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This study is being conducted to compare the efficacy and safety of ofatumumab in addition to salvage chemotherapy versus rituximab in addition to salvage chemotherapy in CD20 positive DLBCL subjects relapsing, or with persistent disease, after first-line treatment with rituximab combined with an anthracycline-based chemotherapy regimen and be eligible for ASCT.
As rituximab-based regimens have become standard first-line treatment in CD20 positive DLBCL, the efficacy of rituximab combined with salvage chemotherapy in the second-line setting has decreased and there is a need for new therapies in patients progressing or relapsing after first-line rituximab-based therapy. Replacement of rituximab with ofatumumab in the second-line setting, following progression/relapse after first-line rituximab-containing regimens, offers the potential to overcome relative or complete rituximab resistance and thus improve response rates, the ability to proceed to consolidative HDT/ASCT, and overall survival.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OFATUMUMAB + DHAP CHEMOTHERAPY REGIMEN | Experimental | This study is a parallel arm study, with ofatumumab + DHAP. The Investigators are required to prospectively choose to treat all of their subjects with either DHAP chemotherapy regimens in combination with ofatumumab. All subjects will receive the same ofatumumab regimen and dose. |
|
| RITUXIMAB + DHAP CHEMOTHERAPY REGIMEN | Active Comparator | This study is a parallel arm study, with rituximab + DHAP. The Investigators are required to prospectively choose to treat all of their subjects with either DHAP chemotherapy regimens in combination with rituximab. All subjects will receive the same rituximab regimen and dose. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OFATUMUMAB + DHAP | Drug | 3 cycles of treatment will be administered. Each cycle will last 21 days. ofatumumab dose: cycle 1, day 1 - 1000 mg; cycle 1, day 8 - 1000 mg; cycle 2, day 1 and cycle 3, day 1 - 1000 mg. DHAP regimen: dexamethasone - 40 mg on days 1, 2, 3, and 4 of dosing cycle; cisplatin - 100 mg/m2/24hrs continuous on day 1 of dosing cycle; cytarabine - 2g/m2 q12 hrs (2 doses) on day 2 of dosing cycle. |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free Survival as Assessed by Independent Reviewers | 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). | From randomization until the date of stable disease after two cycles of salvage chemotherapy, progression, or death (assessed for up to 5 years) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Overall Response (OR) and Complete Response (CR) After Salvage Chemoimmunotherapy | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Sacramento | California | 95816 | United States | ||
| GSK Investigational Site |
Eligible participants were randomized to receive either rituximab or ofatumumab in addition to salvage chemotherapy.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| RITUXIMAB + DHAP | Drug | 3 cycles of treatment will be administered. Each cycle will last 21 days. rituximab dose: cycle 1, day 1 - 375 mg/m2; cycle 1, day 8 - 375 mg/m2; cycle 2, day 1 and cycle 3, day 1 - 375 mg/m2. DHAP regimen: dexamethasone - 40 mg on days 1, 2, 3, and 4 of dosing cycle; cisplatin - 100 mg/m2/24hrs continuous on day 1 of dosing cycle; cytarabine - 2g/m2 q12 hrs (2 doses) on day 2 of dosing cycle. |
|
| At completion of up to 3 cycles of salvage chemoimmunotherapy (assessed up to 9 weeks) |
| Number of Participants With Overall Response (OR) and Complete Response (CR) Three Months After Autologous Stem Cell Transplant | 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. | At 3 months after completion of autologous stem cell transplantation (ASCT) (assessed up to 6 months) |
| Event-free Survival | 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). | 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) |
| Overall Survival (OS) | 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. | From randomization to death due to any cause (assessed for up to 5 years) |
| Number of Participants With the Ability to Mobilize at Least 2 Million Cluster of Differentiation (CD)34+ Cells Per Kilogram From Peripheral Blood | 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. | During Cycles 2 and/or 3 (Weeks 4-9) |
| Number of Participants Completing Autologous Stem Cell Transplant (ASCT) | The number of participants who completed ASCT is reported. | Approximately 4 to 6 weeks following Cycle 3 (assessed up to 3 months) |
| Change From Baseline in Functional Assessment of Cancer Therapy-General (FACT-G) During Treatment | 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. | Baseline and the end of the treatment period (until approximately 4 to 6 weeks following Cycle 3 [assessed up to 3 months]) |
