Trial · NCT01014208
Ofatumumab Versus Rituximab Salvage Chemoimmunotherapy Followed by Autologous Stem Cell Transplant in Relapsed or Refractory Diffuse Large B Cell Lymphoma
NCT01014208, Phase 3, Completed, GlaxoSmithKline; results first posted 2014-10-16
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Ofatumumab Versus Rituximab Salvage Chemoimmunotherapy Followed by Autologous Stem Cell Transplant in Relapsed or Refractory Diffuse Large B Cell Lymphoma. Trials, record NCT01014208. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01014208
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Ofatumumab Versus Rituximab Salvage Chemoimmunotherapy Followed by Autologous Stem Cell Transplant in Relapsed or Refractory Diffuse Large B Cell Lymphoma
- NCT number
- NCT01014208
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 447 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Lymphoma, Large-Cell, Diffuse
- Interventions
- OFATUMUMAB + DHAP, RITUXIMAB + DHAP
- First posted
- 2009-11-16
- Last updated
- 2015-08-07
- Results first posted
- 2014-10-16
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression-free Survival as Assessed by Independent Reviewers | From randomization until the date of stable disease after two cycles of salvage chemotherapy, progression, or death (assessed for up to 5 years) | 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). |
| Secondary | Number of Participants With Overall Response (OR) and Complete Response (CR) After Salvage Chemoimmunotherapy | At completion of up to 3 cycles of salvage chemoimmunotherapy (assessed up to 9 weeks) | 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. |
| Secondary | Number of Participants With Overall Response (OR) and Complete Response (CR) Three Months After Autologous Stem Cell Transplant | At 3 months after completion of autologous stem cell transplantation (ASCT) (assessed up to 6 months) | 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. |
| Secondary | Event-free Survival | 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) | 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). |
| Secondary | Overall Survival (OS) | From randomization to death due to any cause (assessed for up to 5 years) | 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. |
| Secondary | Number of Participants With the Ability to Mobilize at Least 2 Million Cluster of Differentiation (CD)34+ Cells Per Kilogram From Peripheral Blood | During Cycles 2 and/or 3 (Weeks 4-9) | 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. |
| Secondary | Number of Participants Completing Autologous Stem Cell Transplant (ASCT) | Approximately 4 to 6 weeks following Cycle 3 (assessed up to 3 months) | The number of participants who completed ASCT is reported. |
| Secondary | Change From Baseline in Functional Assessment of Cancer Therapy-General (FACT-G) During Treatment | Baseline and the end of the treatment period (until approximately 4 to 6 weeks following Cycle 3 [assessed up to 3 months]) | 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. |
| Secondary | Change From Baseline in the Functional Assessment of Cancer Therapy Lymphoma Trial Outcome Index (FACT-Lym TOI) Total Score During Treatment | Baseline and the end of the treatment period (until approximately 4 to 6 weeks following Cycle 3 [assessed up to 3 months]) | 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. |
| Secondary | Time to Neutrophil and Platelet Recovery After Each Cycle of Salvage Chemotherapy | 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) | 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. |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Progression-free Survival as Assessed by Independent Reviewers | From randomization until the date of stable disease after two cycles of salvage chemotherapy, progression, or death (assessed for up to 5 years) | Intent-to-Treat (ITT) Population: all participants who were randomized and commenced study therapy (at least one dose of a study drug) | Months | MEDIAN |
| SECONDARY | Number of Participants With Overall Response (OR) and Complete Response (CR) After Salvage Chemoimmunotherapy | At completion of up to 3 cycles of salvage chemoimmunotherapy (assessed up to 9 weeks) | ITT Population | Participants | NUMBER |
| SECONDARY | Number of Participants With Overall Response (OR) and Complete Response (CR) Three Months After Autologous Stem Cell Transplant | At 3 months after completion of autologous stem cell transplantation (ASCT) (assessed up to 6 months) | ITT Population. Only participants completing HDT/ASCT are included. | Participants | NUMBER |
| SECONDARY | Event-free Survival | 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) | ITT Population | Months | MEDIAN |
| SECONDARY | Overall Survival (OS) | From randomization to death due to any cause (assessed for up to 5 years) | ITT Population | Months | MEDIAN |
| SECONDARY | Number of Participants With the Ability to Mobilize at Least 2 Million Cluster of Differentiation (CD)34+ Cells Per Kilogram From Peripheral Blood | During Cycles 2 and/or 3 (Weeks 4-9) | ITT Population. Only participants commencing leukapheresis are included. | Participants | NUMBER |
| SECONDARY | Number of Participants Completing Autologous Stem Cell Transplant (ASCT) | Approximately 4 to 6 weeks following Cycle 3 (assessed up to 3 months) | ITT Population | Participants | NUMBER |
