Imatinib Mesylate and Decitabine in Treating Patients With Chronic Myelogenous Leukemia

Relapsing Chronic Myelogenous Leukemia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00054431
• Other study ID #: NCI-2012-02516
• Secondary ID: MDA-ID-02205N01C
• Status: Completed
• Phase: Phase 2
• First received: February 5, 2003
• Last updated: January 22, 2013
• Start date: January 2003

Study information

• Verified date: January 2013
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. primary completion date: May 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

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

Intervention

Drug:
• imatinib mesylate
Given orally
• decitabine
Given IV

Other:
• laboratory biomarker analysis
Correlative studies

Locations

Country	Name	City	State
United States	M D Anderson Cancer Center	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complete and partial response		6 months	No
Primary	Hematologic improvement		Up to 1 year	No
Primary	Duration of response		Date of documented response until relapse, assessed up to 4 years	No
Secondary	Toxicities, graded according to the National Cancer Institute Common Toxicity Criteria (NCI CTC) v2.0		Up to 4 years	Yes