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
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
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.
- Histologically confirmed chronic myelogenous leukemia
- Philadelphia chromosome positive by cytogenetics OR fluorescent in situ
- Accelerated or non-lymphoid blastic phase
- 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
- Patients who received at least 4 weeks of prior imatinib mesylate must have
failed therapy, as evidenced by resistance after 8 weeks or disease progression
- No concurrent grapefruit or grapefruit juice