| Change From Baseline in the Functional Assessment of Cancer Therapy Lymphoma Trial Outcome Index (FACT-Lym TOI) Total Score During Treatment | 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. | Baseline and the end of the treatment period (until approximately 4 to 6 weeks following Cycle 3 [assessed up to 3 months]) |
| Time to Neutrophil and Platelet Recovery After Each Cycle of Salvage Chemotherapy | 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. | 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) |
| Time to Engraftment After High-dose Therapy (HDT)/ASCT | 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. | From ASCT up to 42 days post-ASCT (Baseline up to approximately 4.5 months) |
| New Haven |
| Connecticut |
| 06520 |
| United States |
| GSK Investigational Site | Chicago | Illinois | 60612-7323 | United States |
| GSK Investigational Site | Chicago | Illinois | 60637 | United States |
| GSK Investigational Site | Westwood | Kansas | 66205 | United States |
| GSK Investigational Site | Jackson | Mississippi | 39216-4505 | United States |
| GSK Investigational Site | New York | New York | 10065 | United States |
| GSK Investigational Site | Syracuse | New York | 13210 | United States |
| GSK Investigational Site | Chaple Hill | North Carolina | 27599-7305 | United States |
| GSK Investigational Site | Philadelphia | Pennsylvania | 19140 | United States |
| GSK Investigational Site | Providence | Rhode Island | 02908 | United States |
| GSK Investigational Site | Charleston | South Carolina | 29425 | United States |
| GSK Investigational Site | Greenville | South Carolina | 29601 | United States |
| GSK Investigational Site | Nashville | Tennessee | 37203 | United States |
| GSK Investigational Site | San Antonio | Texas | 78229 | United States |
| GSK Investigational Site | Seattle | Washington | 98108 | United States |
| GSK Investigational Site | Capital Federal | Buenos Aires | C1426ANZ | Argentina |
| GSK Investigational Site | Ciudad Autonoma de Buenos Aires | Buenos Aires | C1431FWO | Argentina |
| GSK Investigational Site | La Plata | Buenos Aires | B1900AXI | Argentina |
| GSK Investigational Site | Graz | 8036 | Austria |
| GSK Investigational Site | Innsbruck | 6020 | Austria |
| GSK Investigational Site | Linz | 4020 | Austria |
| GSK Investigational Site | Linz | 4021 | Austria |
| GSK Investigational Site | Salzburg | A-5020 | Austria |
| GSK Investigational Site | Vienna | 1090 | Austria |
| GSK Investigational Site | Vienna | 1140 | Austria |
| GSK Investigational Site | Bruges | 8000 | Belgium |
| GSK Investigational Site | Brussels | 1200 | Belgium |
| GSK Investigational Site | Ghent | 9000 | Belgium |
| GSK Investigational Site | Hasselt | 3500 | Belgium |
| GSK Investigational Site | Leuven | 3000 | Belgium |
| GSK Investigational Site | Yvoir | 5530 | Belgium |
| GSK Investigational Site | Fuzhou | Fujian | 350014 | China |
| GSK Investigational Site | Guangzhou | Guangdong | 510060 | China |
| GSK Investigational Site | Guangzhou | Guangdong | 510080 | China |
| GSK Investigational Site | Guangzhou | Guangdong | 510515 | China |
| GSK Investigational Site | Nanjing | Jiangsu | 210029 | China |
| GSK Investigational Site | Jianan | Shandong | 250012 | China |
| GSK Investigational Site | Hangzhou | Zhejiang | 310003 | China |
| GSK Investigational Site | Beijing | 100021 | China |
| GSK Investigational Site | Beijing | 100044 | China |
| GSK Investigational Site | Beijing | 100071 | China |
| GSK Investigational Site | Beijing | 100142 | China |
| GSK Investigational Site | Beijing | 100191 | China |
| GSK Investigational Site | Beijing | 100730 | China |
| GSK Investigational Site | Beijing | 100853 | China |
| GSK Investigational Site | Chengdu | 610041 | China |
| GSK Investigational Site | Jiang Su Province | 215006 | China |
| GSK Investigational Site | Shanghai | 200025 | China |
| GSK Investigational Site | Shanghai | 200032 | China |
| GSK Investigational Site | Tianjin | 300020 | China |
| GSK Investigational Site | Brno | 625 00 | Czechia |
| GSK Investigational Site | Hradec Králové | Czechia |
| GSK Investigational Site | Aarhus | 8000 C | Denmark |
| GSK Investigational Site | Copenhagen | 2100 | Denmark |
| GSK Investigational Site | Tallinn | 13419 | Estonia |
| GSK Investigational Site | Tartu | 51014 | Estonia |
| GSK Investigational Site | Helsinki | 00029 | Finland |
| GSK Investigational Site | Oulu | 90029 | Finland |
| GSK Investigational Site | Tampere | 33520 | Finland |
| GSK Investigational Site | Ulm | Baden-Wurttemberg | 89081 | Germany |
| GSK Investigational Site | Aachen | North Rhine-Westphalia | 52074 | Germany |
