STI571 Plus Cytarabine in Treating Patients With Chronic Myelogenous Leukemia
Blastic Phase Chronic Myelogenous Leukemia, Chronic Myelogenous Leukemia, BCR-ABL1 Positive, Relapsing Chronic Myelogenous Leukemia
About this trial
This is an interventional treatment trial for Blastic Phase Chronic Myelogenous Leukemia
Eligibility Criteria
Inclusion Criteria: Diagnosis of chronic myelogenous leukemia in myeloid blast crisis At least 30% blasts in bone marrow Philadelphia chromosome positive by cytogenetic analysis bcr/abl translocation by fluorescent in situ hybridization Ineligible for or refused allogeneic stem cell transplantation Not previously treated with imatinib mesylate OR currently receiving imatinib mesylate with stable disease on 2 bone marrow biopsies at least 2 weeks apart Performance status - ECOG 0-2 See Disease Characteristics Bilirubin less than 3 times upper limit of normal (ULN) AST and ALT less than 3 times ULN Creatinine less than 2 times ULN No New York Heart Association class III or IV heart disease Not pregnant or nursing Negative pregnancy test Fertile patients must use effective barrier contraception during and for at least 2 weeks after study for female patients and at least 3 months after study for male patients See Disease Characteristics No prior allogeneic bone marrow or peripheral blood stem cell transplantation At least 48 hours since prior interferon alfa At least 24 hours since prior hydroxyurea At least 6 weeks since prior busulfan No other prior chemotherapy for blast crisis (except hydroxyurea) Concurrent hydroxyurea or anagrelide for severe leukocytosis or thrombocytosis allowed At least 4 weeks since prior investigational agents
Sites / Locations
- University of California at Los Angeles (UCLA )
Arms of the Study
Arm 1
Experimental
Treatment (imatinib mesylate, cytarabine)
Patients who have not previously received imatinib mesylate receive oral imatinib mesylate daily on days 1-35. Patients who have previously received imatinib mesylate for at least 28 days receive oral imatinib mesylate on days 22-35. All patients receive cytarabine IV over 2 hours every 12 hours on days 29-32. Patients with more than 5% residual blasts in bone marrow on day 28 receive a second course in the absence of disease progression or unacceptable toxicity.