Trial Outcomes & Findings for Phase II Study of Ofatumumab Plus Ifosfamide, Carboplatin, Etoposide (ICE) or Dexamethasone, Cytarabine, Cisplatin (DHAP) Chemotherapy Regimen in Relapsed/ Refractory Diffuse Large B Cell Lymphoma (DLBCL) (NCT NCT00823719)

Last Updated: 2013-03-12

Results Overview

Responders with OR included participants with complete response (CR) and partial response (PR). This was based on adequate responses from the investigator assessment after the completion of treatment. CR: complete disappearance of all detectable clinical evidence of disease and disease-related symptoms. PR: at least a 50% decrease from baseline in the sum of the product of the diameters of target lesions.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

61 participants

Primary outcome timeframe

From Day 14 (Study Day 56) to Day 21 (approximately Study Day 63) of treatment Cycle 3, or earlier in the case of early withdrawal or missing response assessment for Cycle 3

Results posted on

2013-03-12

Participant Flow

Participant milestones

Participant milestones
Measure	Ofatumumab + DHAP Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy. Ofatumumab (1000 milligrams \[mg\]) was intravenously (IV) infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. The DHAP (dexamethasone, cytarabine, cisplatin) regimen (salvage chemotherapy) contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/square meter \[m\^2\]/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 gram (g)/m\^2 over 3 hours (hr) every 12 hr (2 doses) for each infusion on Day 2 of each cycle.	Ofatumumab + ICE Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy. Ofatumumab (1000 mg) was IV infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. The ICE (ifosfamide, carboplatin, etoposide) regimen (salvage chemotherapy) contained: etoposide (100 mg/m\^2/day) administered IV on Days 1, 2, and 3 of each cycle; carboplatin (up to 800 mg) on Day 2 of each cycle; and ifosfamide plus mesna, both at 5 g/m\^2/day as an IV continuous infusion on Day 2 of each cycle.
Overall Study STARTED	26	35
Overall Study COMPLETED	20	24
Overall Study NOT COMPLETED	6	11

Reasons for withdrawal

Reasons for withdrawal
Measure	Ofatumumab + DHAP Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy. Ofatumumab (1000 milligrams \[mg\]) was intravenously (IV) infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. The DHAP (dexamethasone, cytarabine, cisplatin) regimen (salvage chemotherapy) contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/square meter \[m\^2\]/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 gram (g)/m\^2 over 3 hours (hr) every 12 hr (2 doses) for each infusion on Day 2 of each cycle.	Ofatumumab + ICE Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy. Ofatumumab (1000 mg) was IV infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. The ICE (ifosfamide, carboplatin, etoposide) regimen (salvage chemotherapy) contained: etoposide (100 mg/m\^2/day) administered IV on Days 1, 2, and 3 of each cycle; carboplatin (up to 800 mg) on Day 2 of each cycle; and ifosfamide plus mesna, both at 5 g/m\^2/day as an IV continuous infusion on Day 2 of each cycle.
Overall Study Adverse Event	1	2
Overall Study Physician Decision	1	4
Overall Study Withdrawal by Subject	0	1
Overall Study Disease Progression	4	4

Baseline Characteristics

Phase II Study of Ofatumumab Plus Ifosfamide, Carboplatin, Etoposide (ICE) or Dexamethasone, Cytarabine, Cisplatin (DHAP) Chemotherapy Regimen in Relapsed/ Refractory Diffuse Large B Cell Lymphoma (DLBCL)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ofatumumab + DHAP n=26 Participants Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy. Ofatumumab (1000 milligrams \[mg\]) was intravenously (IV) infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. The DHAP (dexamethasone, cytarabine, cisplatin) regimen (salvage chemotherapy) contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/square meter \[m\^2\]/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 gram (g)/m\^2 over 3 hours (hr) every 12 hr (2 doses) for each infusion on Day 2 of each cycle.	Ofatumumab + ICE n=35 Participants Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy. Ofatumumab (1000 mg) was IV infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. The ICE (ifosfamide, carboplatin, etoposide) regimen (salvage chemotherapy) contained: etoposide (100 mg/m\^2/day) administered IV on Days 1, 2, and 3 of each cycle; carboplatin (up to 800 mg) on Day 2 of each cycle; and ifosfamide plus mesna, both at 5 g/m\^2/day as an IV continuous infusion on Day 2 of each cycle.	Total n=61 Participants Total of all reporting groups
Age Continuous	49.7 Years STANDARD_DEVIATION 13.79 • n=5 Participants	53.0 Years STANDARD_DEVIATION 13.02 • n=7 Participants	51.6 Years STANDARD_DEVIATION 13.34 • n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants	15 Participants n=7 Participants	26 Participants n=5 Participants
Sex: Female, Male Male	15 Participants n=5 Participants	20 Participants n=7 Participants	35 Participants n=5 Participants
Race/Ethnicity, Customized African American/African Heritage	2 participants n=5 Participants	2 participants n=7 Participants	4 participants n=5 Participants
Race/Ethnicity, Customized Asian-Central/South Asian Heritage	1 participants n=5 Participants	0 participants n=7 Participants	1 participants n=5 Participants
Race/Ethnicity, Customized Asian-Japanese/East or South East Asian Heritage	1 participants n=5 Participants	0 participants n=7 Participants	1 participants n=5 Participants
Race/Ethnicity, Customized White	22 participants n=5 Participants	33 participants n=7 Participants	55 participants n=5 Participants
Number of participants with the indicated number of risk factors 0 or 1	13 participants n=5 Participants	19 participants n=7 Participants	32 participants n=5 Participants
Number of participants with the indicated number of risk factors 2 or 3	13 participants n=5 Participants	16 participants n=7 Participants	29 participants n=5 Participants
Number of participants in the indicated categories per best response to first line treatment Late relapsers	4 participants n=5 Participants	8 participants n=7 Participants	12 participants n=5 Participants
Number of participants in the indicated categories per best response to first line treatment Early relapsers/Refractory	22 participants n=5 Participants	27 participants n=7 Participants	49 participants n=5 Participants

PRIMARY outcome

Timeframe: From Day 14 (Study Day 56) to Day 21 (approximately Study Day 63) of treatment Cycle 3, or earlier in the case of early withdrawal or missing response assessment for Cycle 3

Population: Per protocol (PP) Population: all participants who received at least one dose of ofatumumab. Participants with major protocol deviations that could have impacted the efficacy outcome, and participants not exposed to ofatumumab or without CD20+ aggressive lymphoma were excluded from assessment. CD, cluster of differentiation.

Outcome measures

Outcome measures
Measure	Ofatumumab + DHAP n=26 Participants Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy. Ofatumumab (1000 milligrams \[mg\]) was intravenously (IV) infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. The DHAP (dexamethasone, cytarabine, cisplatin) regimen (salvage chemotherapy) contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/square meter \[m\^2\]/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 gram (g)/m\^2 over 3 hours (hr) every 12 hr (2 doses) for each infusion on Day 2 of each cycle.	Ofatumumab + ICE n=33 Participants Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy. Ofatumumab (1000 mg) was IV infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. The ICE (ifosfamide, carboplatin, etoposide) regimen (salvage chemotherapy) contained: etoposide (100 mg/m\^2/day) administered IV on Days 1, 2, and 3 of each cycle; carboplatin (up to 800 mg) on Day 2 of each cycle; and ifosfamide plus mesna, both at 5 g/m\^2/day as an IV continuous infusion on Day 2 of each cycle.	Total Ofatumumab + Chemotherapy n=59 Participants Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy (either DHAP or ICE). Ofatumumab (1000 mg) was IV infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. DHAP contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/m\^2/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 g/m\^2 over 3 hr every 12 hr (2 doses) for each infusion on Day 2 of each cycle. ICE contained: etoposide (100 mg/m\^2/day) administered IV on Days 1, 2, and 3 of each cycle; carboplatin (up to 800 mg) on Day 2 of each cycle; and ifosfamide plus mesna, both at 5 g/m\^2/day as an IV continuous infusion on Day 2 of each cycle.
Number of Participants With Overall Response (OR), as Assessed by the Investigator	18 participants	18 participants	36 participants

SECONDARY outcome

Timeframe: From Day 14 (Study Day 56) to Day 21 (approximately Study Day 63) of treatment Cycle 3, or earlier in the case of early withdrawal or missing response assessment for Cycle 3

Population: PP Population

CR is defined as the complete disappearance of all detectable clinical evidence of disease and disease-related symptoms.

