants
Number of Participants With the Indicated Grade 3 or Grade 4 Myelosuppression (Anemia, Neutropenia, and Thrombocytopenia), as Assessed by the Investigator Thrombocytopenia, Grade 4	0 Participants	2 Participants
Number of Participants With the Indicated Grade 3 or Grade 4 Myelosuppression (Anemia, Neutropenia, and Thrombocytopenia), as Assessed by the Investigator Anemia, Grade 3	1 Participants	0 Participants
Number of Participants With the Indicated Grade 3 or Grade 4 Myelosuppression (Anemia, Neutropenia, and Thrombocytopenia), as Assessed by the Investigator Anemia, Grade 4	0 Participants	0 Participants

SECONDARY outcome

Population: Safety Population: All subjects who receive at least one dose of study medication.

Participants with the indicated Grade 3 or Grade 4 adverse event of infection are presented. AEs were graded according to the NCI CTCAE grade, version 4.0 (1, mild; 2, moderate; 3, severe; 4, life-threatening/disabling; 5, death).

Outcome measures

Outcome measures
Measure	Ofatumumab + Bendamustine 90 mg/m^2 n=44 Participants Participants with previously untreated CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 90 mg/m\^2 on Days 1 and 2 of each cycle (6 cycles).	Ofatumumab + Bendamustine 70 mg/m^2 n=53 Participants Participants with relapsed CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 70 mg/m\^2 on Days 1 and 2 of each cycle (6 cycles).
Number of Participants With the Indicated Grade 3 or Grade 4 Adverse Event of Infection	5 Participants	10 Participants

SECONDARY outcome

Timeframe: Screening (SCR), Cycle 3 Day 1 (C3D1), Cycle 6 Day 1 (C6D1), 12, 24 and 36 Month Follow-up (F/U)

Population: Safety Population: All subjects who receive at least one dose of study medication. Only those participants with data available at the specified time points were analyzed (represented by n=X, X in the category titles).

Participants with the indicated constitutional or B-symptoms (night sweats, weight loss, fever or extreme fatigue) were presented for different time points.

Outcome measures

Outcome measures
Measure	Ofatumumab + Bendamustine 90 mg/m^2 n=44 Participants Participants with previously untreated CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 90 mg/m\^2 on Days 1 and 2 of each cycle (6 cycles).	Ofatumumab + Bendamustine 70 mg/m^2 n=53 Participants Participants with relapsed CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 70 mg/m\^2 on Days 1 and 2 of each cycle (6 cycles).
Number of Participants With the Indicated Constitutional or B-symptoms SCR, weight loss, n=44, 52	4 Participants	5 Participants
Number of Participants With the Indicated Constitutional or B-symptoms C3D1, extreme fatigue, n=42, 49	2 Participants	4 Participants
Number of Participants With the Indicated Constitutional or B-symptoms C6D1, night sweats, n =39, 47	0 Participants	1 Participants
Number of Participants With the Indicated Constitutional or B-symptoms C6D1, weight loss, n =39, 47	0 Participants	0 Participants
Number of Participants With the Indicated Constitutional or B-symptoms 24 Month F/U, night sweats, n =29, 17	0 Participants	0 Participants
Number of Participants With the Indicated Constitutional or B-symptoms 24 Month F/U, weight loss, n=29, 17	0 Participants	0 Participants
Number of Participants With the Indicated Constitutional or B-symptoms 24 Month F/U, fever, n=29, 17	0 Participants	0 Participants
Number of Participants With the Indicated Constitutional or B-symptoms 36 Month F/U, weight loss, n=21, 9	0 Participants	0 Participants
Number of Participants With the Indicated Constitutional or B-symptoms 36 Month F/U, fever, n=21, 9	0 Participants	0 Participants
Number of Participants With the Indicated Constitutional or B-symptoms 24 Month F/U, extreme fatigue, n=29, 17	1 Participants	0 Participants
Number of Participants With the Indicated Constitutional or B-symptoms 36 Month F/U, night sweats, n =21, 9	0 Participants	0 Participants
Number of Participants With the Indicated Constitutional or B-symptoms 36 Month F/U, extreme fatigue, n=21, 9	0 Participants	0 Participants
Number of Participants With the Indicated Constitutional or B-symptoms SCR, night sweats, n =44, 52	19 Participants	22 Participants
Number of Participants With the Indicated Constitutional or B-symptoms SCR, fever, n=44, 52	1 Participants	2 Participants
Number of Participants With the Indicated Constitutional or B-symptoms SCR, extreme fatigue, n=44, 52	14 Participants	15 Participants
Number of Participants With the Indicated Constitutional or B-symptoms C3D1, night sweats, n =42, 49	5 Participants	2 Participants
Number of Participants With the Indicated Constitutional or B-symptoms C3D1, weight loss, n=42, 49	0 Participants	2 Participants
Number of Participants With the Indicated Constitutional or B-symptoms C3D1, fever, n=42, 49	0 Participants	0 Participants
Number of Participants With the Indicated Constitutional or B-symptoms C6D1, fever, n =39, 47	0 Participants	0 Participants
Number of Participants With the Indicated Constitutional or B-symptoms C6D1, extreme fatigue, n =39, 47	0 Participants	1 Participants
Number of Participants With the Indicated Constitutional or B-symptoms 12 Month F/U, night sweats, n =39, 29	0 Participants	0 Participants
Number of Participants With the Indicated Constitutional or B-symptoms 12 Month F/U, weight loss, n =39, 29	1 Participants	0 Participants
Number of Participants With the Indicated Constitutional or B-symptoms 12 Month F/U, fever, n =39, 29	0 Participants	0 Participants
Number of Participants With the Indicated Constitutional or B-symptoms 12 Month F/U, extreme fatigue, n =39, 29	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline (BL), Cycle 3 Day 1 (C3D1), Cycle 6 Day 1 (C6D1), 12, 24 and 36 month follow up (F/U)

Population: Safety Population. All subjects who receive at least one dose of study medication.. Only those participants with data available at the specified time points were analyzed (represented by n=X, X in the category titles).

