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NCT01082939 · ClinicalTrials.gov registry record · Phase 2
Cyclophosphamide, Fludarabine, Alemtuzumab, and Rituximab (CFAR) for Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL)
A Phase 2 study, sponsored by M.D. Anderson Cancer Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 80
- Enrollment target
NCT01082939: Completed Phase 2 study, sponsored by M.D. Anderson Cancer Center.
NCT01082939 is a Phase 2 study that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 80 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (40% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01082939, a Phase 2 study, has completed, sponsored by M.D. Anderson Cancer Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 80 participants
- Enrollment target
Study Summary
The goal of this clinical research study is to learn if the combination of fludarabine, cyclophosphamide, alemtuzumab, and rituximab is effective in treating chronic lymphocytic leukemia in patients who have already been treated with chemotherapy. Primary Objectives: Evaluate the therapeutic efficacy, including the complete remission (CR), nodular partial remission (NPR), and partial remission (PR) rates (overall response) of combined cyclophosphamide, fludarabine, alemtuzumab, and rituximab (CFAR) in previously treated patients with Chronic Lymphocytic Leukemia (CLL). Second Objectives: * Assess the toxicity profile of CFAR in previously treated patients with CLL. * Monitor for infection and determine incidence and etiology of infection including cytomegalovirus in patients treated with CFAR. * Evaluate molecular remission by polymerase chain reaction (PCR) for the clonal immunoglobulin heavy chain variable gene in responding patients treated with CFAR. * Assess immune parameters, including pretreatment, during treatment, and post-treatment blood T-cell counts and subset distribution and serum immunoglobulin levels in patients treated with CFAR.
Primary Outcome
Overall (OR) is the total number of participants with any response: Complete remission (CR), is defined as \> 30% lymphocytes in the bone marrow, recovery of blood counts and no clinical symptoms; Nodular partial remission (NPR), is the same as CR but with nodules; Partial remission (PR) is \> 50% decrease of clinical symptoms from baseline and recovery from blood counts.
Interventions
- DRUG Cyclophosphamide
- DRUG Fludarabine
- DRUG Alemtuzumab
- DRUG Rituximab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 2002-12 |
| Est. Completion | 2011-01 |
| Phase | Phase 2 |
What the finished NCT01082939 record still lists
NCT01082939 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 80 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (40% lower).
The record links to 0 conditions, and to 4 interventions - of which Cyclophosphamide is the first listed.
NCT01082939 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01082939 about?
NCT01082939 is a clinical study titled "Cyclophosphamide, Fludarabine, Alemtuzumab, and Rituximab (CFAR) for Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL)". The goal of this clinical research study is to learn if the combination of fludarabine, cyclophosphamide, alemtuzumab, and rituximab is effective in treating chronic lymphocytic leukemia in patients who have already been treated with chemotherapy. Primary Objectives: Evaluate the therapeutic effic...
What is the current status of trial NCT01082939?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 80 participants. The study started on 2002-12. Estimated completion is 2011-01.
What interventions are being tested in trial NCT01082939?
The interventions under investigation include: Cyclophosphamide (DRUG), Fludarabine (DRUG), Alemtuzumab (DRUG), Rituximab (DRUG).
Who is sponsoring clinical trial NCT01082939?
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 NCT01082939's enrollment target sits among peer trials
80 842nd of 2000 higher than 1,117 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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