Outcome measures

Outcome measures
Measure	Ofatumumab + DHAP n=26 Participants Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy. Ofatumumab (1000 milligrams \[mg\]) was intravenously (IV) infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. The DHAP (dexamethasone, cytarabine, cisplatin) regimen (salvage chemotherapy) contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/square meter \[m\^2\]/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 gram (g)/m\^2 over 3 hours (hr) every 12 hr (2 doses) for each infusion on Day 2 of each cycle.	Ofatumumab + ICE n=33 Participants Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy. Ofatumumab (1000 mg) was IV infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. The ICE (ifosfamide, carboplatin, etoposide) regimen (salvage chemotherapy) contained: etoposide (100 mg/m\^2/day) administered IV on Days 1, 2, and 3 of each cycle; carboplatin (up to 800 mg) on Day 2 of each cycle; and ifosfamide plus mesna, both at 5 g/m\^2/day as an IV continuous infusion on Day 2 of each cycle.	Total Ofatumumab + Chemotherapy n=59 Participants Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy (either DHAP or ICE). Ofatumumab (1000 mg) was IV infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. DHAP contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/m\^2/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 g/m\^2 over 3 hr every 12 hr (2 doses) for each infusion on Day 2 of each cycle. ICE contained: etoposide (100 mg/m\^2/day) administered IV on Days 1, 2, and 3 of each cycle; carboplatin (up to 800 mg) on Day 2 of each cycle; and ifosfamide plus mesna, both at 5 g/m\^2/day as an IV continuous infusion on Day 2 of each cycle.
Number of Participants With CR, as Assessed by the Investigator	11 participants	11 participants	22 participants

SECONDARY outcome

Timeframe: During treatment Cycle 2 (Study Days 22-42) and/or Cycle 3 (Study Days 43-63)

Population: Stem Cell Mobilization Population. All participants in the PP Population in whom stem cell mobilization was attempted and CD34+ cell data are available.

CD34+ cells are a mixture of stem cells and white blood cells of various degrees of maturity. Stem cell mobilization is the process of stimulating the hematopoietic stem cells (CD34+) to move out of the bone marrow and into the bloodstream, where they can be collected via a process called apheresis. Successful mobilization was defined as the collection of \>2x10\^6 CD34+ cells/kg. Only those participants, who commenced mobilization, following the administration of ofatumumab in combination with either ICE or DHAP combination chemotherapy, were assessed.

Outcome measures

Outcome measures
Measure	Ofatumumab + DHAP n=23 Participants Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy. Ofatumumab (1000 milligrams \[mg\]) was intravenously (IV) infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. The DHAP (dexamethasone, cytarabine, cisplatin) regimen (salvage chemotherapy) contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/square meter \[m\^2\]/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 gram (g)/m\^2 over 3 hours (hr) every 12 hr (2 doses) for each infusion on Day 2 of each cycle.	Ofatumumab + ICE n=22 Participants Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy. Ofatumumab (1000 mg) was IV infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. The ICE (ifosfamide, carboplatin, etoposide) regimen (salvage chemotherapy) contained: etoposide (100 mg/m\^2/day) administered IV on Days 1, 2, and 3 of each cycle; carboplatin (up to 800 mg) on Day 2 of each cycle; and ifosfamide plus mesna, both at 5 g/m\^2/day as an IV continuous infusion on Day 2 of each cycle.	Total Ofatumumab + Chemotherapy n=45 Participants Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy (either DHAP or ICE). Ofatumumab (1000 mg) was IV infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. DHAP contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/m\^2/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 g/m\^2 over 3 hr every 12 hr (2 doses) for each infusion on Day 2 of each cycle. ICE contained: etoposide (100 mg/m\^2/day) administered IV on Days 1, 2, and 3 of each cycle; carboplatin (up to 800 mg) on Day 2 of each cycle; and ifosfamide plus mesna, both at 5 g/m\^2/day as an IV continuous infusion on Day 2 of each cycle.
Number of Participants With the Ability to Mobilize at Least 2 Million Cluster of Differentiation (CD)34+ Cells Per Kilogram (kg) From Peripheral Blood	23 participants	20 participants	43 participants

SECONDARY outcome

Timeframe: From Day 14 (Study Day 56) to Day 21 (approximately Study Day 63) of treatment Cycle 3, or earlier in the case of early withdrawal or missing response assessment for Cycle 3

Population: PP Population

PFS is defined as the interval of time between the date of treatment start and the earlier of the date of disease progression and the date of death due to any cause. Disease progression was based on the assessments locally by investigators for the disease under study. Disease progression was based on imaging data or clinical assessment data (if radiologic assessment data were not possible or assessment was not performed).

Outcome measures

Outcome measures
Measure	Ofatumumab + DHAP n=26 Participants Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy. Ofatumumab (1000 milligrams \[mg\]) was intravenously (IV) infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. The DHAP (dexamethasone, cytarabine, cisplatin) regimen (salvage chemotherapy) contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/square meter \[m\^2\]/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 gram (g)/m\^2 over 3 hours (hr) every 12 hr (2 doses) for each infusion on Day 2 of each cycle.	Ofatumumab + ICE n=33 Participants Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy. Ofatumumab (1000 mg) was IV infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. The ICE (ifosfamide, carboplatin, etoposide) regimen (salvage chemotherapy) contained: etoposide (100 mg/m\^2/day) administered IV on Days 1, 2, and 3 of each cycle; carboplatin (up to 800 mg) on Day 2 of each cycle; and ifosfamide plus mesna, both at 5 g/m\^2/day as an IV continuous infusion on Day 2 of each cycle.	Total Ofatumumab + Chemotherapy n=59 Participants Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy (either DHAP or ICE). Ofatumumab (1000 mg) was IV infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. DHAP contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/m\^2/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 g/m\^2 over 3 hr every 12 hr (2 doses) for each infusion on Day 2 of each cycle. ICE contained: etoposide (100 mg/m\^2/day) administered IV on Days 1, 2, and 3 of each cycle; carboplatin (up to 800 mg) on Day 2 of each cycle; and ifosfamide plus mesna, both at 5 g/m\^2/day as an IV continuous infusion on Day 2 of each cycle.
Progression-free Survival (PFS)	301.0 days Interval 152.0 to Medan survival follow-up was 208 days (6.8 months); therefore, there was not sufficient follow-up to provide an estimable upper limit of the confidence interval.	288.0 days Interval 177.0 to Medan survival follow-up was 208 days (6.8 months); therefore, there was not sufficient follow-up to provide an estimable upper limit of the confidence interval.	288.0 days Interval 184.0 to 349.0

SECONDARY outcome

Timeframe: From Day 14 (Study Day 56) to Day 21 (approximately Study Day 63) of treatment Cycle 3, or earlier in the case of early withdrawal or missing response assessment for Cycle 3

Population: PP Population

Overall survival is defined as the interval of time between the date of treatment start 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 + DHAP n=26 Participants Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy. Ofatumumab (1000 milligrams \[mg\]) was intravenously (IV) infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. The DHAP (dexamethasone, cytarabine, cisplatin) regimen (salvage chemotherapy) contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/square meter \[m\^2\]/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 gram (g)/m\^2 over 3 hours (hr) every 12 hr (2 doses) for each infusion on Day 2 of each cycle.	Ofatumumab + ICE n=33 Participants Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy. Ofatumumab (1000 mg) was IV infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. The ICE (ifosfamide, carboplatin, etoposide) regimen (salvage chemotherapy) contained: etoposide (100 mg/m\^2/day) administered IV on Days 1, 2, and 3 of each cycle; carboplatin (up to 800 mg) on Day 2 of each cycle; and ifosfamide plus mesna, both at 5 g/m\^2/day as an IV continuous infusion on Day 2 of each cycle.	Total Ofatumumab + Chemotherapy n=59 Participants Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy (either DHAP or ICE). Ofatumumab (1000 mg) was IV infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. DHAP contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/m\^2/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 g/m\^2 over 3 hr every 12 hr (2 doses) for each infusion on Day 2 of each cycle. ICE contained: etoposide (100 mg/m\^2/day) administered IV on Days 1, 2, and 3 of each cycle; carboplatin (up to 800 mg) on Day 2 of each cycle; and ifosfamide plus mesna, both at 5 g/m\^2/day as an IV continuous infusion on Day 2 of each cycle.
Overall Survival	433.0 days Interval 166.0 to Medan survival follow-up was 208 days (6.8 months); therefore, there was not sufficient follow-up to provide an estimable upper limit (UL) of the confidence interval (CI).	NA days Interval 320.0 to Half of the participants assessed did not die by the time of assessment; therefore, the median was not reached. Medan survival follow-up was 208 days (6.8 months); therefore, there was not sufficient follow-up to provide an estimable UL of the CL.	508.0 days Interval 369.0 to Medan survival follow-up was 208 days (6.8 months); therefore, there was not sufficient follow-up to provide an estimable upper limit of the confidence interval.

SECONDARY outcome

Timeframe: Cycle 1 Day 1 (Study Day 1; up to 1 week) and Cycle 3 (Study Day 43; up to 6 weeks)

Population: Pharmacokinetic Population: all participants (par.) exposed to ofatumumab from whom a pharmacokinetic sample was obtained and analyzed. Data for par. who switched chemotherapy regimen are not included in the summaries by chemotherapy after the switch but are included in the total summaries. Data are provided for the par. attending each visit.