The ECOG performance status scales and criteria are used by doctors and researchers to assess how a participant's disease is progressing, assess how the disease affects the daily living abilities of the participant, and determine appropriate treatment and prognosis. Grade 0, fully active, able to carry on all pre-disease performance without restriction. Grade 1, restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work. Grade 2, ambulatory and capable of all selfcare, but unable to carry out any work activities; up and about more than 50% of waking hours. Grade 3, capable of only limited selfcare; confined to bed or chair more than 50% of waking hours. Grade 4, completely disabled; cannot carry on any selfcare; totally confined to bed or chair. Grade 5, dead.

Outcome measures

Outcome measures
Measure	Ofatumumab + Bendamustine 90 mg/m^2 n=44 Participants Participants with previously untreated CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 90 mg/m\^2 on Days 1 and 2 of each cycle (6 cycles).	Ofatumumab + Bendamustine 70 mg/m^2 n=53 Participants Participants with relapsed CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 70 mg/m\^2 on Days 1 and 2 of each cycle (6 cycles).
Number of Participants With the Indicated Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) BL, Score of 1, n=44, 53	28 Participants	29 Participants
Number of Participants With the Indicated Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) BL, Score of 2, n=44, 53	0 Participants	1 Participants
Number of Participants With the Indicated Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) BL, Score of 3, n=44, 53	0 Participants	0 Participants
Number of Participants With the Indicated Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) BL, Score of 4-5, n=44, 53	0 Participants	0 Participants
Number of Participants With the Indicated Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) C3D1, Score of 0, n=42, 48	17 Participants	27 Participants
Number of Participants With the Indicated Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) C3D1, Score of 2, n=42, 48	0 Participants	0 Participants
Number of Participants With the Indicated Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) C3D1, Score of 4-5, n=42, 48	0 Participants	0 Participants
Number of Participants With the Indicated Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) C6D1, Score of 1, n=38, 47	19 Participants	19 Participants
Number of Participants With the Indicated Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) C6D1, Score of 2, n=38, 47	0 Participants	1 Participants
Number of Participants With the Indicated Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) C6D1, Score of 3, n=38, 47	0 Participants	0 Participants
Number of Participants With the Indicated Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) C6D1, Score of 4-5, n=38, 47	0 Participants	0 Participants
Number of Participants With the Indicated Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 12 Month F/U, Score of 0, n=39, 28	24 Participants	19 Participants
Number of Participants With the Indicated Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 12 Month F/U, Score of 2, n=39, 28	1 Participants	1 Participants
Number of Participants With the Indicated Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 12 Month F/U, Score of 3, n=39, 28	0 Participants	0 Participants
Number of Participants With the Indicated Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 12 Month F/U, Score of 4-5, n=39, 28	0 Participants	0 Participants
Number of Participants With the Indicated Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 24 Month F/U, Score of 0, n=28, 16	16 Participants	13 Participants
Number of Participants With the Indicated Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 24 Month F/U, Score of 1, n=28, 16	11 Participants	3 Participants
Number of Participants With the Indicated Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 36 Month F/U, Score of 0, n=21, 9	15 Participants	8 Participants
Number of Participants With the Indicated Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 36 Month F/U, Score of 4-5, n=21, 9	0 Participants	0 Participants
Number of Participants With the Indicated Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) BL, Score of 0, n=44, 53	16 Participants	23 Participants
Number of Participants With the Indicated Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) C3D1, Score of 1, n=42, 48	25 Participants	21 Participants
Number of Participants With the Indicated Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) C3D1, Score of 3, n=42, 48	0 Participants	0 Participants
Number of Participants With the Indicated Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) C6D1, Score of 0, n=38, 47	19 Participants	27 Participants
Number of Participants With the Indicated Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 12 Month F/U, Score of 1, n=39, 28	14 Participants	8 Participants
Number of Participants With the Indicated Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 24 Month F/U, Score of 2, n=28, 16	1 Participants	0 Participants
Number of Participants With the Indicated Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 24 Month F/U, Score of 3, n=28, 16	0 Participants	0 Participants
Number of Participants With the Indicated Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 24 Month F/U, Score of 4-5, n=28, 16	0 Participants	0 Participants
Number of Participants With the Indicated Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 36 Month F/U, Score of 2, n=21, 9	1 Participants	0 Participants
Number of Participants With the Indicated Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 36 Month F/U, Score of 1, n=21, 9	5 Participants	1 Participants
Number of Participants With the Indicated Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 36 Month F/U, Score of 3, n=21, 9	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Cycle 1 Day 1 (C1D1), Cycle 6 Day 1 (C6D1), 6-Month Follow-up (F/U), and any post-dose time point

Population: Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n=X, X in the category titles).

The presence of HAHA in human serum was determined using a validated electrochemiluminescent assay in a multi-tier assay format. All samples were first assessed in a screening (SCR) assay, and the potential positive (Pos) samples were further tested in the confirmation (CNF) assays. Confirmed positives were reported as HAHA positive and titer was determined for each positive sample. The drug tolerance of the HAHA assay is 200 microgram/milliliter (µg/mL); thus, samples that tested negative in the assay and had ofatumumab concentrations no more than 200 µg/mL were considered as conclusive negative (C Neg) results.

