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NCT01476787 · ClinicalTrials.gov registry record · Phase 3
Combined Rituximab and Lenalidomide Treatment for Untreated Patients With Follicular Lymphoma
A Phase 3 study of Follicular Lymphoma, sponsored by Celgene.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,030
- Enrollment target
- 20
- Study locations
NCT01476787: Completed Phase 3 study of Follicular Lymphoma, sponsored by Celgene.
NCT01476787 is a Phase 3 study of Follicular Lymphoma that has completed, run by Celgene. The registered enrollment target is 1,030 participants, above the 124-participant average among 89 other Follicular Lymphoma trials with a reported enrollment target (731% higher). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01476787, a Phase 3 study of Follicular Lymphoma, has completed, sponsored by Celgene.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,030 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to evaluate the effect of the combined treatment of lenalidomide and rituximab in controlling the Follicular Lymphoma disease and also increase the length of response compared to the available standard combination chemotherapy treatment for Follicular Lymphoma.
Primary Outcome
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.
Conditions Studied
Interventions
- DRUG Rituximab
- DRUG Lenalidomide
- DRUG Rituximab-CHOP
- DRUG Rituximab-CVP
- DRUG Rituximab-Bendamustine
Study Locations (20)
New Jersey
- Local Institution - 54403 - Cherry Hill
- Local Institution - 53703 - Hackensack
- Local Institution - 50903 - Morristown
- Local Institution - 54303 - Sparta
Florida
- Local Institution - 52503 - Englewood
- Local Institution - 51703 - Orlando
- Local Institution - 53803 - St. Petersburg
California
- Local Institution - 51803 - Fullerton
- Local Institution - 52003 - Los Angeles
Massachusetts
- Local Institution - 50403 - Boston
- Local Institution - 50503 - Boston
New York
- Local Institution - 52403 - New York
- Local Institution - 50203 - New York
Arizona
- Local Institution - 54103 - Chandler
Colorado
- Local Institution - 51603 - Colorado Springs
Illinois
- Local Institution - 50803 - Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,030 participants |
| Start Date | 2011-12-29 |
| Est. Completion | 2024-04-30 |
| Phase | Phase 3 |
What the finished NCT01476787 record still lists
NCT01476787 is an interventional study that assigns participants to a tested intervention. Its 1,030 participants enrollment target places it among the larger protocols in the corpus, above the 124-participant average among 89 other Follicular Lymphoma trials with a reported enrollment target (731% higher).
The record links to 1 condition, with Follicular Lymphoma appearing as the primary indexed condition, and to 5 interventions - of which Rituximab is the first listed.
NCT01476787 names 20 study sites across 12 states, led by New Jersey, Florida, California.
Frequently Asked Questions
What is clinical trial NCT01476787 about?
NCT01476787 is a clinical study titled "Combined Rituximab and Lenalidomide Treatment for Untreated Patients With Follicular Lymphoma". The purpose of this study is to evaluate the effect of the combined treatment of lenalidomide and rituximab in controlling the Follicular Lymphoma disease and also increase the length of response compared to the available standard combination chemotherapy treatment for Follicular Lymphoma.
What is the current status of trial NCT01476787?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,030 participants. The study started on 2011-12-29. Estimated completion is 2024-04-30.
What conditions does trial NCT01476787 study?
This clinical trial studies the following conditions: Follicular Lymphoma.
What interventions are being tested in trial NCT01476787?
The interventions under investigation include: Rituximab (DRUG), Lenalidomide (DRUG), Rituximab-CHOP (DRUG), Rituximab-CVP (DRUG), Rituximab-Bendamustine (DRUG).
Who is sponsoring clinical trial NCT01476787?
This trial is sponsored by Celgene, which has 308 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01476787 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Florida, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Follicular Lymphoma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01476787's enrollment target sits among peer trials
1,030 1st of 89 higher than 89 of 89 other Follicular Lymphoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Follicular Lymphoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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