AUC is defined as the area under the ofatumumab (Ofa) concentration-time curve as a measure of drug exposure. AUC(0-inf) is AUC from the start of infusion extrapolated to infinite time. Results are reported by first dose group and combined, as appropriate.

Outcome measures

Outcome measures
Measure	Ofatumumab + DHAP n=26 Participants Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy. Ofatumumab (1000 milligrams \[mg\]) was intravenously (IV) infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. The DHAP (dexamethasone, cytarabine, cisplatin) regimen (salvage chemotherapy) contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/square meter \[m\^2\]/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 gram (g)/m\^2 over 3 hours (hr) every 12 hr (2 doses) for each infusion on Day 2 of each cycle.	Ofatumumab + ICE n=35 Participants Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy. Ofatumumab (1000 mg) was IV infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. The ICE (ifosfamide, carboplatin, etoposide) regimen (salvage chemotherapy) contained: etoposide (100 mg/m\^2/day) administered IV on Days 1, 2, and 3 of each cycle; carboplatin (up to 800 mg) on Day 2 of each cycle; and ifosfamide plus mesna, both at 5 g/m\^2/day as an IV continuous infusion on Day 2 of each cycle.	Total Ofatumumab + Chemotherapy n=61 Participants Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy (either DHAP or ICE). Ofatumumab (1000 mg) was IV infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. DHAP contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/m\^2/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 g/m\^2 over 3 hr every 12 hr (2 doses) for each infusion on Day 2 of each cycle. ICE contained: etoposide (100 mg/m\^2/day) administered IV on Days 1, 2, and 3 of each cycle; carboplatin (up to 800 mg) on Day 2 of each cycle; and ifosfamide plus mesna, both at 5 g/m\^2/day as an IV continuous infusion on Day 2 of each cycle.
Area Under the Concentration-time Curve From Time Zero to Infinity, AUC(0-inf), of Ofatumumab at the First Infusion (Cycle 1, Day 1) and the Last Infusion (Cycle 3) Cycle 1 Day 1, 300 mg; n=4, 17, 21	34056 µg*hr/mL Geometric Coefficient of Variation 0.14	33606 µg*hr/mL Geometric Coefficient of Variation 0.15	33691 µg*hr/mL Geometric Coefficient of Variation 0.14
Area Under the Concentration-time Curve From Time Zero to Infinity, AUC(0-inf), of Ofatumumab at the First Infusion (Cycle 1, Day 1) and the Last Infusion (Cycle 3) Cycle 1 Day 1, 1000 mg; n=22, 18, 40	115741 µg*hr/mL Geometric Coefficient of Variation 0.16	105898 µg*hr/mL Geometric Coefficient of Variation 0.14	111203 µg*hr/mL Geometric Coefficient of Variation 0.16
Area Under the Concentration-time Curve From Time Zero to Infinity, AUC(0-inf), of Ofatumumab at the First Infusion (Cycle 1, Day 1) and the Last Infusion (Cycle 3) Cycle 3, 300 mg; n=4, 6, 10	222713 µg*hr/mL Geometric Coefficient of Variation 0.23	206389 µg*hr/mL Geometric Coefficient of Variation 0.06	212770 µg*hr/mL Geometric Coefficient of Variation 0.14
Area Under the Concentration-time Curve From Time Zero to Infinity, AUC(0-inf), of Ofatumumab at the First Infusion (Cycle 1, Day 1) and the Last Infusion (Cycle 3) Cycle 3, 1000 mg; n=14, 13, 30	258487 µg*hr/mL Geometric Coefficient of Variation 0.21	216885 µg*hr/mL Geometric Coefficient of Variation 0.17	232310 µg*hr/mL Geometric Coefficient of Variation 0.21
Area Under the Concentration-time Curve From Time Zero to Infinity, AUC(0-inf), of Ofatumumab at the First Infusion (Cycle 1, Day 1) and the Last Infusion (Cycle 3) Cycle 3, both doses; n=18, 19, 40	250070 µg*hr/mL Geometric Coefficient of Variation 0.22	213514 µg*hr/mL Geometric Coefficient of Variation 0.14	227263 µg*hr/mL Geometric Coefficient of Variation 0.20

SECONDARY outcome

Timeframe: Cycle 3 (Study Day 43; 3 weeks)

Population: Pharmacokinetic Population. Data for participants who switched chemotherapy regimen are not included in the summaries by chemotherapy after the switch but are included in the total summaries. Data are provided for the number of participants attending each visit. Results are reported by first dose group and combined, as appropriate.

AUC(0-tau) is the area under the plasma concentration-time curve from time zero (0) over the dosing interval, tau, and is a measure of drug exposure. Tau is 21 days (504 hours) in this study.

Outcome measures

Outcome measures
Measure	Ofatumumab + DHAP n=26 Participants Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy. Ofatumumab (1000 milligrams \[mg\]) was intravenously (IV) infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. The DHAP (dexamethasone, cytarabine, cisplatin) regimen (salvage chemotherapy) contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/square meter \[m\^2\]/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 gram (g)/m\^2 over 3 hours (hr) every 12 hr (2 doses) for each infusion on Day 2 of each cycle.	Ofatumumab + ICE n=35 Participants Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy. Ofatumumab (1000 mg) was IV infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. The ICE (ifosfamide, carboplatin, etoposide) regimen (salvage chemotherapy) contained: etoposide (100 mg/m\^2/day) administered IV on Days 1, 2, and 3 of each cycle; carboplatin (up to 800 mg) on Day 2 of each cycle; and ifosfamide plus mesna, both at 5 g/m\^2/day as an IV continuous infusion on Day 2 of each cycle.	Total Ofatumumab + Chemotherapy n=61 Participants Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy (either DHAP or ICE). Ofatumumab (1000 mg) was IV infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. DHAP contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/m\^2/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 g/m\^2 over 3 hr every 12 hr (2 doses) for each infusion on Day 2 of each cycle. ICE contained: etoposide (100 mg/m\^2/day) administered IV on Days 1, 2, and 3 of each cycle; carboplatin (up to 800 mg) on Day 2 of each cycle; and ifosfamide plus mesna, both at 5 g/m\^2/day as an IV continuous infusion on Day 2 of each cycle.
Area Under the Concentration-time Curve During the Dosing Interval (AUC(0-tau)) of Ofatumumab at the Last Infusion (Cycle 3) Cycle 3, 300 mg; n=4, 6, 10	95112 µg*hr/mL Geometric Coefficient of Variation 0.09	83385 µg*hr/mL Geometric Coefficient of Variation 0.33	87891 µg*hr/mL Geometric Coefficient of Variation 0.26
Area Under the Concentration-time Curve During the Dosing Interval (AUC(0-tau)) of Ofatumumab at the Last Infusion (Cycle 3) Cycle 3, 1000 mg; n=14, 13, 30	112676 µg*hr/mL Geometric Coefficient of Variation 0.22	95341 µg*hr/mL Geometric Coefficient of Variation 0.15	101948 µg*hr/mL Geometric Coefficient of Variation 0.21
Area Under the Concentration-time Curve During the Dosing Interval (AUC(0-tau)) of Ofatumumab at the Last Infusion (Cycle 3) Cycle 3 both doses; n=18, 19, 40	108511 µg*hr/mL Geometric Coefficient of Variation 0.21	91391 µg*hr/mL Geometric Coefficient of Variation 0.22	98236 µg*hr/mL Geometric Coefficient of Variation 0.23

SECONDARY outcome

Timeframe: Study Day 1 up to Study Day 85 (up to 12 weeks)

Population: Pharmacokinetic Population

CL is the clearance of drug from plasma, which is defined as the volume of plasma from which drug is removed per unit time.

Outcome measures

Outcome measures
Measure	Ofatumumab + DHAP n=26 Participants Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy. Ofatumumab (1000 milligrams \[mg\]) was intravenously (IV) infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. The DHAP (dexamethasone, cytarabine, cisplatin) regimen (salvage chemotherapy) contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/square meter \[m\^2\]/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 gram (g)/m\^2 over 3 hours (hr) every 12 hr (2 doses) for each infusion on Day 2 of each cycle.	Ofatumumab + ICE n=35 Participants Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy. Ofatumumab (1000 mg) was IV infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. The ICE (ifosfamide, carboplatin, etoposide) regimen (salvage chemotherapy) contained: etoposide (100 mg/m\^2/day) administered IV on Days 1, 2, and 3 of each cycle; carboplatin (up to 800 mg) on Day 2 of each cycle; and ifosfamide plus mesna, both at 5 g/m\^2/day as an IV continuous infusion on Day 2 of each cycle.	Total Ofatumumab + Chemotherapy n=61 Participants Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy (either DHAP or ICE). Ofatumumab (1000 mg) was IV infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. DHAP contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/m\^2/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 g/m\^2 over 3 hr every 12 hr (2 doses) for each infusion on Day 2 of each cycle. ICE contained: etoposide (100 mg/m\^2/day) administered IV on Days 1, 2, and 3 of each cycle; carboplatin (up to 800 mg) on Day 2 of each cycle; and ifosfamide plus mesna, both at 5 g/m\^2/day as an IV continuous infusion on Day 2 of each cycle.
Clearance (CL) of Ofatumumab	8.7 mL/hr Geometric Coefficient of Variation 0.15	9.2 mL/hr Geometric Coefficient of Variation 0.14	9.0 mL/hr Geometric Coefficient of Variation 0.15

SECONDARY outcome

Timeframe: Cycle 1 Day 1 (Study Day 1; up to 48 hours), Cycle 1 Day 8 (Study Day 8; up to 24 hours), Cycle 3 (Study Day 43; up to 48 hours)

Cmax is defined as the maximum concentration of drug in plasma samples for the dosing occasion.

