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About
This phase II trial is studying how well giving imatinib mesylate together with decitabine works in treating patients with accelerated or blast phase chronic myelogenous leukemia. Imatinib mesylate may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Giving imatinib mesylate together with decitabine may kill more cancer cells
Full description
OBJECTIVES:
I. Determine the duration of response and response rate in patients with accelerated or blastic phase chronic myelogenous leukemia treated with imatinib mesylate and decitabine.
II. Determine the survival rate of patients treated with this regimen. III. Determine the toxicity of this regimen in these patients. IV. Determine the effects of this regimen on gene methylation in the leukemic cells of these patients.
OUTLINE: Patients are stratified according to prior exposure to imatinib mesylate (yes vs no).
Patients receive oral imatinib mesylate daily and decitabine IV over 1 hour daily, 5 days per week, for 2 consecutive weeks. Courses repeat every 4-6 weeks in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 20-80 patients (10-40 per stratum) will be accrued for this study within 20 months.
Enrollment
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Volunteers
Inclusion and exclusion criteria
Inclusion Criteria:
Histologically confirmed chronic myelogenous leukemia
Performance status - ECOG 0-2
Bilirubin no greater than 2 times upper limit of normal (ULN)
AST no greater than 2 times ULN
Creatinine less than 2.0 mg/dL
Normal cardiac function
No New York Heart Association class III or IV heart disease
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
No prior decitabine
At least 2 weeks since other prior chemotherapy (unless there is evidence of rapidly progressive disease) and recovered
Concurrent hydroxyurea allowed during the first 2 courses of study therapy in patients with rapidly progressing disease
Prior imatinib mesylate allowed
No concurrent grapefruit or grapefruit juice
Primary purpose
Allocation
Interventional model
Masking
80 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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