Outcome measures

Outcome measures
Measure	Ofatumumab + Bendamustine 90 mg/m^2 n=44 Participants Participants with previously untreated CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 90 mg/m\^2 on Days 1 and 2 of each cycle (6 cycles).	Ofatumumab + Bendamustine 70 mg/m^2 n=53 Participants Participants with relapsed CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 70 mg/m\^2 on Days 1 and 2 of each cycle (6 cycles).
Number of Participants With Confirmed Positive Response for Human Anti-human Antibodies (HAHA) at the Indicated Time Points C1D1, n=41, 53	0 Participants	0 Participants
Number of Participants With Confirmed Positive Response for Human Anti-human Antibodies (HAHA) at the Indicated Time Points 6-Month F/U, n=35, 37	0 Participants	0 Participants
Number of Participants With Confirmed Positive Response for Human Anti-human Antibodies (HAHA) at the Indicated Time Points Any post dose time, n=42, 47	0 Participants	0 Participants
Number of Participants With Confirmed Positive Response for Human Anti-human Antibodies (HAHA) at the Indicated Time Points C6D1, n=34, 43	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline, Cycle 2 Day 1 (C2D1), Cycle 3 Day 1 (C3D1), Cycle 4 Day 1 (C4D1), Cycle 5 Day 1 (C5D1), Cycle 6 Day 1 (C6D1), 3-Month Follow-Up (F/U), 6-Month F/U and 9-Month F/U

Population: ATS Population. Only those participants with data available at the specified time points were analyzed (represented by n=X, X in the category titles).

Lymph nodes were evaluated by physical examination which involved recording the diameter in two planes (sum of the product of the diameter \[SPD\]) of the largest palpable node in each of the following sites: cervical, axillary, supraclavicular, inguinal and femoral. Lymphadenopathy is defined as lymph nodes with the largest diameter greater than 1.5 centimeters. The maximum reduction in SPD from Baseline at C2D1, C3D1, C4D1, C5D1, C6D1, 3-Month F/U, 6-Month F/U and 9-Month F/U are provided.

Outcome measures

Outcome measures
Measure	Ofatumumab + Bendamustine 90 mg/m^2 n=44 Participants Participants with previously untreated CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 90 mg/m\^2 on Days 1 and 2 of each cycle (6 cycles).	Ofatumumab + Bendamustine 70 mg/m^2 n=53 Participants Participants with relapsed CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 70 mg/m\^2 on Days 1 and 2 of each cycle (6 cycles).
Maximum Decrease in Sum of the Product of the Diameter (SPD) From Baseline in Participants With Lymphadenopathy at Baseline C2D1, n=34, 35	-83.5 cm^2 (centimeters squared) Standard Deviation 23.69	-77.3 cm^2 (centimeters squared) Standard Deviation 31.62
Maximum Decrease in Sum of the Product of the Diameter (SPD) From Baseline in Participants With Lymphadenopathy at Baseline C3D1, n=32, 35	-92.1 cm^2 (centimeters squared) Standard Deviation 20.17	-90.9 cm^2 (centimeters squared) Standard Deviation 17.18
Maximum Decrease in Sum of the Product of the Diameter (SPD) From Baseline in Participants With Lymphadenopathy at Baseline C5D1, n=29, 35	-99.6 cm^2 (centimeters squared) Standard Deviation 1.22	-96.2 cm^2 (centimeters squared) Standard Deviation 8.95
Maximum Decrease in Sum of the Product of the Diameter (SPD) From Baseline in Participants With Lymphadenopathy at Baseline C6D1, n=30, 33	-99.6 cm^2 (centimeters squared) Standard Deviation 2.28	-97.0 cm^2 (centimeters squared) Standard Deviation 7.78
Maximum Decrease in Sum of the Product of the Diameter (SPD) From Baseline in Participants With Lymphadenopathy at Baseline 9-Month F/U, n=1, 0	-68.4 cm^2 (centimeters squared) Standard Deviation NA Only one participant was analyzed in this treatment arm at this time point; therefore the standard deviation cannot be calculated.	NA cm^2 (centimeters squared) Standard Deviation NA No participants were analyzed in this treatment arm at this time point.
Maximum Decrease in Sum of the Product of the Diameter (SPD) From Baseline in Participants With Lymphadenopathy at Baseline C4D1, n=32, 35	-99.1 cm^2 (centimeters squared) Standard Deviation 2.67	-94.6 cm^2 (centimeters squared) Standard Deviation 11.56
Maximum Decrease in Sum of the Product of the Diameter (SPD) From Baseline in Participants With Lymphadenopathy at Baseline 3-Month F/U, n=33, 32	-99.2 cm^2 (centimeters squared) Standard Deviation 3.64	-95.9 cm^2 (centimeters squared) Standard Deviation 19.17
Maximum Decrease in Sum of the Product of the Diameter (SPD) From Baseline in Participants With Lymphadenopathy at Baseline 6-Month F/U, n=3, 1	-100.0 cm^2 (centimeters squared) Standard Deviation 0.00	-100.0 cm^2 (centimeters squared) Standard Deviation NA Only one participant was analyzed in this treatment arm at this time point; therefore the standard deviation cannot be calculated.

SECONDARY outcome

Timeframe: Screening (Scr), Cycle 3 Day 1 (C3D1), Cycle 6 Day 1 (C6D1), 12, 24 and 36 -Month Follow-Up (F/U)

Population: Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n=X, X in the category titles).

Organomegaly is the abnormal enlargement of organs. Physical examination of the liver (L) and spleen (S) were done at Screening (SCR), C3D1, C6D1, 12-Month F/U, 24-Month F/U and 36-Month F/U. The result of the physical examination of the liver (L) and spleen (S) was presented as normal (NOR), enlarged (EL) and not assessed (NOA).

