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NCT01236391 · ClinicalTrials.gov registry record · Phase 2
Safety and Efficacy of PCI-32765 in Participants With Relapsed/Refractory Mantle Cell Lymphoma (MCL)
A Phase 2 study, sponsored by Pharmacyclics.
- Completed
- Registry status
- Phase 2
- Development phase
- 115
- Enrollment target
NCT01236391: Completed Phase 2 study, sponsored by Pharmacyclics.
NCT01236391 is a Phase 2 study that has completed, run by Pharmacyclics. The registered enrollment target is 115 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (14% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01236391, a Phase 2 study, has completed, sponsored by Pharmacyclics.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 115 participants
- Enrollment target
Study Summary
The primary objective of this study was to evaluate the efficacy of ibrutinib in participants with relapsed or refractory MCL. The secondary objective was to evaluate the safety of a fixed daily dosing regimen (560 mg daily) of PCI-32765 in this population.
Primary Outcome
The primary endpoint of the study was overall response rate (ORR), defined as the proportion of participants who achieved a best overall response of complete response (CR) or partial response (PR), according to the revised International Working Group Criteria for non-Hodgkin's lymphoma (Cheson et al, 2007), as assessed by the investigator. CR is a complete disappearance of all disease, no new lesions, lymph nodes must have regressed and be PET negative, spleen and liver should not be palpable an
Interventions
- DRUG PCI-32765
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 115 participants |
| Start Date | 2011-02 |
| Est. Completion | 2014-01 |
| Phase | Phase 2 |
What the finished NCT01236391 record still lists
NCT01236391 is an interventional study that assigns participants to a tested intervention. The registered 115 participants enrollment target is mid-sized for trials with a published cap, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (14% lower).
The record links to 0 conditions, and to 1 intervention - of which PCI-32765 is the first listed.
NCT01236391 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01236391 about?
NCT01236391 is a clinical study titled "Safety and Efficacy of PCI-32765 in Participants With Relapsed/Refractory Mantle Cell Lymphoma (MCL)". The primary objective of this study was to evaluate the efficacy of ibrutinib in participants with relapsed or refractory MCL. The secondary objective was to evaluate the safety of a fixed daily dosing regimen (560 mg daily) of PCI-32765 in this population.
What is the current status of trial NCT01236391?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 115 participants. The study started on 2011-02. Estimated completion is 2014-01.
What interventions are being tested in trial NCT01236391?
The interventions under investigation include: PCI-32765 (DRUG).
Who is sponsoring clinical trial NCT01236391?
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 NCT01236391's enrollment target sits among peer trials
115 626th of 2000 higher than 1,374 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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