Trial Outcomes & Findings for Ofatumumab Versus Rituximab Salvage Chemoimmunotherapy Followed by Autologous Stem Cell Transplant in Relapsed or Refractory Diffuse Large B Cell Lymphoma (NCT NCT01014208)

Last Updated: 2015-08-07

Results Overview

Progression-free survival is defined as the interval of time from the randomization date until the date of stable disease (SD; failure to attain the criteria needed for a CR or PR and no fulfillment of the criteria for progressive disease \[PD\]) after two cycles of salvage chemotherapy, progression, or death, whichever occurs first. Disease progression was based on the assessments of independent reviewers for the disease under study. Disease progression was based on imaging data via the Revised Response Criteria for Malignant Lymphoma (RRCML).

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

447 participants

Primary outcome timeframe

From randomization until the date of stable disease after two cycles of salvage chemotherapy, progression, or death (assessed for up to 5 years)

Results posted on

2015-08-07

Participant Flow

Participants who were refractory to, or had relapsed following, first-line treatment with rituximab in combination with an anthracycline- or anthracenedione-containing chemotherapy regimen, and who were eligible for autologous stem cell transplant (ASCT), were eligible for enrollment.

Eligible participants were randomized to receive either rituximab or ofatumumab in addition to salvage chemotherapy.

Participant milestones

Participant milestones
Measure	Rituximab + Chemotherapy Participants received 3 cycles (21 days per cycle) of rituximab combined with salvage chemotherapy (SC): either the DHAP regimen (3 cycles of dexamethasone, cytarabine, cisplatin \[DHAP\]) or the DVD regimen (DHAP-VIM \[etoposide, ifosfamide, mesna, methotrexate\]-DHAP). Rituximab (375 milligrams per meters squared \[mg/m\^2\]) was infused intravenously (IV) on Day (D) 1 (or up to 3 days prior to D1) and D8 (+/-2 days) of Cycle 1 of the SC, and then on D1 only of Cycles 2 and 3. The DHAP regimen (SC) 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 D1 of each cycle; and cytarabine 2 grams (g)/m\^2 over 3 hours every 12 hours (2 doses) for each infusion on D2 of each cycle. VIM: etoposide (90 mg/m\^2 IV on Days 1, 3, and 5), ifosfamide (1200 mg/m\^2 IV on Days 1, 2, 3, 4, and 5), mesna (10 or 20 mg/kilogram \[kg\] IV on Days 1, 2, 3, 4, and 5), methotrexate (30 mg/m\^2 IV on Days 1 and 5).	Ofatumumab + Chemotherapy Participants received 3 cycles (21 days per cycle) of ofatumumab combined with SC: either the DHAP regimen (three cycles of DHAP) or the DVD regimen (DHAP-VIM-DHAP). Ofatumumab (1000 mg/1000 milliliter \[mL\]) was infused IV on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the SC, and then on Day 1 only of Cycles 2 and 3. The DHAP regimen (SC) 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 hours every 12 hours (2 doses) for each infusion on Day 2 of each cycle. VIM: etoposide (90 mg/m\^2 IV on Days 1, 3, and 5), ifosfamide (1200 mg/m\^2 IV on Days 1, 2, 3, 4, and 5), mesna (10 or 20 mg/kg IV on Days 1, 2, 3, 4, and 5), methotrexate (30 mg/m\^2 IV on Days 1 and 5).
Overall Study STARTED	225	222
Overall Study Intent-to-Treat Population	223	222
Overall Study COMPLETED	131	122
Overall Study NOT COMPLETED	94	100

Reasons for withdrawal

Reasons for withdrawal
Measure	Rituximab + Chemotherapy Participants received 3 cycles (21 days per cycle) of rituximab combined with salvage chemotherapy (SC): either the DHAP regimen (3 cycles of dexamethasone, cytarabine, cisplatin \[DHAP\]) or the DVD regimen (DHAP-VIM \[etoposide, ifosfamide, mesna, methotrexate\]-DHAP). Rituximab (375 milligrams per meters squared \[mg/m\^2\]) was infused intravenously (IV) on Day (D) 1 (or up to 3 days prior to D1) and D8 (+/-2 days) of Cycle 1 of the SC, and then on D1 only of Cycles 2 and 3. The DHAP regimen (SC) 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 D1 of each cycle; and cytarabine 2 grams (g)/m\^2 over 3 hours every 12 hours (2 doses) for each infusion on D2 of each cycle. VIM: etoposide (90 mg/m\^2 IV on Days 1, 3, and 5), ifosfamide (1200 mg/m\^2 IV on Days 1, 2, 3, 4, and 5), mesna (10 or 20 mg/kilogram \[kg\] IV on Days 1, 2, 3, 4, and 5), methotrexate (30 mg/m\^2 IV on Days 1 and 5).	Ofatumumab + Chemotherapy Participants received 3 cycles (21 days per cycle) of ofatumumab combined with SC: either the DHAP regimen (three cycles of DHAP) or the DVD regimen (DHAP-VIM-DHAP). Ofatumumab (1000 mg/1000 milliliter \[mL\]) was infused IV on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the SC, and then on Day 1 only of Cycles 2 and 3. The DHAP regimen (SC) 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 hours every 12 hours (2 doses) for each infusion on Day 2 of each cycle. VIM: etoposide (90 mg/m\^2 IV on Days 1, 3, and 5), ifosfamide (1200 mg/m\^2 IV on Days 1, 2, 3, 4, and 5), mesna (10 or 20 mg/kg IV on Days 1, 2, 3, 4, and 5), methotrexate (30 mg/m\^2 IV on Days 1 and 5).
Overall Study Lost to Follow-up	2	5
Overall Study Participant Withdrew Consent	12	12
Overall Study Did Not Receive Study Drug	2	0
Overall Study Study Closed/terminated	78	83

