Trial · NCT02285062
Efficacy and Safety Study of Lenalidomide Plus R-CHOP Chemotherapy Versus Placebo Plus R-CHOP Chemotherapy in Untreated ABC Type Diffuse Large B-cell Lymphoma
NCT02285062, Phase 3, Completed, Celgene; results first posted 2020-03-30
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Efficacy and Safety Study of Lenalidomide Plus R-CHOP Chemotherapy Versus Placebo Plus R-CHOP Chemotherapy in Untreated ABC Type Diffuse Large B-cell Lymphoma. Trials, record NCT02285062. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02285062
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety Study of Lenalidomide Plus R-CHOP Chemotherapy Versus Placebo Plus R-CHOP Chemotherapy in Untreated ABC Type Diffuse Large B-cell Lymphoma
- NCT number
- NCT02285062
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 570 participants, actual
- Lead sponsor
- Celgene
- Conditions
- Lymphoma, Large B-Cell, Diffuse
- Interventions
- lenalidomide, Placebo, Rituximab, Cyclophosphamide, Doxorubicin, prednisone, vincristine
- First posted
- 2014-11-06
- Last updated
- 2023-06-22
- Other registries' IDs
- eudract:2013-004054-21
- Results first posted
- 2020-03-30
Source ClinicalTrials.gov
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Kaplan-Meier Estimate of Progression Free Survival (PFS) | From the date of randomization up to the data cut off date of 15 March 2019; median follow-up of 24.5 months | Progression free survival was defined as the time (months) from the date of randomization to the date of disease progression or death (any cause), whichever occurred earlier and was assessed by the Independent Response Adjudication Committee (IRAC). Relapse from complete response (CR) was considered as disease progression throughout the study. Disease progression was determined based on the Revised Response Criteria for Malignant Lymphoma. The PFS analysis was based on the censoring rules using the Food and Drug Administration (FDA) Guidance. Participants who did not experience disease progression and who did not die before the clinical data cutoff date were censored at the date of last adequate response assessment. |
| Secondary | Kaplan-Meier (K-M) Estimate of Event Free Survival (EFS) | From the date of randomization up to the data cut off date of 15 March 2019; median follow-up was 24.5 months | EFS was defined as the time (months) from randomization until occurrence of one of the following events, whichever occurred first: • Disease progression • Initiation of subsequent systemic anti-lymphoma therapy • Death due to any cause The assessment of EFS was conducted by the IRAC using the International Working Group (IWG) criteria for NHL. Pre-specified optional therapies such as the extra 2 doses of single agent rituximab after Cycle 6 or consolidation radiotherapy did not count as an EFS event (initiation of subsequent systemic anti-lymphoma therapy) if the decision to treat and the location to be treated was determined prior to randomization. Participants who did not experience any of the events defined in the categories above before the clinical data cutoff date were censored at date last known alive. |
| Secondary | K-M Estimate of Overall Survival (OS) | From randomization until death due to any cause (up to approximately 86 months) | Overall survival was assessed by the Independent Response Adjudication Committee (IRAC) and defined as time from randomization until death due to any cause. Participants who withdrew consent were censored at the time of withdrawal. Participants who were still alive before the clinical data cutoff date and participants who were lost to follow-up were censored at date last known alive. |
| Secondary | Percentage of Participants Who Achieved a Complete Response (CR) | From randomization date up to the data cut off date of 15 March 2019; median follow-up was 24.5 months | The percentage of participants who achieved a CR after initiation of the study treatment and prior to initiation of subsequent systemic antilymphoma therapy as assessed by the IRAC. A CR = complete metabolic response; target nodes/nodal masses regressed on computed tomography to (≤ 1.5 cm in their greatest transverse diameter for nodes \> 1.5 cm prior to therapy. Regressed to normal size by imaging, and absence of nodules related to lymphoma. If bone marrow was involved prior to therapy, no evidence of fluorodeoxyglucose avid disease in marrow per International Working Group (IWG) 2014 for Non-Hodgkin's Lymphoma (NHL). Participants who did not have any adequate response assessments during this period were not considered as responders. |
