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NCT00206726 · ClinicalTrials.gov registry record · Phase 2
Alemtuzumab/Fludarabine for Relapsed/Refractory B-cell Chronic Lymphocytic Leukemia (B-CLL)
A Phase 2 study, sponsored by Genzyme, a Sanofi Company.
- Completed
- Registry status
- Phase 2
- Development phase
- 60
- Enrollment target
NCT00206726 is a Phase 2 study that has completed, run by Genzyme, a Sanofi Company. The registered enrollment target is 60 participants.
The verdict
NCT00206726, a Phase 2 study, has completed, sponsored by Genzyme, a Sanofi Company.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 60 participants
- Enrollment target
Study Summary
This is a multi-center, Phase II, open label trial evaluating the efficacy and safety of alemtuzumab and fludarabine in the treatment of B-cell chronic lymphocytic leukemia (B-CLL) patients who have received at least one prior therapy. Treatments will be administered on a 28-day cycle for 4-6 cycles, with an evaluation during Cycle 4 to permit re-staging. Alemtuzumab and fludarabine will be administered on Days 1-5 of each cycle. Patients will be assessed for response at the time of re-staging at Cycle 4 and at the end of Cycle 6. At the time of the re-staging, patients achieving a Partial Remission (PR) or Stable Disease (SD) will be given an additional 2 cycles of treatment and patients demonstrating presumptive signs of a Complete Remission (CR) will receive no further treatment but will be followed for response.
Interventions
- DRUG Alemtuzumab plus Fludarabine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2005-05 |
| Est. Completion | 2008-04 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00206726
The ClinicalTrials.gov registry entry for NCT00206726 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Genzyme, a Sanofi Company, which has 196 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Alemtuzumab plus Fludarabine is the first listed.
NCT00206726 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00206726 about?
NCT00206726 is a clinical study titled "Alemtuzumab/Fludarabine for Relapsed/Refractory B-cell Chronic Lymphocytic Leukemia (B-CLL)". This is a multi-center, Phase II, open label trial evaluating the efficacy and safety of alemtuzumab and fludarabine in the treatment of B-cell chronic lymphocytic leukemia (B-CLL) patients who have received at least one prior therapy. Treatments will be administered on a 28-day cycle for 4-6 cycle...
What is the current status of trial NCT00206726?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 60 participants. The study started on 2005-05. Estimated completion is 2008-04.
What interventions are being tested in trial NCT00206726?
The interventions under investigation include: Alemtuzumab plus Fludarabine (DRUG).
Who is sponsoring clinical trial NCT00206726?
This trial is sponsored by Genzyme, a Sanofi Company, which has 196 total clinical trials registered on ClinicalTrials.gov.
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