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NCT00123487 · ClinicalTrials.gov registry record · Phase 3
Advanced 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
- 638
- Enrollment target
NCT00123487: Completed Phase 3 study, sponsored by Bristol-Myers Squibb.
NCT00123487 is a Phase 3 study that has completed, run by Bristol-Myers Squibb. The registered enrollment target is 638 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (17% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00123487, a Phase 3 study, has completed, sponsored by Bristol-Myers Squibb.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 638 participants
- Enrollment target
Study Summary
This is a phase III study of BMS-354825 in subjects with chronic myelogenous leukemia in accelerated phase, or in myeloid or lymphoid blast phase or with Philadelphia chromosome positive (Ph+) acute lymphoblastic leukemia who are resistant or intolerant to imatinib mesylate (Gleevec).
Primary Outcome
MaHR defined by either complete hematologic response (CHR) or no evidence of leukemia (NEL). CHR defined as: white blood cells (WBC) ≤ upper limit of normal (ULN); absolute neutrophil count (ANC) ≥ 1,000/mm\^3; platelets ≥ 100,000/mm\^3; no blasts or promyelocytes in peripheral blood (PB); bone marrow (BM) blasts ≤ 5%; \<5% myelocytes plus metamyelocytes in PB; basophils in PB \< 20%; no extra-medullar involvement (including no hepatomegaly or splenomegaly). NEL defined by same criteria as CHR e
Interventions
- DRUG dasatinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 638 participants |
| Start Date | 2005-06 |
| Est. Completion | 2013-06 |
| Phase | Phase 3 |
What the finished NCT00123487 record still lists
NCT00123487 is an interventional study that assigns participants to a tested intervention. The registered 638 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 (17% lower).
The record links to 0 conditions, and to 1 intervention - of which dasatinib is the first listed.
NCT00123487 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00123487 about?
NCT00123487 is a clinical study titled "Advanced 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 myelogenous leukemia in accelerated phase, or in myeloid or lymphoid blast phase or with Philadelphia chromosome positive (Ph+) acute lymphoblastic leukemia who are resistant or intolerant to imatinib mesylate (Gleevec).
What is the current status of trial NCT00123487?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 638 participants. The study started on 2005-06. Estimated completion is 2013-06.
What interventions are being tested in trial NCT00123487?
The interventions under investigation include: dasatinib (DRUG).
Who is sponsoring clinical trial NCT00123487?
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 NCT00123487's enrollment target sits among peer trials
638 579th of 2000 higher than 1,422 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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