Outcome measures

Outcome measures
Measure	Ofatumumab + DHAP n=26 Participants Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy. Ofatumumab (1000 milligrams \[mg\]) was intravenously (IV) infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. The DHAP (dexamethasone, cytarabine, cisplatin) regimen (salvage chemotherapy) contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/square meter \[m\^2\]/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 gram (g)/m\^2 over 3 hours (hr) every 12 hr (2 doses) for each infusion on Day 2 of each cycle.	Ofatumumab + ICE n=35 Participants Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy. Ofatumumab (1000 mg) was IV infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. The ICE (ifosfamide, carboplatin, etoposide) regimen (salvage chemotherapy) contained: etoposide (100 mg/m\^2/day) administered IV on Days 1, 2, and 3 of each cycle; carboplatin (up to 800 mg) on Day 2 of each cycle; and ifosfamide plus mesna, both at 5 g/m\^2/day as an IV continuous infusion on Day 2 of each cycle.	Total Ofatumumab + Chemotherapy n=61 Participants Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy (either DHAP or ICE). Ofatumumab (1000 mg) was IV infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. DHAP contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/m\^2/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 g/m\^2 over 3 hr every 12 hr (2 doses) for each infusion on Day 2 of each cycle. ICE contained: etoposide (100 mg/m\^2/day) administered IV on Days 1, 2, and 3 of each cycle; carboplatin (up to 800 mg) on Day 2 of each cycle; and ifosfamide plus mesna, both at 5 g/m\^2/day as an IV continuous infusion on Day 2 of each cycle.
Maximum Plasma Concentration (Cmax) of Ofatumumab at the First Infusion (Cycle 1 Day 1), Second Infusion (Cycle 1 Day 8), and Last Infusion (Cycle 3) Cycle 1 Day 1, 300 mg; n=4, 17, 21	89.8 µg/mL Geometric Coefficient of Variation 0.08	80.0 µg/mL Geometric Coefficient of Variation 0.63	81.8 µg/mL Geometric Coefficient of Variation 0.56
Maximum Plasma Concentration (Cmax) of Ofatumumab at the First Infusion (Cycle 1 Day 1), Second Infusion (Cycle 1 Day 8), and Last Infusion (Cycle 3) Cycle 1 Day 1, 1000 mg; n=22, 18, 40	323 µg/mL Geometric Coefficient of Variation 0.40	268 µg/mL Geometric Coefficient of Variation 0.30	297 µg/mL Geometric Coefficient of Variation 0.37
Maximum Plasma Concentration (Cmax) of Ofatumumab at the First Infusion (Cycle 1 Day 1), Second Infusion (Cycle 1 Day 8), and Last Infusion (Cycle 3) Cycle 1 Day 8, 300 mg; n=4, 13, 17	245 µg/mL Geometric Coefficient of Variation 0.10	273 µg/mL Geometric Coefficient of Variation 0.28	266 µg/mL Geometric Coefficient of Variation 0.25
Maximum Plasma Concentration (Cmax) of Ofatumumab at the First Infusion (Cycle 1 Day 1), Second Infusion (Cycle 1 Day 8), and Last Infusion (Cycle 3) Cycle 1 Day 8, 1000 mg; n=21, 18, 39	431 µg/mL Geometric Coefficient of Variation 0.23	368 µg/mL Geometric Coefficient of Variation 0.21	401 µg/mL Geometric Coefficient of Variation 0.23
Maximum Plasma Concentration (Cmax) of Ofatumumab at the First Infusion (Cycle 1 Day 1), Second Infusion (Cycle 1 Day 8), and Last Infusion (Cycle 3) Cycle 3, 300 mg; n=4, 11, 15	416 µg/mL Geometric Coefficient of Variation 0.24	417 µg/mL Geometric Coefficient of Variation 0.26	417 µg/mL Geometric Coefficient of Variation 0.24
Maximum Plasma Concentration (Cmax) of Ofatumumab at the First Infusion (Cycle 1 Day 1), Second Infusion (Cycle 1 Day 8), and Last Infusion (Cycle 3) Cycle 3, 1000 mg; n=14, 14, 33	466 µg/mL Geometric Coefficient of Variation 0.31	397 µg/mL Geometric Coefficient of Variation 0.18	421 µg/mL Geometric Coefficient of Variation 0.25
Maximum Plasma Concentration (Cmax) of Ofatumumab at the First Infusion (Cycle 1 Day 1), Second Infusion (Cycle 1 Day 8), and Last Infusion (Cycle 3) Cycle 3, both doses; n=18, 25, 48	455 µg/mL Geometric Coefficient of Variation 0.29	406 µg/mL Geometric Coefficient of Variation 0.21	420 µg/mL Geometric Coefficient of Variation 0.25

SECONDARY outcome

Timeframe: Cycle 1 Day 8 (Study Day 8; up to 8 hours prior to infusion start), Cycle 2 (Study Day 22; up to 7 hours prior to infusion start), Cycle 3 (Study Day 43; up to 6 hours prior to infusion start)

Ctrough is defined as the trough plasma concentration, which is the measured concentration at the end of a dosing interval (taken directly before the start of the next infusion).

Outcome measures

Outcome measures
Measure	Ofatumumab + DHAP n=26 Participants Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy. Ofatumumab (1000 milligrams \[mg\]) was intravenously (IV) infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. The DHAP (dexamethasone, cytarabine, cisplatin) regimen (salvage chemotherapy) contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/square meter \[m\^2\]/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 gram (g)/m\^2 over 3 hours (hr) every 12 hr (2 doses) for each infusion on Day 2 of each cycle.	Ofatumumab + ICE n=35 Participants Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy. Ofatumumab (1000 mg) was IV infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. The ICE (ifosfamide, carboplatin, etoposide) regimen (salvage chemotherapy) contained: etoposide (100 mg/m\^2/day) administered IV on Days 1, 2, and 3 of each cycle; carboplatin (up to 800 mg) on Day 2 of each cycle; and ifosfamide plus mesna, both at 5 g/m\^2/day as an IV continuous infusion on Day 2 of each cycle.	Total Ofatumumab + Chemotherapy n=61 Participants Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy (either DHAP or ICE). Ofatumumab (1000 mg) was IV infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. DHAP contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/m\^2/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 g/m\^2 over 3 hr every 12 hr (2 doses) for each infusion on Day 2 of each cycle. ICE contained: etoposide (100 mg/m\^2/day) administered IV on Days 1, 2, and 3 of each cycle; carboplatin (up to 800 mg) on Day 2 of each cycle; and ifosfamide plus mesna, both at 5 g/m\^2/day as an IV continuous infusion on Day 2 of each cycle.
Trough Plasma Concentration (Ctrough) of Ofatumumab Prior to Second Infusion (Cycle 1 Day 8), Third Infusion (Cycle 2), and Last Infusion (Cycle 3) Cycle 3, both doses; n=22, 31, 57	146 µg/mL Geometric Coefficient of Variation 0.41	100 µg/mL Geometric Coefficient of Variation 0.59	117 µg/mL Geometric Coefficient of Variation 0.54
Trough Plasma Concentration (Ctrough) of Ofatumumab Prior to Second Infusion (Cycle 1 Day 8), Third Infusion (Cycle 2), and Last Infusion (Cycle 3) Cycle 1 Day 8, 300 mg; n=4, 15, 19	31.8 µg/mL Geometric Coefficient of Variation 0.19	28.3 µg/mL Geometric Coefficient of Variation 0.93	29.1 µg/mL Geometric Coefficient of Variation 0.79
Trough Plasma Concentration (Ctrough) of Ofatumumab Prior to Second Infusion (Cycle 1 Day 8), Third Infusion (Cycle 2), and Last Infusion (Cycle 3) Cycle 1 Day 8, 1000 mg; n=19, 18, 37	95.8 µg/mL Geometric Coefficient of Variation 1.63	106 µg/mL Geometric Coefficient of Variation 0.23	101 µg/mL Geometric Coefficient of Variation 0.98
Trough Plasma Concentration (Ctrough) of Ofatumumab Prior to Second Infusion (Cycle 1 Day 8), Third Infusion (Cycle 2), and Last Infusion (Cycle 3) Cycle 2, 300 mg; n=4, 16, 20	112 µg/mL Geometric Coefficient of Variation 0.28	71.5 µg/mL Geometric Coefficient of Variation 0.81	78.2 µg/mL Geometric Coefficient of Variation 0.75
Trough Plasma Concentration (Ctrough) of Ofatumumab Prior to Second Infusion (Cycle 1 Day 8), Third Infusion (Cycle 2), and Last Infusion (Cycle 3) Cycle 2, 1000 mg; n=21, 18, 39	138 µg/mL Geometric Coefficient of Variation 0.49	147 µg/mL Geometric Coefficient of Variation 0.21	142 µg/mL Geometric Coefficient of Variation 0.38
Trough Plasma Concentration (Ctrough) of Ofatumumab Prior to Second Infusion (Cycle 1 Day 8), Third Infusion (Cycle 2), and Last Infusion (Cycle 3) Cycle 3, 300 mg; n=4, 13, 17	120 µg/mL Geometric Coefficient of Variation 0.26	76.7 µg/mL Geometric Coefficient of Variation 0.65	85.2 µg/mL Geometric Coefficient of Variation 0.60
Trough Plasma Concentration (Ctrough) of Ofatumumab Prior to Second Infusion (Cycle 1 Day 8), Third Infusion (Cycle 2), and Last Infusion (Cycle 3) Cycle 3, 1000 mg; n=18, 18, 40	153 µg/mL Geometric Coefficient of Variation 0.43	122 µg/mL Geometric Coefficient of Variation 0.45	134 µg/mL Geometric Coefficient of Variation 0.44