Outcome measures

Outcome measures
Measure	Ofatumumab + Bendamustine 90 mg/m^2 n=44 Participants Participants with previously untreated CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 90 mg/m\^2 on Days 1 and 2 of each cycle (6 cycles).	Ofatumumab + Bendamustine 70 mg/m^2 n=53 Participants Participants with relapsed CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 70 mg/m\^2 on Days 1 and 2 of each cycle (6 cycles).
Number of Participants With the Indicated Reduction in Organomegaly (Spleen and Liver) 36 Month F/U, S, NOR, n=21, 9	21 Participants	9 Participants
Number of Participants With the Indicated Reduction in Organomegaly (Spleen and Liver) SCR, S, NOR, n=44, 50	23 Participants	31 Participants
Number of Participants With the Indicated Reduction in Organomegaly (Spleen and Liver) SCR, S, EL, n=44, 50	21 Participants	19 Participants
Number of Participants With the Indicated Reduction in Organomegaly (Spleen and Liver) SCR, S, NOA, n=44, 50	0 Participants	0 Participants
Number of Participants With the Indicated Reduction in Organomegaly (Spleen and Liver) SCR, L, NOR, n=44, 51	38 Participants	41 Participants
Number of Participants With the Indicated Reduction in Organomegaly (Spleen and Liver) C3D1, S, NOR, n=42, 48	37 Participants	41 Participants
Number of Participants With the Indicated Reduction in Organomegaly (Spleen and Liver) C3D1, S, EL, n=42, 48	5 Participants	6 Participants
Number of Participants With the Indicated Reduction in Organomegaly (Spleen and Liver) C6D1, S, NOR, n=39, 46	39 Participants	43 Participants
Number of Participants With the Indicated Reduction in Organomegaly (Spleen and Liver) C6D1, S, EL, n=39, 46	0 Participants	2 Participants
Number of Participants With the Indicated Reduction in Organomegaly (Spleen and Liver) C6D1, L, NOR, n=39, 46	37 Participants	44 Participants
Number of Participants With the Indicated Reduction in Organomegaly (Spleen and Liver) 12 Month F/U, S, EL, n=39, 29	0 Participants	1 Participants
Number of Participants With the Indicated Reduction in Organomegaly (Spleen and Liver) 12 Month F/U, S, NOA, n=39, 29	0 Participants	0 Participants
Number of Participants With the Indicated Reduction in Organomegaly (Spleen and Liver) 12 Month F/U, L, NOR, n=39, 29	38 Participants	28 Participants
Number of Participants With the Indicated Reduction in Organomegaly (Spleen and Liver) 12 Month F/U, L, EL, n=39, 29	1 Participants	1 Participants
Number of Participants With the Indicated Reduction in Organomegaly (Spleen and Liver) 12 Month F/U, L, NOA, n=39, 29	0 Participants	0 Participants
Number of Participants With the Indicated Reduction in Organomegaly (Spleen and Liver) 24 Month F/U, S, NOA, n=29, 17	0 Participants	0 Participants
Number of Participants With the Indicated Reduction in Organomegaly (Spleen and Liver) 24 Month F/U, L, NOR, n=29, 17	29 Participants	16 Participants
Number of Participants With the Indicated Reduction in Organomegaly (Spleen and Liver) 24 Month F/U, L, EL, n=29, 17	0 Participants	1 Participants
Number of Participants With the Indicated Reduction in Organomegaly (Spleen and Liver) 24 Month F/U, L, NOA, n=29, 17	0 Participants	0 Participants
Number of Participants With the Indicated Reduction in Organomegaly (Spleen and Liver) 24 Month F/U, S, EL, n=29, 17	0 Participants	1 Participants
Number of Participants With the Indicated Reduction in Organomegaly (Spleen and Liver) 36 Month F/U, L, NOA, n=21, 9	0 Participants	0 Participants
Number of Participants With the Indicated Reduction in Organomegaly (Spleen and Liver) SCR, L, EL, n=44, 51	6 Participants	9 Participants
Number of Participants With the Indicated Reduction in Organomegaly (Spleen and Liver) SCR, L, NOA, n=44, 51	0 Participants	1 Participants
Number of Participants With the Indicated Reduction in Organomegaly (Spleen and Liver) C3D1, S, NOA, n=42, 48	0 Participants	1 Participants
Number of Participants With the Indicated Reduction in Organomegaly (Spleen and Liver) C3D1, L, NOR, n=42, 48	38 Participants	42 Participants
Number of Participants With the Indicated Reduction in Organomegaly (Spleen and Liver) C3D1, L, EL, n=42, 48	4 Participants	5 Participants
Number of Participants With the Indicated Reduction in Organomegaly (Spleen and Liver) C3D1, L, NOA, n=42, 48	0 Participants	1 Participants
Number of Participants With the Indicated Reduction in Organomegaly (Spleen and Liver) C6D1, S, NOA, n=39, 46	0 Participants	1 Participants
Number of Participants With the Indicated Reduction in Organomegaly (Spleen and Liver) C6D1, L, EL, n=39, 46	2 Participants	0 Participants
Number of Participants With the Indicated Reduction in Organomegaly (Spleen and Liver) C6D1, L, NOA, n=39, 46	0 Participants	2 Participants
Number of Participants With the Indicated Reduction in Organomegaly (Spleen and Liver) 12 Month F/U, S, NOR, n=39, 29	39 Participants	28 Participants
Number of Participants With the Indicated Reduction in Organomegaly (Spleen and Liver) 24 Month F/U, S, NOR, n=29, 17	29 Participants	16 Participants
Number of Participants With the Indicated Reduction in Organomegaly (Spleen and Liver) 36 Month F/U, L, NOR, n=21, 9	21 Participants	9 Participants
Number of Participants With the Indicated Reduction in Organomegaly (Spleen and Liver) 36 Month F/U, L, EL, n=21, 9	0 Participants	0 Participants
Number of Participants With the Indicated Reduction in Organomegaly (Spleen and Liver) 36 Month F/U, S, EL, n=21, 9	0 Participants	0 Participants
Number of Participants With the Indicated Reduction in Organomegaly (Spleen and Liver) 36 Month F/U, S, NOA, n=21, 9	0 Participants	0 Participants

SECONDARY outcome

Timeframe: From the start of study treatment until earliest date of disease progression or death (up to up to 3 months following last dose of study treatment)

Population: ATS Population. Only those participants with data available at the specified time points were analyzed (represented by n=X, X in the category titles).

