Trial · NCT01476787
Combined Rituximab and Lenalidomide Treatment for Untreated Patients With Follicular Lymphoma
NCT01476787, Phase 3, Completed, Celgene; results first posted 2025-05-14
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Combined Rituximab and Lenalidomide Treatment for Untreated Patients With Follicular Lymphoma. Trials, record NCT01476787. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01476787
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Combined Rituximab and Lenalidomide Treatment for Untreated Patients With Follicular Lymphoma
- NCT number
- NCT01476787
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,030 participants, actual
- Lead sponsor
- Celgene
- Conditions
- Follicular Lymphoma
- Interventions
- Rituximab, Lenalidomide, Rituximab-CHOP, Rituximab-CVP, Rituximab-Bendamustine
- First posted
- 2011-11-22
- Last updated
- 2025-05-14
- Other registries' IDs
- eudract:2011-002792-42
- Results first posted
- 2025-05-14
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Complete Response Rate (CR/CRu) at 120 Weeks by Independent Central Review | At 120 weeks | The Complete Response Rate (CR/CRu) is the percentage of participants who achieve complete response (CR/CRu) at 120 weeks as assessed per Independent Central Review. * Complete Response (CR): Disappearance of all evidence of disease. * Complete Response Unconfirmed (CRu): Disappearance of all disease with the exception of residual lymph nodes that are 1.5 cm or less in greatest transverse diameter and/or indeterminate bone marrow findings. |
| Primary | Progression-free Survival (PFS) | From randomization into the study to the first observation of documented disease progression or death due to any cause (up to approximately 140 months). | Progression-free survival (PFS) is defined as the time from randomization into the study to the first observation of documented disease progression or death due to any cause. Progressive Disease (PD) is characterized by any of the following: * An increase of at least 50% in the sum of the products of the greatest diameters (SPD) of any previously identified abnormal lymph node(s) or other disease sites. * The appearance of any new lesion during or after treatment. * An increase of at least 50% in the longest diameter of a previously identified node that was 1 cm or more in its short axis. * An increase of at least 50% in the size of other lesions (e.g., splenomegaly, hepatomegaly). Based on Kaplan-Meier estimates. |
| Secondary | Complete Response Rate (CR) at 120 Weeks Per Independent Central Review | At 120 weeks | The Complete Response Rate (CR) is the percentage of participants who achieve confirmed complete response (CR) at 120 weeks as assessed per Independent Central Review. \- Complete Response (CR): Disappearance of all evidence of disease. |
| Secondary | Event-free Survival (EFS) | From randomization to the date of first documented progression, relapse, and initiation of a new anti-lymphoma treatment or death by any cause (up to approximately 140 months). | Event Free Survival (EFS) is defined as the time a participant remains free from certain negative events (disease progression, relapse, initiation of a new anti-lymphoma treatment, or death) between the date of randomization to the date of first documented progression, relapse, and initiation of a new anti-lymphoma treatment or death by any cause. Responding participants and those lost to follow up were censored at their last tumor assessment date. Progressive Disease (PD) is characterized by any of the following: * An increase of at least 50% in the sum of the products of the greatest diameters (SPD) of any previously identified abnormal lymph node(s) or other disease sites. * The appearance of any new lesion during or after treatment. * An increase of at least 50% in the longest diameter of a previously identified node that was 1 cm or more in its short axis. * An increase of at least 50% in the size of other lesions (e.g., splenomegaly, hepatomegaly). Based on Kaplan-Meier estimates. |
| Secondary | Overall Survival (OS) | From randomization to the date of death by any cause (up to approximately 144 months). | Overall survival (OS) is defined as the median length of time a participant stays alive from randomization. Participants who died, regardless of the cause of death, were considered to have had an event. Participants who withdrew consent for the study were considered censored at the time of withdrawal. Participants who completed the study and were still alive at the time of the clinical data cut-off date were censored. All participants who were lost to follow-up prior to the clinical data cut-off date were also considered censored at the time of last contact. Based on Kaplan-Meier estimates. |
| Secondary | Time to Next Anti-Lymphoma Treatment (TTNLT) | From the date of randomization to the date of the first documented administration of any new anti-lymphoma treatment (up to approximately 140 months). | Time to Next Lymphoma Treatment (TTNLT) was measured from the date of randomization to the date of the first documented administration of any new anti-lymphoma treatment (such as chemotherapy, radiotherapy, radio-immunotherapy, or immunotherapy). Participants who continued to respond to treatment or who were lost to follow-up were considered censored on their last visit date. Participants who died (due to any cause) before receiving a new anti-lymphoma treatment were included in the statistical analysis, with death being counted as an event. Based on Kaplan-Meier estimates. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Complete Response Rate (CR/CRu) at 120 Weeks by Independent Central Review | At 120 weeks | All randomized participants | Percent of participants | NUMBER |
