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Study Investigating the Efficacy of Crenolanib With Chemotherapy vs Chemotherapy Alone in R / R FLT3 Mutated AML

Trial Status: Active

This is a randomized, multi-center, double-blind, placebo-controlled study designed to evaluate the efficacy of crenolanib administered following salvage chemotherapy, consolidation chemotherapy, post bone marrow transplantation and as maintenance in relapsed / refractory AML subjects with FLT3 activating mutation.

Inclusion Criteria

  • Confirmed diagnosis of AML according to World Health Organization (WHO) 2016 classification
  • Presence of FLT3-ITD and/or D835 mutation(s)
  • Subjects must be primary refractory or relapsed to 1st line intensive treatment for AML or refractory or relapsed after second line of treatment for AML
  • Age ≥ 18 years and ≤ 75 years
  • Adequate hepatic function
  • Adequate renal functions
  • ECOG performance status ≤ 3

Exclusion Criteria

  • Known clinically active central nervous system(CNS) leukemia
  • Severe liver disease
  • Known, active infection with hepatitis B virus (HBV) or hepatitis C virus (HCV)
  • Prior anti-leukemia therapy within the 14 days prior to randomization. Prior use of quizartinib or gilteritinib must be discontinued 21 days prior to randomization. Prior use of hydroxyurea or other palliative treatment for leukocytosis is allowed.
  • Previous treatment with crenolanib or prior participation in clinical trial involving crenolanib.

California

Duarte
City of Hope Comprehensive Cancer Center
Status: ACTIVE
Los Angeles
USC / Norris Comprehensive Cancer Center
Status: APPROVED
Contact: Christine Duran
Phone: 323-865-0371
Sacramento
University of California Davis Comprehensive Cancer Center
Status: CLOSED_TO_ACCRUAL

Illinois

Chicago
University of Chicago 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

Michigan

Detroit
Wayne State University / Karmanos Cancer Institute
Status: ACTIVE

New York

Buffalo
Roswell Park Cancer Institute
Status: ACTIVE
New York
NYP / Columbia University Medical Center / Herbert Irving Comprehensive Cancer Center
Status: COMPLETED

North Carolina

Winston-Salem
Wake Forest University Health Sciences
Status: ACTIVE

Trial Phase Phase III

Trial Type Treatment

Lead Organization
Arog Pharmaceuticals, Inc.

  • Primary ID ARO-013
  • Secondary IDs NCI-2018-00334
  • Clinicaltrials.gov ID NCT03250338