Midostaurin Access Program for Newly Diagnosed FLT3 (ITD or TKD) Mutated AML Adult Patients Eligible for Standard Induction and Consolidation Chemotherapy



Status:Available
Conditions:Blood Cancer, Hematology
Therapuetic Areas:Hematology, Oncology
Healthy:No
Age Range:18 - Any
Updated:7/5/2018
Contact:Novartis Pharmaceuticals
Email:novartis.email@novartis.com
Phone:1-888-669-6682

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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.

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.

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.
We found this trial at
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500 University Drive
Hershey, Pennsylvania 17033
Principal Investigator: David Claxton
Phone: 717-531-8309
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800 Washington St
Boston, Massachusetts 02111
(617) 636-5000
Principal Investigator: Kellie Sprague
Phone: 617-636-7438
Tufts Medical Center Tufts Medical Center is an internationally-respected academic medical center – a teaching...
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Augusta, Georgia 30912
Principal Investigator: Locke J Bryan
Phone: 706-721-2171
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1600 Albany Street
Beech Grove, Indiana 46107
Principal Investigator: Michael John Dugan
Phone: +1 317 528 7298
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2420 Ashby Avenue
Berkeley, California 94705
Principal Investigator: Oleg Krijanovski
Phone: 510-204-3428
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96 Jonathan Lucas Street
Charleston, South Carolina 29425
Principal Investigator: Robert K. Stuart
Phone: 843-792-9300
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975 East 3rd Street
Chattanooga, Tennessee 37403
Principal Investigator: Robert Matthew Graham
Phone: +1 423 752 5004
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Cheyenne, Wyoming 82001
Principal Investigator: Natalie Alana Workman
Phone: 917-331-0613
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1653 West Congress Parkway
Chicago, Illinois 60612
Principal Investigator: Melissa Larson
Phone: 312-563-2540
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Chicago, Illinois 60637
Principal Investigator: Hongtao Liu
Phone: 773-702-4400
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9900 Southeast Sunnyside Road
Clackamas, Oregon 97015
Principal Investigator: Abdul Hai Mansoor
Phone: +1 503 249 3316
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Denver, Colorado
Principal Investigator: Susan M Freeman
Phone: 303-861-3302
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4100 John R Street
Detroit, Michigan 48201
Principal Investigator: Jay Yang
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Detroit, Michigan 48202
Principal Investigator: Ahmad Mattour
Phone: 313-916-1784
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1500 East Duarte Road
Duarte, California 91010
Principal Investigator: Al Malki Monzr
Phone: +00 626 256 4673 x62405
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1024 South Lemay Avenue
Fort Collins, Colorado 80528
Principal Investigator: Steven R. Schuster
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4402 East State Boulevard
Fort Wayne, Indiana 46815
Principal Investigator: Sunil Babu
Phone: 219-484-8830
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101 East Valencia Mesa Drive
Fullerton, California 92835
Principal Investigator: Steven Kim
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301 University Boulevard
Galveston, Texas 77555
Principal Investigator: Avi B. Markowitz
Phone: 409-772-1164
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Hollywood, Florida 33021
Principal Investigator: Yehuda Deutsch
Phone: 954-265-1846
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Houston, Texas 77024
Principal Investigator: Julio Peguero
Phone: 713-600-0992
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6431 Fannin Street
Houston, Texas 77004
Principal Investigator: Modupe Idowu
Phone: 713-486-5660
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3006 South Maryland Parkway
Las Vegas, Nevada 89109
Principal Investigator: Vikas Gupta
Phone: 702-735-7154
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676 South Floyd Street
Louisville, Kentucky 40202
Principal Investigator: Don A. Stevens
Phone: +1 502-899-3366 X152
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505 South Hancock Street
Louisville, Kentucky 40202
Principal Investigator: Maxim Krim
Phone: 502-562-3429
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5131 Cottonwood Street
Murray, Utah 84107
Principal Investigator: Julie Asch
Phone: +1 801408 3729
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1211 Medical Center Drive
Nashville, Tennessee 37212
Principal Investigator: Stephen Strickland
Phone: 615-322-6515
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New Orleans, Louisiana 70112
Principal Investigator: Hana Safah
Phone: 504-588-5135
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New Orleans, Louisiana 70121
Principal Investigator: Andrew Dalovisio
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New York, New York 10021
Principal Investigator: Gail J Roboz
Phone: 212-746-6736
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5900 Lake Wright Drive
Norfolk, Virginia 23502
Principal Investigator: Scott J. Cross
Phone: 757-213-5624
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Omaha, Nebraska 68106
Principal Investigator: Gamini S Soori
Phone: 402-991-8070
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Orange, California 92868
Principal Investigator: Deepa Jeyakumar
Phone: 714-456-5153
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1400 South Orange Avenue
Orlando, Florida 32806
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3400 Spruce Street
Philadelphia, Pennsylvania 19104
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601 Elmwood Avenue
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2000 Circle of Hope Drive
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1660 S Columbian Way
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Principal Investigator: Thomas Chauncey
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Tampa, Florida 33612
Principal Investigator: Kendra Sweet
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Wenatchee, Washington 98801
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