Baseline Characteristics

Ofatumumab Versus Rituximab Salvage Chemoimmunotherapy Followed by Autologous Stem Cell Transplant in Relapsed or Refractory Diffuse Large B Cell Lymphoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Rituximab + Chemotherapy n=223 Participants Participants received 3 cycles (21 days per cycle) of rituximab combined with salvage chemotherapy (SC): either the DHAP regimen (3 cycles of dexamethasone, cytarabine, cisplatin \[DHAP\]) or the DVD regimen (DHAP-VIM \[etoposide, ifosfamide, mesna, methotrexate\]-DHAP). Rituximab (375 milligrams per meters squared \[mg/m\^2\]) was infused intravenously (IV) on Day (D) 1 (or up to 3 days prior to D1) and D8 (+/-2 days) of Cycle 1 of the SC, and then on D1 only of Cycles 2 and 3. The DHAP regimen (SC) 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 D1 of each cycle; and cytarabine 2 grams (g)/m\^2 over 3 hours every 12 hours (2 doses) for each infusion on D2 of each cycle. VIM: etoposide (90 mg/m\^2 IV on Days 1, 3, and 5), ifosfamide (1200 mg/m\^2 IV on Days 1, 2, 3, 4, and 5), mesna (10 or 20 mg/kilogram \[kg\] IV on Days 1, 2, 3, 4, and 5), methotrexate (30 mg/m\^2 IV on Days 1 and 5).	Ofatumumab + Chemotherapy n=222 Participants Participants received 3 cycles (21 days per cycle) of ofatumumab combined with SC: either the DHAP regimen (three cycles of DHAP) or the DVD regimen (DHAP-VIM-DHAP). Ofatumumab (1000 mg/1000 milliliter \[mL\]) was infused IV on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the SC, and then on Day 1 only of Cycles 2 and 3. The DHAP regimen (SC) 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 hours every 12 hours (2 doses) for each infusion on Day 2 of each cycle. VIM: etoposide (90 mg/m\^2 IV on Days 1, 3, and 5), ifosfamide (1200 mg/m\^2 IV on Days 1, 2, 3, 4, and 5), mesna (10 or 20 mg/kg IV on Days 1, 2, 3, 4, and 5), methotrexate (30 mg/m\^2 IV on Days 1 and 5).	Total n=445 Participants Total of all reporting groups
Age, Continuous	53.4 Years STANDARD_DEVIATION 12.22 • n=5 Participants	55.2 Years STANDARD_DEVIATION 10.80 • n=7 Participants	54.3 Years STANDARD_DEVIATION 11.55 • n=5 Participants
Sex: Female, Male Female	88 Participants n=5 Participants	85 Participants n=7 Participants	173 Participants n=5 Participants
Sex: Female, Male Male	135 Participants n=5 Participants	137 Participants n=7 Participants	272 Participants n=5 Participants
Race/Ethnicity, Customized African American/African Heritage	4 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Asian - Central/South Asian Heritage	3 Participants n=5 Participants	4 Participants n=7 Participants	7 Participants n=5 Participants
Race/Ethnicity, Customized Asian - East Asian Heritage	24 Participants n=5 Participants	31 Participants n=7 Participants	55 Participants n=5 Participants
Race/Ethnicity, Customized Asian - Japanese Heritage	19 Participants n=5 Participants	22 Participants n=7 Participants	41 Participants n=5 Participants
Race/Ethnicity, Customized Asian - South East Asian Heritage	4 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants
Race/Ethnicity, Customized Asian - Mixed Race	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized White - Arabic/North African Heritage	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race/Ethnicity, Customized White - White/Caucasian/European Heritage	168 Participants n=5 Participants	151 Participants n=7 Participants	319 Participants n=5 Participants
Race/Ethnicity, Customized Missing	0 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants
Number of participants with the indicated SaaIPI scores 0 or 1	136 Participants n=5 Participants	133 Participants n=7 Participants	269 Participants n=5 Participants
Number of participants with the indicated SaaIPI scores 2 or 3	87 Participants n=5 Participants	89 Participants n=7 Participants	176 Participants n=5 Participants
Number of participants in the indicated categories per best response to first-line treatment Late relapsers	66 Participants n=5 Participants	63 Participants n=7 Participants	129 Participants n=5 Participants
Number of participants in the indicated categories per best response to first-line treatment Early relapsers/Refractory	157 Participants n=5 Participants	159 Participants n=7 Participants	316 Participants n=5 Participants

PRIMARY outcome

Timeframe: From randomization until the date of stable disease after two cycles of salvage chemotherapy, progression, or death (assessed for up to 5 years)

Population: Intent-to-Treat (ITT) Population: all participants who were randomized and commenced study therapy (at least one dose of a study drug)