SECONDARY outcome

Timeframe: Study Day 1 up to Study Day 85 (up to 12 weeks)

Population: Pharmacokinetic Population

t1/2 is defined as terminal phase half-life, which is the time required for the amount of the drug in the body to decrease by half.

Outcome measures

Outcome measures
Measure	Ofatumumab + DHAP n=26 Participants Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy. Ofatumumab (1000 milligrams \[mg\]) was intravenously (IV) infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. The DHAP (dexamethasone, cytarabine, cisplatin) regimen (salvage chemotherapy) contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/square meter \[m\^2\]/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 gram (g)/m\^2 over 3 hours (hr) every 12 hr (2 doses) for each infusion on Day 2 of each cycle.	Ofatumumab + ICE n=35 Participants Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy. Ofatumumab (1000 mg) was IV infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. The ICE (ifosfamide, carboplatin, etoposide) regimen (salvage chemotherapy) contained: etoposide (100 mg/m\^2/day) administered IV on Days 1, 2, and 3 of each cycle; carboplatin (up to 800 mg) on Day 2 of each cycle; and ifosfamide plus mesna, both at 5 g/m\^2/day as an IV continuous infusion on Day 2 of each cycle.	Total Ofatumumab + Chemotherapy n=61 Participants Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy (either DHAP or ICE). Ofatumumab (1000 mg) was IV infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. DHAP contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/m\^2/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 g/m\^2 over 3 hr every 12 hr (2 doses) for each infusion on Day 2 of each cycle. ICE contained: etoposide (100 mg/m\^2/day) administered IV on Days 1, 2, and 3 of each cycle; carboplatin (up to 800 mg) on Day 2 of each cycle; and ifosfamide plus mesna, both at 5 g/m\^2/day as an IV continuous infusion on Day 2 of each cycle.
Terminal Phase Half-life (t1/2) of Ofatumumab	595 hr Geometric Coefficient of Variation 0.35	646 hr Geometric Coefficient of Variation 0.47	624 hr Geometric Coefficient of Variation 0.42

SECONDARY outcome

Timeframe: Study Day 1 up to Study Day 85 (up to 12 weeks)

Population: Pharmacokinetic Population

Vss is the apparent volume of distribution when plasma concentrations are measured under steady state conditions. At steady state, the plasma concentration-time profile of the drug is similar after each dose.

Outcome measures

Outcome measures
Measure	Ofatumumab + DHAP n=26 Participants Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy. Ofatumumab (1000 milligrams \[mg\]) was intravenously (IV) infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. The DHAP (dexamethasone, cytarabine, cisplatin) regimen (salvage chemotherapy) contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/square meter \[m\^2\]/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 gram (g)/m\^2 over 3 hours (hr) every 12 hr (2 doses) for each infusion on Day 2 of each cycle.	Ofatumumab + ICE n=35 Participants Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy. Ofatumumab (1000 mg) was IV infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. The ICE (ifosfamide, carboplatin, etoposide) regimen (salvage chemotherapy) contained: etoposide (100 mg/m\^2/day) administered IV on Days 1, 2, and 3 of each cycle; carboplatin (up to 800 mg) on Day 2 of each cycle; and ifosfamide plus mesna, both at 5 g/m\^2/day as an IV continuous infusion on Day 2 of each cycle.	Total Ofatumumab + Chemotherapy n=61 Participants Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy (either DHAP or ICE). Ofatumumab (1000 mg) was IV infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. DHAP contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/m\^2/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 g/m\^2 over 3 hr every 12 hr (2 doses) for each infusion on Day 2 of each cycle. ICE contained: etoposide (100 mg/m\^2/day) administered IV on Days 1, 2, and 3 of each cycle; carboplatin (up to 800 mg) on Day 2 of each cycle; and ifosfamide plus mesna, both at 5 g/m\^2/day as an IV continuous infusion on Day 2 of each cycle.
Volume of Distribution at Steady State (Vss) of Ofatumumab	7.12 Liters Geometric Coefficient of Variation 0.38	8.13 Liters Geometric Coefficient of Variation 0.50	7.68 Liters Geometric Coefficient of Variation 0.46

SECONDARY outcome

Timeframe: Study Day 1 up to approximately Study Day 63

Population: Safety Population. Data are presented for those participants who contributed a sample.

Human anti-human antibodies (HAHA) indicate immune response to the administered human monoclonal antibody in a two-step assay. A positive screening result is confirmed in a second step. Negative Conclusive is subset of Negative and is a negative HAHA test result with an ofatumumab concentration \<200 µg/mL in a pharmacokinetic sample collected at the same time as the HAHA sample. Data are presented when a HAHA sample was collected. WD, withdrawal; FU, follow up.

Outcome measures

Outcome measures
Measure	Ofatumumab + DHAP n=26 Participants Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy. Ofatumumab (1000 milligrams \[mg\]) was intravenously (IV) infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. The DHAP (dexamethasone, cytarabine, cisplatin) regimen (salvage chemotherapy) contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/square meter \[m\^2\]/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 gram (g)/m\^2 over 3 hours (hr) every 12 hr (2 doses) for each infusion on Day 2 of each cycle.	Ofatumumab + ICE n=35 Participants Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy. Ofatumumab (1000 mg) was IV infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. The ICE (ifosfamide, carboplatin, etoposide) regimen (salvage chemotherapy) contained: etoposide (100 mg/m\^2/day) administered IV on Days 1, 2, and 3 of each cycle; carboplatin (up to 800 mg) on Day 2 of each cycle; and ifosfamide plus mesna, both at 5 g/m\^2/day as an IV continuous infusion on Day 2 of each cycle.	Total Ofatumumab + Chemotherapy n=61 Participants Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy (either DHAP or ICE). Ofatumumab (1000 mg) was IV infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. DHAP contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/m\^2/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 g/m\^2 over 3 hr every 12 hr (2 doses) for each infusion on Day 2 of each cycle. ICE contained: etoposide (100 mg/m\^2/day) administered IV on Days 1, 2, and 3 of each cycle; carboplatin (up to 800 mg) on Day 2 of each cycle; and ifosfamide plus mesna, both at 5 g/m\^2/day as an IV continuous infusion on Day 2 of each cycle.
Number of Participants Who Were Positive and Negative for Human Anti-human Antibodies (HAHA) at the Indicated Time Points Positive at Day 1; n=26, 35, 61	0 participants	0 participants	0 participants
Number of Participants Who Were Positive and Negative for Human Anti-human Antibodies (HAHA) at the Indicated Time Points Negative at Day 1; n=26, 35, 61	26 participants	35 participants	61 participants
Number of Participants Who Were Positive and Negative for Human Anti-human Antibodies (HAHA) at the Indicated Time Points Positive at Early WD or FU; n=24, 30, 54	0 participants	0 participants	0 participants
Number of Participants Who Were Positive and Negative for Human Anti-human Antibodies (HAHA) at the Indicated Time Points Negative at Early WD or FU; n=24, 30, 54	24 participants	30 participants	54 participants
Number of Participants Who Were Positive and Negative for Human Anti-human Antibodies (HAHA) at the Indicated Time Points Negative conclusive at Early WD or FU; n=24, 30, 5	18 participants	28 participants	46 participants

SECONDARY outcome

Timeframe: Study Day 1 to approximately Study Day 63

Population: Safety Population

Neutropenia is defined as an abnormal decrease in the number of neutrophils (type of white blood cell in blood) in the blood. Febrile neutropenia is the development of fever in participants with neutropenia. Pancytopenia is defined as inadequate blood-cell formation by bone marrow, resulting in a lack of all blood-cell types.

