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NCT00103844 · ClinicalTrials.gov registry record · Phase 2
Dasatinib (BMS-354835) Versus Imatinib Mesylate in Subjects With Chronic Myeloid Leukemia
A Phase 2 study of Chronic Myeloid Leukemia and Philadelphia-Positive Myeloid Leukemia, sponsored by Bristol-Myers Squibb.
- Completed
- Registry status
- Phase 2
- Development phase
- 150
- Enrollment target
- 20
- Study locations
NCT00103844: Completed Phase 2 study of Chronic Myeloid Leukemia and Philadelphia-Positive Myeloid Leukemia, sponsored by Bristol-Myers Squibb.
NCT00103844 is a Phase 2 study of Chronic Myeloid Leukemia and Philadelphia-Positive Myeloid Leukemia that has completed, run by Bristol-Myers Squibb. The registered enrollment target is 150 participants, below the 206-participant average among 35 other Chronic Myeloid Leukemia trials with a reported enrollment target (27% lower). The trial reports 20 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00103844, a Phase 2 study of Chronic Myeloid Leukemia and Philadelphia-Positive Myeloid Leukemia, has completed, sponsored by Bristol-Myers Squibb.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 150 participants
- Enrollment target
- 20
- Study locations
Study Summary
The primary purpose of this study is to estimate the major cytogenetic response rates of BMS-354825 and imatinib (800 mg/d) in subjects with chronic phase, Philadelphia chromosome positive, chronic myeloid leukemia (PH+ CML) with disease resistant to imatinib at a dose of 400-600 mg/d.
Primary Outcome
Cytogenetic response was based on the prevalence of Philadelphia chromosome positive (Ph+) metaphases among cells in metaphase on a bone marrow sample (aspirate/biopsy). MCyR was defined as Complete CyR (CCyR; 0% Ph+ cells in metaphase in bone marrow) or Partial CyR (PCyR; \>0% to 35% Ph+ cells in metaphase in bone marrow).
Conditions Studied
Interventions
- DRUG Dasatinib
- DRUG Imatinib
Study Locations (20)
California
- Local Institution - Anaheim
- Local Institution - Bakersfield
- Local Institution - Fullerton
- Local Institution - Loma Linda
- Local Institution - Los Angeles
- Local Institution - Monterey Park
- Local Institution - San Diego
- Local Institution - Santa Barbara
- Local Institution - Santa Maria
- Local Institution - Stanford
- Local Institution - Vallejo
Georgia
- Local Institution - Athens
- Local Institution - Atlanta
- Local Institution - Lawrenceville
Florida
- Local Institution - Jacksonville
- Local Institution - Tampa
Alabama
- Local Institution - Birmingham
Colorado
- Local Institution - Aurora
Connecticut
- Local Institution - Hartford
District of Columbia
- Local Institution - Washington D.C.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 150 participants |
| Start Date | 2005-02 |
| Est. Completion | 2008-03 |
| Phase | Phase 2 |
What the finished NCT00103844 record still lists
NCT00103844 is an interventional study that assigns participants to a tested intervention. The registered 150 participants enrollment target is mid-sized for trials with a published cap, below the 206-participant average among 35 other Chronic Myeloid Leukemia trials with a reported enrollment target (27% lower).
The record links to 2 conditions, with Chronic Myeloid Leukemia appearing as the primary indexed condition, and to 2 interventions - of which Dasatinib is the first listed.
NCT00103844 names 20 study sites across 7 states, led by California, Georgia, Florida.
Frequently Asked Questions
What is clinical trial NCT00103844 about?
NCT00103844 is a clinical study titled "Dasatinib (BMS-354835) Versus Imatinib Mesylate in Subjects With Chronic Myeloid Leukemia". The primary purpose of this study is to estimate the major cytogenetic response rates of BMS-354825 and imatinib (800 mg/d) in subjects with chronic phase, Philadelphia chromosome positive, chronic myeloid leukemia (PH+ CML) with disease resistant to imatinib at a dose of 400-600 mg/d.
What is the current status of trial NCT00103844?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 150 participants. The study started on 2005-02. Estimated completion is 2008-03.
What conditions does trial NCT00103844 study?
This clinical trial studies the following conditions: Chronic Myeloid Leukemia, Philadelphia-Positive Myeloid Leukemia.
What interventions are being tested in trial NCT00103844?
The interventions under investigation include: Dasatinib (DRUG), Imatinib (DRUG).
Who is sponsoring clinical trial NCT00103844?
This trial is sponsored by Bristol-Myers Squibb, which has 1,025 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00103844 being conducted?
This trial has 20 study locations across Alabama, California, Colorado, Connecticut, District of Columbia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT00103844's enrollment target sits among peer trials
150 10th of 35 higher than 26 of 35 other Chronic Myeloid Leukemia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Chronic Myeloid Leukemia 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.
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