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NCT02077166 · ClinicalTrials.gov registry record · Phase 1
Ibrutinib in Combination With Lenalidomide and Rituximab in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma
A Phase 1 study, sponsored by Pharmacyclics.
- Completed
- Registry status
- Phase 1
- Development phase
- 138
- Enrollment target
NCT02077166: Completed Phase 1 study, sponsored by Pharmacyclics.
NCT02077166 is a Phase 1 study that has completed, run by Pharmacyclics. The registered enrollment target is 138 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (130% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02077166, a Phase 1 study, has completed, sponsored by Pharmacyclics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 138 participants
- Enrollment target
Study Summary
This Phase 1b/2 study is designed to assess the safety and efficacy of ibrutinib in combination with lenalidomide and rituximab in subjects with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) not eligible for transplant.
Primary Outcome
The dose levels of lenalidomide were explored, and dose escalation of lenalidomide followed the 3+3+3 dose escalation schema. A Dose Level Review Committee evaluated safety data following completion of each dose observation period of the Phase 1b portion.
Interventions
- DRUG Rituximab
- DRUG Lenalidomide
- DRUG Ibrutinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 138 participants |
| Start Date | 2014-03-13 |
| Est. Completion | 2020-12-17 |
| Phase | Phase 1 |
What the finished NCT02077166 record still lists
NCT02077166 is an interventional study that assigns participants to a tested intervention. The registered 138 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (130% higher).
The record links to 0 conditions, and to 3 interventions - of which Rituximab is the first listed.
NCT02077166 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02077166 about?
NCT02077166 is a clinical study titled "Ibrutinib in Combination With Lenalidomide and Rituximab in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma". This Phase 1b/2 study is designed to assess the safety and efficacy of ibrutinib in combination with lenalidomide and rituximab in subjects with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) not eligible for transplant.
What is the current status of trial NCT02077166?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 138 participants. The study started on 2014-03-13. Estimated completion is 2020-12-17.
What interventions are being tested in trial NCT02077166?
The interventions under investigation include: Rituximab (DRUG), Lenalidomide (DRUG), Ibrutinib (DRUG).
Who is sponsoring clinical trial NCT02077166?
This trial is sponsored by Pharmacyclics, which has 54 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02077166's enrollment target sits among peer trials
138 418th of 2000 higher than 1,581 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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