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NCT00123474 · ClinicalTrials.gov registry record · Phase 3
Chronic Myelogenous Leukemia (CML) - Follow on: Study of BMS-354825 in Subjects With CML
A Phase 3 study, sponsored by Bristol-Myers Squibb.
- Completed
- Registry status
- Phase 3
- Development phase
- 724
- Enrollment target
NCT00123474: Completed Phase 3 study, sponsored by Bristol-Myers Squibb.
NCT00123474 is a Phase 3 study that has completed, run by Bristol-Myers Squibb. The registered enrollment target is 724 participants, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00123474, a Phase 3 study, has completed, sponsored by Bristol-Myers Squibb.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 724 participants
- Enrollment target
Study Summary
This is a phase III study of BMS-354825 in subjects with chronic phase Philadelphia chromosome or BCR-ABL positive chronic myelogenous leukemia, who are resistant or intolerant to imatinib mesylate (Gleevec).
Primary Outcome
Cytogenetic response (CyR) was based on the number of Philadelphia chromosome positive (Ph+) metaphases among cells in metaphase on a Bone Marrow (BM) sample. The criteria for CyR were as follows: Complete cytogenetic response (CCyR): 0% Ph+ cells in metaphase in BM; Partial cytogenetic response (PCyR): \>0 to 35% Ph+ cells in metaphase in BM; Minor cytogenetic response: \>35 to 65% Ph+ cells in metaphase in BM; Minimal cytogenetic response: \>65 to 95% Ph+ cells in metaphase in BM; No cytogenet
Interventions
- DRUG dasatinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 724 participants |
| Start Date | 2005-07 |
| Est. Completion | 2014-07 |
| Phase | Phase 3 |
What the finished NCT00123474 record still lists
NCT00123474 is an interventional study that assigns participants to a tested intervention. The registered 724 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target.
The record links to 0 conditions, and to 1 intervention - of which dasatinib is the first listed.
NCT00123474 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00123474 about?
NCT00123474 is a clinical study titled "Chronic Myelogenous Leukemia (CML) - Follow on: Study of BMS-354825 in Subjects With CML". This is a phase III study of BMS-354825 in subjects with chronic phase Philadelphia chromosome or BCR-ABL positive chronic myelogenous leukemia, who are resistant or intolerant to imatinib mesylate (Gleevec).
What is the current status of trial NCT00123474?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 724 participants. The study started on 2005-07. Estimated completion is 2014-07.
What interventions are being tested in trial NCT00123474?
The interventions under investigation include: dasatinib (DRUG).
Who is sponsoring clinical trial NCT00123474?
This trial is sponsored by Bristol-Myers Squibb, which has 1,025 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00123474's enrollment target sits among peer trials
724 491st of 2000 higher than 1,509 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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