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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. 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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01082939
The ClinicalTrials.gov registry entry for NCT01082939 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 80 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is M.D. Anderson Cancer Center, which has 2,692 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Cyclophosphamide is the first listed.
NCT01082939 reports 0 study locations.
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.
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