Outcome measures

Outcome measures
Measure	Ofatumumab + DHAP n=26 Participants Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy. Ofatumumab (1000 milligrams \[mg\]) was intravenously (IV) infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. The DHAP (dexamethasone, cytarabine, cisplatin) regimen (salvage chemotherapy) contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/square meter \[m\^2\]/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 gram (g)/m\^2 over 3 hours (hr) every 12 hr (2 doses) for each infusion on Day 2 of each cycle.	Ofatumumab + ICE n=35 Participants Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy. Ofatumumab (1000 mg) was IV infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. The ICE (ifosfamide, carboplatin, etoposide) regimen (salvage chemotherapy) contained: etoposide (100 mg/m\^2/day) administered IV on Days 1, 2, and 3 of each cycle; carboplatin (up to 800 mg) on Day 2 of each cycle; and ifosfamide plus mesna, both at 5 g/m\^2/day as an IV continuous infusion on Day 2 of each cycle.	Total Ofatumumab + Chemotherapy n=61 Participants Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy (either DHAP or ICE). Ofatumumab (1000 mg) was IV infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. DHAP contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/m\^2/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 g/m\^2 over 3 hr every 12 hr (2 doses) for each infusion on Day 2 of each cycle. ICE contained: etoposide (100 mg/m\^2/day) administered IV on Days 1, 2, and 3 of each cycle; carboplatin (up to 800 mg) on Day 2 of each cycle; and ifosfamide plus mesna, both at 5 g/m\^2/day as an IV continuous infusion on Day 2 of each cycle.
Number of Participants With the Indicated Adverse Events (AEs) Associated With Neutropenia Any Event of Decreased Neutrophils; n=26, 35, 61	12 participants	11 participants	23 participants
Number of Participants With the Indicated Adverse Events (AEs) Associated With Neutropenia Neutropenia; n=12, 11, 23	7 participants	11 participants	18 participants
Number of Participants With the Indicated Adverse Events (AEs) Associated With Neutropenia Febrile Neutropenia; n=12, 11, 23	8 participants	1 participants	9 participants
Number of Participants With the Indicated Adverse Events (AEs) Associated With Neutropenia Pancytopenia; n=12, 11, 23	1 participants	0 participants	1 participants

SECONDARY outcome

Timeframe: Study Day 1 to approximately Study Day 63

Population: Safety Population

Anaemia is defined as a pathological deficiency in the oxygen-carrying component of the blood, measured in unit volume concentrations of hemoglobin, red blood-cell volume, or red blood-cell number. Pancytopenia is defined as inadequate blood-cell formation by bone marrow, resulting in a lack of all blood-cell types.

Outcome measures

Outcome measures
Measure	Ofatumumab + DHAP n=26 Participants Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy. Ofatumumab (1000 milligrams \[mg\]) was intravenously (IV) infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. The DHAP (dexamethasone, cytarabine, cisplatin) regimen (salvage chemotherapy) contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/square meter \[m\^2\]/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 gram (g)/m\^2 over 3 hours (hr) every 12 hr (2 doses) for each infusion on Day 2 of each cycle.	Ofatumumab + ICE n=35 Participants Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy. Ofatumumab (1000 mg) was IV infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. The ICE (ifosfamide, carboplatin, etoposide) regimen (salvage chemotherapy) contained: etoposide (100 mg/m\^2/day) administered IV on Days 1, 2, and 3 of each cycle; carboplatin (up to 800 mg) on Day 2 of each cycle; and ifosfamide plus mesna, both at 5 g/m\^2/day as an IV continuous infusion on Day 2 of each cycle.	Total Ofatumumab + Chemotherapy n=61 Participants Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy (either DHAP or ICE). Ofatumumab (1000 mg) was IV infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. DHAP contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/m\^2/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 g/m\^2 over 3 hr every 12 hr (2 doses) for each infusion on Day 2 of each cycle. ICE contained: etoposide (100 mg/m\^2/day) administered IV on Days 1, 2, and 3 of each cycle; carboplatin (up to 800 mg) on Day 2 of each cycle; and ifosfamide plus mesna, both at 5 g/m\^2/day as an IV continuous infusion on Day 2 of each cycle.
Number of Participants With the Indicated AEs Associated With Decreased Hemoglobin Counts Pancytopenia; n=16, 18, 34	1 participants	0 participants	1 participants
Number of Participants With the Indicated AEs Associated With Decreased Hemoglobin Counts Any Event of Decreased Hemoglobin; n=26, 35, 61	16 participants	18 participants	34 participants
Number of Participants With the Indicated AEs Associated With Decreased Hemoglobin Counts Anaemia; n=16, 18, 34	14 participants	16 participants	30 participants
Number of Participants With the Indicated AEs Associated With Decreased Hemoglobin Counts Haemoglobin Decreased; n=16, 18, 34	3 participants	2 participants	5 participants

SECONDARY outcome

Timeframe: Study Day 1 to approximately Study Day 63

Population: Safety Population

Thrombocytopenia is defined as an abnormal decrease in the number of platelets in circulatory blood. Pancytopenia is defined as inadequate blood-cell formation by bone marrow, resulting in a lack of all blood-cell types.

Outcome measures

Outcome measures
Measure	Ofatumumab + DHAP n=26 Participants Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy. Ofatumumab (1000 milligrams \[mg\]) was intravenously (IV) infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. The DHAP (dexamethasone, cytarabine, cisplatin) regimen (salvage chemotherapy) contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/square meter \[m\^2\]/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 gram (g)/m\^2 over 3 hours (hr) every 12 hr (2 doses) for each infusion on Day 2 of each cycle.	Ofatumumab + ICE n=35 Participants Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy. Ofatumumab (1000 mg) was IV infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. The ICE (ifosfamide, carboplatin, etoposide) regimen (salvage chemotherapy) contained: etoposide (100 mg/m\^2/day) administered IV on Days 1, 2, and 3 of each cycle; carboplatin (up to 800 mg) on Day 2 of each cycle; and ifosfamide plus mesna, both at 5 g/m\^2/day as an IV continuous infusion on Day 2 of each cycle.	Total Ofatumumab + Chemotherapy n=61 Participants Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy (either DHAP or ICE). Ofatumumab (1000 mg) was IV infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. DHAP contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/m\^2/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 g/m\^2 over 3 hr every 12 hr (2 doses) for each infusion on Day 2 of each cycle. ICE contained: etoposide (100 mg/m\^2/day) administered IV on Days 1, 2, and 3 of each cycle; carboplatin (up to 800 mg) on Day 2 of each cycle; and ifosfamide plus mesna, both at 5 g/m\^2/day as an IV continuous infusion on Day 2 of each cycle.
Number of Participants With the Indicated AEs Associated With Decreased Platelet Counts Any Event of Decreased Platelets; n=26, 35, 61	21 participants	19 participants	40 participants
Number of Participants With the Indicated AEs Associated With Decreased Platelet Counts Thrombocytopenia; n=21, 19, 40	20 participants	19 participants	39 participants
Number of Participants With the Indicated AEs Associated With Decreased Platelet Counts Pancytopenia; n=21, 19, 40	1 participants	0 participants	1 participants

Adverse Events

Ofatumumab + DHAP

Serious events: 17 serious events

Other events: 26 other events

Deaths: 0 deaths

Ofatumumab + ICE

Serious events: 7 serious events

Other events: 35 other events

Deaths: 0 deaths

Total Ofatumumab + Chemotherapy

Serious events: 24 serious events

Other events: 61 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Results disclosure agreements