| Secondary | Percentage of Participants Who Achieved an Objective Response | From randomization date up to the data cut off date of 15 March 2019; median total treatment duration was 18.10 weeks for both treatment arms; range = 1.6 to 29.0 weeks for R2-CHOP arm and 0.3 to 22.9 weeks for placebo-R-CHOP arm | An objective response = percentage of participants who achieved a complete response or partial response after initiation of the treatment and prior to initiation of subsequent systemic anti-lymphoma therapy. A CR = complete metabolic response; Target nodes/nodal masses regressed on computed tomography to (≤ 1.5 cm in their greatest transverse diameter for nodes \> 1.5 cm prior to therapy. Regressed to normal size by imaging, and absence of nodules related to lymphoma. If bone marrow was involved prior to therapy, no evidence of fluorodeoxyglucose avid disease in marrow. PR = ≥ 50% decrease in sum of the product of the diameters (SPD) of up to 6 of the largest dominant nodes or nodal masses. No increase in other nodes, liver, or spleen. Splenic nodules regressed by ≥ 50% in their SPD or for single nodules, in the greatest transverse diameter; no new lesions. Participants who did not have any adequate response assessments during this period were not considered as responders. |
| Secondary | K-M Estimate of Duration of Complete Response | From randomization date up to the data cut off date of 15 March 2019; median follow-up was 24.5 months. | Duration of complete response was calculated for complete responders only and was defined as the time from documented initial complete response prior to initiation of subsequent systemic antilymphoma therapy until documented disease progression or death, whichever occurred earlier. Participants who had not progressed or died at the time of the analysis were censored at the date of last response assessment demonstrating no disease progression. Participants who changed treatment without evidence of disease progression were censored at the last assessment showing no progression prior to treatment change. |
| Secondary | K-M Estimate of Time to Next Lymphoma Therapy (TTNLT) | From randomization date up to the data cut off date of 15 March 2019; median follow-up was 24.5 months | Time to next lymphoma therapy was defined as the time from randomization to the time of treatment change for the next lymphoma treatment. Participants without treatment change were censored at date last known alive. Pre-specified optional therapies such as the extra 2 doses of single agent rituximab after Cycle 6 or consolidation radiotherapy did not count as treatment change for the next lymphoma therapy if the decision to treat and the location to be treated were determined prior to randomization. |
| Secondary | Percentage of Participants Who Completed the Functional Assessment of Cancer Therapy Lymphoma (FACT-Lym) Questionnaire | Screening, Midcycle = after Cycle 3 but before Cycle 4, Cycle 6 Day 1 (C6D1), End of Treatment (C6,D21), and Follow-Up Period up to Week 34 | The completion rate for FACT-Lym assessments was judged by looking at the number of completed FACT-Lym assessments at each time point. The FACT-Lym was considered completed if at least 1 calculable score was present. Completion rates were calculated as the number and percentage of participants out of the total number of patients in the ITT population and summarized by visit/cycle and treatment group. The FACT-Lym is a health related quality of life (HRQoL) questionnaire targeted to the management of chronic illness, predominantly within oncology and is considered an extension of the FACT-General questionnaire. |
| Secondary | Percentage of Participants Who Completed the Euroqol 5-Dimension 3-Level (EQ-5D-3L) Health Related Quality of Life (HR-QoL) Questionnaire | Screening, Midcycle = after Cycle 3 but before Cycle 4, Cycle 6 Day 1 (C6D1), End of Treatment (C6,D21), and Follow-Up Period up to Week 34 | The completion rate for EQ-5D assessments was judged by looking at the number of completed assessments at each time point. Completion rates were calculated as the number and percentage of participants out of the total number of patients in the ITT population and summarized by visit/cycle and treatment group. The EQ-5D-3L is a generic, self-reported preference-based measure of health across five dimensions: mobility, self-care, pain, usual activities, and anxiety/depression. Each dimension has three levels of 'severity' corresponding to "no problems", "some problems" and "extreme problems". The instrument is scored using the United Kingdom (UK) index ranges from -0.594 - 1, where 0 equates to death and 1 equates to full health -0.594 is considered 'worse than death'. |