Cytogenetics refers to the study of numerical and structural chromosomal abnormalities. Cytogenetics (analyzed by fluorescent in situ hybridization \[FISH\]) of 17p deletion, 11q deletion, 17p or 11q deletions, 6q- or +12q or 13q- deletions, and no aberration at Baseline were summarized by clinical responses after the last dose of study treatment. Clinical responses included complete remission (CR), nodular partial remission (nPR), complete response with incomplete bone marrow Recovery (CRi), partial remission (PR), disease progression (PD), and stable disease (SD). The participants with a PR, CRi, PR or nPR are called responders and the participants with SD and PD are called non-responders.

Outcome measures

Outcome measures
Measure	Ofatumumab + Bendamustine 90 mg/m^2 n=44 Participants Participants with previously untreated CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 90 mg/m\^2 on Days 1 and 2 of each cycle (6 cycles).	Ofatumumab + Bendamustine 70 mg/m^2 n=53 Participants Participants with relapsed CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 70 mg/m\^2 on Days 1 and 2 of each cycle (6 cycles).
Number of Participants With the Indicated Cytogenetics Testing at Baseline Who Also Had a Clinical Response After Last Dose of Study Treatment 6q- or +12q or 13q-, CR, n=20, 24	11 Participants	3 Participants
Number of Participants With the Indicated Cytogenetics Testing at Baseline Who Also Had a Clinical Response After Last Dose of Study Treatment 6q- or +12q or 13q-, CRi, n=20, 24	1 Participants	2 Participants
Number of Participants With the Indicated Cytogenetics Testing at Baseline Who Also Had a Clinical Response After Last Dose of Study Treatment 6q- or +12q or 13q-, nPR, n=20, 24	1 Participants	4 Participants
Number of Participants With the Indicated Cytogenetics Testing at Baseline Who Also Had a Clinical Response After Last Dose of Study Treatment 6q- or +12q or 13q-, PR, n=20, 24	7 Participants	10 Participants
Number of Participants With the Indicated Cytogenetics Testing at Baseline Who Also Had a Clinical Response After Last Dose of Study Treatment 6q- or +12q or 13q-, SD, n=20, 24	0 Participants	2 Participants
Number of Participants With the Indicated Cytogenetics Testing at Baseline Who Also Had a Clinical Response After Last Dose of Study Treatment 6q- or +12q or 13q-, PD, n=20, 24	0 Participants	2 Participants
Number of Participants With the Indicated Cytogenetics Testing at Baseline Who Also Had a Clinical Response After Last Dose of Study Treatment No aberration, nPR, n= 14, 8	3 Participants	1 Participants
Number of Participants With the Indicated Cytogenetics Testing at Baseline Who Also Had a Clinical Response After Last Dose of Study Treatment 17p-, nPR, n=2, 6	0 Participants	0 Participants
Number of Participants With the Indicated Cytogenetics Testing at Baseline Who Also Had a Clinical Response After Last Dose of Study Treatment 17p-, PR, n=2, 6	0 Participants	1 Participants
Number of Participants With the Indicated Cytogenetics Testing at Baseline Who Also Had a Clinical Response After Last Dose of Study Treatment 17p-, SD, n=2, 6	1 Participants	3 Participants
Number of Participants With the Indicated Cytogenetics Testing at Baseline Who Also Had a Clinical Response After Last Dose of Study Treatment 17p-, PD, n=2, 6	0 Participants	2 Participants
Number of Participants With the Indicated Cytogenetics Testing at Baseline Who Also Had a Clinical Response After Last Dose of Study Treatment 17p- or 11q-, PD, n=10, 20	0 Participants	5 Participants
Number of Participants With the Indicated Cytogenetics Testing at Baseline Who Also Had a Clinical Response After Last Dose of Study Treatment 11q-, CR, n=8, 15	3 Participants	1 Participants
Number of Participants With the Indicated Cytogenetics Testing at Baseline Who Also Had a Clinical Response After Last Dose of Study Treatment 11q-, CRi, No, n=8, 15	0 Participants	0 Participants
Number of Participants With the Indicated Cytogenetics Testing at Baseline Who Also Had a Clinical Response After Last Dose of Study Treatment 11q-, nPR, n=8, 15	1 Participants	3 Participants
Number of Participants With the Indicated Cytogenetics Testing at Baseline Who Also Had a Clinical Response After Last Dose of Study Treatment 17p- or 11q-, CRi, n=10, 20	0 Participants	0 Participants
Number of Participants With the Indicated Cytogenetics Testing at Baseline Who Also Had a Clinical Response After Last Dose of Study Treatment 17p- or 11q-, nPR, n=10, 20	1 Participants	3 Participants
Number of Participants With the Indicated Cytogenetics Testing at Baseline Who Also Had a Clinical Response After Last Dose of Study Treatment 17p- or 11q-, PR, n=10, 20	4 Participants	8 Participants
Number of Participants With the Indicated Cytogenetics Testing at Baseline Who Also Had a Clinical Response After Last Dose of Study Treatment 17p- or 11q-, SD, n=10, 20	1 Participants	3 Participants
Number of Participants With the Indicated Cytogenetics Testing at Baseline Who Also Had a Clinical Response After Last Dose of Study Treatment No aberration, CR, n= 14, 8	5 Participants	2 Participants
Number of Participants With the Indicated Cytogenetics Testing at Baseline Who Also Had a Clinical Response After Last Dose of Study Treatment No aberration, CRi, n= 14, 8	2 Participants	0 Participants
Number of Participants With the Indicated Cytogenetics Testing at Baseline Who Also Had a Clinical Response After Last Dose of Study Treatment No aberration, PR, n= 14, 8	4 Participants	4 Participants
Number of Participants With the Indicated Cytogenetics Testing at Baseline Who Also Had a Clinical Response After Last Dose of Study Treatment No aberration, SD, n= 14, 8	0 Participants	0 Participants
Number of Participants With the Indicated Cytogenetics Testing at Baseline Who Also Had a Clinical Response After Last Dose of Study Treatment No aberration, PD, n= 14, 8	0 Participants	1 Participants
Number of Participants With the Indicated Cytogenetics Testing at Baseline Who Also Had a Clinical Response After Last Dose of Study Treatment 17p-, CR, n=2, 6	0 Participants	0 Participants
Number of Participants With the Indicated Cytogenetics Testing at Baseline Who Also Had a Clinical Response After Last Dose of Study Treatment 17p-, CRi, n=2, 6	0 Participants	0 Participants
Number of Participants With the Indicated Cytogenetics Testing at Baseline Who Also Had a Clinical Response After Last Dose of Study Treatment 11q-, PR, n=8, 15	4 Participants	7 Participants
Number of Participants With the Indicated Cytogenetics Testing at Baseline Who Also Had a Clinical Response After Last Dose of Study Treatment 11q-, SD, n=8, 15	0 Participants	1 Participants
Number of Participants With the Indicated Cytogenetics Testing at Baseline Who Also Had a Clinical Response After Last Dose of Study Treatment 11q-, PD, n=8, 15	0 Participants	3 Participants
Number of Participants With the Indicated Cytogenetics Testing at Baseline Who Also Had a Clinical Response After Last Dose of Study Treatment 17p- or 11q-, CR, n=10, 20	3 Participants	1 Participants

