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

Trial Status: Active

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)

California

Duarte
City of Hope Comprehensive Cancer Center
Status: ACTIVE
Los Angeles
UCLA / Jonsson Comprehensive Cancer Center
Status: ACTIVE
Contact: Vlad Kustanovich
Phone: 310-206-5755
Sacramento
University of California Davis Comprehensive Cancer Center
Status: ACTIVE

Connecticut

New Haven
Yale University
Status: ACTIVE

Florida

Tampa
Moffitt Cancer Center
Status: ACTIVE
Contact: Kendra L Sweet
Phone: 813-745-6841

Illinois

Chicago
University of Chicago Comprehensive Cancer Center
Status: CLOSED_TO_ACCRUAL

Indiana

Indianapolis
Indiana University / Melvin and Bren Simon Cancer Center
Status: ACTIVE
Contact: Bobbie Ann Frye
Phone: 317-274-2992

Iowa

Iowa City
University of Iowa / Holden Comprehensive Cancer Center
Status: ACTIVE

Kansas

Kansas City
University of Kansas Cancer Center
Status: ACTIVE
Westwood
University of Kansas Hospital-Westwood Cancer Center
Status: ACTIVE

Massachusetts

Boston
Beth Israel Deaconess Medical Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL_AND_INTERVENTION
Contact: Lourdes M. Mendez
Phone: 617-667-9920
Brigham and Women's Hospital
Status: ACTIVE
Dana-Farber Cancer Institute
Status: ACTIVE
Contact: Richard M. Stone
Phone: 617-632-2214
Massachusetts General Hospital Cancer Center
Status: ACTIVE
Contact: Amir Tahmasb Fathi
Phone: 617-724-1124

Michigan

Detroit
Wayne State University / Karmanos Cancer Institute
Status: ACTIVE

Minnesota

Minneapolis
University of Minnesota / Masonic Cancer Center
Status: ACTIVE

New Jersey

New Brunswick
Rutgers Cancer Institute of New Jersey
Status: ACTIVE

New York

Bronx
Montefiore Medical Center-Weiler Hospital
Status: COMPLETED
Buffalo
Roswell Park Cancer Institute
Status: ACTIVE
New York
Icahn School of Medicine at Mount Sinai
Status: ACTIVE
Laura and Isaac Perlmutter Cancer Center at NYU Langone
Status: CLOSED_TO_ACCRUAL_AND_INTERVENTION
Memorial Sloan Kettering Cancer Center
Status: ACTIVE
NYP / Columbia University Medical Center / Herbert Irving Comprehensive Cancer Center
Status: ACTIVE

North Carolina

Chapel Hill
UNC Lineberger Comprehensive Cancer Center
Status: ACTIVE
Winston-Salem
Wake Forest University Health Sciences
Status: ACTIVE

Oregon

Portland
OHSU Knight Cancer Institute
Status: ACTIVE

Pennsylvania

Philadelphia
Fox Chase Cancer Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: systems coordinator
Phone: 215-214-1558

Virginia

Charlottesville
University of Virginia Cancer Center
Status: ACTIVE

Trial Phase Phase III

Trial Type Treatment

Lead Organization
Arog Pharmaceuticals, Inc.

  • Primary ID ARO-021
  • Secondary IDs NCI-2018-00266
  • Clinicaltrials.gov ID NCT03258931