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.
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.
Drug: Midostaurin
Midostaurin, also known as PKC412 is a multi-kinase inhibitor of FLT3 (fms-like tyrosine kinase-3)
Other Name: PKC412
Inclusion Criteria:
Written informed consent must be obtained prior to any screening procedures. Patients must
meet all Inclusion Criteria:
- Patient is able to communicate well with the investigator, to understand and comply with the requirements of the study.
- Patients must be 18 years of age or older; elderly patients must be fit to receive intensive induction and consolidation chemotherapy
- Patients must have a documented FLT3 mutation (ITD or TKD)
- Patients must have an ECOG Performance Status of ≤ 2
- Patients must have a documented unequivocal diagnosis of AML according to WHO 2008 classification (>20% blasts in the bone marrow and/or peripheral blood), excluding M3 (acute promyelocytic leukemia).
- Patients requiring intrathecal chemotherapy must have a minimum washout of 48 hours prior to the first dose of midostaurin
- AML patients with a history of antecedent treatment for myelodysplasia (MDS), e.g. azacitidine or decitabine, remain eligible for treatment on this study. These agents must have been discontinued for a period of at least 30 days or 5 half-lives of the drug (whichever is greater) before midostaurin can be administered.
- Secondary AML, e.g. patients with antecedent history of treatment for prior malignancy Patients must have the following laboratory values (Direct Bilirubin ≤ 2.5 x ULN, Serum Creatinine ≤ 2.5 x ULN)
Exclusion Criteria:
Patients eligible for this study must not meet any of the following criteria:
- Prior therapy for AML with the following exceptions: (emergency leukapheresis, emergency treatment for hyperleukocytosis with hydroxyurea for ≤ 5 days, cranial RT for CNS leukostasis (one dose only), growth factor/cytokine support)
- Patients with LVEF less than 45% (by echocardiogram or MUGA) or symptomatic congestive heart failure, Class III or IV according to New York Heart Association (NYHA) classification
- Patients with any uncontrolled illness, including, but not limited to, acute or chronic pancreatitis or uncontrolled infection
- QTc >500 msec on screening ECG. History of hypersensitivity to any drugs or metabolites of similar chemical classes as the IMP.
- Participation in a prior investigational interventional (drug) study with administration of the investigational product within 30 days or 5 half-lives of the investigational product, whichever is longer.
- Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, including women whose career, lifestyle, or sexual orientation precludes intercourse with a male partner and women whose partners have been sterilized by vasectomy or other means, UNLESS they are using two birth control methods.
- Sexually active males should not father a child during this study and for upto 5 months following.
Mayo Clinic Arizona
Phoenix, Arizona, 85054
Contact: 480-342-2545
Investigator: Lisa Sproat
The Jordan Research and Education Center ABSMC Comprehensive Cancer Ctr
Berkeley, California, 94705
Contact: 510-204-3428
Investigator: Oleg Krijanovski
City of Hope National Medical Center Department of Hematology & HCT
Duarte, California, 91010
Contact: +00 626 256 4673 x62405
Investigator: Al Malki Monzr
St. Judes Medical Center
Fullerton, California, 92835
Investigator: Steven Kim
University of Calif Irvine Medical Center Family Comp Cancer Cntr
Orange, California, 92868
Contact: 714-456-5153
Investigator: Deepa Jeyakumar
Kaiser Permanente Northwest Kaiser
Denver, Colorado, 80209
Contact: 303-861-3302
Investigator: Susan M Freeman
Poudre Valley Hospital Poudre Valley Hospital -U of C
Fort Collins, Colorado, 80528
Investigator: Steven R. Schuster
Memorial Healthcare System Memorial Healthcare System
Hollywood, Florida, 33021
Contact: 954-265-1846
Investigator: Yehuda Deutsch
UF Health Cancer Center at Orlando Health Orlando Health
Orlando, Florida, 32806
Investigator: Julio Hajdenberg
H Lee Moffitt Cancer Center and Research Institute SC - 5
Tampa, Florida, 33612
Contact: 813-745-3685
Investigator: Kendra Sweet
Augusta University Georgia Cancer Center Pharmacy
Augusta, Georgia, 30912
Contact: 706-721-2171
Investigator: Locke J Bryan
Rush University Medical Center Dept.of Rush UniversityMedCtr.
Chicago, Illinois, 60612
Contact: 312-563-2540
Investigator: Melissa Larson
University of Chicago Medical Center
Chicago, Illinois, 60637
Contact: 773-702-4400
Investigator: Hongtao Liu
Indiana Blood and Marrow Institute Indiana Blood and Marrow Trans
Beech Grove, Indiana, 46107
Contact: +1 317 528 7298
Investigator: Michael John Dugan
Ft. Wayne Medical Oncology & Hematology, Inc.
