A Study to Determine the Efficacy and Safety of STI571 in Patients With Chronic Myeloid Leukemia in Accelerated Phase

Inclusion Criteria

DISEASE CHARACTERISTICS: Confirmed diagnosis of chronic myelogenous leukemia in
accelerated phase At least 15% but less than 30% blasts in blood or bone marrow At least
30% blasts plus promyelocytes in the peripheral blood or bone marrow At least 20%
peripheral basophils Thrombocyte count less than 100,000/mm3 (unrelated to therapy)
Patients must have never been in blastic phase Ph chromosome positive OR Ph chromosome
negative and Bcr/Abl positive

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-3 Life expectancy:
Not specified Hematopoietic: See Disease Characteristics Blood counts recovered from any
prior antileukemic agents Hepatic: Bilirubin no greater than 1.5 times upper limit of
normal (ULN) (no greater than 3 times ULN if liver involvement suspected) AST and ALT no
greater than 3 times ULN (no greater than 5 times ULN if liver involvement suspected)
Renal: Creatinine no greater than 2 times ULN Cardiovascular: No grade 3 or 4 cardiac
disease Other: No serious other concurrent medical condition 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 at least 3 months after study for men
No history of noncompliance with medical regimens

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 48 hours since prior interferon alfa
Prior hematopoietic stem cell transplantation allowed if blood counts have recovered No
concurrent biologic therapy Chemotherapy: At least 14 days since prior homoharringtonine
At least 24 hours since prior hydroxyurea At least 7 days since prior low dose cytarabine
(less than 30 mg/m2 every 12-24 hours daily) At least 14 days since prior moderate dose
cytarabine (100-200 mg/m2 for 5-7 days) At least 28 days since prior high dose cytarabine
(1-3 g/m2 every 12-24 hours for 6-12 doses) At least 21 days since prior anthracyclines,
mitoxantrone, etoposide, methotrexate, or cyclophosphamide At least 6 weeks since prior
busulfan No concurrent chemotherapy Endocrine therapy: Not specified Radiotherapy: Not
specified Surgery: Not specified Other: At least 28 days since prior other investigational
agents No concurrent other investigational agents