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NCT00101647 · ClinicalTrials.gov registry record · Phase 2
Study of Dasatinib (BMS-354825) in Patients With Accelerated Phase Chronic Myeloid Leukemia
A Phase 2 study, sponsored by Bristol-Myers Squibb.
- Completed
- Registry status
- Phase 2
- Development phase
- 197
- Enrollment target
NCT00101647: Completed Phase 2 study, sponsored by Bristol-Myers Squibb.
NCT00101647 is a Phase 2 study that has completed, run by Bristol-Myers Squibb. The registered enrollment target is 197 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (48% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00101647, a Phase 2 study, has completed, sponsored by Bristol-Myers Squibb.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 197 participants
- Enrollment target
Study Summary
The purpose of this clinical research study is to learn if BMS-354825 will have activity, defined by hematologic response, in subjects who have accelerated phase chronic myeloid leukemia (CML) who are resistant to or intolerant to imatinib mesylate. The safety of this treatment will also be studied.
Primary Outcome
MaHR=best confirmed response of complete hematologic response (CHR) or No Evidence of Leukemia (NEL). OHR=best confirmed response of MaHR or minor hematologic response (MiHR). Confirmed hematologic response=response confirmed ≥4 weeks after first documented event with no concomitant use of anagrelide or hydroxyurea. Maintaining a response=no 2 consecutive records of nonresponse at assessment. Criteria for CHR and NEL specified in Outcome Measure 2 and criteria for MiHR in Outcome Measure 4.
Interventions
- DRUG Dasatinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 197 participants |
| Start Date | 2004-12 |
| Est. Completion | 2008-03 |
| Phase | Phase 2 |
What the finished NCT00101647 record still lists
NCT00101647 is an interventional study that assigns participants to a tested intervention. The registered 197 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 (48% higher).
The record links to 0 conditions, and to 1 intervention - of which Dasatinib is the first listed.
NCT00101647 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00101647 about?
NCT00101647 is a clinical study titled "Study of Dasatinib (BMS-354825) in Patients With Accelerated Phase Chronic Myeloid Leukemia". The purpose of this clinical research study is to learn if BMS-354825 will have activity, defined by hematologic response, in subjects who have accelerated phase chronic myeloid leukemia (CML) who are resistant to or intolerant to imatinib mesylate. The safety of this treatment will also be studied.
What is the current status of trial NCT00101647?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 197 participants. The study started on 2004-12. Estimated completion is 2008-03.
What interventions are being tested in trial NCT00101647?
The interventions under investigation include: Dasatinib (DRUG).
Who is sponsoring clinical trial NCT00101647?
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 NCT00101647's enrollment target sits among peer trials
197 349th of 2000 higher than 1,652 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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