Outcome measures

Outcome measures
Measure	Rituximab + Chemotherapy n=223 Participants Participants received 3 cycles (21 days per cycle) of rituximab combined with salvage chemotherapy (SC): either the DHAP regimen (3 cycles of dexamethasone, cytarabine, cisplatin \[DHAP\]) or the DVD regimen (DHAP-VIM \[etoposide, ifosfamide, mesna, methotrexate\]-DHAP). Rituximab (375 milligrams per meters squared \[mg/m\^2\]) was infused intravenously (IV) on Day (D) 1 (or up to 3 days prior to D1) and D8 (+/-2 days) of Cycle 1 of the SC, and then on D1 only of Cycles 2 and 3. The DHAP regimen (SC) 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 D1 of each cycle; and cytarabine 2 grams (g)/m\^2 over 3 hours every 12 hours (2 doses) for each infusion on D2 of each cycle. VIM: etoposide (90 mg/m\^2 IV on Days 1, 3, and 5), ifosfamide (1200 mg/m\^2 IV on Days 1, 2, 3, 4, and 5), mesna (10 or 20 mg/kilogram \[kg\] IV on Days 1, 2, 3, 4, and 5), methotrexate (30 mg/m\^2 IV on Days 1 and 5).	Ofatumumab + Chemotherapy n=222 Participants Participants received 3 cycles (21 days per cycle) of ofatumumab combined with SC: either the DHAP regimen (three cycles of DHAP) or the DVD regimen (DHAP-VIM-DHAP). Ofatumumab (1000 mg/1000 milliliter \[mL\]) was infused IV on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the SC, and then on Day 1 only of Cycles 2 and 3. The DHAP regimen (SC) 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 hours every 12 hours (2 doses) for each infusion on Day 2 of each cycle. VIM: etoposide (90 mg/m\^2 IV on Days 1, 3, and 5), ifosfamide (1200 mg/m\^2 IV on Days 1, 2, 3, 4, and 5), mesna (10 or 20 mg/kg IV on Days 1, 2, 3, 4, and 5), methotrexate (30 mg/m\^2 IV on Days 1 and 5).
Progression-free Survival as Assessed by Independent Reviewers	2.14 Months Interval 1.64 to 4.37	1.81 Months Interval 1.54 to 2.53

SECONDARY outcome

Timeframe: At completion of up to 3 cycles of salvage chemoimmunotherapy (assessed up to 9 weeks)

Population: ITT Population

OR is defined as the number of participants achieving either a complete response (CR) or a partial response (PR). CR is defined as the complete disappearance of all detectable clinical evidence of disease and disease-related symptoms. PR is defined as at least a 50% decrease from Baseline in the sum of the product of the diameters of target lesions. RRCML was used to assess CR and PR.

Outcome measures

Outcome measures
Measure	Rituximab + Chemotherapy n=223 Participants Participants received 3 cycles (21 days per cycle) of rituximab combined with salvage chemotherapy (SC): either the DHAP regimen (3 cycles of dexamethasone, cytarabine, cisplatin \[DHAP\]) or the DVD regimen (DHAP-VIM \[etoposide, ifosfamide, mesna, methotrexate\]-DHAP). Rituximab (375 milligrams per meters squared \[mg/m\^2\]) was infused intravenously (IV) on Day (D) 1 (or up to 3 days prior to D1) and D8 (+/-2 days) of Cycle 1 of the SC, and then on D1 only of Cycles 2 and 3. The DHAP regimen (SC) 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 D1 of each cycle; and cytarabine 2 grams (g)/m\^2 over 3 hours every 12 hours (2 doses) for each infusion on D2 of each cycle. VIM: etoposide (90 mg/m\^2 IV on Days 1, 3, and 5), ifosfamide (1200 mg/m\^2 IV on Days 1, 2, 3, 4, and 5), mesna (10 or 20 mg/kilogram \[kg\] IV on Days 1, 2, 3, 4, and 5), methotrexate (30 mg/m\^2 IV on Days 1 and 5).	Ofatumumab + Chemotherapy n=222 Participants Participants received 3 cycles (21 days per cycle) of ofatumumab combined with SC: either the DHAP regimen (three cycles of DHAP) or the DVD regimen (DHAP-VIM-DHAP). Ofatumumab (1000 mg/1000 milliliter \[mL\]) was infused IV on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the SC, and then on Day 1 only of Cycles 2 and 3. The DHAP regimen (SC) 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 hours every 12 hours (2 doses) for each infusion on Day 2 of each cycle. VIM: etoposide (90 mg/m\^2 IV on Days 1, 3, and 5), ifosfamide (1200 mg/m\^2 IV on Days 1, 2, 3, 4, and 5), mesna (10 or 20 mg/kg IV on Days 1, 2, 3, 4, and 5), methotrexate (30 mg/m\^2 IV on Days 1 and 5).
Number of Participants With Overall Response (OR) and Complete Response (CR) After Salvage Chemoimmunotherapy Independent reviewer-assessed OR	94 Participants	84 Participants
Number of Participants With Overall Response (OR) and Complete Response (CR) After Salvage Chemoimmunotherapy Independent reviewer-assessed CR	48 Participants	34 Participants

SECONDARY outcome

Timeframe: At 3 months after completion of autologous stem cell transplantation (ASCT) (assessed up to 6 months)

Population: ITT Population. Only participants completing HDT/ASCT are included.

