Trial · NCT01938001
Rituximab Plus Lenalidomide for Patients With Relapsed / Refractory Indolent Non-Hodgkin's Lymphoma (Follicular Lymphoma and Marginal Zone Lymphoma)
NCT01938001, Phase 3, Completed, Celgene; results first posted 2019-08-13
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Rituximab Plus Lenalidomide for Patients With Relapsed / Refractory Indolent Non-Hodgkin's Lymphoma (Follicular Lymphoma and Marginal Zone Lymphoma). Trials, record NCT01938001. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01938001
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Rituximab Plus Lenalidomide for Patients With Relapsed / Refractory Indolent Non-Hodgkin's Lymphoma (Follicular Lymphoma and Marginal Zone Lymphoma)
- NCT number
- NCT01938001
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 358 participants, actual
- Lead sponsor
- Celgene
- Conditions
- Lymphoma, Non-Hodgkin
- Interventions
- Rituximab, Lenalidomide, Placebo
- First posted
- 2013-09-10
- Last updated
- 2023-02-22
- Results first posted
- 2019-08-13
Source ClinicalTrials.gov
Registered outcomes10
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 Assessed by the Independent Review Committee (IRC) According to the 2007 International Working Group Response Criteria (IWGRC) | From randomization of study drug up to disease progression or death, which occurred first; up to the data cut-off date of 22 June 2018; overall median follow-up time for all participants was 28.30 months (range: 0.1 to 51.3 months). | Progression-free survival (PFS) was defined as the time from date of randomization into the study to the first observation of documented disease progression or death due to any cause, whichever occurred first. PFS was based on the data from the IRC review using the modified 2007 International Working Group Response Criteria (IWGRC) using FDA censoring rules. |
| Secondary | Durable Complete Response Rate (DCCR) as Assessed by the IRC According to the 2007 IWGRC | From first dose of investigational product (IP) to data cut-off date of 22 June 2018; the median treatment duration was 11.19 months in the rituximab/lenalidomiade arm and 11.04 months in the rituximab/placebo arm | DCCR was defined as the percentage of participants with a best response of complete response (CR) that lasted no less than one year (≥ 48 weeks) during the study prior to administration of new anti-lymphoma therapy. A CR is defined as a complete disappearance of any disease-related symptoms and normalization of biochemical abnormalities. |
| Secondary | Kaplan-Meier Estimate of Overall Survival (OS) | From date of randomization to death due to any cause (Average of 55.71 months and a maximum up to 95.2 months) | Overall survival was defined as the time from randomization to death from any cause. Overall survival was censored at the last date that the participant was known to be alive for participants who were alive at the time of analysis and for participants who were lost to follow-up before death was documented. |
| Secondary | Percentage of Participants With an Objective Response as Assessed by the IRC According to the 2007 IWGRC | From date of first dose to data cut-off date of 22 June 2018; the median treatment duration was 11.19 months in the rituximab/lenalidomide arm and 11.04 months in the rituximab/placebo arm | Percentage of participants with an objective response is defined as having a response of at least a PR during the study without administration of new anti-lymphoma therapy. A complete response = a complete disappearance of all detectable clinical and radiographic evidence of disease, disappearance of any disease-related symptoms, and normalization of biochemical abnormalities; a partial response (PR) = 50% decrease in SPD of the 6 largest dominant nodes or nodal masses. No increase in the size of other nodes, liver, or spleen. Splenic and hepatic nodules must regress by at least 50% in the SPD. |
| Secondary | Percentage of Participants With a Best Response of Complete Response as Assessed by the IRC According to the 2007 IWGRC | From date of first dose up to data cut-off date of 22 June 2018; the median treatment duration was 11.19 months in the rituximab/lenalidomide arm and 11.04 months in the rituximab/placebo arm | Percentage of participants with a best response of at CR during the study without administration of new anti-lymphoma therapy. A CR = Complete disappearance of all detectable clinical and radiographic evidence of disease, disappearance of any disease-related symptoms, and normalization of biochemical abnormalities. |
| Secondary | Kaplan-Meier Estimate of Duration of Objective Response as Assessed by the IRC According to the 2007 IWGRC | From randomization up to data cut-off date of 22 June 2018; overall median follow-up time for all participants was 28.30 months (range: 0.1 to 51.3 months). | Duration of response (DOR) was defined as the time from initial response (at least PR) until documented progressive disease (PD) or death. Participants who had not progressed at the time of analysis were censored at the last assessment date that the participant was known to be progression free. Participants who received a new treatment without documented progression were censored at the last assessment date that the participants was known to be progression free. |
