Back to resultsImatinib Mesylate and Decitabine in Treating Patients With Chronic Myelogenous Leukemia
Primary Purpose
Accelerated Phase Chronic Myelogenous Leukemia, Blastic Phase Chronic Myelogenous Leukemia, Childhood Chronic Myelogenous Leukemia
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
imatinib mesylate
decitabine
laboratory biomarker analysis
Sponsored by
About this trial
This is an interventional treatment trial for Accelerated Phase Chronic Myelogenous Leukemia
Eligibility Criteria
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
Sites / Locations
- M D Anderson Cancer Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Treatment (imatinib mesylate, decitabine)
Arm Description
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.
Outcomes
Primary Outcome Measures
Complete and partial response
Hematologic improvement
Duration of response
Secondary Outcome Measures
Toxicities, graded according to the National Cancer Institute Common Toxicity Criteria (NCI CTC) v2.0
Full Information
NCT ID
NCT00054431
First Posted
February 5, 2003
Last Updated
January 22, 2013
Sponsor
National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT00054431
Brief Title
Imatinib Mesylate and Decitabine in Treating Patients With Chronic Myelogenous Leukemia
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
January 2003 (undefined)
Primary Completion Date
May 2007 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cancer Institute (NCI)
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Accelerated Phase Chronic Myelogenous Leukemia, Blastic Phase Chronic Myelogenous Leukemia, Childhood Chronic Myelogenous Leukemia, Chronic Myelogenous Leukemia, BCR-ABL1 Positive, Relapsing Chronic Myelogenous Leukemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment (imatinib mesylate, decitabine)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
imatinib mesylate
Other Intervention Name(s)
CGP 57148, Gleevec, Glivec
Intervention Description
Given orally
Intervention Type
Drug
Intervention Name(s)
decitabine
Other Intervention Name(s)
5-aza-dCyd, 5AZA, DAC
Intervention Description
Given IV
Intervention Type
Other
Intervention Name(s)
laboratory biomarker analysis
Intervention Description
Correlative studies
Primary Outcome Measure Information:
Title
Complete and partial response
Time Frame
6 months
Title
Hematologic improvement
Time Frame
Up to 1 year
Title
Duration of response
Time Frame
Date of documented response until relapse, assessed up to 4 years
Secondary Outcome Measure Information:
Title
Toxicities, graded according to the National Cancer Institute Common Toxicity Criteria (NCI CTC) v2.0
Time Frame
Up to 4 years
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Pierre Issa
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
M D Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Imatinib Mesylate and Decitabine in Treating Patients With Chronic Myelogenous Leukemia
We'll reach out to this number within 24 hrs