| GSK Investigational Site | Münster | North Rhine-Westphalia | 48149 | Germany |
| GSK Investigational Site | Berlin | State of Berlin | 13353 | Germany |
| GSK Investigational Site | Athens | 11 527 | Greece |
| GSK Investigational Site | Athens | 11525 | Greece |
| GSK Investigational Site | Budapest | 1097 | Hungary |
| GSK Investigational Site | Budapest | 1122 | Hungary |
| GSK Investigational Site | Debrecen | 4012 | Hungary |
| GSK Investigational Site | Győr | 9023 | Hungary |
| GSK Investigational Site | Kaposvár | 7400 | Hungary |
| GSK Investigational Site | Szeged | 6720 | Hungary |
| GSK Investigational Site | Szombathely | 9700 | Hungary |
| GSK Investigational Site | Ludhiana | 141008 | India |
| GSK Investigational Site | Pune | 411001 | India |
| GSK Investigational Site | Vellore | 632004 | India |
| GSK Investigational Site | Dublin | 4 | Ireland |
| GSK Investigational Site | Galway | Ireland |
| GSK Investigational Site | James Street | 8 | Ireland |
| GSK Investigational Site | Petah Tikva | 49100 | Israel |
| GSK Investigational Site | Ramat Gan | 52621 | Israel |
| GSK Investigational Site | Aichi | 466-8650 | Japan |
| GSK Investigational Site | Akita | 010-8543 | Japan |
| GSK Investigational Site | Fukuoka | 811-1395 | Japan |
| GSK Investigational Site | Hokkaido | 060-8648 | Japan |
| GSK Investigational Site | Hyōgo | 650-0047 | Japan |
| GSK Investigational Site | Ibaraki | 305-8576 | Japan |
| GSK Investigational Site | Kanagawa | 236-0004 | Japan |
| GSK Investigational Site | Kanagawa | 259-1143 | Japan |
| GSK Investigational Site | Kyoto | 602-8566 | Japan |
| GSK Investigational Site | Miyagi | 980-8574 | Japan |
| GSK Investigational Site | Nagano | 390-8621 | Japan |
| GSK Investigational Site | Nagasaki | 852-8501 | Japan |
| GSK Investigational Site | Okayama | 700-8558 | Japan |
| GSK Investigational Site | Osaka | 589-8511 | Japan |
| GSK Investigational Site | Tochigi | 329-0498 | Japan |
| GSK Investigational Site | Tokushima | 770-8503 | Japan |
| GSK Investigational Site | Tokyo | 104-0045 | Japan |
| GSK Investigational Site | Tokyo | 113-8655 | Japan |
| GSK Investigational Site | Tokyo | 135-8550 | Japan |
| GSK Investigational Site | Tokyo | 162-8655 | Japan |
| GSK Investigational Site | Amersfoort | 3818 ES | Netherlands |
| GSK Investigational Site | Amsterdam | 1066 CX | Netherlands |
| GSK Investigational Site | Amsterdam | 1081 HV | Netherlands |
| GSK Investigational Site | Amsterdam | 1105 AZ | Netherlands |
| GSK Investigational Site | Enschede | 7511JX | Netherlands |
| GSK Investigational Site | Groningen | 9713 GZ | Netherlands |
| GSK Investigational Site | Hoofddorp | 2134 TM | Netherlands |
| GSK Investigational Site | Leiden | 2333 ZA | Netherlands |
| GSK Investigational Site | Maastricht | 6229 HX | Netherlands |
| GSK Investigational Site | Nieuwegein | 3435 CM | Netherlands |
| GSK Investigational Site | Nijmegen | 6525 GA | Netherlands |
| GSK Investigational Site | Rotterdam | 3015 CE | Netherlands |
| GSK Investigational Site | Rotterdam | 3075 EA | Netherlands |
| GSK Investigational Site | Rotterdam | 3079 DZ | Netherlands |
| GSK Investigational Site | Sittard-geleen | 6162 BG | Netherlands |
| GSK Investigational Site | The Hague | 2545 CH | Netherlands |
| GSK Investigational Site | Utrecht | 3584 CX | Netherlands |
| GSK Investigational Site | Zwolle | 8025 AB | Netherlands |
| GSK Investigational Site | Oslo | 0310 | Norway |
| GSK Investigational Site | Chorzów | 41-500 | Poland |
| GSK Investigational Site | Gdansk | 80-952 | Poland |
| GSK Investigational Site | Poznan | 60-833 | Poland |
| GSK Investigational Site | Warsaw | 02-776 | Poland |
| GSK Investigational Site | Warsaw | 02-781 | Poland |
| GSK Investigational Site | Wroclaw | 50-367 | Poland |
| GSK Investigational Site | Moscow | 125101 | Russia |
| GSK Investigational Site | Saint Petersburg | 197022 | Russia |
| GSK Investigational Site | Saint Petersburg | 197110 | Russia |
| GSK Investigational Site | Singapore | 119074 | Singapore |
| GSK Investigational Site | Jellanamdo | 519-809 | South Korea |
| GSK Investigational Site | Seoul | 120-752 | South Korea |
| GSK Investigational Site | Seoul | 135-710 | South Korea |
| GSK Investigational Site | Barcelona | 08041 | Spain |
| GSK Investigational Site | Madrid | 28006 | Spain |
| GSK Investigational Site | Madrid | 28007 | Spain |
| GSK Investigational Site | Madrid | 28008 | Spain |
| GSK Investigational Site | Madrid | 28041 | Spain |
| GSK Investigational Site | Majadahonda (Madrid) | 28222 | Spain |
| GSK Investigational Site | Murcia | 30120 | Spain |
| GSK Investigational Site | Pamplona | 31008 | Spain |
| GSK Investigational Site | Pozuelo de Alarcón/Madrid | 28223 | Spain |
| GSK Investigational Site | Salamanca | 37007 | Spain |
