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NCT00464633 · ClinicalTrials.gov registry record · Phase 2
Alvocidib in Patients With Previously Treated Chronic Lymphocytic Leukemia or Prolymphocytic Leukemia Arising From Chronic Lymphocytic Leukemia (CLL)
A Phase 2 study, sponsored by Sanofi.
- Completed
- Registry status
- Phase 2
- Development phase
- 165
- Enrollment target
NCT00464633: Completed Phase 2 study, sponsored by Sanofi.
NCT00464633 is a Phase 2 study that has completed, run by Sanofi. The registered enrollment target is 165 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (24% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00464633, a Phase 2 study, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 165 participants
- Enrollment target
Study Summary
Multicenter, open-label, study of alvocidib in previously treated chronic lymphocytic leukemia patients. Primary objective is to determine overall response rate. The secondary objectives are: * to assess overall safety, * to assess duration of response, progression free survival, and overall survival. Clinical benefit and pharmacokinetics parameters are also evaluated.
Primary Outcome
Objective Response Rate (ORR) is defined as the proportion of participants with complete response or partial response (including nodular partial response) relative to the total number of participants. Response assessment is based on evaluation of nodal disease by Computerized Tomography (CT) and National Cancer Institute Working Group 96 criteria (NCI-96) for assessment of liver, spleen, constitutional symptoms, peripheral blood (±) bone marrow.
Interventions
- DRUG alvocidib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 165 participants |
| Start Date | 2007-03 |
| Est. Completion | 2011-12 |
| Phase | Phase 2 |
What the finished NCT00464633 record still lists
NCT00464633 is an interventional study that assigns participants to a tested intervention. The registered 165 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (24% higher).
The record links to 0 conditions, and to 1 intervention - of which alvocidib is the first listed.
NCT00464633 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00464633 about?
NCT00464633 is a clinical study titled "Alvocidib in Patients With Previously Treated Chronic Lymphocytic Leukemia or Prolymphocytic Leukemia Arising From Chronic Lymphocytic Leukemia (CLL)". Multicenter, open-label, study of alvocidib in previously treated chronic lymphocytic leukemia patients. Primary objective is to determine overall response rate. The secondary objectives are: * to assess overall safety, * to assess duration of response, progression free survival, and overall surv...
What is the current status of trial NCT00464633?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 165 participants. The study started on 2007-03. Estimated completion is 2011-12.
What interventions are being tested in trial NCT00464633?
The interventions under investigation include: alvocidib (DRUG).
Who is sponsoring clinical trial NCT00464633?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00464633's enrollment target sits among peer trials
165 410th of 2000 higher than 1,588 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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