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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
214
Crenolanib will be administered orally
Midostaurin will be administered orally
100 mg/m² IV continuous infusion over 24 hours
90 mg/m2 IV
City of Hope National Medical Center
Duarte, California, United States
Ronald Reagan UCLA Medical Center
Los Angeles, California, United States
US Davis Health
Sacramento, California, United States
Yale Cancer Center
New Haven, Connecticut, United States
Moffitt Cancer Center
Tampa, Florida, United States
Event-free survival (EFS)
Time frame: 5 years
Overall Survival
Time frame: 7 years
Relapse free survival
Time frame: 5 years
Composite complete remission rate
Time frame: 5 years
Duration of response
Time frame: 5 years
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Rush Medical Center
Chicago, Illinois, United States
University of Illinois at Chicago
Chicago, Illinois, United States
University of Chicago
Chicago, Illinois, United States
Indiana University
Indianapolis, Indiana, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States
...and 21 more locations