SECONDARY outcome

Timeframe: From the start of study treatment until earliest date of disease progression or death (up to up to 3 months following last dose of study treatment)

Population: ATS Population. Only those participants with data available at the specified time points were analyzed (represented by n=X, X in the category titles).

Participants with B2M concentration of \<=4000 µg/L and \>4000 µg/L at Baseline and who had clinical response after the last dose of study treatment were provided. Clinical responses included complete remission (CR), complete response with incomplete bone marrow Recovery (CRi), nodular partial remission (nPR), and partial remission (PR), disease progression (PD), and stable disease (SD). The participants with a PR, CRi, PR or nPR are called responders and the participants with SD and PD are called non-responders.

Outcome measures

Outcome measures
Measure	Ofatumumab + Bendamustine 90 mg/m^2 n=44 Participants Participants with previously untreated CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 90 mg/m\^2 on Days 1 and 2 of each cycle (6 cycles).	Ofatumumab + Bendamustine 70 mg/m^2 n=53 Participants Participants with relapsed CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 70 mg/m\^2 on Days 1 and 2 of each cycle (6 cycles).
Number of Participants With the Indicated Beta 2 Microglobulin (B2M) at Baseline Who Also Had a Clinical Response After the Last Dose of Study Treatment <= 4000 µg/L, CRi, n=23, 24	3 Participants	2 Participants
Number of Participants With the Indicated Beta 2 Microglobulin (B2M) at Baseline Who Also Had a Clinical Response After the Last Dose of Study Treatment <= 4000 µg/L, SD, n=23, 24	0 Participants	2 Participants
Number of Participants With the Indicated Beta 2 Microglobulin (B2M) at Baseline Who Also Had a Clinical Response After the Last Dose of Study Treatment > 4000 µg/L, PD, n=17, 29	0 Participants	6 Participants
Number of Participants With the Indicated Beta 2 Microglobulin (B2M) at Baseline Who Also Had a Clinical Response After the Last Dose of Study Treatment <= 4000 µg/L, CR, n=23, 24	9 Participants	3 Participants
Number of Participants With the Indicated Beta 2 Microglobulin (B2M) at Baseline Who Also Had a Clinical Response After the Last Dose of Study Treatment <= 4000 µg/L, nPR, n=23, 24	4 Participants	6 Participants
Number of Participants With the Indicated Beta 2 Microglobulin (B2M) at Baseline Who Also Had a Clinical Response After the Last Dose of Study Treatment <= 4000 µg/L, PR, n=23, 24	7 Participants	9 Participants
Number of Participants With the Indicated Beta 2 Microglobulin (B2M) at Baseline Who Also Had a Clinical Response After the Last Dose of Study Treatment <= 4000 µg/L, PD, n=23, 24	0 Participants	2 Participants
Number of Participants With the Indicated Beta 2 Microglobulin (B2M) at Baseline Who Also Had a Clinical Response After the Last Dose of Study Treatment > 4000 µg/L, CR, n=17, 29	9 Participants	3 Participants
Number of Participants With the Indicated Beta 2 Microglobulin (B2M) at Baseline Who Also Had a Clinical Response After the Last Dose of Study Treatment > 4000 µg/L, CRi, n=17, 29	0 Participants	0 Participants
Number of Participants With the Indicated Beta 2 Microglobulin (B2M) at Baseline Who Also Had a Clinical Response After the Last Dose of Study Treatment > 4000 µg/L, nPR, n=17, 29	1 Participants	2 Participants
Number of Participants With the Indicated Beta 2 Microglobulin (B2M) at Baseline Who Also Had a Clinical Response After the Last Dose of Study Treatment > 4000 µg/L, PR, n=17, 29	6 Participants	14 Participants
Number of Participants With the Indicated Beta 2 Microglobulin (B2M) at Baseline Who Also Had a Clinical Response After the Last Dose of Study Treatment > 4000 µg/L, SD, n=17, 29	0 Participants	3 Participants

SECONDARY outcome

Timeframe: From the start of study treatment until earliest date of disease progression or death (up to up to 3 months following last dose of study treatment)

Population: ATS Population. Only those participants with data available at the specified time points were analyzed (represented by n=X, X in the category titles).

