Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

Imatinib Mesylate and Decitabine in Treating Patients With Chronic Myelogenous Leukemia

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Treatment Completed Any age NCI MDA-ID-02205 NCI-5737, NCT00054431, 5737

Objectives

1. Determine the duration of response and response rate in patients with accelerated or blastic phase chronic myelogenous leukemia treated with imatinib mesylate and decitabine.
2. Determine the survival rate of patients treated with this regimen.
3. Determine the toxicity of this regimen in these patients.
4. Determine the effects of this regimen on gene methylation in the leukemic cells of these patients.

Entry Criteria

Disease Characteristics:

• Histologically confirmed chronic myelogenous leukemia
  • Philadelphia chromosome positive by cytogenetics OR fluorescent in situ hybridization
  • Accelerated or non-lymphoid blastic phase

Prior/Concurrent Therapy:

Biologic therapy

• Not specified

Chemotherapy

• 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

Endocrine therapy

• Not specified

Radiotherapy

• Not specified

Surgery

• Not specified

Other

• 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

Patient Characteristics:

Age

• Any age

Performance status

• ECOG 0-2

Life expectancy

• Not specified

Hematopoietic

• Not specified

Hepatic

• Bilirubin no greater than 2 times upper limit of normal (ULN)
• AST no greater than 2 times ULN

Renal

• Creatinine less than 2.0 mg/dL

Cardiovascular

• Normal cardiac function
• No New York Heart Association class III or IV heart disease

Other

• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception

Expected Enrollment

A total of 20-80 patients (10-40 per stratum) will be accrued for this study within 20 months.

Outcomes

Complete and partial response at 6 weeks after each course

Toxicity at 6 weeks after each course

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.

Oki Y, Kantarjian HM, Gharibyan V, et al.: Phase II study of low-dose decitabine in combination with imatinib mesylate in patients with accelerated or myeloid blastic phase of chronic myelogenous leukemia. Cancer 109 (5): 899-906, 2007.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

M. D. Anderson Cancer Center at University of Texas

Jean-Pierre Issa, MD, Protocol chair		Ph: 713-745-2260; 800-392-1611

Registry Information
Official Title		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
Trial Start Date		2003-01-10
Registered in ClinicalTrials.gov		NCT00054431
Date Submitted to PDQ		2003-01-03
Information Last Verified		2006-11-30
NCI Grant/Contract Number		CM17003, CA16672

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