Trial · NCT01996865
Lenalidomide Plus Rituximab Followed by Lenalidomide Versus Rituximab Maintenance for Relapsed/Refractory Follicular, Marginal Zone or Mantle Cell Lymphoma.
NCT01996865, Phase 3, Completed, Celgene; results first posted 2025-07-10
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Lenalidomide Plus Rituximab Followed by Lenalidomide Versus Rituximab Maintenance for Relapsed/Refractory Follicular, Marginal Zone or Mantle Cell Lymphoma. Trials, record NCT01996865. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01996865
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Lenalidomide Plus Rituximab Followed by Lenalidomide Versus Rituximab Maintenance for Relapsed/Refractory Follicular, Marginal Zone or Mantle Cell Lymphoma.
- NCT number
- NCT01996865
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 503 participants, actual
- Lead sponsor
- Celgene
- Conditions
- Lymphoma, Non-Hodgkin
- Interventions
- Lenalidomide, Rituximab
- First posted
- 2013-11-27
- Last updated
- 2025-07-10
- Results first posted
- 2025-07-10
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression Free Survival (PFS) | From the first dose date of maintenance therapy to objective disease progression or death from any cause, whichever occurs first (up to approximately 432 weeks) | Progression free survival (PFS) is defined as the time from the date of first dose of maintenance therapy to the date of the first objective documentation of tumor progression or death due to any cause. Analysis was based on Kaplan Meier estimates. The PFS events were determined using a modification of the IWG 1999 criteria. |
| Secondary | Overall Survival (OS) | From the first dose date of maintenance therapy to death from any cause (up to approximately 480 weeks) | Overall Survival (OS) is defined as the time between the first dose date of maintenance therapy and death from any cause. Participants who complete the study and are still alive at the time of the clinical data cutoff date will be censored at the last visit date or the last contact date, whichever is later. Participants who were lost to follow-up prior to the clinical data cut-off date will also be censored at the time of the last contact. Analysis was based on Kaplan Meier estimates and Hazard Ratio (HR). |
| Secondary | Improvement of Response (IOR) | From the first dose date of maintenance therapy to death from any cause (up to approximately 432 weeks) | Improvement of Response (IOR) is the percentage of participants with improved tumor response during the maintenance phase (converted from partial response at end of induction to complete response or complete response unconfirmed as best response) and participants who converted from stable disease at the end of induction period to partial response or better as best response during maintenance phase. |
| Secondary | Overall Response Rate (ORR) | From the first dose date of maintenance therapy up to CR, CRu, PR, or treatment change (up to approximately 432 weeks) | The overall response rate (ORR) is defined as the percentage of participants with a best response of at least partial response (including complete response, complete response unconfirmed and partial response) after the first dose date of maintenance therapy and prior to any treatment change. |
| Secondary | Complete Response Rate (CRR) | From the first dose date of maintenance therapy up to CR or CRu (up to approximately 432 weeks) | Best Complete Response Rate (CRR), defined as the proportion of participants with a best response of at least CRu (including CR and CRu) after the first dose date of maintenance therapy and prior to any treatment change. |
| Secondary | Duration of Response (DOR) | From the initial response (at least PR) after the first dose date of maintenance therapy and prior to treatment change to documented disease progression or death, whichever occurs first (up to approximately 432 weeks) | DOR is from initial response (at least CRu) after the first dose date of maintenance therapy and prior to treatment change to documented disease progression or death. Participants who have not progressed or died at the time of the clinical data cutoff date will be censored at the last assessment showing no progression. Participants who change treatment without evidence of disease progression will be censored at the last assessment showing no progression prior to treatment change. Analysis was based on Kaplan Meier estimates. |
| Secondary | Time to Next Anti-lymphoma Treatment | From the first dose date of maintenance therapy to the time of first documented administration of new anti-lymphoma therapy (up to approximately 300 weeks) | Time to next anti-lymphoma treatment is defined as the time from the first dose date of maintenance therapy to the time of first documented administration of new anti-lymphoma therapy. Participants without new treatment therapy will be censored at the last visit. Analysis was based on Kaplan Meier estimates. |