| Secondary | Mean Change From Baseline in the FACT-Lym Physical Well-Being Subscale | Baseline and Midcycle = after Cycle 3 but before Cycle 4, Cycle 6 Day 1 (C6D1), End of Treatment (C6,D21), and Follow-Up Period up to Week 34 | The FACT-Lym questionnaire is a validated instrument for assessing the impact of lymphoma on HRQL and contains 42 questions covering HRQL and common lymphoma symptoms and treatment side-effects. It begins with the Functional Assessment of Cancer Therapy - General (FACT-G), which contains 27 questions covering four core subscales: Physical Wellbeing (7 items), Social/Family Wellbeing (7), Emotional Wellbeing (6), and Functional Wellbeing (7). The FACT-Lym also includes an Additional Concerns subscale (15 questions) used to assess NHL-related symptoms and concerns. All questions are answered on a 5-point scale ranging from "not at all" (0) to "very much" (4). The physical well-being subscale ranges from 0 to 28, where higher scores reflect better HRQoL. |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 registered outcomesOutcomes15
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Kaplan-Meier Estimate of Progression Free Survival (PFS) | From the date of randomization up to the data cut off date of 15 March 2019; median follow-up of 24.5 months | The Intent-to-treat (ITT) population was defined as all participants who were randomized into the trial, regardless of whether they received study treatment or not. | months | MEDIAN |
| SECONDARY | Kaplan-Meier (K-M) Estimate of Event Free Survival (EFS) | From the date of randomization up to the data cut off date of 15 March 2019; median follow-up was 24.5 months | The ITT population was defined as all participants who were randomized into the trial, regardless of whether they received study treatment or not. | Months | MEDIAN |
| SECONDARY | K-M Estimate of Overall Survival (OS) | From randomization until death due to any cause (up to approximately 86 months) | The ITT population was defined as all participants who were randomized into the trial, regardless of whether they received study treatment or not. | Months | MEDIAN |
| SECONDARY | Percentage of Participants Who Achieved a Complete Response (CR) | From randomization date up to the data cut off date of 15 March 2019; median follow-up was 24.5 months | The ITT population was defined as all participants who were randomized into the trial, regardless of whether they received study treatment or not. Participants who had a CR. | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Participants Who Achieved an Objective Response | From randomization date up to the data cut off date of 15 March 2019; median total treatment duration was 18.10 weeks for both treatment arms; range = 1.6 to 29.0 weeks for R2-CHOP arm and 0.3 to 22.9 weeks for placebo-R-CHOP arm | The Intent-to-treat population was defined as all participants who were randomized into the trial, regardless of whether they received study treatment or not. Participants who had a PR or better. | Percentage of Participants | NUMBER |
| SECONDARY | K-M Estimate of Duration of Complete Response | From randomization date up to the data cut off date of 15 March 2019; median follow-up was 24.5 months. | The ITT population was defined as all participants who were randomized into the trial, regardless of whether they received study treatment or not. Participants who had a response. | Months | MEDIAN |
| SECONDARY | K-M Estimate of Time to Next Lymphoma Therapy (TTNLT) | From randomization date up to the data cut off date of 15 March 2019; median follow-up was 24.5 months | The Intent-to-treat (ITT) population was defined as all participants who were randomized into the trial, regardless of whether they received study treatment or not. | Months | MEDIAN |
| SECONDARY | Percentage of Participants Who Completed the Functional Assessment of Cancer Therapy Lymphoma (FACT-Lym) Questionnaire | Screening, Midcycle = after Cycle 3 but before Cycle 4, Cycle 6 Day 1 (C6D1), End of Treatment (C6,D21), and Follow-Up Period up to Week 34 | The ITT population was defined as all participants who were randomized into the trial, regardless of whether they received study treatment or not. | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Participants Who Completed the Euroqol 5-Dimension 3-Level (EQ-5D-3L) Health Related Quality of Life (HR-QoL) Questionnaire | Screening, Midcycle = after Cycle 3 but before Cycle 4, Cycle 6 Day 1 (C6D1), End of Treatment (C6,D21), and Follow-Up Period up to Week 34 | The ITT population was defined as all participants who were randomized into the trial, regardless of whether they received study treatment or not. | Percentage of Participants | NUMBER |