Participants with IgVH mutation results as mutated and unmutated status and clinical response after last dose of study treatment were provided. Clinical responses included complete remission (CR), complete response with incomplete bone marrow recovery (CRi), nodular partial remission (nPR), partial remission (PR), disease progression (PD), and stable disease (SD). The participants with a PR, CRi, PR or nPR are called responders and the participants with SD and PD are called non-responders.

Outcome measures

Outcome measures
Measure	Ofatumumab + Bendamustine 90 mg/m^2 n=44 Participants Participants with previously untreated CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 90 mg/m\^2 on Days 1 and 2 of each cycle (6 cycles).	Ofatumumab + Bendamustine 70 mg/m^2 n=53 Participants Participants with relapsed CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 70 mg/m\^2 on Days 1 and 2 of each cycle (6 cycles).
Number of Participants With the Indicated Immunoglobulin Heavy Chain Variable Region (IgVH) Testing at Baseline Who Also Had a Clinical Response After Last Dose of Study Treatment IgVH Mutated (<=98 %), CR, n=12, 13	6 Participants	4 Participants
Number of Participants With the Indicated Immunoglobulin Heavy Chain Variable Region (IgVH) Testing at Baseline Who Also Had a Clinical Response After Last Dose of Study Treatment IgVH Mutated (<=98 %), CRi, n=12, 13	2 Participants	0 Participants
Number of Participants With the Indicated Immunoglobulin Heavy Chain Variable Region (IgVH) Testing at Baseline Who Also Had a Clinical Response After Last Dose of Study Treatment IgVH Mutated (<=98 %), nPR, n=12, 13	0 Participants	4 Participants
Number of Participants With the Indicated Immunoglobulin Heavy Chain Variable Region (IgVH) Testing at Baseline Who Also Had a Clinical Response After Last Dose of Study Treatment IgVH Mutated (<=98 %), PR, n=12, 13	4 Participants	2 Participants
Number of Participants With the Indicated Immunoglobulin Heavy Chain Variable Region (IgVH) Testing at Baseline Who Also Had a Clinical Response After Last Dose of Study Treatment IgVH Mutated (<=98 %), SD, n=12, 13	0 Participants	0 Participants
Number of Participants With the Indicated Immunoglobulin Heavy Chain Variable Region (IgVH) Testing at Baseline Who Also Had a Clinical Response After Last Dose of Study Treatment IgVH Mutated (<=98 %), PD, n=12, 13	0 Participants	3 Participants
Number of Participants With the Indicated Immunoglobulin Heavy Chain Variable Region (IgVH) Testing at Baseline Who Also Had a Clinical Response After Last Dose of Study Treatment IgVH unmutated (>98%), CR, n=23, 34	11 Participants	1 Participants
Number of Participants With the Indicated Immunoglobulin Heavy Chain Variable Region (IgVH) Testing at Baseline Who Also Had a Clinical Response After Last Dose of Study Treatment IgVH unmutated (>98%), CRi, n=23, 34	1 Participants	2 Participants
Number of Participants With the Indicated Immunoglobulin Heavy Chain Variable Region (IgVH) Testing at Baseline Who Also Had a Clinical Response After Last Dose of Study Treatment IgVH unmutated (>98%), nPR, n=23, 34	5 Participants	4 Participants
Number of Participants With the Indicated Immunoglobulin Heavy Chain Variable Region (IgVH) Testing at Baseline Who Also Had a Clinical Response After Last Dose of Study Treatment IgVH unmutated (>98%), PR, n=23, 34	5 Participants	18 Participants
Number of Participants With the Indicated Immunoglobulin Heavy Chain Variable Region (IgVH) Testing at Baseline Who Also Had a Clinical Response After Last Dose of Study Treatment IgVH unmutated (>98%), SD, n=23, 34	0 Participants	5 Participants
Number of Participants With the Indicated Immunoglobulin Heavy Chain Variable Region (IgVH) Testing at Baseline Who Also Had a Clinical Response After Last Dose of Study Treatment IgVH unmutated (>98%), PD, n=23, 34	0 Participants	3 Participants

SECONDARY outcome

Timeframe: From the start of study treatment until earliest date of disease progression or death (up to 3 months following last dose of study treatment)

Population: ATS Population. Only those participants with data available at the specified time points were analyzed (represented by n=X, X in the category titles).

ZAP-70 is a protein normally expressed near the surface membrane of T cells and natural killer cells. ZAP-70 in B cells is used as a prognostic marker in identifying different forms of CLL. Participants with ZAP-70 testing results intermediate (Int), positive (Pos) and negative (Neg) at Baseline and who had a clinical response after last dose of study treatment are provided. Clinical responses included complete remission (CR), complete response with incomplete bone marrow recovery (CRi), nodular partial remission (nPR), partial remission (PR), disease progression (PD), and stable disease (SD). The participants with a PR, CRi, PR or nPR are called responders and the participants with SD and PD are called non-responders.

