Leukemia Clinical Trial
Official title:
Long-Term Safety and Efficacy of Dasatinib (BMS-354825) in Subjects Who Experienced Clinical Benefit on Protocol CA 180-002
RATIONALE: Dasatinib may stop the growth of cancer cells by blocking some of the enzymes
needed for cell growth.
PURPOSE: This phase I trial is studying the side effects of dasatinib in treating patients
with chronic myelogenous leukemia or acute lymphoblastic leukemia.
OBJECTIVES:
Primary
- Determine the long-term safety and tolerability of dasatinib in patients with
Philadelphia chromosome-positive chronic myelogenous leukemia or acute lymphoblastic
leukemia resistant or intolerant to imatinib mesylate.
Secondary
- Describe any hematologic or cytogenetic response in patients treated with this drug.
- Determine the duration of hematologic and cytogenetic response in patients using this
drug during trial UCLA-0303035.
- Determine the progression-free survival and overall survival of patients treated with
this drug.
OUTLINE: This is an open-label, roll-over study of protocol UCLA-0303035.
Patients receive oral dasatinib once or twice daily for 5, 6, or 7 days. Treatment repeats
every 7 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically for 5 years.
PROJECTED ACCRUAL: A total of 54 patients will be accrued for this study.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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