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.
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Wenatchee, Washington 98801
Principal Investigator: Lindsay Overton
Phone: 509-663-8711
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800 Washington St
Boston, Massachusetts 02111
(617) 636-5000
Principal Investigator: Kellie Sprague
Phone: 617-636-7438
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Augusta, Georgia 30912
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1600 Albany Street
Beech Grove, Indiana 46107
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2420 Ashby Avenue
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96 Jonathan Lucas Street
Charleston, South Carolina 29425
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975 East 3rd Street
Chattanooga, Tennessee 37403
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Cheyenne, Wyoming 82001
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1653 West Congress Parkway
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Principal Investigator: Melissa Larson
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Chicago, Illinois 60637
Principal Investigator: Hongtao Liu
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9900 Southeast Sunnyside Road
Clackamas, Oregon 97015
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Denver, Colorado
Principal Investigator: Susan M Freeman
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4100 John R Street
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Detroit, Michigan 48202
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1500 East Duarte Road
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1024 South Lemay Avenue
Fort Collins, Colorado 80528
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4402 East State Boulevard
Fort Wayne, Indiana 46815
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101 East Valencia Mesa Drive
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301 University Boulevard
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500 University Drive
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Hollywood, Florida 33021
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Houston, Texas 77024
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6431 Fannin Street
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3006 South Maryland Parkway
Las Vegas, Nevada 89109
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676 South Floyd Street
Louisville, Kentucky 40202
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505 South Hancock Street
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5131 Cottonwood Street
Murray, Utah 84107
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1211 Medical Center Drive
Nashville, Tennessee 37212
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New Orleans, Louisiana 70112
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5900 Lake Wright Drive
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