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Brief Title: Combination Chemotherapy and Dasatinib in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia
Official Title: A Phase II Study of Induction (Daunorubicin/Cytarabine) and Consolidation (High-Dose Cytarabine) Chemotherapy Plus Dasatinib (NSC #732517) and Continuation Therapy With Dasatinib Alone in Newly Diagnosed Patients With Core Binding Factor Acute Myeloid Leukemia (AML)
Study ID: NCT01238211
Brief Summary: This phase II trial studies the side effects and how well giving combination chemotherapy together with dasatinib works in treating patients with newly diagnosed acute myeloid leukemia. Drugs used in chemotherapy, such as daunorubicin hydrochloride and cytarabine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Dasatinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving combination chemotherapy together with dasatinib may kill more cancer cells.
Detailed Description: PRIMARY OBJECTIVES: I. To assess the safety and tolerability of dasatinib 100 mg/day given after intensive induction (daunorubicin hydrochloride \[daunorubicin\]/cytarabine), and consolidation chemotherapy (high-dose cytarabine) and as single agent in maintenance therapy to newly diagnosed patients with core binding factor acute myeloid leukemia (AML). II. 30-day survival rate during induction (the lack of early/hypoplastic death). III. The absence of pleural or pericardial effusion, and absence of liver toxicity that exceeds grade 2. SECONDARY OBJECTIVES: I. To assess clinical outcomes such as event-free survival (EFS), complete response (CR) rate, cumulative incidence of relapse (CIR), cumulative incidence of death (CID), disease-free survival (DFS), and overall survival (OS). II. To describe the frequency and severity of adverse events of patients treated on this study during induction, consolidation, and continuation therapy. III. To describe the interaction of pretreatment disease and patient characteristics including morphology, cytogenetics, immunophenotype, molecular genetic features, white blood cell (WBC) count and hemogram, and performance status on clinical outcomes. OUTLINE: INDUCTION THERAPY (course 1): Patients receive daunorubicin hydrochloride intravenously (IV) on days 1-3, cytarabine IV continuously over 168 hours on days 1-7, and dasatinib orally (PO) once daily (QD) on days 8-21. Patients with responsive disease on day 21 undergo consolidation therapy, and patients with non-responsive disease on day 21 (bone marrow cellularity \>= 20 % and leukemia blasts \>= 5%) receive a second course of induction therapy. INDUCTION THERAPY (course 2): Patients receive daunorubicin hydrochloride IV on days 1-3, cytarabine IV continuously over 120 hours on days 1-5, and dasatinib PO once a day on days 6-19. Patients achieving complete response receive consolidation therapy. CONSOLIDATION THERAPY: Patients receive high-dose cytarabine IV over 3 hours on days 1, 3, and 5, and dasatinib PO QD on days 6-26 or 7-27. Treatment repeats every 28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. Patients in complete remission receive continuation therapy. CONTINUATION THERAPY: Patients receive dasatinib PO on days 1-28. Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity. After completion of study therapy, patients are followed up every 2 months for 2 years, every 3 months for 2 years, and then every year for up to 10 years from study entry.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Beebe Medical Center, Lewes, Delaware, United States
Christiana Care Health System-Christiana Hospital, Newark, Delaware, United States
AdventHealth Orlando, Orlando, Florida, United States
Saint Joseph Medical Center, Bloomington, Illinois, United States
Illinois CancerCare-Bloomington, Bloomington, Illinois, United States
Graham Hospital Association, Canton, Illinois, United States
Illinois CancerCare-Canton, Canton, Illinois, United States
Memorial Hospital, Carthage, Illinois, United States
University of Illinois, Chicago, Illinois, United States
