Imatinib Mesylate in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia Who Have Received Chemotherapy

Phase 2

Completed

Interventions: Drug: imatinib mesylate
Genetic: gene expression analysis
Genetic: mutation analysis
Genetic: polymerase chain reaction
Other: flow cytometry
Procedure: biopsy

Brief Summary: RATIONALE: Imatinib mesylate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.

PURPOSE: This phase II trial is studying how well imatinib mesylate works in treating patients with newly diagnosed acute myeloid leukemia who have received chemotherapy.

Detailed Description: OBJECTIVES:

Primary

* To determine whether adding imatinib mesylate as maintenance therapy improves progression-free survival in patients with c-kit positive acute myeloid leukemia (AML) compared with historical controls.

Secondary

* To assess the feasibility of administering imatinib mesylate as maintenance therapy after the completion of induction and consolidation therapy in these patients.

* To evaluate potential mechanisms of relapse/resistance in c-kit positive AML by examining multidrug resistance gene expression and AF1q gene expression and to determine whether these levels correlate with c-kit expression.

OUTLINE: This is a multicenter study.

Patients receive oral imatinib mesylate once daily for up to 12 months.

Bone marrow and peripheral blood are collected at baseline. Laboratory endpoints are evaluated by flow cytometry; mutation and gene analysis by PCR.

Recruitment & Eligibility

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arm && Interventions

Primary Outcome Measures

Name	Time	Method
Median Progression-free Survival (PFS) for Patients Less Than 60 Years of Age	up to 5 years from the End of Treatment	PFS measured from the date of Complete Response (CR) to the date of relapse or death. Progression defined as any of the following event: progression to accelerated phase or blast crisis, death, loss of CHR or MCyR, or in patients not achieving a CHR an increasing WBC despite appropriate therapeutic management This outcome will be reported as median progression-free survival in months for participants less than 60 years of age.
Percent of Participants 60 Years of Age or Older With PFS at 8 and 13 Months Post-treatment	at 8 and 13 months after treatment.	Percent of participants 60 years of age or older with PFS at 8 and 13 months post-treatment
Progression-free Survival for Patients 60 Years of Age and Older	up to 5 years from the End of Treatment	Progression free survival will be measured from the date of Complete Response (CR) to the date of relapse or death.
Percent of Participants Less Than 60 Years of Age With PFS at 8 and 13 Months Post-treatment	at 8 and 13 months after treatment.	Percent of participants less than 60 years of age with PFS at 8 and 13 months post-treatment

Secondary Outcome Measures

Name	Time	Method
Toxicity as Measured by NCI CTC v. 3.0	13 months from start of treatment	Number of patients (%) experiencing an adverse event See adverse events section for details

Locations (4): Roswell Park Cancer Institute
🇺🇸
Buffalo, New York, United States
University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
🇺🇸
Cleveland, Ohio, United States
Duke University Medical Center
🇺🇸
Durham, North Carolina, United States
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
🇺🇸
Cleveland, Ohio, United States