| SECONDARY | Mean Change From Baseline in the FACT-Lym Physical Well-Being Subscale | Baseline and Midcycle = after Cycle 3 but before Cycle 4, Cycle 6 Day 1 (C6D1), End of Treatment (C6,D21), and Follow-Up Period up to Week 34 | The HRQoL evaluable population was defined as all participants in the ITT population who had: at least one baseline and the corresponding post-baseline calculable FACT-Lym score assessment; where post-baseline is any subsequent time excluding unscheduled visits (i.e. at Midcycle, C6D1, EOT or a follow-up visit). | Units on a Scale | MEAN |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 outcomesResults by group78
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Kaplan-Meier Estimate of Progression Free Survival (PFS) | Lenalidomide Plus R-CHOP (R2-CHOP) | NA | 95% Confidence Interval NA to NA | months | |
| Kaplan-Meier Estimate of Progression Free Survival (PFS) | Placebo Plus R-CHOP | NA | 95% Confidence Interval 35.5 to NA | months | |
| Kaplan-Meier (K-M) Estimate of Event Free Survival (EFS) | Lenalidomide Plus R-CHOP (R2-CHOP) | NA | 95% Confidence Interval NA to NA | Months | |
| Kaplan-Meier (K-M) Estimate of Event Free Survival (EFS) | Placebo Plus R-CHOP | NA | 95% Confidence Interval 31.3 to NA | Months | |
| K-M Estimate of Overall Survival (OS) | Lenalidomide Plus R-CHOP (R2-CHOP) | NA | 95% Confidence Interval NA to NA | Months | |
| K-M Estimate of Overall Survival (OS) | Placebo Plus R-CHOP | NA | 95% Confidence Interval NA to NA | Months | |
| Percentage of Participants Who Achieved a Complete Response (CR) | Lenalidomide Plus R-CHOP (R2-CHOP) | 69.1 | 95% Confidence Interval 63.4 to 74.4 | Percentage of Participants | |
| Percentage of Participants Who Achieved a Complete Response (CR) | Placebo Plus R-CHOP | 64.9 | 95% Confidence Interval 59.1 to 70.4 | Percentage of Participants | |
| Percentage of Participants Who Achieved an Objective Response | Lenalidomide Plus R-CHOP (R2-CHOP) | 90.9 | 95% Confidence Interval 86.9 to 94.0 | Percentage of Participants | |
| Percentage of Participants Who Achieved an Objective Response | Placebo Plus R-CHOP | 90.9 | 95% Confidence Interval 86.9 to 94.0 | Percentage of Participants |
1 to 10 of 78Source ClinicalTrials.gov
See all 78 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Pre-Treatment Period | STARTED | Lenalidomide Plus R-CHOP (R2-CHOP) | 285 | |
| Pre-Treatment Period | STARTED | Placebo Plus R-CHOP | 285 | |
| Pre-Treatment Period | COMPLETED | Lenalidomide Plus R-CHOP (R2-CHOP) | 284 | |
| Pre-Treatment Period | COMPLETED | Placebo Plus R-CHOP | 283 | |
| Pre-Treatment Period | NOT COMPLETED | Lenalidomide Plus R-CHOP (R2-CHOP) | 1 | |
| Pre-Treatment Period | NOT COMPLETED | Placebo Plus R-CHOP | 2 | |
| Treatment Period | STARTED | Lenalidomide Plus R-CHOP (R2-CHOP) | 283 | |
| Treatment Period | STARTED | Placebo Plus R-CHOP | 284 | |
| Treatment Period | COMPLETED | Lenalidomide Plus R-CHOP (R2-CHOP) | 211 | |
| Treatment Period | COMPLETED | Placebo Plus R-CHOP | 240 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events402
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 | Anaemia | Blood and lymphatic system disorders | Lenalidomide Plus R-CHOP (R2-CHOP) | 127 | 283 | |
| other | Anaemia | Blood and lymphatic system disorders | Placebo Plus R-CHOP | 95 | 284 | |
| other | Leukopenia | Blood and lymphatic system disorders | Lenalidomide Plus R-CHOP (R2-CHOP) | 50 | 283 | |
| other | Leukopenia | Blood and lymphatic system disorders | Placebo Plus R-CHOP | 50 | 284 | |
| other | Lymphopenia | Blood and lymphatic system disorders | Lenalidomide Plus R-CHOP (R2-CHOP) | 35 | 283 | |
| other | Lymphopenia | Blood and lymphatic system disorders | Placebo Plus R-CHOP | 31 | 284 | |
| other | Neutropenia | Blood and lymphatic system disorders | Lenalidomide Plus R-CHOP (R2-CHOP) | 183 | 283 | |
| other | Neutropenia | Blood and lymphatic system disorders | Placebo Plus R-CHOP | 150 | 284 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Lenalidomide Plus R-CHOP (R2-CHOP) | 68 | 283 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Placebo Plus R-CHOP | 55 | 284 |
1 to 10 of 402Source ClinicalTrials.gov
See all 402 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Lenalidomide Plus R-CHOP (R2-CHOP) | 85 | 285 |
| Total, all-cause mortality | Placebo Plus R-CHOP | 88 | 285 |
| Total, other adverse events | Lenalidomide Plus R-CHOP (R2-CHOP) | 272 | 283 |
| Total, other adverse events | Placebo Plus R-CHOP | 270 | 284 |
| Total, serious adverse events | Lenalidomide Plus R-CHOP (R2-CHOP) | 104 | 283 |
| Total, serious adverse events | Placebo Plus R-CHOP | 88 | 284 |
Source ClinicalTrials.gov
Papers3
The papers the trial lists on ClinicalTrials.gov.
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Lenalidomide Plus R-CHOP (R2-CHOP) vs Placebo Plus R-CHOP: deaths from any cause | Trial comparisons |
| Lenalidomide Plus R-CHOP (R2-CHOP) vs Placebo Plus R-CHOP: 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/NCT02285062
GET https://conductscience.org/api/trials/v1/NCT02285062/results?page=2