Study of Dasatinib in Imatinib Resistant or Intolerant Subjects With Chronic or Advanced Phase CML or Philadelphia Chromosome Positive ALL
Phase 2
Withdrawn
- Conditions
- Chronic Myeloid LeukemiaAcute Lymphoblastic Leukemia
- Registration Number
- NCT00349518
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
The purpose of this study is to further assess the safety of dasatinib in imatinib intolerant or resistant patients with chronic phase chronic myeloid leukemia, advanced phase chronic myeloid leukemia or Philadelphia chromosome positive acute lymphoblastic leukemia. The efficacy of the drug in this kind of patients will also further be documented.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
- Males and females, 18 or older
- CP or AD CML or Ph+ ALL
- Intolerant of resistant to imatinib
- ECOG PS 0-2 (CP CML)
- ECOG PS 0-3 (AD CML and Ph+ ALL)
- Adequate hepatic and renal function
Exclusion Criteria
- Pregnant or breastfeeding females
- History of significant cardiac disease
- History of significant bleeding disorder (not CML)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Incidence and severity of drug-related adverse events.
- Secondary Outcome Measures
Name Time Method Chronic Phase CML: Cytogenetic and Hematologic Response Time to and duration of Cytogenetic and Hematologic Response Advanced Phase CML and Philadelphia positive ALL: Hematologic Response
Trial Locations
- Locations (2)
Local Institution
🇬🇧Birmingham, West Midlands, United Kingdom
Local Instiution
🇵🇱Lodz, Poland