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

Restriction type: OTHER

Measure	Ofatumumab + DHAP n=26 participants at risk Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy. Ofatumumab (1000 milligrams \[mg\]) was intravenously (IV) infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. The DHAP (dexamethasone, cytarabine, cisplatin) regimen (salvage chemotherapy) contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/square meter \[m\^2\]/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 gram (g)/m\^2 over 3 hours (hr) every 12 hr (2 doses) for each infusion on Day 2 of each cycle.	Ofatumumab + ICE n=35 participants at risk Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy. Ofatumumab (1000 mg) was IV infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. The ICE (ifosfamide, carboplatin, etoposide) regimen (salvage chemotherapy) contained: etoposide (100 mg/m\^2/day) administered IV on Days 1, 2, and 3 of each cycle; carboplatin (up to 800 mg) on Day 2 of each cycle; and ifosfamide plus mesna, both at 5 g/m\^2/day as an IV continuous infusion on Day 2 of each cycle.	Total Ofatumumab + Chemotherapy n=61 participants at risk Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy (either DHAP or ICE). Ofatumumab (1000 mg) was IV infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. DHAP contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/m\^2/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 g/m\^2 over 3 hr every 12 hr (2 doses) for each infusion on Day 2 of each cycle. ICE contained: etoposide (100 mg/m\^2/day) administered IV on Days 1, 2, and 3 of each cycle; carboplatin (up to 800 mg) on Day 2 of each cycle; and ifosfamide plus mesna, both at 5 g/m\^2/day as an IV continuous infusion on Day 2 of each cycle.
Blood and lymphatic system disorders Febrile neutropenia	30.8% 8/26 • Serious adverse events (SAEs) and non-serious AEs were collected from Study Day 1 to approximately Study Day 63.	2.9% 1/35 • Serious adverse events (SAEs) and non-serious AEs were collected from Study Day 1 to approximately Study Day 63.	14.8% 9/61 • Serious adverse events (SAEs) and non-serious AEs were collected from Study Day 1 to approximately Study Day 63.
Blood and lymphatic system disorders Thrombocytopenia	26.9% 7/26 • Serious adverse events (SAEs) and non-serious AEs were collected from Study Day 1 to approximately Study Day 63.	5.7% 2/35 • Serious adverse events (SAEs) and non-serious AEs were collected from Study Day 1 to approximately Study Day 63.	14.8% 9/61 • Serious adverse events (SAEs) and non-serious AEs were collected from Study Day 1 to approximately Study Day 63.
Blood and lymphatic system disorders Anaemia	7.7% 2/26 • Serious adverse events (SAEs) and non-serious AEs were collected from Study Day 1 to approximately Study Day 63.	2.9% 1/35 • Serious adverse events (SAEs) and non-serious AEs were collected from Study Day 1 to approximately Study Day 63.	4.9% 3/61 • Serious adverse events (SAEs) and non-serious AEs were collected from Study Day 1 to approximately Study Day 63.
Infections and infestations Cellulitis	7.7% 2/26 • Serious adverse events (SAEs) and non-serious AEs were collected from Study Day 1 to approximately Study Day 63.	0.00% 0/35 • Serious adverse events (SAEs) and non-serious AEs were collected from Study Day 1 to approximately Study Day 63.	3.3% 2/61 • Serious adverse events (SAEs) and non-serious AEs were collected from Study Day 1 to approximately Study Day 63.
Infections and infestations Clostridium difficile colitis	3.8% 1/26 • Serious adverse events (SAEs) and non-serious AEs were collected from Study Day 1 to approximately Study Day 63.	0.00% 0/35 • Serious adverse events (SAEs) and non-serious AEs were collected from Study Day 1 to approximately Study Day 63.	1.6% 1/61 • Serious adverse events (SAEs) and non-serious AEs were collected from Study Day 1 to approximately Study Day 63.
Infections and infestations Device related sepsis	3.8% 1/26 • Serious adverse events (SAEs) and non-serious AEs were collected from Study Day 1 to approximately Study Day 63.	0.00% 0/35 • Serious adverse events (SAEs) and non-serious AEs were collected from Study Day 1 to approximately Study Day 63.	1.6% 1/61 • Serious adverse events (SAEs) and non-serious AEs were collected from Study Day 1 to approximately Study Day 63.
Infections and infestations Parainfluenzae virus infection	3.8% 1/26 • Serious adverse events (SAEs) and non-serious AEs were collected from Study Day 1 to approximately Study Day 63.	0.00% 0/35 • Serious adverse events (SAEs) and non-serious AEs were collected from Study Day 1 to approximately Study Day 63.	1.6% 1/61 • Serious adverse events (SAEs) and non-serious AEs were collected from Study Day 1 to approximately Study Day 63.
Infections and infestations Pneumonia	3.8% 1/26 • Serious adverse events (SAEs) and non-serious AEs were collected from Study Day 1 to approximately Study Day 63.	0.00% 0/35 • Serious adverse events (SAEs) and non-serious AEs were collected from Study Day 1 to approximately Study Day 63.	1.6% 1/61 • Serious adverse events (SAEs) and non-serious AEs were collected from Study Day 1 to approximately Study Day 63.
Infections and infestations Urinary tract infection staphylococcal	0.00% 0/26 • Serious adverse events (SAEs) and non-serious AEs were collected from Study Day 1 to approximately Study Day 63.	2.9% 1/35 • Serious adverse events (SAEs) and non-serious AEs were collected from Study Day 1 to approximately Study Day 63.	1.6% 1/61 • Serious adverse events (SAEs) and non-serious AEs were collected from Study Day 1 to approximately Study Day 63.
Investigations Haemoglobin decreased	11.5% 3/26 • Serious adverse events (SAEs) and non-serious AEs were collected from Study Day 1 to approximately Study Day 63.	0.00% 0/35 • Serious adverse events (SAEs) and non-serious AEs were collected from Study Day 1 to approximately Study Day 63.	4.9% 3/61 • Serious adverse events (SAEs) and non-serious AEs were collected from Study Day 1 to approximately Study Day 63.
Investigations Blood creatinine increased	7.7% 2/26 • Serious adverse events (SAEs) and non-serious AEs were collected from Study Day 1 to approximately Study Day 63.	0.00% 0/35 • Serious adverse events (SAEs) and non-serious AEs were collected from Study Day 1 to approximately Study Day 63.	3.3% 2/61 • Serious adverse events (SAEs) and non-serious AEs were collected from Study Day 1 to approximately Study Day 63.
Investigations Blood creatinine	3.8% 1/26 • Serious adverse events (SAEs) and non-serious AEs were collected from Study Day 1 to approximately Study Day 63.	0.00% 0/35 • Serious adverse events (SAEs) and non-serious AEs were collected from Study Day 1 to approximately Study Day 63.	1.6% 1/61 • Serious adverse events (SAEs) and non-serious AEs were collected from Study Day 1 to approximately Study Day 63.
Respiratory, thoracic and mediastinal disorders Dyspnoea	3.8% 1/26 • Serious adverse events (SAEs) and non-serious AEs were collected from Study Day 1 to approximately Study Day 63.	2.9% 1/35 • Serious adverse events (SAEs) and non-serious AEs were collected from Study Day 1 to approximately Study Day 63.	3.3% 2/61 • Serious adverse events (SAEs) and non-serious AEs were collected from Study Day 1 to approximately Study Day 63.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/26 • Serious adverse events (SAEs) and non-serious AEs were collected from Study Day 1 to approximately Study Day 63.	2.9% 1/35 • Serious adverse events (SAEs) and non-serious AEs were collected from Study Day 1 to approximately Study Day 63.	1.6% 1/61 • Serious adverse events (SAEs) and non-serious AEs were collected from Study Day 1 to approximately Study Day 63.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	3.8% 1/26 • Serious adverse events (SAEs) and non-serious AEs were collected from Study Day 1 to approximately Study Day 63.	0.00% 0/35 • Serious adverse events (SAEs) and non-serious AEs were collected from Study Day 1 to approximately Study Day 63.	1.6% 1/61 • Serious adverse events (SAEs) and non-serious AEs were collected from Study Day 1 to approximately Study Day 63.
Respiratory, thoracic and mediastinal disorders Respiratory distress	0.00% 0/26 • Serious adverse events (SAEs) and non-serious AEs were collected from Study Day 1 to approximately Study Day 63.	2.9% 1/35 • Serious adverse events (SAEs) and non-serious AEs were collected from Study Day 1 to approximately Study Day 63.	1.6% 1/61 • Serious adverse events (SAEs) and non-serious AEs were collected from Study Day 1 to approximately Study Day 63.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/26 • Serious adverse events (SAEs) and non-serious AEs were collected from Study Day 1 to approximately Study Day 63.	2.9% 1/35 • Serious adverse events (SAEs) and non-serious AEs were collected from Study Day 1 to approximately Study Day 63.	1.6% 1/61 • Serious adverse events (SAEs) and non-serious AEs were collected from Study Day 1 to approximately Study Day 63.
Gastrointestinal disorders Nausea	7.7% 2/26 • Serious adverse events (SAEs) and non-serious AEs were collected from Study Day 1 to approximately Study Day 63.	0.00% 0/35 • Serious adverse events (SAEs) and non-serious AEs were collected from Study Day 1 to approximately Study Day 63.	3.3% 2/61 • Serious adverse events (SAEs) and non-serious AEs were collected from Study Day 1 to approximately Study Day 63.