Outcome measures

Outcome measures
Measure	Ofatumumab + Bendamustine 90 mg/m^2 n=36 Participants Participants with previously untreated CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 90 mg/m\^2 on Days 1 and 2 of each cycle (6 cycles).	Ofatumumab + Bendamustine 70 mg/m^2 n=44 Participants Participants with relapsed CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 70 mg/m\^2 on Days 1 and 2 of each cycle (6 cycles).
Number of Participants With Zeta-chain-associated Protein Kinase (ZAP) 70 Testing at Baseline Who Also Had a Clinical Response After Last Dose of Study Treatment ZAP-70, Neg, CR, n=2, 2	1 Participants	0 Participants
Number of Participants With Zeta-chain-associated Protein Kinase (ZAP) 70 Testing at Baseline Who Also Had a Clinical Response After Last Dose of Study Treatment ZAP-70, Pos, CR, n=36, 44	17 Participants	5 Participants
Number of Participants With Zeta-chain-associated Protein Kinase (ZAP) 70 Testing at Baseline Who Also Had a Clinical Response After Last Dose of Study Treatment ZAP-70, Neg, CRi, n=2, 2	0 Participants	0 Participants
Number of Participants With Zeta-chain-associated Protein Kinase (ZAP) 70 Testing at Baseline Who Also Had a Clinical Response After Last Dose of Study Treatment ZAP-70, Int, CR, n=6, 6	1 Participants	1 Participants
Number of Participants With Zeta-chain-associated Protein Kinase (ZAP) 70 Testing at Baseline Who Also Had a Clinical Response After Last Dose of Study Treatment ZAP-70, Int, CRi, n=6, 6	0 Participants	0 Participants
Number of Participants With Zeta-chain-associated Protein Kinase (ZAP) 70 Testing at Baseline Who Also Had a Clinical Response After Last Dose of Study Treatment ZAP-70, Int, nPR, n=6, 6	0 Participants	0 Participants
Number of Participants With Zeta-chain-associated Protein Kinase (ZAP) 70 Testing at Baseline Who Also Had a Clinical Response After Last Dose of Study Treatment ZAP-70, Int, PR, n=6, 6	3 Participants	3 Participants
Number of Participants With Zeta-chain-associated Protein Kinase (ZAP) 70 Testing at Baseline Who Also Had a Clinical Response After Last Dose of Study Treatment ZAP-70, Int, PD, n=6, 6	0 Participants	1 Participants
Number of Participants With Zeta-chain-associated Protein Kinase (ZAP) 70 Testing at Baseline Who Also Had a Clinical Response After Last Dose of Study Treatment ZAP-70, Int, SD, n=6, 6	1 Participants	0 Participants
Number of Participants With Zeta-chain-associated Protein Kinase (ZAP) 70 Testing at Baseline Who Also Had a Clinical Response After Last Dose of Study Treatment ZAP-70, Pos, CRi, n=36, 44	3 Participants	2 Participants
Number of Participants With Zeta-chain-associated Protein Kinase (ZAP) 70 Testing at Baseline Who Also Had a Clinical Response After Last Dose of Study Treatment ZAP-70, Pos, nPR, n=36, 44	5 Participants	8 Participants
Number of Participants With Zeta-chain-associated Protein Kinase (ZAP) 70 Testing at Baseline Who Also Had a Clinical Response After Last Dose of Study Treatment ZAP-70, Pos, PR, n=36, 44	11 Participants	17 Participants
Number of Participants With Zeta-chain-associated Protein Kinase (ZAP) 70 Testing at Baseline Who Also Had a Clinical Response After Last Dose of Study Treatment ZAP-70, Pos, PD, n=36, 44	0 Participants	7 Participants
Number of Participants With Zeta-chain-associated Protein Kinase (ZAP) 70 Testing at Baseline Who Also Had a Clinical Response After Last Dose of Study Treatment ZAP-70, Pos, SD, n=36, 44	0 Participants	5 Participants
Number of Participants With Zeta-chain-associated Protein Kinase (ZAP) 70 Testing at Baseline Who Also Had a Clinical Response After Last Dose of Study Treatment ZAP-70, Neg, nPR, n=2, 2	0 Participants	0 Participants
Number of Participants With Zeta-chain-associated Protein Kinase (ZAP) 70 Testing at Baseline Who Also Had a Clinical Response After Last Dose of Study Treatment ZAP-70, Neg, PR, n=2, 2	1 Participants	2 Participants
Number of Participants With Zeta-chain-associated Protein Kinase (ZAP) 70 Testing at Baseline Who Also Had a Clinical Response After Last Dose of Study Treatment ZAP-70, Neg, PD, n=2, 2	0 Participants	0 Participants
Number of Participants With Zeta-chain-associated Protein Kinase (ZAP) 70 Testing at Baseline Who Also Had a Clinical Response After Last Dose of Study Treatment ZAP-70, Neg, SD, n=2, 2	0 Participants	0 Participants

SECONDARY outcome

Timeframe: From the first dose of study medication to 60 days after the last dose of study medication (up to 24 hours after last dose of study treatment)

Population: Safety Population: All subjects who receive at least one dose of study medication.

An Infusion reaction is defined as events occurring after the beginning of an infusion of ofatumumab or within 24 hours following the end of an infusion of bendamustine.

Outcome measures

Outcome measures
Measure	Ofatumumab + Bendamustine 90 mg/m^2 n=44 Participants Participants with previously untreated CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 90 mg/m\^2 on Days 1 and 2 of each cycle (6 cycles).	Ofatumumab + Bendamustine 70 mg/m^2 n=53 Participants Participants with relapsed CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 70 mg/m\^2 on Days 1 and 2 of each cycle (6 cycles).
Number of Participants With an Adverse Event of Any Infusion Reactions (IR) or Serious Infusion Reactions (SIR) Any ofatumumab only IR	30 Participants	34 Participants
Number of Participants With an Adverse Event of Any Infusion Reactions (IR) or Serious Infusion Reactions (SIR) Any ofatumumab only SIR	3 Participants	4 Participants
Number of Participants With an Adverse Event of Any Infusion Reactions (IR) or Serious Infusion Reactions (SIR) Any ofatumumab plus bendamustine IR	30 Participants	35 Participants
Number of Participants With an Adverse Event of Any Infusion Reactions (IR) or Serious Infusion Reactions (SIR) Any ofatumumab plus bendamustine SIR	4 Participants	4 Participants

Adverse Events

Ofatumumab + Bendamustine 70mg/m^2

Serious events: 25 serious events

Other events: 49 other events

Deaths: 0 deaths

Ofatumumab + Bendamustine 90mg/m^2

Serious events: 20 serious events

Other events: 40 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Study Director

Novartis Pharmaceuticals

Phone: 862-778-8300

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial or disclosure of trial results in their entirety.
Publication restrictions are in place

Restriction type: OTHER