| GSK Investigational Site | Gothenburg | Sweden |
| GSK Investigational Site | Lund | SE-221 85 | Sweden |
| GSK Investigational Site | Stockholm | SE-141 86 | Sweden |
| GSK Investigational Site | Uppsala | SE-751 85 | Sweden |
| GSK Investigational Site | Bangkok | 10330 | Thailand |
| GSK Investigational Site | Bangkok | 10400 | Thailand |
| GSK Investigational Site | Bangkok | 10700 | Thailand |
| GSK Investigational Site | Birmingham | B15 2TH | United Kingdom |
| GSK Investigational Site | Blackpool | FY3 8NR | United Kingdom |
| GSK Investigational Site | Bristol | BS2 8ED | United Kingdom |
| GSK Investigational Site | Cambridge | CB2 2XY | United Kingdom |
| GSK Investigational Site | Cheltenham | GL53 7AN | United Kingdom |
| GSK Investigational Site | Edinburgh | EH4 2XU | United Kingdom |
| GSK Investigational Site | Glasgow | G12 0YN | United Kingdom |
| GSK Investigational Site | Headington, Oxford | OX3 7LE | United Kingdom |
| GSK Investigational Site | Leeds | LS9 7TF | United Kingdom |
| GSK Investigational Site | Liverpool | L7 8XP | United Kingdom |
| GSK Investigational Site | London | NW1 2PG | United Kingdom |
| GSK Investigational Site | London | NW3 2QG | United Kingdom |
| GSK Investigational Site | London | SE5 9RS | United Kingdom |
| GSK Investigational Site | London | W12 0HS | United Kingdom |
| GSK Investigational Site | Manchester | M13 9WL | United Kingdom |
| GSK Investigational Site | Manchester | M20 4BX | United Kingdom |
| GSK Investigational Site | Newcastle upon Tyne | NE7 7DN | United Kingdom |
| GSK Investigational Site | Northwood | HA6 2RN | United Kingdom |
| GSK Investigational Site | Nottingham | NG5 1PB | United Kingdom |
| GSK Investigational Site | Sheffield | S10 2JF | United Kingdom |
| GSK Investigational Site | Southampton | SO16 6YD | United Kingdom |
| GSK Investigational Site | Whitchurch, Cardiff | CF14 2TL | United Kingdom |
| GSK Investigational Site | Wolverhampton | WV10 OQP | United Kingdom |
| FG001 | 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). |
| Intent-to-Treat Population |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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). |
| BG001 | 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). |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | Participants |
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| Number of participants with the indicated SaaIPI scores | The secondary age adjusted international prognostic index (SaaIPI) is assessed according to the absence or presence of 3 risk factors (RFs) at the start of Screening: Eastern Cooperative Oncology Group performance status greater than 1, lactate dehydrogenase level greater than the upper level of normal, and Ann Arbor stage II or IV disease. The presence of 0, 1, or more than 1 RFs corresponds to a SaaIPI score reflecting low, intermediate, and high risk of disease progression. | Number | Participants |
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| Number of participants in the indicated categories per best response to first-line treatment | Late relapsers are those participants with a complete response (CR: complete disappearance of all detectable clinical evidence of disease/disease-related symptoms) following first line treatment which lasts >12 months from diagnosis. Early relapsers/refractory are those participants with a CR <= 12 months, PR (>=50% decrease from Baseline in the sum of the product of the diameters of target lesions), SD (failure to attain CR or PR; no fulfillment of PD), or PD (disease that has grown or spread) after first-line treatment. | Number | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Progression-free Survival as Assessed by Independent Reviewers | 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). | Intent-to-Treat (ITT) Population: all participants who were randomized and commenced study therapy (at least one dose of a study drug) | Posted | Median | 95% Confidence Interval | Months | From randomization until the date of stable disease after two cycles of salvage chemotherapy, progression, or death (assessed for up to 5 years) |
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| Secondary | Number of Participants With Overall Response (OR) and Complete Response (CR) After Salvage Chemoimmunotherapy | 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. | ITT Population | Posted | Number | Participants | At completion of up to 3 cycles of salvage chemoimmunotherapy (assessed up to 9 weeks) |
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| Secondary | Number of Participants With Overall Response (OR) and Complete Response (CR) Three Months After Autologous Stem Cell Transplant | 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. | ITT Population. Only participants completing HDT/ASCT are included. | Posted | Number | Participants | At 3 months after completion of autologous stem cell transplantation (ASCT) (assessed up to 6 months) |