| SECONDARY | Change From Baseline in Functional Assessment of Cancer Therapy-General (FACT-G) During Treatment | Baseline and the end of the treatment period (until approximately 4 to 6 weeks following Cycle 3 [assessed up to 3 months]) | ITT Population. Only those participants who provided data were assessed. | scores on a scale | MEAN |
| SECONDARY | Change From Baseline in the Functional Assessment of Cancer Therapy Lymphoma Trial Outcome Index (FACT-Lym TOI) Total Score During Treatment | Baseline and the end of the treatment period (until approximately 4 to 6 weeks following Cycle 3 [assessed up to 3 months]) | ITT Population. Only those participants who provided data were assessed. | scores on a scale | MEAN |
| SECONDARY | Time to Neutrophil and Platelet Recovery After Each Cycle of Salvage Chemotherapy | 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) | Safety Population. Only those participants available for analysis in the given cycle were assessed. | days | MEDIAN |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group36
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Progression-free Survival as Assessed by Independent Reviewers | Rituximab + Chemotherapy | 2.14 | 95% Confidence Interval 1.64 to 4.37 | Months | |
| Progression-free Survival as Assessed by Independent Reviewers | Ofatumumab + Chemotherapy | 1.81 | 95% Confidence Interval 1.54 to 2.53 | Months | |
| Number of Participants With Overall Response (OR) and Complete Response (CR) After Salvage Chemoimmunotherapy | Rituximab + Chemotherapy | Independent reviewer-assessed OR | 94 | Participants | |
| Number of Participants With Overall Response (OR) and Complete Response (CR) After Salvage Chemoimmunotherapy | Ofatumumab + Chemotherapy | Independent reviewer-assessed OR | 84 | Participants | |
| Number of Participants With Overall Response (OR) and Complete Response (CR) After Salvage Chemoimmunotherapy | Rituximab + Chemotherapy | Independent reviewer-assessed CR | 48 | Participants | |
| Number of Participants With Overall Response (OR) and Complete Response (CR) After Salvage Chemoimmunotherapy | Ofatumumab + Chemotherapy | Independent reviewer-assessed CR | 34 | Participants | |
| Number of Participants With Overall Response (OR) and Complete Response (CR) Three Months After Autologous Stem Cell Transplant | Rituximab + Chemotherapy | Independent reviewer-assessed OR | 57 | Participants | |
| Number of Participants With Overall Response (OR) and Complete Response (CR) Three Months After Autologous Stem Cell Transplant | Ofatumumab + Chemotherapy | Independent reviewer-assessed OR | 53 | Participants | |
| Number of Participants With Overall Response (OR) and Complete Response (CR) Three Months After Autologous Stem Cell Transplant | Rituximab + Chemotherapy | Independent reviewer-assessed CR | 44 | Participants | |
| Number of Participants With Overall Response (OR) and Complete Response (CR) Three Months After Autologous Stem Cell Transplant | Ofatumumab + Chemotherapy | Independent reviewer-assessed CR | 43 | Participants |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Rituximab + Chemotherapy | 225 | |
| Overall Study | STARTED | Ofatumumab + Chemotherapy | 222 | |
| Overall Study | Intent-to-Treat Population | Rituximab + Chemotherapy | 223 | |
| Overall Study | Intent-to-Treat Population | Ofatumumab + Chemotherapy | 222 | |
| Overall Study | COMPLETED | Rituximab + Chemotherapy | 131 | |
| Overall Study | COMPLETED | Ofatumumab + Chemotherapy | 122 | |
| Overall Study | NOT COMPLETED | Rituximab + Chemotherapy | 94 | |
| Overall Study | NOT COMPLETED | Ofatumumab + Chemotherapy | 100 |
Source ClinicalTrials.gov
Adverse events482
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Nausea | Gastrointestinal disorders | Rituximab + Chemotherapy | 136 | 223 | |
| other | Nausea | Gastrointestinal disorders | Ofatumumab + Chemotherapy | 129 | 222 | |
| other | Vomiting | Gastrointestinal disorders | Rituximab + Chemotherapy | 81 | 223 | |
| other | Vomiting | Gastrointestinal disorders | Ofatumumab + Chemotherapy | 68 | 222 | |
| other | Constipation | Gastrointestinal disorders | Rituximab + Chemotherapy | 65 | 223 | |
| other | Constipation | Gastrointestinal disorders | Ofatumumab + Chemotherapy | 76 | 222 | |
| other | Diarrhoea | Gastrointestinal disorders | Rituximab + Chemotherapy | 70 | 223 | |
| other | Diarrhoea | Gastrointestinal disorders | Ofatumumab + Chemotherapy | 50 | 222 | |
| other | Dyspepsia | Gastrointestinal disorders | Rituximab + Chemotherapy | 24 | 223 | |
| other | Dyspepsia | Gastrointestinal disorders | Ofatumumab + Chemotherapy | 16 | 222 |
1 to 10 of 482Source ClinicalTrials.gov
See all 482 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Rituximab + Chemotherapy | ||
| Total, all-cause mortality | Ofatumumab + Chemotherapy | ||
| Total, other adverse events | Rituximab + Chemotherapy | 217 | 223 |
| Total, other adverse events | Ofatumumab + Chemotherapy | 215 | 222 |
| Total, serious adverse events | Rituximab + Chemotherapy | 115 | 223 |
| Total, serious adverse events | Ofatumumab + Chemotherapy | 118 | 222 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
Rituximab + Chemotherapy vs Ofatumumab + Chemotherapy: Number of Participants With the Ability to Mobilize at Least 2 Million Cluster of Differentiation (CD)34+ Cells Per Kilogram From Peripheral Blood | Trial comparisons |
| Rituximab + Chemotherapy vs Ofatumumab + Chemotherapy: Number of Participants Completing Autologous Stem Cell Transplant (ASCT) | Trial comparisons |
| Rituximab + Chemotherapy vs Ofatumumab + Chemotherapy: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01014208
GET https://conductscience.org/api/trials/v1/NCT01014208/results?page=2