University of Chicago Comprehensive Cancer Center, Chicago, Illinois, United States
Heartland Cancer Research NCORP, Decatur, Illinois, United States
Eureka Hospital, Eureka, Illinois, United States
Illinois CancerCare-Eureka, Eureka, Illinois, United States
Illinois CancerCare-Galesburg, Galesburg, Illinois, United States
Mason District Hospital, Havana, Illinois, United States
Illinois CancerCare-Macomb, Macomb, Illinois, United States
Mcdonough District Hospital, Macomb, Illinois, United States
Bromenn Regional Medical Center, Normal, Illinois, United States
Carle Cancer Institute Normal, Normal, Illinois, United States
Illinois CancerCare-Community Cancer Center, Normal, Illinois, United States
Illinois CancerCare-Ottawa Clinic, Ottawa, Illinois, United States
Ottawa Regional Hospital and Healthcare Center, Ottawa, Illinois, United States
Illinois CancerCare-Pekin, Pekin, Illinois, United States
OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center, Pekin, Illinois, United States
Proctor Hospital, Peoria, Illinois, United States
Illinois CancerCare-Peoria, Peoria, Illinois, United States
Methodist Medical Center of Illinois, Peoria, Illinois, United States
OSF Saint Francis Medical Center, Peoria, Illinois, United States
Illinois CancerCare-Peru, Peru, Illinois, United States
Illinois Valley Hospital, Peru, Illinois, United States
Perry Memorial Hospital, Princeton, Illinois, United States
Illinois CancerCare-Spring Valley, Spring Valley, Illinois, United States
Fort Wayne Medical Oncology and Hematology Inc-Parkview, Fort Wayne, Indiana, United States
University of Iowa/Holden Comprehensive Cancer Center, Iowa City, Iowa, United States
Harold Alfond Center for Cancer Care, Augusta, Maine, United States
Eastern Maine Medical Center, Bangor, Maine, United States
University of Maryland/Greenebaum Cancer Center, Baltimore, Maryland, United States
Christiana Care - Union Hospital, Elkton, Maryland, United States
Massachusetts General Hospital Cancer Center, Boston, Massachusetts, United States
Brigham and Women's Hospital, Boston, Massachusetts, United States
Dana-Farber Cancer Institute, Boston, Massachusetts, United States
Bronson Battle Creek, Battle Creek, Michigan, United States
Spectrum Health Big Rapids Hospital, Big Rapids, Michigan, United States
Cancer Research Consortium of West Michigan NCORP, Grand Rapids, Michigan, United States
Mercy Health Saint Mary's, Grand Rapids, Michigan, United States
Spectrum Health at Butterworth Campus, Grand Rapids, Michigan, United States
Mercy Health Mercy Campus, Muskegon, Michigan, United States
Spectrum Health Reed City Hospital, Reed City, Michigan, United States
Munson Medical Center, Traverse City, Michigan, United States
University of Missouri - Ellis Fischel, Columbia, Missouri, United States
Washington University School of Medicine, Saint Louis, Missouri, United States
Dartmouth Hitchcock Medical Center, Lebanon, New Hampshire, United States
Cooper Hospital University Medical Center, Camden, New Jersey, United States
Roswell Park Cancer Institute, Buffalo, New York, United States
Northwell Health NCORP, Lake Success, New York, United States
Northwell Health/Center for Advanced Medicine, Lake Success, New York, United States
North Shore University Hospital, Manhasset, New York, United States
Long Island Jewish Medical Center, New Hyde Park, New York, United States
NYP/Weill Cornell Medical Center, New York, New York, United States
State University of New York Upstate Medical University, Syracuse, New York, United States
Wayne Memorial Hospital, Goldsboro, North Carolina, United States
Wake Forest University Health Sciences, Winston-Salem, North Carolina, United States
Ohio State University Comprehensive Cancer Center, Columbus, Ohio, United States
Central Vermont Medical Center/National Life Cancer Treatment, Berlin, Vermont, United States
University of Vermont and State Agricultural College, Burlington, Vermont, United States
Name: Guido Marcucci
Affiliation: Alliance for Clinical Trials in Oncology
Role: PRINCIPAL_INVESTIGATOR