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| Secondary | Event-free Survival | 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). | ITT Population | Posted | Median | 95% Confidence Interval | Months | 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) |
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| Secondary | Overall Survival (OS) | 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. | ITT Population | Posted | Median | 95% Confidence Interval | Months | From randomization to death due to any cause (assessed for up to 5 years) |
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| Secondary | Number of Participants With the Ability to Mobilize at Least 2 Million Cluster of Differentiation (CD)34+ Cells Per Kilogram From Peripheral Blood | 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. | ITT Population. Only participants commencing leukapheresis are included. | Posted | Number | Participants | During Cycles 2 and/or 3 (Weeks 4-9) |
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| Secondary | Number of Participants Completing Autologous Stem Cell Transplant (ASCT) | The number of participants who completed ASCT is reported. | ITT Population | Posted | Number | Participants | Approximately 4 to 6 weeks following Cycle 3 (assessed up to 3 months) |
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| Secondary | Change From Baseline in Functional Assessment of Cancer Therapy-General (FACT-G) During Treatment | 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. | ITT Population. Only those participants who provided data were assessed. | Posted | Mean | Standard Error | scores on a scale | Baseline and the end of the treatment period (until approximately 4 to 6 weeks following Cycle 3 [assessed up to 3 months]) |
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| Secondary | Change From Baseline in the Functional Assessment of Cancer Therapy Lymphoma Trial Outcome Index (FACT-Lym TOI) Total Score During Treatment | 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. | ITT Population. Only those participants who provided data were assessed. | Posted | Mean | Standard Error | scores on a scale | Baseline and the end of the treatment period (until approximately 4 to 6 weeks following Cycle 3 [assessed up to 3 months]) |
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| Secondary | Time to Neutrophil and Platelet Recovery After Each Cycle of Salvage Chemotherapy | 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. | Safety Population. Only those participants available for analysis in the given cycle were assessed. | Posted | Median | 95% Confidence Interval | days | 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) |
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| Secondary | Time to Engraftment After High-dose Therapy (HDT)/ASCT | 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. | Safety population. Only participants completing HDT/ASCT are included. | Posted | Median | 95% Confidence Interval | Days | From ASCT up to 42 days post-ASCT (Baseline up to approximately 4.5 months) |
|
Adverse events (AEs) were collected up to 60 days after the last dose of study treatment, or the commencement of high-dose chemotherapy, or anti-cancer therapy, whichever occurred first (up to approximately 16 study weeks).
Serious adverse events (SAEs) and non-serious AEs were collected in members of the Safety Population, comprised of all participants who received at least one dose of study drug.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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). | 115 | 223 | 217 | 223 | ||
| EG001 | 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). | 118 | 222 | 215 | 222 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
| |
| Pancytopenia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
| |