| Secondary | Kaplan-Meier Estimate of Duration of Complete Response (DOCR) as Assessed by the IRC According to the 2007 IWGRC | From randomization up to data cut-off date of 22 June 2018; overall median follow-up time for all participants was 28.30 months (range: 0.1 to 51.3 months). | DOCR was defined as the time from initial CR until documented PD or death. Participants who had not progressed at the time of analysis were censored at the last assessment date that the participant was known to be progression free. Participants who received a new treatment without documented progression were censored at the last assessment date that the participants was known to be progression free. |
| Secondary | Kaplan Meier Estimate of Event Free Survival as Assessed by the IRC According to the 2007 IWGRC | From date of randomization to data cut-off date of 22 June 2018; overall median follow-up time for all participants was 28.30 months (range: 0.1 to 51.3 months). | Event-free survival (EFS) was defined as the time from date of randomization to date of first documented progression, relapse, institution of new anti-lymphoma treatment (chemotherapy, radiotherapy or immunotherapy) or death from any cause. Responding participants and those who were lost to follow up were censored at their last tumor assessment date. |
| Secondary | Kaplan Meier Estimate of Time to Next Anti-Lymphoma Treatment (TTNLT) | From date of randomization to date of first documented administration of a new anti-lymphoma treatment (Average of 55.71 months and a maximum up to 95.2 months) | Time to next anti-lymphoma treatment (TTNLT) was defined as the time from date of randomization to date of first documented administration of a new anti-lymphoma treatment (including chemotherapy, radiotherapy, radioimmunotherapy or immunotherapy). The time to the next anti-lymphoma treatment was of special interest to the study. |
| Secondary | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | From first dose to 28 days post last dose (Average of 55.71 months and a maximum up to 95.2 months) | TEAEs include AEs that started or worsened between the date of the first dose and 28 days after the date of the last dose. A serious adverse event (SAE) is any: • Death; • Life-threatening event; • Any inpatient hospitalization or prolongation of existing hospitalization; • Persistent or significant disability or incapacity; • Congenital anomaly or birth defect; • Any other important medical event. The investigator determined the relationship of an AE to study drug based on the timing of the AE relative to drug administration and whether or not other drugs, therapeutic interventions, or underlying conditions could provide a sufficient explanation for the event. The severity of an AE was evaluated by the investigator according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) (Version 4.03) where Grade 1 = Mild, Grade 2 = Moderate, Grade 3 = Severe, Grade 4 = Life-threatening and Grade 5 = Death |
Source ClinicalTrials.gov
Outcomes10
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 Assessed by the Independent Review Committee (IRC) According to the 2007 International Working Group Response Criteria (IWGRC) | From randomization of study drug up to disease progression or death, which occurred first; up to the data cut-off date of 22 June 2018; overall median follow-up time for all participants was 28.30 months (range: 0.1 to 51.3 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 | Durable Complete Response Rate (DCCR) as Assessed by the IRC According to the 2007 IWGRC | From first dose of investigational product (IP) to data cut-off date of 22 June 2018; the median treatment duration was 11.19 months in the rituximab/lenalidomiade arm and 11.04 months in the rituximab/placebo arm | 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 | Kaplan-Meier Estimate of Overall Survival (OS) | From date of randomization to death due to any cause (Average of 55.71 months and a maximum up to 95.2 months) | The ITT population is 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 With an Objective Response as Assessed by the IRC According to the 2007 IWGRC | From date of first dose to data cut-off date of 22 June 2018; the median treatment duration was 11.19 months in the rituximab/lenalidomide arm and 11.04 months in the rituximab/placebo arm | 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 With a Best Response of Complete Response as Assessed by the IRC According to the 2007 IWGRC | From date of first dose up to data cut-off date of 22 June 2018; the median treatment duration was 11.19 months in the rituximab/lenalidomide arm and 11.04 months in the rituximab/placebo arm | 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 | Kaplan-Meier Estimate of Duration of Objective Response as Assessed by the IRC According to the 2007 IWGRC | From randomization up to data cut-off date of 22 June 2018; overall median follow-up time for all participants was 28.30 months (range: 0.1 to 51.3 months). | Participants who achieved an objective response in the ITT population. | months | MEDIAN |
| SECONDARY | Kaplan-Meier Estimate of Duration of Complete Response (DOCR) as Assessed by the IRC According to the 2007 IWGRC | From randomization up to data cut-off date of 22 June 2018; overall median follow-up time for all participants was 28.30 months (range: 0.1 to 51.3 months). | Participants who achieved a complete response in the ITT population. | months | MEDIAN |