Outcome measures

Outcome measures
Measure	Rituximab + Chemotherapy n=83 Participants Participants received 3 cycles (21 days per cycle) of rituximab combined with salvage chemotherapy (SC): either the DHAP regimen (3 cycles of dexamethasone, cytarabine, cisplatin \[DHAP\]) or the DVD regimen (DHAP-VIM \[etoposide, ifosfamide, mesna, methotrexate\]-DHAP). Rituximab (375 milligrams per meters squared \[mg/m\^2\]) was infused intravenously (IV) on Day (D) 1 (or up to 3 days prior to D1) and D8 (+/-2 days) of Cycle 1 of the SC, and then on D1 only of Cycles 2 and 3. The DHAP regimen (SC) 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 D1 of each cycle; and cytarabine 2 grams (g)/m\^2 over 3 hours every 12 hours (2 doses) for each infusion on D2 of each cycle. VIM: etoposide (90 mg/m\^2 IV on Days 1, 3, and 5), ifosfamide (1200 mg/m\^2 IV on Days 1, 2, 3, 4, and 5), mesna (10 or 20 mg/kilogram \[kg\] IV on Days 1, 2, 3, 4, and 5), methotrexate (30 mg/m\^2 IV on Days 1 and 5).	Ofatumumab + Chemotherapy n=74 Participants Participants received 3 cycles (21 days per cycle) of ofatumumab combined with SC: either the DHAP regimen (three cycles of DHAP) or the DVD regimen (DHAP-VIM-DHAP). Ofatumumab (1000 mg/1000 milliliter \[mL\]) was infused IV on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the SC, and then on Day 1 only of Cycles 2 and 3. The DHAP regimen (SC) 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 hours every 12 hours (2 doses) for each infusion on Day 2 of each cycle. VIM: etoposide (90 mg/m\^2 IV on Days 1, 3, and 5), ifosfamide (1200 mg/m\^2 IV on Days 1, 2, 3, 4, and 5), mesna (10 or 20 mg/kg IV on Days 1, 2, 3, 4, and 5), methotrexate (30 mg/m\^2 IV on Days 1 and 5).
Number of Participants With Overall Response (OR) and Complete Response (CR) Three Months After Autologous Stem Cell Transplant Independent reviewer-assessed OR	57 Participants	53 Participants
Number of Participants With Overall Response (OR) and Complete Response (CR) Three Months After Autologous Stem Cell Transplant Independent reviewer-assessed CR	44 Participants	43 Participants

SECONDARY outcome

Timeframe: From randomization to progressive disease, stable disease after completion of 2 cycles of therapy, commencement of a new treatment for DLBCL, or death due to any cause (assessed for up to 5 years)

Population: ITT Population

Event-free survival is defined as the time from randomization to progressive disease (PD; disease whose course is growth, or spread of the disease), stable disease (SD; failure to attain the criteria needed for a CR or PR and no fulfillment of the criteria for PD) after completion of 2 cycles of therapy, commencement of a new treatment for diffuse large B cell lymphoma (DLBCL) (e.g., radiotherapy), or death from any cause, whichever occurs first. Disease progression was based on the assessments of independent reviewers for the disease under study. Disease progression was based on imaging data via the Revised Response Criteria for Malignant Lymphoma (RRCML).

Outcome measures

Outcome measures
Measure	Rituximab + Chemotherapy n=223 Participants Participants received 3 cycles (21 days per cycle) of rituximab combined with salvage chemotherapy (SC): either the DHAP regimen (3 cycles of dexamethasone, cytarabine, cisplatin \[DHAP\]) or the DVD regimen (DHAP-VIM \[etoposide, ifosfamide, mesna, methotrexate\]-DHAP). Rituximab (375 milligrams per meters squared \[mg/m\^2\]) was infused intravenously (IV) on Day (D) 1 (or up to 3 days prior to D1) and D8 (+/-2 days) of Cycle 1 of the SC, and then on D1 only of Cycles 2 and 3. The DHAP regimen (SC) 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 D1 of each cycle; and cytarabine 2 grams (g)/m\^2 over 3 hours every 12 hours (2 doses) for each infusion on D2 of each cycle. VIM: etoposide (90 mg/m\^2 IV on Days 1, 3, and 5), ifosfamide (1200 mg/m\^2 IV on Days 1, 2, 3, 4, and 5), mesna (10 or 20 mg/kilogram \[kg\] IV on Days 1, 2, 3, 4, and 5), methotrexate (30 mg/m\^2 IV on Days 1 and 5).	Ofatumumab + Chemotherapy n=222 Participants Participants received 3 cycles (21 days per cycle) of ofatumumab combined with SC: either the DHAP regimen (three cycles of DHAP) or the DVD regimen (DHAP-VIM-DHAP). Ofatumumab (1000 mg/1000 milliliter \[mL\]) was infused IV on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the SC, and then on Day 1 only of Cycles 2 and 3. The DHAP regimen (SC) 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 hours every 12 hours (2 doses) for each infusion on Day 2 of each cycle. VIM: etoposide (90 mg/m\^2 IV on Days 1, 3, and 5), ifosfamide (1200 mg/m\^2 IV on Days 1, 2, 3, 4, and 5), mesna (10 or 20 mg/kg IV on Days 1, 2, 3, 4, and 5), methotrexate (30 mg/m\^2 IV on Days 1 and 5).
Event-free Survival	1.84 Months Interval 1.61 to 2.5	1.74 Months Interval 1.54 to 2.23

SECONDARY outcome

Timeframe: From randomization to death due to any cause (assessed for up to 5 years)

Population: ITT Population

OS is defined as the time from randomization to death due to any cause. Participants who were still alive by the end of the study were censored.