| Bone marrow failure | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Neutropenic sepsis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Device related infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Lung infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Pneumonia cytomegaloviral | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Pulmonary mycosis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Abscess | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Bronchopulmonary aspergillosis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Clostridial infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Clostridium difficile colitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Device related sepsis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Diarrhoea infectious | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Escherichia bacteraemia | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Fungal endocarditis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Gastrointestinal candidiasis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Gastrointestinal infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Herpes simplex | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Neutropenic infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Parainfluenzae virus infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Pneumonia klebsiella | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Post procedural sepsis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Postoperative wound infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Rhinovirus infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Skin infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Staphylococcal bacteraemia | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Staphylococcal skin infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Wound infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Dental caries | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Duodenal ulcer | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Gastric haemorrhage | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Gastrointestinal inflammation | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Ileal stenosis | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Lower gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Renal failure acute | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Renal impairment | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Renal injury | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Nephropathy toxic | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA | Systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA | Systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA | Systematic Assessment |
| |
| Chills | General disorders | MedDRA | Systematic Assessment |
| |
| Pain | General disorders | MedDRA | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA | Systematic Assessment |
| |
| Blood potassium decreased | Investigations | MedDRA | Systematic Assessment |
| |
| Blood urea increased | Investigations | MedDRA | Systematic Assessment |
| |
| C-reactive protein increased | Investigations | MedDRA | Systematic Assessment |
| |
| Creatinine renal clearance decreased | Investigations | MedDRA | Systematic Assessment |
| |
| Electrocardiogram change | Investigations | MedDRA | Systematic Assessment |
| |
| Weight increased | Investigations | MedDRA | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Tumour lysis syndrome | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Fluid overload | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Hyperlipidaemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Lactic acidosis | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Encephalopathy | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Subarachnoid haemorrhage | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Haemorrhage intracranial | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| VIIth nerve paralysis | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Cerebral haemorrhage | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Cerebral infarction | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Epilepsy | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Peripheral motor neuropathy | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Presyncope | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Lung disorder | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Pneumothorax spontaneous | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Acute coronary syndrome | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Atrial flutter | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Left ventricular failure | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Pericarditis | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Sinus bradycardia | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Supraventricular tachycardia | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Tachyarrhythmia | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA | Systematic Assessment |
| |
| Orthostatic hypotension | Vascular disorders | MedDRA | Systematic Assessment |
| |
| Thrombosis | Vascular disorders | MedDRA | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA | Systematic Assessment |
| |
