At a glance
ClinicalIndex Comparison Record- ✓Age ≥18 years
- ✓Chronic phase Philadelphia chromosome-positive chronic myeloid leukemia (CML)
- ✓Progressive disease on imatinib at dose >600 mg/day, OR resistant to imatinib at dose ≤600 mg/day with BCR-ABL mutation associated with high-level imatinib resistance, OR intolerant to imatinib at any dose
- ✓Adequate organ function
- ✕Accelerated phase or blast crisis CML
- ✕Eligible and willing to undergo transplantation during the screening period
- ✕Uncontrolled or significant cardiovascular disease
- ✕Prior therapy with dasatinib
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase II Study to Determine the Activity of BMS-354825 in Subjects With Chronic Phase Philadelphia Chromosome-Positive Chronic Myeloid Leukemia Who Have Disease That is Resistant to High Dose Imatinib Mesylate (Gleevec) or Who Are Intolerant of Imatinib
In Brief
A Phase 2 clinical trial evaluating Dasatinib for Chronic Myeloid Leukemia and Philadelphia-Positive Myeloid Leukemia. Completed, enrolled 387 participants across 85 sites in 22 countries.
Detailed Summary
The purpose of this study is assess the effects of the investigational drug dasatinib on participants who are in chronic phase Philadelphia chromosome chronic myeloid leukemia and who are either resistant to or intolerant of imatinib. Other purposes of the study are to identify any side effects the drug may produce and to study the level of dasatanib in the blood and assess the efficacy of dasatanib in the treatment of leukemia.
Study Details
Timeline
Interventions
Tablets; oral; 70 mg BID, depending on response