NCT00345826

Dasatinib in Treating Patients With Chronic Myelogenous Leukemia or Acute Lymphoblastic Leukemia

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: Jonsson Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Leukemia

Interventions

Type	Name	Description
DRUG	dasatinib

Timeline

• Start date: 2005-11-01
• Primary completion: 2010-07-01
• First posted: 2006-06-29
• Last updated: 2013-01-08

Locations

1 site across 1 country: United States