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NCT00481247 · ClinicalTrials.gov registry record · Phase 3
A Phase III Study of Dasatinib vs Imatinib in Patients With Newly Diagnosed Chronic Phase Chronic Myeloid Leukemia
A Phase 3 study, sponsored by Bristol-Myers Squibb.
- Completed
- Registry status
- Phase 3
- Development phase
- 547
- Enrollment target
NCT00481247: Completed Phase 3 study, sponsored by Bristol-Myers Squibb.
NCT00481247 is a Phase 3 study that has completed, run by Bristol-Myers Squibb. The registered enrollment target is 547 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (29% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00481247, a Phase 3 study, has completed, sponsored by Bristol-Myers Squibb.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 547 participants
- Enrollment target
Study Summary
The purpose of this clinical research study is to compare the confirmed complete cytogenetic response of dasatinib with that of imatinib within 12 months after randomization in patients with newly diagnosed chronic-phase Philadelphia positive chronic myeloid leukemia. The safety of this treatment will also be studied.
Primary Outcome
Cytogenetic response (CyR) is based on the prevalence of Philadelphia positive (Ph+) cells in metaphase from bone marrow (BM) sample. (Ideally, 25 metaphases but at least 20 metaphases from a BM sample were evaluated). Complete Cytogenetic Response (CCyR)=0% Ph+ cells in metaphase in BM. A cCCyR=those in which all measurements up to at least 28 days after the initial response show an equivalent or better CCyR.
Interventions
- DRUG Dasatinib
- DRUG Imatinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 547 participants |
| Start Date | 2007-09 |
| Est. Completion | 2015-12 |
| Phase | Phase 3 |
What the finished NCT00481247 record still lists
NCT00481247 is an interventional study that assigns participants to a tested intervention. The registered 547 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 (29% lower).
The record links to 0 conditions, and to 2 interventions - of which Dasatinib is the first listed.
NCT00481247 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00481247 about?
NCT00481247 is a clinical study titled "A Phase III Study of Dasatinib vs Imatinib in Patients With Newly Diagnosed Chronic Phase Chronic Myeloid Leukemia". The purpose of this clinical research study is to compare the confirmed complete cytogenetic response of dasatinib with that of imatinib within 12 months after randomization in patients with newly diagnosed chronic-phase Philadelphia positive chronic myeloid leukemia. The safety of this treatment wi...
What is the current status of trial NCT00481247?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 547 participants. The study started on 2007-09. Estimated completion is 2015-12.
What interventions are being tested in trial NCT00481247?
The interventions under investigation include: Dasatinib (DRUG), Imatinib (DRUG).
Who is sponsoring clinical trial NCT00481247?
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 NCT00481247's enrollment target sits among peer trials
547 689th of 2000 higher than 1,312 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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