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NCT01217749 · ClinicalTrials.gov registry record · Phase 1
Efficacy and Safety Study of PCI-32765 Combine With Ofatumumab in CLL
A Phase 1 study, sponsored by Pharmacyclics.
- Completed
- Registry status
- Phase 1
- Development phase
- 71
- Enrollment target
NCT01217749: Completed Phase 1 study, sponsored by Pharmacyclics.
NCT01217749 is a Phase 1 study that has completed, run by Pharmacyclics. The registered enrollment target is 71 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (18% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01217749, a Phase 1 study, has completed, sponsored by Pharmacyclics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 71 participants
- Enrollment target
Study Summary
The purpose of this study is to determine the efficacy and safety of a fixed-dose, daily regimen of orally administered PCI-32765 combined with ofatumumab in subjects with relapsed/refractory CLL/SLL and related diseases
Primary Outcome
The primary endpoint for the study was overall response rate (ORR), defined as the proportion of participants who achieved a best overall response of complete response (CR), CR with incomplete blood count recovery (Cri), or partial response (PR), according to the guidelines from the International Workshop on Chronic Lymphocytic Leukemia (IWCLL1) published in 2008 for CLL participants and International Working Group for non-Hodgkin's lymphoma (IWG NHL) 2007 criteria for SLL participants, with the
Interventions
- DRUG PCI-32765
- DRUG ofatumumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 71 participants |
| Start Date | 2010-12 |
| Est. Completion | 2014-05 |
| Phase | Phase 1 |
What the finished NCT01217749 record still lists
NCT01217749 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 71 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (18% higher).
The record links to 0 conditions, and to 2 interventions - of which PCI-32765 is the first listed.
NCT01217749 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01217749 about?
NCT01217749 is a clinical study titled "Efficacy and Safety Study of PCI-32765 Combine With Ofatumumab in CLL". The purpose of this study is to determine the efficacy and safety of a fixed-dose, daily regimen of orally administered PCI-32765 combined with ofatumumab in subjects with relapsed/refractory CLL/SLL and related diseases
What is the current status of trial NCT01217749?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 71 participants. The study started on 2010-12. Estimated completion is 2014-05.
What interventions are being tested in trial NCT01217749?
The interventions under investigation include: PCI-32765 (DRUG), ofatumumab (DRUG).
Who is sponsoring clinical trial NCT01217749?
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 NCT01217749's enrollment target sits among peer trials
71 747th of 2000 higher than 1,252 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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