Study of Crenolanib vs Midostaurin Following Induction Chemotherapy and Consolidation Therapy in Newly Diagnosed FLT3 Mutated AML



Status:Recruiting
Healthy:No
Age Range:18 - 60
Updated:2/17/2019
Start Date:August 15, 2018
End Date:November 2024

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Phase III Randomized Study of Crenolanib Versus Midostaurin Administered Following Induction Chemotherapy and Consolidation Therapy in Newly Diagnosed Subjects With FLT3 Mutated Acute Myeloid Leukemia

A phase III randomized multi-center study designed to compare the efficacy of crenolanib with
that of midostaurin when administered following induction chemotherapy, consolidation
chemotherapy and bone marrow transplantation in newly diagnosed AML subjects with FLT3
mutation. About 510 subjects will be randomized in a 1:1 ratio to receive either crenolanib
in addition to standard first line treatment of AML (chemotherapy and if eligible,
transplantation) (arm A) or midostaurin and standard treatment (arm B). Potentially eligible
subjects will be registered and tested for the presence of FLT3 mutation. Once the FLT3
mutation status is confirmed and additional eligibility is established, subject will be
randomized and enter into the treatment phase.


Inclusion Criteria:

- Confirmed diagnosis of de novo AML according to World Health Organization (WHO) 2016
classification

- Presence of FLT3-ITD and/or D835 mutation(s) in bone marrow or peripheral blood

- Age ≥ 18 years and ≤ 60 years

- Adequate hepatic function within 48 hours prior to induction chemotherapy

- Adequate renal functions within 48 hours prior to induction chemotherapy

- ECOG performance status within 48 hours prior to induction chemotherapy ≤ 3

- Eligible for intensive cytarabine/daunorubicin (7+3) chemotherapy specified

Exclusion Criteria:

- Acute promyelocytic leukemia (APL)

- Known clinically active central nervous system (CNS) leukemia

- Severe liver disease

- Active infections

- Known, active infection with hepatitis B virus (HBV) or hepatitis C virus (HCV)

- Known infection with human immunodeficiency virus (HIV)

- Prior systemic anti-cancer treatment (e.g. chemotherapy, tyrosine kinase inhibitors,
immunotherapy, or investigational agents)(except for hydroxyurea and/or leukapheresis)
We found this trial at
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1275 York Ave
New York, New York 10021
(212) 639-2000
Phone: 212-639-2126
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
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5801 South Ellis Avenue
Chicago, Illinois 60637
 773.702.1234
University of Chicago One of the world's premier academic and research institutions, the University of...
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425 University Blvd.
Indianapolis, Indiana 46202
(317) 274-4591
Indiana University INDIANA UNIVERSITY is a major multi-campus public research institution, grounded in the liberal...
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Minneapolis, Minnesota 55455
(612) 625-5000
Univ of Minnesota With a flagship campus in the heart of the Twin Cities, and...
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Beverly Hills, California 90211
Phone: 310-423-1160
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Boston, Massachusetts 02215
Phone: 617-632-2214
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Buffalo, New York 14263
Phone: 716-845-3544
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Detroit, Michigan 48201
Phone: 800-527-6266
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Detroit, Michigan 48202
Phone: 800-436-7936
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1500 East Duarte Road
Duarte, California 91010
626-256-HOPE (4673)
Phone: 626-218-2405
City of Hope National Medical Center City of Hope is dedicated to making a difference...
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Fairway, Kansas 66205
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Kansas City, Kansas
Phone: 913-588-9281
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New York, New York
Phone: 212-241-3417
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New York, New York 10021
Phone: 646-962-2700
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New York, New York 14642
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Sacramento, California 95817
Phone: 800-282-3284
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Tampa, Florida 33612
Phone: 813-745-6841
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