Outcome measures

Outcome measures
Measure	Rituximab + Chemotherapy n=223 Participants Participants received 3 cycles (21 days per cycle) of rituximab combined with salvage chemotherapy (SC): either the DHAP regimen (3 cycles of dexamethasone, cytarabine, cisplatin \[DHAP\]) or the DVD regimen (DHAP-VIM \[etoposide, ifosfamide, mesna, methotrexate\]-DHAP). Rituximab (375 milligrams per meters squared \[mg/m\^2\]) was infused intravenously (IV) on Day (D) 1 (or up to 3 days prior to D1) and D8 (+/-2 days) of Cycle 1 of the SC, and then on D1 only of Cycles 2 and 3. The DHAP regimen (SC) 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 D1 of each cycle; and cytarabine 2 grams (g)/m\^2 over 3 hours every 12 hours (2 doses) for each infusion on D2 of each cycle. VIM: etoposide (90 mg/m\^2 IV on Days 1, 3, and 5), ifosfamide (1200 mg/m\^2 IV on Days 1, 2, 3, 4, and 5), mesna (10 or 20 mg/kilogram \[kg\] IV on Days 1, 2, 3, 4, and 5), methotrexate (30 mg/m\^2 IV on Days 1 and 5).	Ofatumumab + Chemotherapy n=222 Participants Participants received 3 cycles (21 days per cycle) of ofatumumab combined with SC: either the DHAP regimen (three cycles of DHAP) or the DVD regimen (DHAP-VIM-DHAP). Ofatumumab (1000 mg/1000 milliliter \[mL\]) was infused IV on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the SC, and then on Day 1 only of Cycles 2 and 3. The DHAP regimen (SC) 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 hours every 12 hours (2 doses) for each infusion on Day 2 of each cycle. VIM: etoposide (90 mg/m\^2 IV on Days 1, 3, and 5), ifosfamide (1200 mg/m\^2 IV on Days 1, 2, 3, 4, and 5), mesna (10 or 20 mg/kg IV on Days 1, 2, 3, 4, and 5), methotrexate (30 mg/m\^2 IV on Days 1 and 5).
Overall Survival (OS)	13.17 Months Interval 10.02 to 14.98	13.86 Months Interval 10.91 to 22.41

SECONDARY outcome

Timeframe: During Cycles 2 and/or 3 (Weeks 4-9)

Population: ITT Population. Only participants commencing leukapheresis are included.

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 is defined as the collection of \>2\*10\^6 CD34+ cells/kg. Only those participants, who commenced harvest, following the administration of rituximab or ofatumumab in combination with DHAP combination chemotherapy, were assessed. The number of participants with adequate harvest of CD34+ stem cells (at least 2\*10\^6 CD34+ cells/kg) after dosing of salvage therapy in Cycle 2 and Cycle 3 was analyzed.

Outcome measures

Outcome measures
Measure	Rituximab + Chemotherapy n=134 Participants Participants received 3 cycles (21 days per cycle) of rituximab combined with salvage chemotherapy (SC): either the DHAP regimen (3 cycles of dexamethasone, cytarabine, cisplatin \[DHAP\]) or the DVD regimen (DHAP-VIM \[etoposide, ifosfamide, mesna, methotrexate\]-DHAP). Rituximab (375 milligrams per meters squared \[mg/m\^2\]) was infused intravenously (IV) on Day (D) 1 (or up to 3 days prior to D1) and D8 (+/-2 days) of Cycle 1 of the SC, and then on D1 only of Cycles 2 and 3. The DHAP regimen (SC) 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 D1 of each cycle; and cytarabine 2 grams (g)/m\^2 over 3 hours every 12 hours (2 doses) for each infusion on D2 of each cycle. VIM: etoposide (90 mg/m\^2 IV on Days 1, 3, and 5), ifosfamide (1200 mg/m\^2 IV on Days 1, 2, 3, 4, and 5), mesna (10 or 20 mg/kilogram \[kg\] IV on Days 1, 2, 3, 4, and 5), methotrexate (30 mg/m\^2 IV on Days 1 and 5).	Ofatumumab + Chemotherapy n=125 Participants Participants received 3 cycles (21 days per cycle) of ofatumumab combined with SC: either the DHAP regimen (three cycles of DHAP) or the DVD regimen (DHAP-VIM-DHAP). Ofatumumab (1000 mg/1000 milliliter \[mL\]) was infused IV on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the SC, and then on Day 1 only of Cycles 2 and 3. The DHAP regimen (SC) 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 hours every 12 hours (2 doses) for each infusion on Day 2 of each cycle. VIM: etoposide (90 mg/m\^2 IV on Days 1, 3, and 5), ifosfamide (1200 mg/m\^2 IV on Days 1, 2, 3, 4, and 5), mesna (10 or 20 mg/kg IV on Days 1, 2, 3, 4, and 5), methotrexate (30 mg/m\^2 IV on Days 1 and 5).
Number of Participants With the Ability to Mobilize at Least 2 Million Cluster of Differentiation (CD)34+ Cells Per Kilogram From Peripheral Blood	121 Participants	120 Participants

SECONDARY outcome

Timeframe: Approximately 4 to 6 weeks following Cycle 3 (assessed up to 3 months)

Population: ITT Population

The number of participants who completed ASCT is reported.

