Study of Crenolanib vs Midostaurin Following Induction Chemotherapy and Consolidation Therapy in Newly Diagnosed FLT3 Mutated AML
- Conditions
- Newly Diagnosed FLT3 Mutated AML
- Interventions
- Registration Number
- NCT03258931
- Lead Sponsor
- Arog Pharmaceuticals, Inc.
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 510
- 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
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Midostaurin Duanorubicin Midostaurin following salvage chemotherapy Crenolanib Duanorubicin Crenolanib following salvage chemotherapy Midostaurin Cytarabine Midostaurin following salvage chemotherapy Crenolanib Crenolanib Crenolanib following salvage chemotherapy Crenolanib Cytarabine Crenolanib following salvage chemotherapy Midostaurin Midostaurin Midostaurin following salvage chemotherapy
- Primary Outcome Measures
Name Time Method Event-free survival (EFS) 5 years
- Secondary Outcome Measures
Name Time Method Relapse free survival 5 years Composite complete remission rate 5 years Overall Survival 7 years Duration of response 5 years
Trial Locations
- Locations (31)
John Theurer Cancer Center at Hackensack UMC
🇺🇸Hackensack, New Jersey, United States
Cornell University
🇺🇸New York, New York, United States
Oregon Health and Science University
🇺🇸Portland, Oregon, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
University of Kansas
🇺🇸Kansas City, Kansas, United States
Beth Israel Deacnss Medical Center Oncology
🇺🇸Boston, Massachusetts, United States
Indiana University
🇺🇸Indianapolis, Indiana, United States
Yale Cancer Center
🇺🇸New Haven, Connecticut, United States
Karmanos Cancer Institute
🇺🇸Detroit, Michigan, United States
Dana-Farber Cancer Insitute
🇺🇸Boston, Massachusetts, United States
University of Minnesota
🇺🇸Minneapolis, Minnesota, United States
Roswell PArk
🇺🇸Buffalo, New York, United States
Henry Ford Health System
🇺🇸Detroit, Michigan, United States
Rutgers Cancer Institute of New Jersey
🇺🇸New Brunswick, New Jersey, United States
Mount Sinai
🇺🇸New York, New York, United States
Wake Forest Baptist Health, Section on Hematology & Oncology
🇺🇸Winston-Salem, North Carolina, United States
University of Rochester Medical Center
🇺🇸New York, New York, United States
University of Virginia Health System
🇺🇸Charlottesville, Virginia, United States
The UNC Lineberger Comprehensive Cancer Center
🇺🇸Chapel Hill, North Carolina, United States
City of Hope National Medical Center
🇺🇸Duarte, California, United States
University of Iowa Hospitals and Clinics
🇺🇸Iowa City, Iowa, United States
New York University
🇺🇸New York, New York, United States
Memorial Sloan-Kettering Cancer Center
🇺🇸New York, New York, United States
Ronald Reagan UCLA Medical Center
🇺🇸Los Angeles, California, United States
US Davis Health
🇺🇸Sacramento, California, United States
University of Illinois at Chicago
🇺🇸Chicago, Illinois, United States
University of Chicago
🇺🇸Chicago, Illinois, United States
Moffitt Cancer Center
🇺🇸Tampa, Florida, United States
Rush Medical Center
🇺🇸Chicago, Illinois, United States
Columbia University
🇺🇸New York, New York, United States
Montefiore Medical Center
🇺🇸Bronx, New York, United States