| Secondary | Time to Histological Transformation | From the first dose date of maintenance therapy to the time of histological transformation (up to approximately 432 weeks) | Time to histological transformation is defined as from the first dose date of maintenance therapy to the time of histological transformation as measured based on documentation of histological transformation (as assessed by the investigator). Analysis was based on Kaplan Meier estimates. In case of clinical suspicion of transformation, including rapid disease progression, unexpected changes in "B" symptoms or rapidly increasing LDH, a biopsy should be performed. In this clinical trial, histological transformation will be considered disease progression. This endpoint will not be calculated for participants randomized with transformed Follicular Lymphoma (tFL). |
| Secondary | Duration of Complete Response (DOCR) | From the initial CR/CRu after the first dose date of maintenance therapy and prior to treatment change to documented disease progression or death, whichever occurs first (up to approximately 432 weeks) | Duration of complete response (DOCR) is calculated as the time from the initial response (CR or CRu) after the first dose date of maintenance therapy and prior to treatment change to documented disease progression or death. Analysis was based on Kaplan Meier estimates. Participants who have not progressed or died at the time of the clinical data cutoff date will be censored at the last assessment showing no progression. Participants who change treatment without evidence of disease progression will be censored at the last assessment showing no progression prior to treatment change. |
| Secondary | Participants Experiencing Treatment Emergent Adverse Events (TEAEs) | From first dose up to 30 days after last dose (up to approximately 64 weeks for induction period and 427 weeks for maintenance period) | Number of participants experiencing AEs, SAEs, AEs leading to study discontinuation, and AEs of interest (AEIs). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. SAEs is any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires inpatient hospitalization; results significant disability; or is a congenital anomaly/birth defect. TEAEs are defined as AEs with an onset date on or after the first dose of study treatment up to 30 days after the last dose of study treatment in the study, or if a pre-existing condition worsens in severity or becomes serious after receiving the first dose of study treatment. |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes13
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Progression Free Survival (PFS) | From the first dose date of maintenance therapy to objective disease progression or death from any cause, whichever occurs first (up to approximately 432 weeks) | All randomized participants in Arm A and Arm B, as prespecified in the protocol | Weeks | MEDIAN |
| SECONDARY | Overall Survival (OS) | From the first dose date of maintenance therapy to death from any cause (up to approximately 480 weeks) | All randomized participants in Arm A and Arm B, as prespecified in the protocol | Weeks | MEDIAN |
| SECONDARY | Improvement of Response (IOR) | From the first dose date of maintenance therapy to death from any cause (up to approximately 432 weeks) | All randomized participants in Arm A and Arm B, as prespecified in the protocol | Percentage of participants | NUMBER |
| SECONDARY | Overall Response Rate (ORR) | From the first dose date of maintenance therapy up to CR, CRu, PR, or treatment change (up to approximately 432 weeks) | All randomized participants in Arm A and Arm B, as prespecified in the protocol | Percentage of participants | NUMBER |
| SECONDARY | Complete Response Rate (CRR) | From the first dose date of maintenance therapy up to CR or CRu (up to approximately 432 weeks) | All randomized participants in Arm A and Arm B, as prespecified in the protocol | Percentage of participants | NUMBER |
| SECONDARY | Duration of Response (DOR) | From the initial response (at least PR) after the first dose date of maintenance therapy and prior to treatment change to documented disease progression or death, whichever occurs first (up to approximately 432 weeks) | The analysis is only performed for participants who have achieved PR or better after the first dose date of maintenance therapy and prior to any treatment change.~Arm B includes 3 additional participants who achieved CR/CRu/PR in the follow-up period. | Weeks | MEDIAN |
| SECONDARY | Time to Next Anti-lymphoma Treatment | From the first dose date of maintenance therapy to the time of first documented administration of new anti-lymphoma therapy (up to approximately 300 weeks) | All randomized participants in Arm A and Arm B, as prespecified in the protocol | Weeks | MEDIAN |
| SECONDARY | Time to Histological Transformation | From the first dose date of maintenance therapy to the time of histological transformation (up to approximately 432 weeks) | All randomized participants in Arm A and Arm B without transformed Follicular Lymphoma (tFL) | Weeks | MEDIAN |
