Skip to main content
OpenTrials
Completed

NCT Number: NCT03250338

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Relapsed/Refractory Acute Myeloid Leukemia With FLT3 Activating Mutations Disease Attributes Pathologic Processes Pathological Conditions, Signs and Symptoms Recurrence

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University of Alberta, Edmonton, Alberta, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

crenolanib

Drug

Crenolanib will be administered orally

Other names: Crenolanib besylate

Cytarabine

Drug

HAM regimen

FLAG-Ida

Mitoxantrone

Drug

HAM regimen

Placebo oral tablet

Drug

Placebo will be administered orally

Fludarabine

Drug

FLAG-Ida regimen

Idarubicin

Drug

FLAG-Ida regimen

G-CSF

Drug

FLAG-Ida regimen

Primary outcomes

  1. Event-free survival (EFS)

    Time frame: 3 years

Secondary outcomes

  1. Overall Survival

    Time frame: 3 years

  2. Relapse-free Survival (RFS)

    Time frame: 3 years

  3. Complete remission rate (CR)

    Time frame: 3 years

  4. MRD negative complete remission rate

    Time frame: 3 years

Sponsors and collaborators

Lead sponsor

Arog Pharmaceuticals, Inc.

Industry

Registry information

Official study title

Phase III Randomized, Double-blind, Placebo-controlled Study Investigating the Efficacy of the Addition of Crenolanib to Salvage Chemotherapy Versus Salvage Chemotherapy Alone in Subjects ≤ 75 Years of Age With Relapsed/Refractory FLT3 Mutated Acute Myeloid Leukemia

Important dates

Study start
2018
Primary completion
2026
Study completion
2026
First posted
Aug 15, 2017
Registry last updated
Apr 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.