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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: Completed Phase 3 study, sponsored by Genzyme, a Sanofi Company.
NCT00086580 is a Phase 3 study that has completed, run by Genzyme, a Sanofi Company. The registered enrollment target is 335 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (57% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Progression-free survival was defined as the number of days from the date of randomization to the date of first objective documentation of progressive disease (PD) as determined by the treatment-blinded IRRP, or death due to any cause. Results are expressed in months.
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 |
What the finished NCT00086580 record still lists
NCT00086580 is an interventional study that assigns participants to a tested intervention. The registered 335 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (57% lower).
The record links to 0 conditions, and to 2 interventions - of which FluCAM [Fludara + Campath] is the first listed.
NCT00086580 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00086580's enrollment target sits among peer trials
335 1061st of 2000 higher than 940 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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