Outcome measures

Outcome measures
Measure	Rituximab + Chemotherapy n=223 Participants Participants received 3 cycles (21 days per cycle) of rituximab combined with salvage chemotherapy (SC): either the DHAP regimen (3 cycles of dexamethasone, cytarabine, cisplatin \[DHAP\]) or the DVD regimen (DHAP-VIM \[etoposide, ifosfamide, mesna, methotrexate\]-DHAP). Rituximab (375 milligrams per meters squared \[mg/m\^2\]) was infused intravenously (IV) on Day (D) 1 (or up to 3 days prior to D1) and D8 (+/-2 days) of Cycle 1 of the SC, and then on D1 only of Cycles 2 and 3. The DHAP regimen (SC) 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 D1 of each cycle; and cytarabine 2 grams (g)/m\^2 over 3 hours every 12 hours (2 doses) for each infusion on D2 of each cycle. VIM: etoposide (90 mg/m\^2 IV on Days 1, 3, and 5), ifosfamide (1200 mg/m\^2 IV on Days 1, 2, 3, 4, and 5), mesna (10 or 20 mg/kilogram \[kg\] IV on Days 1, 2, 3, 4, and 5), methotrexate (30 mg/m\^2 IV on Days 1 and 5).	Ofatumumab + Chemotherapy n=222 Participants Participants received 3 cycles (21 days per cycle) of ofatumumab combined with SC: either the DHAP regimen (three cycles of DHAP) or the DVD regimen (DHAP-VIM-DHAP). Ofatumumab (1000 mg/1000 milliliter \[mL\]) was infused IV on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the SC, and then on Day 1 only of Cycles 2 and 3. The DHAP regimen (SC) 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 hours every 12 hours (2 doses) for each infusion on Day 2 of each cycle. VIM: etoposide (90 mg/m\^2 IV on Days 1, 3, and 5), ifosfamide (1200 mg/m\^2 IV on Days 1, 2, 3, 4, and 5), mesna (10 or 20 mg/kg IV on Days 1, 2, 3, 4, and 5), methotrexate (30 mg/m\^2 IV on Days 1 and 5).
Number of Participants Completing Autologous Stem Cell Transplant (ASCT)	83 Participants	74 Participants

SECONDARY outcome

Timeframe: Baseline and the end of the treatment period (until approximately 4 to 6 weeks following Cycle 3 [assessed up to 3 months])

Population: ITT Population. Only those participants who provided data were assessed.

The FACT-G was developed by the Functional Assessment of Chronic Illness Therapy (FACIT) group for use in adults in a wide range of oncology clinical trial populations. The 27 items of the FACT-G are scored in the following domains: Physical Well-being (7 items), Social/Family Wellbeing (7 items), Emotional Well-being (6 items), and Functional Well-being (7 items). Participants responded to the items on a five-point Likert scale ranging from 0, "Not at all" to 4, "Very much." The total score ranges from 0 to 108; higher scores indicate a better patient-reported outcome/quality of life. Participants were asked to think back over the past week when responding to the items.

Outcome measures

Outcome measures
Measure	Rituximab + Chemotherapy n=172 Participants Participants received 3 cycles (21 days per cycle) of rituximab combined with salvage chemotherapy (SC): either the DHAP regimen (3 cycles of dexamethasone, cytarabine, cisplatin \[DHAP\]) or the DVD regimen (DHAP-VIM \[etoposide, ifosfamide, mesna, methotrexate\]-DHAP). Rituximab (375 milligrams per meters squared \[mg/m\^2\]) was infused intravenously (IV) on Day (D) 1 (or up to 3 days prior to D1) and D8 (+/-2 days) of Cycle 1 of the SC, and then on D1 only of Cycles 2 and 3. The DHAP regimen (SC) 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 D1 of each cycle; and cytarabine 2 grams (g)/m\^2 over 3 hours every 12 hours (2 doses) for each infusion on D2 of each cycle. VIM: etoposide (90 mg/m\^2 IV on Days 1, 3, and 5), ifosfamide (1200 mg/m\^2 IV on Days 1, 2, 3, 4, and 5), mesna (10 or 20 mg/kilogram \[kg\] IV on Days 1, 2, 3, 4, and 5), methotrexate (30 mg/m\^2 IV on Days 1 and 5).	Ofatumumab + Chemotherapy n=175 Participants Participants received 3 cycles (21 days per cycle) of ofatumumab combined with SC: either the DHAP regimen (three cycles of DHAP) or the DVD regimen (DHAP-VIM-DHAP). Ofatumumab (1000 mg/1000 milliliter \[mL\]) was infused IV on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the SC, and then on Day 1 only of Cycles 2 and 3. The DHAP regimen (SC) 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 hours every 12 hours (2 doses) for each infusion on Day 2 of each cycle. VIM: etoposide (90 mg/m\^2 IV on Days 1, 3, and 5), ifosfamide (1200 mg/m\^2 IV on Days 1, 2, 3, 4, and 5), mesna (10 or 20 mg/kg IV on Days 1, 2, 3, 4, and 5), methotrexate (30 mg/m\^2 IV on Days 1 and 5).
Change From Baseline in Functional Assessment of Cancer Therapy-General (FACT-G) During Treatment	-2.561 scores on a scale Standard Error 0.7671	-2.591 scores on a scale Standard Error 0.7696

SECONDARY outcome

Timeframe: Baseline and the end of the treatment period (until approximately 4 to 6 weeks following Cycle 3 [assessed up to 3 months])

Population: ITT Population. Only those participants who provided data were assessed.