| SECONDARY | Duration of Complete Response (DOCR) | From the initial CR/CRu after the first dose date of maintenance therapy and prior to treatment change to documented disease progression or death, whichever occurs first (up to approximately 432 weeks) | The analysis is only performed for participants who have achieved CR or CRu after the first dose date of maintenance therapy and prior to any treatment change. | Weeks | MEDIAN |
| SECONDARY | Participants Experiencing Treatment Emergent Adverse Events (TEAEs) | From first dose up to 30 days after last dose (up to approximately 64 weeks for induction period and 427 weeks for maintenance period) | All treated participants | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 outcomesResults by group123
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Progression Free Survival (PFS) | Arm A: Lenalidomide + Rituximab | 263.1 | 95% Confidence Interval 166.1 to NA | Weeks | |
| Progression Free Survival (PFS) | Arm B: Rituximab | 229.1 | 95% Confidence Interval 173.7 to NA | Weeks | |
| Overall Survival (OS) | Arm A: Lenalidomide + Rituximab | NA | 95% Confidence Interval 439.4 to NA | Weeks | |
| Overall Survival (OS) | Arm B: Rituximab | NA | 95% Confidence Interval 395.7 to NA | Weeks | |
| Improvement of Response (IOR) | Arm A: Lenalidomide + Rituximab | 20 | 95% Confidence Interval 13.6 to 27.7 | Percentage of participants | |
| Improvement of Response (IOR) | Arm B: Rituximab | 11.4 | 95% Confidence Interval 6.5 to 18.0 | Percentage of participants | |
| Overall Response Rate (ORR) | Arm A: Lenalidomide + Rituximab | 85.2 | 95% Confidence Interval 78.1 to 90.7 | Percentage of participants | |
| Overall Response Rate (ORR) | Arm B: Rituximab | 79.5 | 95% Confidence Interval 71.7 to 86.1 | Percentage of participants | |
| Complete Response Rate (CRR) | Arm A: Lenalidomide + Rituximab | 60.7 | 95% Confidence Interval 52.0 to 69.0 | Percentage of participants | |
| Complete Response Rate (CRR) | Arm B: Rituximab | 58.3 | 95% Confidence Interval 49.4 to 66.8 | Percentage of participants |
1 to 10 of 123Source ClinicalTrials.gov
See all 123 results by groupParticipant flow24
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Induction Period | STARTED | Induction Period: Lenalidomide + Rituximab | 503 | |
| Induction Period | STARTED | Arm A: Lenalidomide + Rituximab | 0 | |
| Induction Period | STARTED | Arm B: Rituximab | 0 | |
| Induction Period | Treated | Induction Period: Lenalidomide + Rituximab | 500 | |
| Induction Period | Treated | Arm A: Lenalidomide + Rituximab | 0 | |
| Induction Period | Treated | Arm B: Rituximab | 0 | |
| Induction Period | COMPLETED | Induction Period: Lenalidomide + Rituximab | 284 | |
| Induction Period | COMPLETED | Arm A: Lenalidomide + Rituximab | 0 | |
| Induction Period | COMPLETED | Arm B: Rituximab | 0 | |
| Induction Period | NOT COMPLETED | Induction Period: Lenalidomide + Rituximab | 219 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 participant flowAdverse events882
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 | Induction Period: Lenalidomide + Rituximab | 77 | 500 | |
| other | Anaemia | Blood and lymphatic system disorders | Arm A: Lenalidomide + Rituximab | 12 | 134 | |
| other | Anaemia | Blood and lymphatic system disorders | Arm B: Rituximab | 8 | 132 | |
| other | Leukopenia | Blood and lymphatic system disorders | Induction Period: Lenalidomide + Rituximab | 67 | 500 | |
| other | Leukopenia | Blood and lymphatic system disorders | Arm A: Lenalidomide + Rituximab | 13 | 134 | |
| other | Leukopenia | Blood and lymphatic system disorders | Arm B: Rituximab | 9 | 132 | |
| other | Lymphopenia | Blood and lymphatic system disorders | Induction Period: Lenalidomide + Rituximab | 33 | 500 | |
| other | Lymphopenia | Blood and lymphatic system disorders | Arm A: Lenalidomide + Rituximab | 5 | 134 | |
| other | Lymphopenia | Blood and lymphatic system disorders | Arm B: Rituximab | 3 | 132 | |
| other | Neutropenia | Blood and lymphatic system disorders | Induction Period: Lenalidomide + Rituximab | 217 | 500 |
1 to 10 of 882Source ClinicalTrials.gov
See all 882 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Induction Period: Lenalidomide + Rituximab | 112 | 500 |
| Total, all-cause mortality | Arm A: Lenalidomide + Rituximab | 26 | 134 |
| Total, all-cause mortality | Arm B: Rituximab | 32 | 132 |
| Total, other adverse events | Induction Period: Lenalidomide + Rituximab | 491 | 500 |
| Total, other adverse events | Arm A: Lenalidomide + Rituximab | 129 | 134 |
| Total, other adverse events | Arm B: Rituximab | 106 | 132 |
| Total, serious adverse events | Induction Period: Lenalidomide + Rituximab | 172 | 500 |
| Total, serious adverse events | Arm A: Lenalidomide + Rituximab | 57 | 134 |
| Total, serious adverse events | Arm B: Rituximab | 22 | 132 |
Source ClinicalTrials.gov
Papers2
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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.
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