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NCT00086580 · ClinicalTrials.gov registry record · Phase 3
Fludarabine (Fludara®) Plus Alemtuzumab (CAMPATH®, MabCampath®) vs Fludarabine Alone in B-Cell Chronic Lymphocytic Leukemia (B-CLL) Patients
A Phase 3 study, sponsored by Genzyme, a Sanofi Company.
- Completed
- Registry status
- Phase 3
- Development phase
- 335
- Enrollment target
NCT00086580 is a Phase 3 study that has completed, run by Genzyme, a Sanofi Company. The registered enrollment target is 335 participants.
The verdict
NCT00086580, a Phase 3 study, has completed, sponsored by Genzyme, a Sanofi Company.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 335 participants
- Enrollment target
Study Summary
This is a Phase 3, prospective, multicenter, open-label, randomized, controlled study to evaluate and compare the efficacy and safety of fludarabine plus alemtuzumab versus fludarabine alone as second-line therapy for patients with relapsed or refractory B-cell chronic lymphocytic leukemia (B-CLL). Patients who meet all eligibility criteria and sign the informed consent document may be entered on the study.
Interventions
- BIOLOGICAL FluCAM [Fludara + Campath]
- BIOLOGICAL fludarabine phosphate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 335 participants |
| Start Date | 2004-07 |
| Est. Completion | 2010-06 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00086580
The ClinicalTrials.gov registry entry for NCT00086580 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 335 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 2 interventions - of which FluCAM [Fludara + Campath] is the first listed.
NCT00086580 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00086580 about?
NCT00086580 is a clinical study titled "Fludarabine (Fludara®) Plus Alemtuzumab (CAMPATH®, MabCampath®) vs Fludarabine Alone in B-Cell Chronic Lymphocytic Leukemia (B-CLL) Patients". This is a Phase 3, prospective, multicenter, open-label, randomized, controlled study to evaluate and compare the efficacy and safety of fludarabine plus alemtuzumab versus fludarabine alone as second-line therapy for patients with relapsed or refractory B-cell chronic lymphocytic leukemia (B-CLL). ...
What is the current status of trial NCT00086580?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 335 participants. The study started on 2004-07. Estimated completion is 2010-06.
What interventions are being tested in trial NCT00086580?
The interventions under investigation include: FluCAM [Fludara + Campath] (BIOLOGICAL), fludarabine phosphate (BIOLOGICAL).
Who is sponsoring clinical trial NCT00086580?
This trial is sponsored by Genzyme, a Sanofi Company, which has 196 total clinical trials registered on ClinicalTrials.gov.
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