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Phase II Study of Imatinib Mesylate (Gleevec, STI-571) (NSC#716051) and Decitabine (5-AZA-2'-Deoxycitidine) (NSC#127716), in Chronic Myelogenous Leukemia in Accelerated and Blastic Phases

Phase 2
Not Enrolling
Accelerated Phase Chronic Myelogenous Leukemia, Blastic Phase Chronic Myelogenous Leukemia, Childhood Chronic Myelogenous Leukemia, Chronic Myelogenous Leukemia, BCR-ABL1 Positive, Relapsing Chronic Myelogenous Leukemia

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Trial Information

Phase II Study of Imatinib Mesylate (Gleevec, STI-571) (NSC#716051) and Decitabine (5-AZA-2'-Deoxycitidine) (NSC#127716), in Chronic Myelogenous Leukemia in Accelerated and Blastic Phases


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.

Inclusion Criteria:

- 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

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Complete and partial response

Outcome Time Frame:

6 months

Safety Issue:


Principal Investigator

Jean-Pierre Issa

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center


United States: Food and Drug Administration

Study ID:




Start Date:

January 2003

Completion Date:

Related Keywords:

  • Accelerated Phase Chronic Myelogenous Leukemia
  • Blastic Phase Chronic Myelogenous Leukemia
  • Childhood Chronic Myelogenous Leukemia
  • Chronic Myelogenous Leukemia, BCR-ABL1 Positive
  • Relapsing Chronic Myelogenous Leukemia
  • Blast Crisis
  • Leukemia
  • Leukemia, Myeloid
  • Leukemia, Myeloid, Accelerated Phase
  • Leukemia, Myelogenous, Chronic, BCR-ABL Positive



M D Anderson Cancer Center Houston, Texas  77030