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NCT01520519 · ClinicalTrials.gov registry record · Phase 2
Phase 2 Study of the Combination of Bruton's Tyrosine Kinase Inhibitor PCI-32765 and Rituximab in High-Risk Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma Patients
A Phase 2 study, sponsored by M.D. Anderson Cancer Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 40
- Enrollment target
NCT01520519: Completed Phase 2 study, sponsored by M.D. Anderson Cancer Center.
NCT01520519 is a Phase 2 study that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 40 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (70% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01520519, a Phase 2 study, has completed, sponsored by M.D. Anderson Cancer Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 40 participants
- Enrollment target
Study Summary
The goal of this clinical research study is to learn if PCI-32765 (Ibrutinib) combined with rituximab can help to control CLL and SLL. The safety of this combination will also be studied. Ibrutinib is designed to stop a protein from working in the cells, which may cause the cancer cells to die or stop growing. Rituximab is designed to attach to cancer cells and damage them, which may cause the cells to die.
Primary Outcome
Progression free survival defined as the time interval from treatment to progressive disease or death, whichever happens earlier. Participants in complete remission (CR), partial remission (PR) or stable disease (SD) are all counted as progression-free. Survival or times to progression functions estimated using the Kaplan-Meier method.
Interventions
- DRUG Rituximab
- DRUG PCI-32765
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2012-02-27 |
| Est. Completion | 2018-08-09 |
| Phase | Phase 2 |
What the finished NCT01520519 record still lists
NCT01520519 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (70% lower).
The record links to 0 conditions, and to 2 interventions - of which Rituximab is the first listed.
NCT01520519 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01520519 about?
NCT01520519 is a clinical study titled "Phase 2 Study of the Combination of Bruton's Tyrosine Kinase Inhibitor PCI-32765 and Rituximab in High-Risk Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma Patients". The goal of this clinical research study is to learn if PCI-32765 (Ibrutinib) combined with rituximab can help to control CLL and SLL. The safety of this combination will also be studied. Ibrutinib is designed to stop a protein from working in the cells, which may cause the cancer cells to die or s...
What is the current status of trial NCT01520519?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 40 participants. The study started on 2012-02-27. Estimated completion is 2018-08-09.
What interventions are being tested in trial NCT01520519?
The interventions under investigation include: Rituximab (DRUG), PCI-32765 (DRUG).
Who is sponsoring clinical trial NCT01520519?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01520519's enrollment target sits among peer trials
40 1362nd of 2000 higher than 542 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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