| Ischaemia | Vascular disorders | MedDRA | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Swelling face | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Blindness | Eye disorders | MedDRA | Systematic Assessment |
| |
| Conjunctivitis | Eye disorders | MedDRA | Systematic Assessment |
| |
| Eyelid function disorder | Eye disorders | MedDRA | Systematic Assessment |
| |
| Ocular hypertension | Eye disorders | MedDRA | Systematic Assessment |
| |
| Periorbital oedema | Eye disorders | MedDRA | Systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA | Systematic Assessment |
| |
| Vitreous haemorrhage | Eye disorders | MedDRA | Systematic Assessment |
| |
| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Facial bones fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Papillary thyroid cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Anaphylactic reaction | Immune system disorders | MedDRA | Systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA | Systematic Assessment |
| |
| Completed suicide | Psychiatric disorders | MedDRA | Systematic Assessment |
| |
| Deafness | Ear and labyrinth disorders | MedDRA | Systematic Assessment |
| |
| Tinnitus | Ear and labyrinth disorders | MedDRA | Systematic Assessment |
| |
| Cholecystitis acute | Hepatobiliary disorders | MedDRA | Systematic Assessment |
| |
| Hepatic failure | Hepatobiliary disorders | MedDRA | Systematic Assessment |
| |
| Epididymitis | Reproductive system and breast disorders | MedDRA | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Meningitis bacterial | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Melaena | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Oesophageal varices haemorrhage | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Renal failure chronic | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Euthanasia | General disorders | MedDRA | Systematic Assessment |
| |
| Brachial plexopathy | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Vena cava thrombosis | Vascular disorders | MedDRA | Systematic Assessment |
| |
| Myelodysplastic syndrome | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Secondary immunodeficiency | Immune system disorders | MedDRA | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA | Systematic Assessment |
| |
| Oedema | General disorders | MedDRA | Systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA | Systematic Assessment |
| |
| Chills | General disorders | MedDRA | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA | Systematic Assessment |
| |
| Weight increased | Investigations | MedDRA | Systematic Assessment |
| |
| Haemoglobin decreased | Investigations | MedDRA | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Hiccups | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA | Systematic Assessment |
| |
| Tinnitus | Ear and labyrinth disorders | MedDRA | Systematic Assessment |
| |
| Lethargy | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Flushing | Vascular disorders | MedDRA | Systematic Assessment |
| |
| Renal failure acute | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Renal impairment | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Blood potassium decreased | Investigations | MedDRA | Systematic Assessment |
| |
| Blood lactate dehydrogenase increased | Investigations | MedDRA | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA | Systematic Assessment |
|
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
| ID | Term |
|---|---|
| D016403 | Lymphoma, Large B-Cell, Diffuse |
| D009369 | Neoplasms |
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D016393 | Lymphoma, B-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| C527517 | ofatumumab |
| D000069283 | Rituximab |
| ID | Term |
|---|---|
| D058846 | Antibodies, Monoclonal, Murine-Derived |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
Not provided
Not provided
| Male |
|
| American Indian or Alaska Native |
|
| Asian - Central/South Asian Heritage |
|
| Asian - East Asian Heritage |
|
| Asian - Japanese Heritage |
|
| Asian - South East Asian Heritage |
|
| Asian - Mixed Race |
|
| White - Arabic/North African Heritage |
|
| White - White/Caucasian/European Heritage |
|
| Missing |
|
| 2 or 3 |
|
| Early relapsers/Refractory |
|
| OG001 | 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). |
|
|
|
| OG001 | 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). |
|
|
|
| OG001 | 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). |
|
|
|
|
|
|
| OG001 | 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). |
|
|
|
|
|
|
| OG001 | 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). |
|
|
|
| OG001 | 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). |
|
|
|
| OG001 | 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). |
|
|
|
| OG001 | 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). |
|
|
|