Imatinib Mesylate and Decitabine in Treating Patients With Chronic Myelogenous Leukemia

Phase 2

Completed

• 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: Drug: imatinib mesylate; Drug: decitabine; Other: laboratory biomarker analysis

• Registration Number: NCT00054431
• Lead Sponsor: National Cancer Institute (NCI)

Brief 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.

Study Timeline

• Study Start: 2003-01
• Study First Submitted: 2003-02-05
• Study First Submitted QC: 2003-02-05
• Study First Posted: 2003-02-06
• Primary Completion: 2007-05
• Status Verified: 2013-01
• Last Update Submitted: 2013-01-22
• Last Update Posted: 2013-01-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• Histologically confirmed chronic myelogenous leukemia

  • Philadelphia chromosome positive by cytogenetics OR fluorescent in situ hybridization
  • 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

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment (imatinib mesylate, decitabine)	imatinib mesylate	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.
Treatment (imatinib mesylate, decitabine)	decitabine	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.
Treatment (imatinib mesylate, decitabine)	laboratory biomarker analysis	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.

Primary Outcome Measures

Name	Time	Method
Complete and partial response	6 months
Hematologic improvement	Up to 1 year
Duration of response	Date of documented response until relapse, assessed up to 4 years

Secondary Outcome Measures

Name	Time	Method
Toxicities, graded according to the National Cancer Institute Common Toxicity Criteria (NCI CTC) v2.0	Up to 4 years

Trial Locations

Locations (1)

M D Anderson Cancer Center; 🇺🇸 Houston, Texas, United States