Leukemia Clinical Trial
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
Verified date | March 2020 |
Source | Case Comprehensive Cancer Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 32 |
Est. completion date | April 9, 2015 |
Est. primary completion date | May 9, 2014 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
INCLUSION CRITERIA - 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 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 = 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. |
Country | Name | City | State |
---|---|---|---|
United States | Roswell Park Cancer Institute | Buffalo | New York |
United States | Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center | Cleveland | Ohio |
United States | University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center | Cleveland | Ohio |
United States | Duke University Medical Center | Durham | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Case Comprehensive Cancer Center | National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Correlation of C-kit Expression With Multidrug Resistance Gene Expression (MDR1, MRP1, LRP, and BCRP) and AF1q Expression | 24 months | ||
Primary | Median Progression-free Survival (PFS) for Patients Less Than 60 Years of Age | 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. |
up to 5 years from the End of Treatment | |
Primary | Progression-free Survival for Patients 60 Years of Age and Older | Progression free survival will be measured from the date of Complete Response (CR) to the date of relapse or death. | up to 5 years from the End of Treatment | |
Primary | Percent of Participants Less Than 60 Years of Age With PFS at 8 and 13 Months Post-treatment | 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. | |
Primary | Percent of Participants 60 Years of Age or Older With PFS at 8 and 13 Months Post-treatment | 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. | |
Secondary | Toxicity as Measured by NCI CTC v. 3.0 | Number of patients (%) experiencing an adverse event See adverse events section for details |
13 months from start of treatment |
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