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Spots Global Cancer Trial Database for Combination Chemotherapy and Dasatinib in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia

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Trial Identification

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

Study Description

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.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

Name: Guido Marcucci

Affiliation: Alliance for Clinical Trials in Oncology

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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