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.
- 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
- 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.
City of Hope Comprehensive Cancer Center
USC / Norris Comprehensive Cancer Center
Contact: Christine Duran
University of California Davis Comprehensive Cancer Center
University of Chicago Comprehensive Cancer Center
University of Kansas Cancer Center
University of Kansas Hospital-Westwood Cancer Center
Wayne State University / Karmanos Cancer Institute
Roswell Park Cancer Institute
NYP / Columbia University Medical Center / Herbert Irving Comprehensive Cancer Center
Wake Forest University Health Sciences
Trial Phase Phase III
Trial Type Treatment
Arog Pharmaceuticals, Inc.
- Primary ID ARO-013
- Secondary IDs NCI-2018-00334
- Clinicaltrials.gov ID NCT03250338