NCT00054431

Imatinib Mesylate and Decitabine in Treating Patients With Chronic Myelogenous Leukemia

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Accelerated Phase Chronic Myelogenous Leukemia
• Blastic Phase Chronic Myelogenous Leukemia
• Childhood Chronic Myelogenous Leukemia
• Chronic Myelogenous Leukemia, BCR-ABL1 Positive
• Relapsing Chronic Myelogenous Leukemia

Interventions

Type	Name	Description
DRUG	imatinib mesylate	Given orally
DRUG	decitabine	Given IV
OTHER	laboratory biomarker analysis	Correlative studies

Timeline

• Start date: 2003-01-01
• Primary completion: 2007-05-01
• First posted: 2003-02-06
• Last updated: 2013-01-23

Locations

1 site across 1 country: United States