The FACT-Lym TOI is a measure that combines the FACT-Lym subscale (15 items; responses to each item range from 0, "Not at all" to 4, "Very much") with two domains taken from the FACT-G (responses to each item range from "Not at all " to "Very much"): Physical Well-being (7 items: lack of energy, nausea, meeting family needs, pain, side effects, feels ill, spends time in bed) and Functional Well-being (7 items: ability to work, work fulfilment, ability to enjoy life, illness acceptance, ability to sleep well, enjoying things done for fun, satisfaction with quality of life). This index is designed to be sensitive to changes in treatment regimens. The total FACT-Lym TOI score ranges from 0 to 116; higher scores indicate a better patient-reported outcome/quality of life. Participants were asked to think back over the past week when responding to the items.

Outcome measures

Outcome measures
Measure	Rituximab + Chemotherapy n=172 Participants Participants received 3 cycles (21 days per cycle) of rituximab combined with salvage chemotherapy (SC): either the DHAP regimen (3 cycles of dexamethasone, cytarabine, cisplatin \[DHAP\]) or the DVD regimen (DHAP-VIM \[etoposide, ifosfamide, mesna, methotrexate\]-DHAP). Rituximab (375 milligrams per meters squared \[mg/m\^2\]) was infused intravenously (IV) on Day (D) 1 (or up to 3 days prior to D1) and D8 (+/-2 days) of Cycle 1 of the SC, and then on D1 only of Cycles 2 and 3. The DHAP regimen (SC) 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 D1 of each cycle; and cytarabine 2 grams (g)/m\^2 over 3 hours every 12 hours (2 doses) for each infusion on D2 of each cycle. VIM: etoposide (90 mg/m\^2 IV on Days 1, 3, and 5), ifosfamide (1200 mg/m\^2 IV on Days 1, 2, 3, 4, and 5), mesna (10 or 20 mg/kilogram \[kg\] IV on Days 1, 2, 3, 4, and 5), methotrexate (30 mg/m\^2 IV on Days 1 and 5).	Ofatumumab + Chemotherapy n=174 Participants Participants received 3 cycles (21 days per cycle) of ofatumumab combined with SC: either the DHAP regimen (three cycles of DHAP) or the DVD regimen (DHAP-VIM-DHAP). Ofatumumab (1000 mg/1000 milliliter \[mL\]) was infused IV on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the SC, and then on Day 1 only of Cycles 2 and 3. The DHAP regimen (SC) 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 hours every 12 hours (2 doses) for each infusion on Day 2 of each cycle. VIM: etoposide (90 mg/m\^2 IV on Days 1, 3, and 5), ifosfamide (1200 mg/m\^2 IV on Days 1, 2, 3, 4, and 5), mesna (10 or 20 mg/kg IV on Days 1, 2, 3, 4, and 5), methotrexate (30 mg/m\^2 IV on Days 1 and 5).
Change From Baseline in the Functional Assessment of Cancer Therapy Lymphoma Trial Outcome Index (FACT-Lym TOI) Total Score During Treatment	-2.028 scores on a scale Standard Error 0.9196	-3.156 scores on a scale Standard Error 0.9204

SECONDARY outcome

Timeframe: From the start of each cycle for a maximum of 5 weeks per cycle (assessed during treatment period of Baseline up to approximately 3 months)

Population: Safety Population. Only those participants available for analysis in the given cycle were assessed.

Neutrophil (absolute neutrophil count \[ANC\]) recovery is defined as ANC \>=0.5\*10\^9/Liter and increasing, and platelet (PLT) recovery is defined as PLT \>=10\*10\^9/Liter and increasing. For each cycle, time to ANC recovery is defined as the time from the first dose to the first ANC \>=0.5\*10\^9/Liter and increasing after the nadir in the cycle. For each cycle, time to PLT recovery is defined as the time from the first dose to the first PLT \>=10\*10\^9/L and increasing after the nadir in the cycle.

