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NCT01996865 · ClinicalTrials.gov registry record · Phase 3
Lenalidomide Plus Rituximab Followed by Lenalidomide Versus Rituximab Maintenance for Relapsed/Refractory Follicular, Marginal Zone or Mantle Cell Lymphoma.
A Phase 3 study, sponsored by Celgene.
- Completed
- Registry status
- Phase 3
- Development phase
- 503
- Enrollment target
NCT01996865: Completed Phase 3 study, sponsored by Celgene.
NCT01996865 is a Phase 3 study that has completed, run by Celgene. The registered enrollment target is 503 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (35% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01996865, a Phase 3 study, has completed, sponsored by Celgene.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 503 participants
- Enrollment target
Study Summary
Follicular lymphoma (FL), marginal zone lymphoma (MZL), and mantle cell lymphoma (MCL) are distinct histologic types of B-cell NHL. Lenalidomide is an immunomodulatory agent with direct and immune-mediated mechanisms of action, as well as clinical activity in NHL. Recent studies in frontline and relapsed/refractory NHL show high activity for lenalidomide plus rituximab (R2), supporting further study of this combination.
Primary Outcome
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.
Interventions
- DRUG Rituximab
- DRUG Lenalidomide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 503 participants |
| Start Date | 2014-04-01 |
| Est. Completion | 2024-09-17 |
| Phase | Phase 3 |
What the finished NCT01996865 record still lists
NCT01996865 is an interventional study that assigns participants to a tested intervention. The registered 503 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (35% lower).
The record links to 0 conditions, and to 2 interventions - of which Rituximab is the first listed.
NCT01996865 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01996865 about?
NCT01996865 is a clinical study titled "Lenalidomide Plus Rituximab Followed by Lenalidomide Versus Rituximab Maintenance for Relapsed/Refractory Follicular, Marginal Zone or Mantle Cell Lymphoma.". Follicular lymphoma (FL), marginal zone lymphoma (MZL), and mantle cell lymphoma (MCL) are distinct histologic types of B-cell NHL. Lenalidomide is an immunomodulatory agent with direct and immune-mediated mechanisms of action, as well as clinical activity in NHL. Recent studies in frontline and rel...
What is the current status of trial NCT01996865?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 503 participants. The study started on 2014-04-01. Estimated completion is 2024-09-17.
What interventions are being tested in trial NCT01996865?
The interventions under investigation include: Rituximab (DRUG), Lenalidomide (DRUG).
Who is sponsoring clinical trial NCT01996865?
This trial is sponsored by Celgene, which has 308 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01996865's enrollment target sits among peer trials
503 743rd of 2000 higher than 1,258 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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