A Phase 2 Study of Imatinib Mesylate (Gleevec) as Maintenance Therapy After Induction and Consolidation Chemotherapy in Patients With Newly Diagnosed C-kit Positive Acute Myeloid Leukemia
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.
Interventional
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Progression-free survival for patients less than 60 years of age
Progression free survival will be measured from the date of Complete Response (CR) to the date of relapse or death.
13 months after treatment
No
Anjali Advani, MD
Principal Investigator
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
United States: Food and Drug Administration
CASE4906
NCT00509093
December 2008
Name | Location |
---|---|
Roswell Park Cancer Institute | Buffalo, New York 14263 |
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center | Cleveland, Ohio 44106-5065 |
Duke University Medical Center | Durham, North Carolina 27710 |
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center | Cleveland, Ohio 44195 |