Outcome measures

Outcome measures
Measure	Rituximab + Chemotherapy n=223 Participants Participants received 3 cycles (21 days per cycle) of rituximab combined with salvage chemotherapy (SC): either the DHAP regimen (3 cycles of dexamethasone, cytarabine, cisplatin \[DHAP\]) or the DVD regimen (DHAP-VIM \[etoposide, ifosfamide, mesna, methotrexate\]-DHAP). Rituximab (375 milligrams per meters squared \[mg/m\^2\]) was infused intravenously (IV) on Day (D) 1 (or up to 3 days prior to D1) and D8 (+/-2 days) of Cycle 1 of the SC, and then on D1 only of Cycles 2 and 3. The DHAP regimen (SC) 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 D1 of each cycle; and cytarabine 2 grams (g)/m\^2 over 3 hours every 12 hours (2 doses) for each infusion on D2 of each cycle. VIM: etoposide (90 mg/m\^2 IV on Days 1, 3, and 5), ifosfamide (1200 mg/m\^2 IV on Days 1, 2, 3, 4, and 5), mesna (10 or 20 mg/kilogram \[kg\] IV on Days 1, 2, 3, 4, and 5), methotrexate (30 mg/m\^2 IV on Days 1 and 5).	Ofatumumab + Chemotherapy n=222 Participants Participants received 3 cycles (21 days per cycle) of ofatumumab combined with SC: either the DHAP regimen (three cycles of DHAP) or the DVD regimen (DHAP-VIM-DHAP). Ofatumumab (1000 mg/1000 milliliter \[mL\]) was infused IV on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the SC, and then on Day 1 only of Cycles 2 and 3. The DHAP regimen (SC) 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 hours every 12 hours (2 doses) for each infusion on Day 2 of each cycle. VIM: etoposide (90 mg/m\^2 IV on Days 1, 3, and 5), ifosfamide (1200 mg/m\^2 IV on Days 1, 2, 3, 4, and 5), mesna (10 or 20 mg/kg IV on Days 1, 2, 3, 4, and 5), methotrexate (30 mg/m\^2 IV on Days 1 and 5).
Time to Neutrophil and Platelet Recovery After Each Cycle of Salvage Chemotherapy Neutrophils, Cycle 1, n=223, 222	8.0 days Interval 6.0 to 13.0	11.0 days Interval 8.0 to 13.0
Time to Neutrophil and Platelet Recovery After Each Cycle of Salvage Chemotherapy Neutrophils, Cycle 2, n=196, 199	8.0 days Interval 6.0 to 10.0	11.0 days Interval 9.0 to 13.0
Time to Neutrophil and Platelet Recovery After Each Cycle of Salvage Chemotherapy Neutrophils, Cycle 3, n=137, 129	10.0 days Interval 6.0 to 12.0	7.0 days Interval 5.0 to 10.0
Time to Neutrophil and Platelet Recovery After Each Cycle of Salvage Chemotherapy Platelets, Cycle 1, n=223, 222	13.0 days Interval 12.0 to 13.0	12.0 days Interval 12.0 to 13.0
Time to Neutrophil and Platelet Recovery After Each Cycle of Salvage Chemotherapy Platelets, Cycle 2, n=196, 199	13.0 days Interval 12.0 to 13.0	13.0 days Interval 12.0 to 13.0
Time to Neutrophil and Platelet Recovery After Each Cycle of Salvage Chemotherapy Platelets, Cycle 3, n=137, 129	13.0 days Interval 12.0 to 14.0	13.0 days Interval 12.0 to 14.0

SECONDARY outcome

Timeframe: From ASCT up to 42 days post-ASCT (Baseline up to approximately 4.5 months)

Population: Safety population. Only participants completing HDT/ASCT are included.

Engraftment is defined as 1) three consecutive days when the ANC is ≥0.5x109/L and 2) an unsupported platelet count of ≥20x109/L, and the engraftment date is the date that this occurs. If engraftment was not achieved by Day 42 or the last observation, engraftment was deemed to be a failure, and censoring took place at Day 42 or at the last observation.

Outcome measures

Outcome measures
Measure	Rituximab + Chemotherapy n=83 Participants Participants received 3 cycles (21 days per cycle) of rituximab combined with salvage chemotherapy (SC): either the DHAP regimen (3 cycles of dexamethasone, cytarabine, cisplatin \[DHAP\]) or the DVD regimen (DHAP-VIM \[etoposide, ifosfamide, mesna, methotrexate\]-DHAP). Rituximab (375 milligrams per meters squared \[mg/m\^2\]) was infused intravenously (IV) on Day (D) 1 (or up to 3 days prior to D1) and D8 (+/-2 days) of Cycle 1 of the SC, and then on D1 only of Cycles 2 and 3. The DHAP regimen (SC) 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 D1 of each cycle; and cytarabine 2 grams (g)/m\^2 over 3 hours every 12 hours (2 doses) for each infusion on D2 of each cycle. VIM: etoposide (90 mg/m\^2 IV on Days 1, 3, and 5), ifosfamide (1200 mg/m\^2 IV on Days 1, 2, 3, 4, and 5), mesna (10 or 20 mg/kilogram \[kg\] IV on Days 1, 2, 3, 4, and 5), methotrexate (30 mg/m\^2 IV on Days 1 and 5).	Ofatumumab + Chemotherapy n=74 Participants Participants received 3 cycles (21 days per cycle) of ofatumumab combined with SC: either the DHAP regimen (three cycles of DHAP) or the DVD regimen (DHAP-VIM-DHAP). Ofatumumab (1000 mg/1000 milliliter \[mL\]) was infused IV on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the SC, and then on Day 1 only of Cycles 2 and 3. The DHAP regimen (SC) 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 hours every 12 hours (2 doses) for each infusion on Day 2 of each cycle. VIM: etoposide (90 mg/m\^2 IV on Days 1, 3, and 5), ifosfamide (1200 mg/m\^2 IV on Days 1, 2, 3, 4, and 5), mesna (10 or 20 mg/kg IV on Days 1, 2, 3, 4, and 5), methotrexate (30 mg/m\^2 IV on Days 1 and 5).
Time to Engraftment After High-dose Therapy (HDT)/ASCT	24.0 Days Interval 16.0 to The upper limit of the confidence interval cannot be calculated because there were too few events of engraftment.	NA Days Interval 26.0 to The median cannot be calculated because there were too few events of engraftment The upper limit of the confidence interval cannot be calculated because there were too few events of engraftment.

Adverse Events

Rituximab + Chemotherapy

Serious events: 115 serious events

Other events: 217 other events

Deaths: 0 deaths

Ofatumumab + Chemotherapy

Serious events: 118 serious events

Other events: 215 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