| PRIMARY | Progression-free Survival (PFS) | From randomization into the study to the first observation of documented disease progression or death due to any cause (up to approximately 140 months). | All randomized participants | Months | MEDIAN |
| SECONDARY | Complete Response Rate (CR) at 120 Weeks Per Independent Central Review | At 120 weeks | All randomized participants | Percent of participants | NUMBER |
| SECONDARY | Event-free Survival (EFS) | From randomization to the date of first documented progression, relapse, and initiation of a new anti-lymphoma treatment or death by any cause (up to approximately 140 months). | All randomized participants | Months | MEDIAN |
| SECONDARY | Overall Survival (OS) | From randomization to the date of death by any cause (up to approximately 144 months). | All randomized participants | Months | MEDIAN |
| SECONDARY | Time to Next Anti-Lymphoma Treatment (TTNLT) | From the date of randomization to the date of the first documented administration of any new anti-lymphoma treatment (up to approximately 140 months). | All randomized participants | Months | MEDIAN |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Complete Response Rate (CR/CRu) at 120 Weeks by Independent Central Review | Rituximab-Lenalidomide | 48.1 | 95% Confidence Interval 43.7 to 52.6 | Percent of participants | |
| Complete Response Rate (CR/CRu) at 120 Weeks by Independent Central Review | Investigator Choice | 53.0 | 95% Confidence Interval 48.6 to 57.4 | Percent of participants | |
| Progression-free Survival (PFS) | Rituximab-Lenalidomide | 120.2 | 95% Confidence Interval 104.9 to 126.3 | Months | |
| Progression-free Survival (PFS) | Investigator Choice | 123.8 | 95% Confidence Interval 107.4 to NA | Months | |
| Complete Response Rate (CR) at 120 Weeks Per Independent Central Review | Rituximab-Lenalidomide | 27.7 | 95% Confidence Interval 23.8 to 31.8 | Percent of participants | |
| Complete Response Rate (CR) at 120 Weeks Per Independent Central Review | Investigator Choice | 32.7 | 95% Confidence Interval 28.7 to 36.9 | Percent of participants | |
| Event-free Survival (EFS) | Rituximab-Lenalidomide | 130.6 | 95% Confidence Interval 121.9 to NA | Months | |
| Event-free Survival (EFS) | Investigator Choice | 132.3 | 95% Confidence Interval 115.7 to NA | Months | |
| Overall Survival (OS) | Rituximab-Lenalidomide | NA | 95% Confidence Interval NA to NA | Months | |
| Overall Survival (OS) | Investigator Choice | NA | 95% Confidence Interval NA to NA | Months |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 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 | 513 | |
| Pre-treatment | STARTED | Investigator Choice | 517 | |
| Pre-treatment | COMPLETED | Rituximab-Lenalidomide | 507 | |
| Pre-treatment | COMPLETED | Investigator Choice | 503 | |
| Pre-treatment | NOT COMPLETED | Rituximab-Lenalidomide | 6 | |
| Pre-treatment | NOT COMPLETED | Investigator Choice | 14 | |
| Treatment | STARTED | Rituximab-Lenalidomide | 507 | |
| Treatment | STARTED | Investigator Choice | 503 | |
| Treatment | COMPLETED | Rituximab-Lenalidomide | 350 | |
| Treatment | COMPLETED | Investigator Choice | 357 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events1,516
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 | 25 | 507 | |
| other | ANAEMIA | Blood and lymphatic system disorders | Investigator Choice Rituximab-CHOP | 44 | 365 | |
| other | ANAEMIA | Blood and lymphatic system disorders | Investigator Choice Rituximab-CVP | 3 | 26 | |
| other | ANAEMIA | Blood and lymphatic system disorders | Investigator Choice Rituximab-Bendamustine | 8 | 112 | |
| other | LEUKOPENIA | Blood and lymphatic system disorders | Rituximab-Lenalidomide | 22 | 507 | |
| other | LEUKOPENIA | Blood and lymphatic system disorders | Investigator Choice Rituximab-CHOP | 47 | 365 | |
| other | LEUKOPENIA | Blood and lymphatic system disorders | Investigator Choice Rituximab-CVP | 2 | 26 | |
| other | LEUKOPENIA | Blood and lymphatic system disorders | Investigator Choice Rituximab-Bendamustine | 7 | 112 | |
| other | LYMPHOPENIA | Blood and lymphatic system disorders | Rituximab-Lenalidomide | 7 | 507 | |
| other | LYMPHOPENIA | Blood and lymphatic system disorders | Investigator Choice Rituximab-CHOP | 19 | 365 |
1 to 10 of 1,516Source ClinicalTrials.gov
See all 1,516 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Rituximab-Lenalidomide | 88 | 513 |
| Total, all-cause mortality | Investigator Choice Rituximab-CHOP | 71 | 372 |
| Total, all-cause mortality | Investigator Choice Rituximab-CVP | 7 | 28 |
| Total, all-cause mortality | Investigator Choice Rituximab-Bendamustine | 12 | 117 |
| Total, other adverse events | Rituximab-Lenalidomide | 496 | 507 |
| Total, other adverse events | Investigator Choice Rituximab-CHOP | 351 | 365 |
| Total, other adverse events | Investigator Choice Rituximab-CVP | 26 | 26 |
| Total, other adverse events | Investigator Choice Rituximab-Bendamustine | 108 | 112 |
| Total, serious adverse events | Rituximab-Lenalidomide | 181 | 507 |
| Total, serious adverse events | Investigator Choice Rituximab-CHOP | 109 | 365 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers6
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.
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/NCT01476787
GET https://conductscience.org/api/trials/v1/NCT01476787/events?page=2