Imatinib Mesylate Plus Cytarabine in Treating Patients With Chronic Myelogenous Leukemia

OBJECTIVES:

- Determine the rate and duration of complete or major and minor cytogenetic responses
after 6 and 12 months of treatment in patients with chronic phase chronic myelogenous
leukemia treated with imatinib mesylate and cytarabine.

- Determine the rate and duration of complete hematologic responses after 6 and 12 months
of treatment in patients treated with this regimen.

- Determine the rate of molecular response in patients with a complete cytogenetic
response after 6 and 12 months of treatment with this regimen.

- Determine the pharmacokinetics of this regimen in these patients.

- Determine the safety of this regimen in these patients.

OUTLINE: This is a nonrandomized, open-label, multicenter study.

Patients receive oral imatinib mesylate on days 1-28 and cytarabine subcutaneously on days
15-28. Courses repeat every 28 days for 12 months in the absence of disease progression or
unacceptable toxicity.

Patients are followed for 30-60 days.

PROJECTED ACCRUAL: A total of 15 patients will be accrued for this study.

DISEASE CHARACTERISTICS:

- Cytogenetically confirmed chronic phase chronic myelogenous leukemia (CML)

- Less than 15% blasts in peripheral blood or bone marrow

- Less than 30% blasts and promyelocytes in peripheral blood or bone marrow

- Less than 20% basophils in blood or bone marrow

- Platelet count at least 100,000/mm^3

- Philadelphia chromosome positive

- No more than 6 months since initial diagnosis

- No presence of leukemia beyond the bone marrow, blood, liver, or spleen (i.e.,
chloroma)

- Refused allogeneic stem cell transplantation as first-line therapy

PATIENT CHARACTERISTICS:

Age:

- 18 and over

Performance status:

- Eastern Cooperative Oncology Group (ECOG) 0-2

Life expectancy:

- Not specified

Hematopoietic:

- See Disease Characteristics

Hepatic:

- Bilirubin no greater than 1.5 times upper limit of normal (ULN)

- AST or ALT no greater than 2 times ULN

Renal:

- Creatinine no greater than 1.5 times ULN

Cardiovascular:

- No New York Heart Association class III or IV heart disease

Other:

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective barrier contraception during and for at least 3
months after study participation

- No other serious uncontrolled medical condition

- No history of noncompliance to medical regimens or potential unreliability

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- See Disease Characteristics

- No prior biologic therapy for CML

Chemotherapy:

- No prior chemotherapy for CML except hydroxyurea

- Concurrent hydroxyurea to control blood counts during first 3 months of treatment
allowed

- No other concurrent chemotherapy

Endocrine therapy:

- No prior endocrine therapy for CML

Radiotherapy:

- No prior radiotherapy for CML

Surgery:

- Not specified

Other:

- More than 28 days since prior investigational anticancer agents

- Prior anagrelide hydrochloride for CML allowed

- Concurrent anagrelide hydrochloride to control blood counts during first 3 months of
treatment allowed

- No concurrent grapefruit juice or grapefruit