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Brief Title: Midostaurin Access Program for Newly Diagnosed FLT3 (ITD or TKD) Mutated AML Adult Patients Eligible for Standard Induction and Consolidation Chemotherapy
Official Title: An Open-label, Multi-center, Expanded Treatment Protocol of Midostaurin (PKC412) in Adult Patients With Newly Diagnosed Fms-like Tyrosine Kinase Receptor (FLT3) Mutated Acute Myeloid Leukemia (AML) Who Are Eligible for Standard Induction and Consolidation Chemotherapy.
Study ID: NCT02624570
Brief Summary: The purpose of this study is to provide access to Midostaurin and gather additional safety data on the combination of Midostaurin and standard of care for adult patients with newly diagnosed Fms-like tyrosine kinase receptor (FLT3) mutated Acute Myeloid Leukemia (AML) who are eligible for standard induction and consolidation chemotherapy.
Detailed Description: The purpose of this study is to provide Midostaurin (study drug) treatment to newly diagnosed FLT3 mutated (ITD or TKD) AML adult patients (18 years or older) eligible for standard standard induction (cytarabine + daunorubicin/Idarubicin) and consolidation (cytarabine) chemotherapy.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Mayo Clinic Arizona, Phoenix, Arizona, United States
The Jordan Research and Education Center ABSMC Comprehensive Cancer Ctr, Berkeley, California, United States
City of Hope National Medical Center Department of Hematology & HCT, Duarte, California, United States
St. Judes Medical Center, Fullerton, California, United States
University of Calif Irvine Medical Center Family Comp Cancer Cntr, Orange, California, United States
Kaiser Permanente Northwest Kaiser, Denver, Colorado, United States
Poudre Valley Hospital Poudre Valley Hospital -U of C, Fort Collins, Colorado, United States
Memorial Healthcare System Memorial Healthcare System, Hollywood, Florida, United States
UF Health Cancer Center at Orlando Health Orlando Health, Orlando, Florida, United States
H Lee Moffitt Cancer Center and Research Institute SC - 5, Tampa, Florida, United States
Augusta University Georgia Cancer Center Pharmacy, Augusta, Georgia, United States
Rush University Medical Center Dept.of Rush UniversityMedCtr., Chicago, Illinois, United States
University of Chicago Medical Center, Chicago, Illinois, United States
Indiana Blood and Marrow Institute Indiana Blood and Marrow Trans, Beech Grove, Indiana, United States
Ft Wayne Medical Oncology and Hematology Inc, Fort Wayne, Indiana, United States
Norton Cancer Institute Norton Cancer Institute, Louisville, Kentucky, United States
University of Louisville / James Graham Brown Cancer Center Louisville 529-539, Louisville, Kentucky, United States
Tulane University Medical Center, New Orleans, Louisiana, United States
Ochsner Clinic Foundation, New Orleans, Louisiana, United States
Tufts Medical Center, Boston, Massachusetts, United States
Karmanos Cancer Institute Harper Hosp. Invest. Pharmacy, Detroit, Michigan, United States
Henry Ford Hospital SC, Detroit, Michigan, United States
Mayo Clinic Mayo Clinic, Rochester, Minnesota, United States
Nebraska Cancer Specialist/Missouri Valley Cancer Consortium, Omaha, Nebraska, United States
Healthcare Partners Medical Group, Las Vegas, Nevada, United States
Weill Cornell Medical College NY Presbyterian Hospital, New York, New York, United States
University of Rochester Medical Center Univ of Rochester (7), Rochester, New York, United States
Kaiser Permanente NW Region Kaiser Permanente Northwest, Clackamas, Oregon, United States
Penn State University / Milton S. Hershey Medical Center Penn State Cancer Institute, Hershey, Pennsylvania, United States
University of Pennsylvania Cancer Center University of Pen/Abr Canc ctr, Philadelphia, Pennsylvania, United States
Medical University of South Carolina Hematology-Oncology Division, Charleston, South Carolina, United States
Erlanger Medical Center Erlanger Health System, Chattanooga, Tennessee, United States
Vanderbilt University Medical Center, Clinical Trials Center Division Hematology/Oncology, Nashville, Tennessee, United States
University of Texas Medical Branch University of Texas MB, Galveston, Texas, United States
McGovern Medical School at the University of Texas Health, Houston, Texas, United States
Oncology Consultants Oncology Consultants, Houston, Texas, United States
Methodist Healthcare System, San Antonio, Texas, United States
Intermountain Healthcare - Huntsman Cancer Clinics Intermountain Healthcare (2), Murray, Utah, United States
Huntsman Cancer Institute Univ of Utah, Salt Lake City, Utah, United States
Virginia Oncology Associates Virginia Oncology Assoc. (6), Norfolk, Virginia, United States
Swedish Cancer Institute Cancer Institute, Seattle, Washington, United States
Veterans Affairs Puget Sound Health Care System VAMC Seattle, WA Divison, Seattle, Washington, United States
Wenatchee Valley Hospital and Clinics, Wenatchee, Washington, United States
Cheyenne Regional Medical Center, Cheyenne, Wyoming, United States