Imatinib Mesylate in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia Who Have Received Chemotherapy
This trial is active, not recruiting.
|Treatments||imatinib mesylate, gene expression analysis, mutation analysis, polymerase chain reaction, flow cytometry, biopsy|
|Sponsor||Case Comprehensive Cancer Center|
|Collaborator||National Cancer Institute (NCI)|
|Start date||December 2008|
|End date||April 2013|
|Trial size||32 participants|
|Trial identifier||NCT00509093, AUS259, CASE4906, NCI-2010-01198, P30CA043703|
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.
|United States||No locations recruiting|
|Other Countries||No locations recruiting|
|Buffalo, NY||Roswell Park Cancer Institute||no longer recruiting|
|Durham, NC||Duke University Medical Center||no longer recruiting|
|Cleveland, OH||Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center||no longer recruiting|
|Cleveland, OH||Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center||no longer recruiting|
|Endpoint classification||efficacy study|
|Intervention model||single group assignment|
Progression-free survival for patients less than 60 years of age
time frame: 13 months after treatment
Progression-free survival for patients 60 years of age and older
time frame: 8 months after treatment
Toxicity as measured by NCI CTC v. 3.0
time frame: 24 months
Correlation of c-kit expression with multidrug resistance gene expression (MDR1, MRP1, LRP, and BCRP) and AF1q expression
time frame: 24 months
Male or female participants at least 18 years old.
INCLUSION CRITERIA - Age > 18. - Diagnostic bone marrow aspirate/ biopsy or peripheral blood confirming AML. - At the time of diagnosis, patients must have c-kit (also known as CD117) positive AML (20% or more of the blasts express c-kit[CD117]). - A flow scattergram (from the diagnostic AML specimen) must be available to calculate a c-kit MFI. - Patients must have received standard induction chemotherapy with ADE (cytarabine, daunorubicin, and etoposide) or with 7+3 (7 days of cytarabine continuous infusion and 3 days of an anthracycline (idarubicin, daunorubicin, or mitoxantrone). Patients with persistent leukemia on a Day 10-28 marrow may have received a second course of chemotherapy. - After the completion of induction therapy, patients must have attained a complete remission based on blood count recovery (neutrophil count > 1,000/µL, platelet count > 100,000/µL), and bone marrow aspirate and biopsy (< 5% myeloblasts). - For patients < 60 years of age, patients must have received at least 2 courses of post-remission therapy with at least intermediate dose (400 mg/m2/day). *Patients with t(8;21) or inversion 16 at the time of diagnosis must have received at least 2 courses of high dose cytarabine. For patients > or = 60 years of age, patients must have received 1 course of post-remission therapy (the type of chemotherapy will not be specified). - Patients must be registered on this study (maintenance Imatinib mesylate) within 60 days of the last dose of post-remission therapy. - A bone marrow aspirate and/or biopsy must be done within 3 weeks of registration documenting CR. - Women of childbearing potential and sexually active males must use an effective method of contraception. - Female patients of childbearing potential must have negative pregnancy test within 7 days before initiation of study drug dosing. Postmenopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential. Male and female patients of reproductive potential must agree to employ an effective barrier method of birth control throughout the study and for up to 3 months following discontinuation of study drug. - ECOG Performance Status 0-2. - Creatinine must be < 1.5 x upper limit of normal. - Total bilirubin must be < 2 mg/dl and AST and ALT must be < 2 times the upper limit of normal. - Previous treatment-related toxicities must have resolved to < Grade 1 excluding alopecia. - Written, voluntary informed consent. EXCLUSION CRITERIA - Acute promyelocytic leukemia. - Patients with an autologous or allogeneic bone marrow transplant. - History of HIV. - Pregnant or breast-feeding. - Serious or poorly controlled medical conditions that would interfere with the protocol. - At the time of study entry, any medications which could significantly interact with imatinib mesylate (see Section 9.4) must be discontinued. - Patients with active extramedullary disease are not eligible. - Patient has received any other investigational agents within 28 days of first day of study drug dosing. - Patient is < 5 years free of another primary malignancy except: if the other primary malignancy is not currently clinically significant nor requiring active intervention, or if other primary malignancy is a basal cell skin cancer or a cervical carcinoma in situ. Existence of any other malignant disease is not allowed. - Patient with Grade III/IV cardiac problems as defined by the New York Heart Association Criteria. (i.e., congestive heart failure, myocardial infarction within 6 months of study) - Patient has known chronic liver disease (i.e., chronic active hepatitis, and cirrhosis). - Patient previously received radiotherapy to > or = 25 % of the bone marrow - Patient had a major surgery within 2 weeks prior to study entry. - Patient with any significant history of non-compliance to medical regimens or with inability to grant reliable informed consent.
|Official title||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|
|Principal investigator||Anjali Advani, MD|
|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.|
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