Fort Wayne, Indiana, 46815
Contact: 219-484-8830
Investigator: Sunil Babu
Norton Cancer Institute Norton Cancer Institute
Louisville, Kentucky, 40202
Contact: +1 502-899-3366 X152
Investigator: Don A. Stevens
University of Louisville / James Graham Brown Cancer Center Louisville 529-539
Louisville, Kentucky, 40202
Contact: 502-562-3429
Investigator: Maxim Krim
Tulane University Medical Center
New Orleans, Louisiana, 70112
Contact: 504-588-5135
Investigator: Hana Safah
Oschner Clinic Foundation
New Orleans, Louisiana, 70121
Contact: 312-942-5495
Investigator: Andrew Dalovisio
Tufts Medical Center
Boston, Massachusetts, 02111
Contact: 617-636-7438
Investigator: Kellie Sprague
Karmanos Cancer Institute Harper Hosp. Invest. Pharmacy
Detroit, Michigan, 48201
Investigator: Jay Yang
Henry Ford Hospital SC
Detroit, Michigan, 48202-2689
Contact: 313-916-1784
Investigator: Ahmad Mattour
Mayo Clinic Mayo Clinic
Rochester, Minnesota, 55905
Contact: 507-284-2358
Investigator: Mark R. Litzow
Nebraska Cancer Specialist/Missouri Valley Cancer Consortium
Omaha, Nebraska, 68106
Contact: 402-991-8070
Investigator: Gamini S Soori
Healthcare Partners Medical Group
Las Vegas, Nevada, 89109
Contact: 702-735-7154
Investigator: Vikas Gupta
Weill Cornell Medical College NY Presbyterian Hospital
New York, New York, 10021
Contact: 212-746-6736
Investigator: Gail J Roboz
University of Rochester Medical Center Univ of Rochester (7)
Rochester, New York, 14642
Contact: 724-900-0558
Investigator: Jane L. Liesveld
Kaiser Permanente NW Region Kaiser Permanente Northwest
Clackamas, Oregon, 97015
Contact: +1 503 249 3316
Investigator: Abdul Hai Mansoor
Penn State University / Milton S. Hershey Medical Center Penn State Cancer Institute
Hershey, Pennsylvania, 17033-085
Contact: 717-531-8309
Investigator: David Claxton
University of Pennsylvania Cancer Center University of Pen/Abr Canc ctr
Philadelphia, Pennsylvania, 19104 4283
Contact: 215-615-5858
Investigator: Alexander Perl
Medical University of South Carolina Hematology-Oncology Division
Charleston, South Carolina, 29425
Contact: 843-792-9300
Investigator: Robert K. Stuart
Erlanger Medical Center Erlanger Health System
Chattanooga, Tennessee, 37403
Contact: +1 423 752 5004
Investigator: Robert Matthew Graham
Vanderbilt University Medical Center, Clinical Trials Center Division Hematology/Oncology
Nashville, Tennessee, 37212
Contact: 615-322-6515
Investigator: Stephen Strickland
University of Texas Medical Branch University of Texas MB
Galveston, Texas, 77555-1188
Contact: 409-772-1164
Investigator: Avi B. Markowitz
McGovern Medical School at the University of Texas Health
Houston, Texas, 77004
Contact: 713-486-5660
Investigator: Modupe Idowu
Oncology Consultants Oncology Consultants
Houston, Texas, 77024
Contact: 713-600-0992
Investigator: Julio Peguero
Methodist Healthcare System
San Antonio, Texas, 78229
Contact: +1 210 575 4000
Investigator: Jose Carlos Cruz
Intermountain Healthcare - Huntsman Cancer Clinics Intermountain Healthcare (2)
Murray, Utah, 84107
Contact: +1 801408 3729
Investigator: Julie Asch
Huntsman Cancer Institute Univ of Utah
Salt Lake City, Utah, 84112 0550
Contact: 801-585-2626
Investigator: Tibor Kovacsovics
Virginia Oncology Associates Virginia Oncology Assoc. (6)
Norfolk, Virginia, 23502
Contact: 757-213-5624
Investigator: Scott J. Cross
Swedish Cancer Institute Cancer Institute
Seattle, Washington, 98104
Contact: 206-215-2658
Investigator: Raya Mawad
Veterans Affairs Puget Sound Health Care System VAMC Seattle, WA Divison
Seattle, Washington, 98108
Investigator: Thomas Chauncey
Wenatchee Valley Hospital and Clinics
Wenatchee, Washington, 98801
Contact: 509-663-8711
Investigator: Lindsay Overton
Cheyenne Regional Medical Center
Cheyenne, Wyoming, 82001
Contact: 917-331-0613
Investigator: Natalie Alana Workman
Novartis Pharmaceuticals
1-888-669-6682
novartis.email@novartis.com
Novartis Pharmaceuticals