| SECONDARY | Kaplan Meier Estimate of Event Free Survival as Assessed by the IRC According to the 2007 IWGRC | From date of randomization to data cut-off date of 22 June 2018; overall median follow-up time for all participants was 28.30 months (range: 0.1 to 51.3 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 | Kaplan Meier Estimate of Time to Next Anti-Lymphoma Treatment (TTNLT) | From date of randomization to date of first documented administration of a new anti-lymphoma treatment (Average of 55.71 months and a maximum up to 95.2 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 | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | From first dose to 28 days post last dose (Average of 55.71 months and a maximum up to 95.2 months) | The safety population was defined as all participants who have received at least one dose of study medication. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group48
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 Assessed by the Independent Review Committee (IRC) According to the 2007 International Working Group Response Criteria (IWGRC) | Rituximab + Lenalidomide (R^2) | 39.4 | 95% Confidence Interval 22.9 to NA | months | |
| Kaplan Meier Estimate of Progression Free Survival Assessed by the Independent Review Committee (IRC) According to the 2007 International Working Group Response Criteria (IWGRC) | Rituximab + Placebo | 14.1 | 95% Confidence Interval 11.4 to 16.7 | months | |
| Durable Complete Response Rate (DCCR) as Assessed by the IRC According to the 2007 IWGRC | Rituximab + Lenalidomide (R^2) | 25.3 | 95% Confidence Interval 19.1 to 32.3 | Percentage of Participants | |
| Durable Complete Response Rate (DCCR) as Assessed by the IRC According to the 2007 IWGRC | Rituximab + Placebo | 11.1 | 95% Confidence Interval 6.9 to 16.6 | Percentage of Participants | |
| Kaplan-Meier Estimate of Overall Survival (OS) | Rituximab + Lenalidomide (R^2) | NA | 95% Confidence Interval NA to NA | Months | |
| Kaplan-Meier Estimate of Overall Survival (OS) | Rituximab + Placebo | NA | 95% Confidence Interval NA to NA | Months | |
| Percentage of Participants With an Objective Response as Assessed by the IRC According to the 2007 IWGRC | Rituximab + Lenalidomide (R^2) | 77.5 | 95% Confidence Interval 70.7 to 83.4 | Percentage of Participants | |
| Percentage of Participants With an Objective Response as Assessed by the IRC According to the 2007 IWGRC | Rituximab + Placebo | 53.3 | 95% Confidence Interval 45.8 to 60.8 | Percentage of Participants | |
| Percentage of Participants With a Best Response of Complete Response as Assessed by the IRC According to the 2007 IWGRC | Rituximab + Lenalidomide (R^2) | 33.7 | 95% Confidence Interval 26.8 to 41.2 | Percentage of Participants | |
| Percentage of Participants With a Best Response of Complete Response as Assessed by the IRC According to the 2007 IWGRC | Rituximab + Placebo | 18.3 | 95% Confidence Interval 13.0 to 24.8 | Percentage of Participants |
1 to 10 of 48Source ClinicalTrials.gov
See all 48 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Pre-Treatment | STARTED | Rituximab + Lenalidomide (R^2) | 178 | |
| Pre-Treatment | STARTED | Rituximab + Placebo | 180 | |
| Pre-Treatment | COMPLETED | Rituximab + Lenalidomide (R^2) | 176 | |
| Pre-Treatment | COMPLETED | Rituximab + Placebo | 180 | |
| Pre-Treatment | NOT COMPLETED | Rituximab + Lenalidomide (R^2) | 2 | |
| Pre-Treatment | NOT COMPLETED | Rituximab + Placebo | 0 | |
| Treatment | STARTED | Rituximab + Lenalidomide (R^2) | 176 | |
| Treatment | STARTED | Rituximab + Placebo | 180 | |
| Treatment | COMPLETED | Rituximab + Lenalidomide (R^2) | 124 | |
| Treatment | COMPLETED | Rituximab + Placebo | 110 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events272
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 | Rituximab + Lenalidomide (R^2) | 28 | 176 | |
| other | Anaemia | Blood and lymphatic system disorders | Rituximab + Placebo | 8 | 180 | |
| other | Leukopenia | Blood and lymphatic system disorders | Rituximab + Lenalidomide (R^2) | 37 | 176 | |
| other | Leukopenia | Blood and lymphatic system disorders | Rituximab + Placebo | 18 | 180 | |
| other | Lymphopenia | Blood and lymphatic system disorders | Rituximab + Lenalidomide (R^2) | 8 | 176 | |
| other | Lymphopenia | Blood and lymphatic system disorders | Rituximab + Placebo | 14 | 180 | |
| other | Neutropenia | Blood and lymphatic system disorders | Rituximab + Lenalidomide (R^2) | 103 | 176 | |
| other | Neutropenia | Blood and lymphatic system disorders | Rituximab + Placebo | 40 | 180 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Rituximab + Lenalidomide (R^2) | 26 | 176 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Rituximab + Placebo | 9 | 180 |
1 to 10 of 272Source ClinicalTrials.gov
See all 272 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Rituximab + Lenalidomide (R^2) | 27 | 178 |
| Total, all-cause mortality | Rituximab + Placebo | 47 | 180 |
| Total, other adverse events | Rituximab + Lenalidomide (R^2) | 170 | 176 |
| Total, other adverse events | Rituximab + Placebo | 158 | 180 |
| Total, serious adverse events | Rituximab + Lenalidomide (R^2) | 45 | 176 |
| Total, serious adverse events | Rituximab + Placebo | 25 | 180 |
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 |
|---|---|
| Rituximab + Lenalidomide (R^2) vs Rituximab + Placebo: deaths from any cause | Trial comparisons |
| Rituximab + Lenalidomide (R^2) vs Rituximab + Placebo: 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/NCT01938001
GET https://conductscience.org/api/trials/v1/NCT01938001/results?page=2