An Open-Label Study to Determine the Efficacy and Safety of STI571 in Patients With Chronic Myeloid Leukemia in Blast Crisis

Inclusion Criteria

DISEASE CHARACTERISTICS: Diagnosis of chronic myelogenous leukemia (CML) in blast crisis,
defined by at least one of the following: 30% blasts in peripheral blood and/or bone
marrow Flow cytometry criteria Extramedullary disease other than spleen, lymph node,
and/or liver involvement Newly diagnosed CML in blast crisis OR CML in blast crisis with
prior therapy for accelerated or blastic phases Philadelphia (Ph) chromosome positive OR
Ph chromosome negative and Bcr/Abl positive

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy:
Not specified Hematopoietic: See Disease Characteristics Hepatic: SGOT and SGPT no greater
than 3 times upper limit of normal (ULN) (no greater than 5 times ULN if liver
involvement) Bilirubin no greater than 3 times ULN Renal: Creatinine no greater than 2
times ULN Cardiovascular: No grade 3 or 4 cardiac disease Other: Not pregnant or nursing
Negative pregnancy test Fertile patients must use effective barrier contraception during
and for at least 2 weeks after study for women and for at least 3 months after study for
men No history of noncompliance with medical regimens No serious concurrent medical
condition

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 48 hours since prior interferon alfa
At least 6 weeks since prior hematopoietic stem cell transplantation No concurrent
anticancer biologic therapy Chemotherapy: At least 6 weeks since prior busulfan At least
24 hours since prior hydroxyurea At least 2 weeks since prior homoharringtonine At least 1
week since prior low-dose cytarabine (less than 30 mg/m2 every 12-24 hours daily) At least
2 weeks since prior moderate-dose cytarabine (100-200 mg/m2 for 5-7 days) At least 4 weeks
since prior high-dose cytarabine (1-3 g/m2 every 12-24 hours for 6-12 doses) At least 3
weeks since prior anthracyclines, mitoxantrone, or etoposide No concurrent anticancer
chemotherapy Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Not
specified Other: At least 4 weeks since other prior investigational agents No other
concurrent anticancer investigational agents