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

Completed · Phase 3

Conditions studied: Newly Diagnosed FLT3 Mutated AML

In brief

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.

Key facts

Study ID

NCT03258931

Run by

Arog Pharmaceuticals, Inc.

People needed

214

Starts

2018-08-15

Expected to finish

2026-04-06

Last updated by the study team

2026-04-09

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• 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
• 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
• University of Kansas — Kansas City, Kansas, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Beth Israel Deacnss Medical Center Oncology — Boston, Massachusetts, United States
• Dana-Farber Cancer Insitute — Boston, Massachusetts, United States
• Karmanos Cancer Institute — Detroit, Michigan, United States
• Henry Ford Health System — Detroit, Michigan, United States
• University of Minnesota — Minneapolis, Minnesota, United States
• John Theurer Cancer Center at Hackensack UMC — Hackensack, New Jersey, United States
• Rutgers Cancer Institute of New Jersey — New Brunswick, New Jersey, United States
• Roswell Park — Buffalo, New York, United States
• New York University — New York, New York, United States
• Mount Sinai — New York, New York, United States
• Columbia University — New York, New York, United States
• Cornell University — New York, New York, United States
• Memorial Sloan-Kettering Cancer Center — New York, New York, United States

Full record on ClinicalTrials.gov

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