Study Investigating the Efficacy of Crenolanib With Chemotherapy vs Chemotherapy Alone in R/R FLT3 Mutated AML
Completed · Phase 3 · Has a placebo group
Conditions studied: Relapsed/Refractory Acute Myeloid Leukemia With FLT3 Activating Mutations
In brief
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.
Key facts
- Study ID
- NCT03250338
- Run by
- Arog Pharmaceuticals, Inc.
- People needed
- 106
- Starts
- 2018-08-16
- Expected to finish
- 2026-04-03
- Last updated by the study team
- 2026-04-09
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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.
Where it is running
- UC Davis Comprehensive Cancer Center — Sacramento, California, United States
- University of Florida — Gainesville, Florida, United States
- University of Chicago — Chicago, Illinois, United States
- Kansas University — Kansas City, Kansas, United States
- Karmanos Cancer Center — Detroit, Michigan, United States
- Henry Ford Health System — Detroit, Michigan, United States
- Roswell Park Cancer Institute — Buffalo, New York, United States
- Wake Forest Baptist Medical Center — Winston-Salem, North Carolina, United States
- University of Alberta — Edmonton, Alberta, Canada
- Hospital Avicenne — Bobigny, France
- CHU Grenoble Alpes — Grenoble, France
- Hospital Center of Versailles (Le Chesnay) — Le Chesnay, France
- Hospital Claude Huriez - Chru Lille — Lille, France
- Institut Paoli-Calmettes — Marseille, France
- CHU de Nantes - Hôtel Dieu — Nantes, France
- University Hospital Nice L'Archet — Nice, France
- Hôpital St Louis — Paris, France
- CHU de Bordeaux — Pessac, France
- Centre Hospitalier Lyon Sud — Pierre-Bénite, France
- CHU de Poitiers — Poitiers, France
- Institut Universitaire du Cancer Toulouse — Toulouse, France
- Klinikum Chemnitz gGmbH — Chemnitz, Germany
- Technische Universität Dresden — Dresden, Germany
- Universitätsklinikum Essen (AöR) — Essen, Germany
- City of Hope National Medical Center — Sacramento, California, United States
Full record on ClinicalTrials.gov
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