Spots Global Cancer Trial Database for Dasatinib in Treating Patients With Chronic Myelogenous Leukemia or Acute Lymphoblastic Leukemia

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Trial Identification

Brief Title: Dasatinib in Treating Patients With Chronic Myelogenous Leukemia or Acute Lymphoblastic Leukemia

Official Title: Long-Term Safety and Efficacy of Dasatinib (BMS-354825) in Subjects Who Experienced Clinical Benefit on Protocol CA 180-002

Study ID: NCT00345826

Conditions

Leukemia

Interventions

dasatinib

Study Description

Brief Summary: 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.

Detailed Description: 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.