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NCT01325701 · ClinicalTrials.gov registry record · Phase 2
Safety and Efficacy Study of a BTK Inhibitor in Subjects With Relapsed or Refractory Diffuse Large B-cell Lymphoma
A Phase 2 study of Diffuse Large Cell B-lymphoma, sponsored by Pharmacyclics.
- Completed
- Registry status
- Phase 2
- Development phase
- 78
- Enrollment target
- 15
- Study locations
NCT01325701: Completed Phase 2 study of Diffuse Large Cell B-lymphoma, sponsored by Pharmacyclics.
NCT01325701 is a Phase 2 study of Diffuse Large Cell B-lymphoma that has completed, run by Pharmacyclics. The registered enrollment target is 78 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (41% lower). The trial reports 15 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01325701, a Phase 2 study of Diffuse Large Cell B-lymphoma, has completed, sponsored by Pharmacyclics.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 78 participants
- Enrollment target
- 15
- Study locations
Study Summary
The purpose of this study is to evaluate the efficacy of ibrutinib (PCI-32765) in relapsed/refractory de novo activated B-cell (ABC) and germinal-cell B-Cell (GCB) Diffuse Large B-cell Lymphoma (DLBCL).
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.
Conditions Studied
Interventions
- DRUG ibrutinib
Study Locations (15)
New York
- Long Island Jewish Medical Center - New Hyde Park
- New York University - New York
- Weill Medical College of Cornell University - New York
- Memorial Sloan-Kettering Cancer Center - New York
- University of Rochester School of Medicine and Dentistry - Rochester
California
- UCLA Medical Center - Los Angeles
- Stanford University School of Medicine - Stanford
Maryland
- National Cancer Institute - Bethesda
Minnesota
- Mayo Clinic - Rochester
Nebraska
- University of Nebraska Medical Center - Omaha
New Jersey
- Hackensack University Medical Center - Hackensack
Ohio
- The Ohio Sate university - Columbus
Texas
- The University of Texas MD Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 78 participants |
| Start Date | 2011-05 |
| Est. Completion | 2014-10 |
| Phase | Phase 2 |
What the finished NCT01325701 record still lists
NCT01325701 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 78 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (41% lower).
The record links to 1 condition, with Diffuse Large Cell B-lymphoma appearing as the primary indexed condition, and to 1 intervention - of which ibrutinib is the first listed.
NCT01325701 lists 15 locations in 10 states (New York, California, Maryland).
Frequently Asked Questions
What is clinical trial NCT01325701 about?
NCT01325701 is a clinical study titled "Safety and Efficacy Study of a BTK Inhibitor in Subjects With Relapsed or Refractory Diffuse Large B-cell Lymphoma". The purpose of this study is to evaluate the efficacy of ibrutinib (PCI-32765) in relapsed/refractory de novo activated B-cell (ABC) and germinal-cell B-Cell (GCB) Diffuse Large B-cell Lymphoma (DLBCL).
What is the current status of trial NCT01325701?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 78 participants. The study started on 2011-05. Estimated completion is 2014-10.
What conditions does trial NCT01325701 study?
This clinical trial studies the following conditions: Diffuse Large Cell B-lymphoma.
What interventions are being tested in trial NCT01325701?
The interventions under investigation include: ibrutinib (DRUG).
Who is sponsoring clinical trial NCT01325701?
This trial is sponsored by Pharmacyclics, which has 54 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01325701 being conducted?
This trial has 15 study locations across California, Maryland, Minnesota, Nebraska, New Jersey. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01325701's enrollment target sits among peer trials
78 884th of 2000 higher than 1,110 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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