Gastrointestinal disorders Vomiting	3.8% 1/26 • Serious adverse events (SAEs) and non-serious AEs were collected from Study Day 1 to approximately Study Day 63.	2.9% 1/35 • Serious adverse events (SAEs) and non-serious AEs were collected from Study Day 1 to approximately Study Day 63.	3.3% 2/61 • Serious adverse events (SAEs) and non-serious AEs were collected from Study Day 1 to approximately Study Day 63.
Gastrointestinal disorders Caecitis	3.8% 1/26 • Serious adverse events (SAEs) and non-serious AEs were collected from Study Day 1 to approximately Study Day 63.	0.00% 0/35 • Serious adverse events (SAEs) and non-serious AEs were collected from Study Day 1 to approximately Study Day 63.	1.6% 1/61 • Serious adverse events (SAEs) and non-serious AEs were collected from Study Day 1 to approximately Study Day 63.
Metabolism and nutrition disorders Hypokalaemia	7.7% 2/26 • Serious adverse events (SAEs) and non-serious AEs were collected from Study Day 1 to approximately Study Day 63.	0.00% 0/35 • Serious adverse events (SAEs) and non-serious AEs were collected from Study Day 1 to approximately Study Day 63.	3.3% 2/61 • Serious adverse events (SAEs) and non-serious AEs were collected from Study Day 1 to approximately Study Day 63.
Metabolism and nutrition disorders Dehydration	3.8% 1/26 • Serious adverse events (SAEs) and non-serious AEs were collected from Study Day 1 to approximately Study Day 63.	0.00% 0/35 • Serious adverse events (SAEs) and non-serious AEs were collected from Study Day 1 to approximately Study Day 63.	1.6% 1/61 • Serious adverse events (SAEs) and non-serious AEs were collected from Study Day 1 to approximately Study Day 63.
Metabolism and nutrition disorders Failure to thrive	3.8% 1/26 • Serious adverse events (SAEs) and non-serious AEs were collected from Study Day 1 to approximately Study Day 63.	0.00% 0/35 • Serious adverse events (SAEs) and non-serious AEs were collected from Study Day 1 to approximately Study Day 63.	1.6% 1/61 • Serious adverse events (SAEs) and non-serious AEs were collected from Study Day 1 to approximately Study Day 63.
Metabolism and nutrition disorders Tumour lysis syndrome	3.8% 1/26 • Serious adverse events (SAEs) and non-serious AEs were collected from Study Day 1 to approximately Study Day 63.	0.00% 0/35 • Serious adverse events (SAEs) and non-serious AEs were collected from Study Day 1 to approximately Study Day 63.	1.6% 1/61 • Serious adverse events (SAEs) and non-serious AEs were collected from Study Day 1 to approximately Study Day 63.
Renal and urinary disorders Renal failure	7.7% 2/26 • Serious adverse events (SAEs) and non-serious AEs were collected from Study Day 1 to approximately Study Day 63.	2.9% 1/35 • Serious adverse events (SAEs) and non-serious AEs were collected from Study Day 1 to approximately Study Day 63.	4.9% 3/61 • Serious adverse events (SAEs) and non-serious AEs were collected from Study Day 1 to approximately Study Day 63.
Renal and urinary disorders Renal failure acute	3.8% 1/26 • Serious adverse events (SAEs) and non-serious AEs were collected from Study Day 1 to approximately Study Day 63.	0.00% 0/35 • Serious adverse events (SAEs) and non-serious AEs were collected from Study Day 1 to approximately Study Day 63.	1.6% 1/61 • Serious adverse events (SAEs) and non-serious AEs were collected from Study Day 1 to approximately Study Day 63.
Nervous system disorders Ataxia	3.8% 1/26 • Serious adverse events (SAEs) and non-serious AEs were collected from Study Day 1 to approximately Study Day 63.	0.00% 0/35 • Serious adverse events (SAEs) and non-serious AEs were collected from Study Day 1 to approximately Study Day 63.	1.6% 1/61 • Serious adverse events (SAEs) and non-serious AEs were collected from Study Day 1 to approximately Study Day 63.
Nervous system disorders Dyskinesia	3.8% 1/26 • Serious adverse events (SAEs) and non-serious AEs were collected from Study Day 1 to approximately Study Day 63.	0.00% 0/35 • Serious adverse events (SAEs) and non-serious AEs were collected from Study Day 1 to approximately Study Day 63.	1.6% 1/61 • Serious adverse events (SAEs) and non-serious AEs were collected from Study Day 1 to approximately Study Day 63.
Nervous system disorders Syncope	3.8% 1/26 • Serious adverse events (SAEs) and non-serious AEs were collected from Study Day 1 to approximately Study Day 63.	0.00% 0/35 • Serious adverse events (SAEs) and non-serious AEs were collected from Study Day 1 to approximately Study Day 63.	1.6% 1/61 • Serious adverse events (SAEs) and non-serious AEs were collected from Study Day 1 to approximately Study Day 63.
Nervous system disorders Toxic encephalopathy	3.8% 1/26 • Serious adverse events (SAEs) and non-serious AEs were collected from Study Day 1 to approximately Study Day 63.	0.00% 0/35 • Serious adverse events (SAEs) and non-serious AEs were collected from Study Day 1 to approximately Study Day 63.	1.6% 1/61 • Serious adverse events (SAEs) and non-serious AEs were collected from Study Day 1 to approximately Study Day 63.
General disorders Fatigue	3.8% 1/26 • Serious adverse events (SAEs) and non-serious AEs were collected from Study Day 1 to approximately Study Day 63.	0.00% 0/35 • Serious adverse events (SAEs) and non-serious AEs were collected from Study Day 1 to approximately Study Day 63.	1.6% 1/61 • Serious adverse events (SAEs) and non-serious AEs were collected from Study Day 1 to approximately Study Day 63.
General disorders Pyrexia	0.00% 0/26 • Serious adverse events (SAEs) and non-serious AEs were collected from Study Day 1 to approximately Study Day 63.	2.9% 1/35 • Serious adverse events (SAEs) and non-serious AEs were collected from Study Day 1 to approximately Study Day 63.	1.6% 1/61 • Serious adverse events (SAEs) and non-serious AEs were collected from Study Day 1 to approximately Study Day 63.
Immune system disorders Hypersensitivity	7.7% 2/26 • Serious adverse events (SAEs) and non-serious AEs were collected from Study Day 1 to approximately Study Day 63.	0.00% 0/35 • Serious adverse events (SAEs) and non-serious AEs were collected from Study Day 1 to approximately Study Day 63.	3.3% 2/61 • Serious adverse events (SAEs) and non-serious AEs were collected from Study Day 1 to approximately Study Day 63.
Psychiatric disorders Mental status changes	0.00% 0/26 • Serious adverse events (SAEs) and non-serious AEs were collected from Study Day 1 to approximately Study Day 63.	5.7% 2/35 • Serious adverse events (SAEs) and non-serious AEs were collected from Study Day 1 to approximately Study Day 63.	3.3% 2/61 • Serious adverse events (SAEs) and non-serious AEs were collected from Study Day 1 to approximately Study Day 63.
Cardiac disorders Arrhythmia supraventricular	3.8% 1/26 • Serious adverse events (SAEs) and non-serious AEs were collected from Study Day 1 to approximately Study Day 63.	0.00% 0/35 • Serious adverse events (SAEs) and non-serious AEs were collected from Study Day 1 to approximately Study Day 63.	1.6% 1/61 • Serious adverse events (SAEs) and non-serious AEs were collected from Study Day 1 to approximately Study Day 63.
Ear and labyrinth disorders Tinnitus	3.8% 1/26 • Serious adverse events (SAEs) and non-serious AEs were collected from Study Day 1 to approximately Study Day 63.	0.00% 0/35 • Serious adverse events (SAEs) and non-serious AEs were collected from Study Day 1 to approximately Study Day 63.	1.6% 1/61 • Serious adverse events (SAEs) and non-serious AEs were collected from Study Day 1 to approximately Study Day 63.
Eye disorders Vision blurred	3.8% 1/26 • Serious adverse events (SAEs) and non-serious AEs were collected from Study Day 1 to approximately Study Day 63.	0.00% 0/35 • Serious adverse events (SAEs) and non-serious AEs were collected from Study Day 1 to approximately Study Day 63.	1.6% 1/61 • Serious adverse events (SAEs) and non-serious AEs were collected from Study Day 1 to approximately Study Day 63.
Musculoskeletal and connective tissue disorders Muscular weakness	3.8% 1/26 • Serious adverse events (SAEs) and non-serious AEs were collected from Study Day 1 to approximately Study Day 63.	0.00% 0/35 • Serious adverse events (SAEs) and non-serious AEs were collected from Study Day 1 to approximately Study Day 63.	1.6% 1/61 • Serious adverse events (SAEs) and non-serious AEs were collected from Study Day 1 to approximately Study Day 63.
Skin and subcutaneous tissue disorders Hyperhidrosis	3.8% 1/26 • Serious adverse events (SAEs) and non-serious AEs were collected from Study Day 1 to approximately Study Day 63.	0.00% 0/35 • Serious adverse events (SAEs) and non-serious AEs were collected from Study Day 1 to approximately Study Day 63.	1.6% 1/61 • Serious adverse events (SAEs) and non-serious AEs were collected from Study Day 1 to approximately Study Day 63.
Vascular disorders Hypotension	3.8% 1/26 • Serious adverse events (SAEs) and non-serious AEs were collected from Study Day 1 to approximately Study Day 63.	0.00% 0/35 • Serious adverse events (SAEs) and non-serious AEs were collected from Study Day 1 to approximately Study Day 63.	1.6% 1/61 • Serious adverse events (SAEs) and non-serious AEs were collected from Study Day 1 to approximately Study Day 63.