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NCT00046683 · ClinicalTrials.gov registry record · Phase 3
Efficacy/Safety of Frontline Alemtuzumab (Campath, MabCampath) vs Chlorambucil in Patients With Progressive B-Cell Lymphocytic Leukemia
A Phase 3 study, sponsored by Genzyme, a Sanofi Company.
- Completed
- Registry status
- Phase 3
- Development phase
- 284
- Enrollment target
NCT00046683 is a Phase 3 study that has completed, run by Genzyme, a Sanofi Company. The registered enrollment target is 284 participants.
The verdict
NCT00046683, a Phase 3 study, has completed, sponsored by Genzyme, a Sanofi Company.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 284 participants
- Enrollment target
Study Summary
This is a Phase III, open-label, multicenter, randomized, comparative study of Campath versus chlorambucil as front line therapy in patients with progressive B-Cell Lymphocytic Leukemia (B-CLL). Eligible patients must have previously untreated, Rai stage I-IV disease, and be experiencing progression of their B-CLL requiring treatment. Patients who meet all eligibility criteria may be randomized on a 1:1 basis to receive either Campath or chlorambucil. An estimated 284 patients (142 per treatment arm) from approximately 40 or more investigational sites will be randomized to one of the two treatment arms.
Interventions
- DRUG alemtuzumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 284 participants |
| Start Date | 2001-07 |
| Est. Completion | 2006-06 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00046683
The ClinicalTrials.gov registry entry for NCT00046683 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 284 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 is the first listed.
NCT00046683 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00046683 about?
NCT00046683 is a clinical study titled "Efficacy/Safety of Frontline Alemtuzumab (Campath, MabCampath) vs Chlorambucil in Patients With Progressive B-Cell Lymphocytic Leukemia". This is a Phase III, open-label, multicenter, randomized, comparative study of Campath versus chlorambucil as front line therapy in patients with progressive B-Cell Lymphocytic Leukemia (B-CLL). Eligible patients must have previously untreated, Rai stage I-IV disease, and be experiencing progression...
What is the current status of trial NCT00046683?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 284 participants. The study started on 2001-07. Estimated completion is 2006-06.
What interventions are being tested in trial NCT00046683?
The interventions under investigation include: alemtuzumab (DRUG).
Who is sponsoring clinical trial NCT00046683?
This trial is sponsored by Genzyme, a Sanofi Company, which has 196 total clinical trials registered on ClinicalTrials.gov.
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