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

April 8, 2026 updated by: Arog Pharmaceuticals, Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

106

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 2R3
        • University of Alberta
  • France
      • Bobigny, France, 93000
        • Hospital AVICENNE
      • Grenoble, France, 38043
        • Chu Grenoble Alpes
      • Le Chesnay, France, 78157
        • Hospital Center of Versailles (Le Chesnay)
      • Lille, France, 59037
        • Hospital Claude Huriez - Chru Lille
      • Marseille, France, 13009
        • Institut Paoli-Calmettes
      • Nantes, France, 44093
        • CHU de Nantes - Hotel Dieu
      • Nice, France, 06200
        • University Hospital Nice L'Archet
      • Paris, France, 75010
        • Hôpital St Louis
      • Pessac, France, 33604
        • CHU de Bordeaux
      • Pierre-Bénite, France, 69494
        • Centre Hospitalier Lyon Sud
      • Poitiers, France, 86021
        • CHU de Poitiers
      • Toulouse, France, 31059
        • Institut Universitaire du Cancer Toulouse
  • Germany
      • Chemnitz, Germany, 09116
        • Klinikum Chemnitz Ggmbh
      • Dresden, Germany
        • Technische Universität Dresden
      • Essen, Germany, 45147
        • Universitatsklinikum Essen (Aor)
      • Frankfurt, Germany
        • Universitätsklinikum Frankfurt
      • Halle, Germany
        • Universitätsklinikum Halle (Saale)
      • Münster, Germany, 48149
        • Universitätsklinikum Münster
  • Italy
      • Bologna, Italy, 40138
        • AOU Policlinico Sant'Orsola-Malpighi
      • Brescia, Italy, 25123
        • ASST Spedali Civili Di Brescia
      • Florence, Italy, 50134
        • AOU Careggi
      • Meldola, Italy, 47014
        • IRST - Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
      • Milan, Italy, 20141
        • Istituto Europeo di Oncologia
      • Milan, Italy, 20132
        • IRCCS San Raffaele Hospital
      • Milan, Italy, 20122
        • IRCCS Foundation Ca 'Granda Ospedale Maggiore Policlinico
      • Naples, Italy, 80131
        • AOU Federico II
      • Naples, Italy, 80131
        • AORN Antonio Cardarelli
      • Novara, Italy, 28100
        • Aou Maggiore Della Carita
      • Palermo, Italy
        • AO Ospedali Riuniti Villa Sofia-Cervello
      • Pesaro, Italy, 61122
        • AO Ospedali Riuniti Marche Nord
      • Ravenna, Italy, 48121
        • Ospedale Santa Maria delle Croci di Ravenna
      • Roma, Italy, 00168
        • Fondazione Policlinico Universitario Agostino Gemelli
      • Torino, Italy, 10126
        • A.O.U. Città della Salute e Della Scienza di Torino
      • Torino, Italy, 10128
        • AO Ordine Mauriziano di Torino
      • Verona, Italy, 37134
        • Policlinico GB Rossi, University Hospital Verona
      • Vicenza, Italy, 36100
        • AULSS n 8 Berica Ospedale San Bortolo
    • RM
      • Roma, RM, Italy, 00133
        • Policlinico Tor Vergata
  • Spain
      • A Coruña, Spain, 15006
        • Complejo Hospitalario Universitario A Coruña
      • Cáceres, Spain, 10003
        • San Pedro de Alcántara Hospital
      • Córdoba, Spain, 14004
        • Reina Sofia University Hospital
      • Donostia / San Sebastian, Spain, 20014
        • Hospital Universitario de Donostia
      • Madrid, Spain, 28040
        • Fundación Jiménez Díaz
      • Madrid, Spain, 28046
        • Hospital Universitario La Paz
      • Madrid, Spain, 28034
        • Hospital Ramon y Cajal
      • Madrid, Spain, 28041
        • Hospital 12 de Octubre
      • Madrid, Spain
        • Hospital Gregorio Maranon Servicio de Hematologia y Hemoterapia
      • Salamanca, Spain, 37007
        • Hospital Clinico Universitario de Salamanca
      • Santiago de Compostela, Spain, 15706
        • Hospital Clínico Universitario de Santiago
      • Valencia, Spain, 46026
        • Hospital Universitario y Politécnico La FE
    • Andalusia
      • Seville, Andalusia, Spain, 41013
        • Hospital U. Virgen del Rocio
    • Cantabria
      • Santander, Cantabria, Spain, 39008
        • Hospital U. Marques de Valdecilla
    • Principality of Asturias
      • Oviedo, Principality of Asturias, Spain, 33011
        • Hospital Universitario Central de Asturias (HUCA)
  • United States
    • California
      • Sacramento, California, United States, 95817
        • UC Davis Comprehensive Cancer Center
      • Sacramento, California, United States, 95817
        • City of Hope National Medical Center
    • Florida
      • Gainesville, Florida, United States, 32610
        • University of Florida
    • Illinois
      • Chicago, Illinois, United States, 60637
        • University of Chicago
    • Kansas
      • Kansas City, Kansas, United States, 666160
        • Kansas University
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Henry Ford Health System
      • Detroit, Michigan, United States, 48201
        • Karmanos Cancer Center
    • New York
      • Buffalo, New York, United States, 14263
        • Roswell Park Cancer Institute
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27104
        • Wake Forest Baptist Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 71 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Confirmed diagnosis of AML according to World Health Organization (WHO) 2016 classification
  2. Presence of FLT3-ITD and/or D835 mutation(s)
  3. 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
  4. Age ≥ 18 years and ≤ 75 years
  5. Adequate hepatic function
  6. Adequate renal functions
  7. ECOG performance status ≤ 3

Exclusion Criteria:

  1. Known clinically active central nervous system(CNS) leukemia
  2. Severe liver disease
  3. Known, active infection with hepatitis B virus (HBV) or hepatitis C virus (HCV)
  4. 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.
  5. Previous treatment with crenolanib or prior participation in clinical trial involving crenolanib.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Crenolanib
Crenolanib following salvage chemotherapy
Drug: Crenolanib
Crenolanib will be administered orally
Other Names:
  • Crenolanib besylate
Drug: Cytarabine

HAM regimen

FLAG-Ida

Drug: Mitoxantrone
HAM regimen
Drug: Fludarabine
FLAG-Ida regimen
Drug: Idarubicin
FLAG-Ida regimen
Drug: G-CSF
FLAG-Ida regimen
Placebo Comparator: Placebo
Placebo following salvage chemotherapy
Drug: Cytarabine

HAM regimen

FLAG-Ida

Drug: Mitoxantrone
HAM regimen
Drug: Fludarabine
FLAG-Ida regimen
Drug: Idarubicin
FLAG-Ida regimen
Drug: G-CSF
FLAG-Ida regimen
Drug: Placebo Oral Tablet
Placebo will be administered orally

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Event-free survival (EFS)
Time Frame: 3 years
3 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall Survival
Time Frame: 3 years
3 years
Relapse-free Survival (RFS)
Time Frame: 3 years
3 years
Complete remission rate (CR)
Time Frame: 3 years
3 years
MRD negative complete remission rate
Time Frame: 3 years
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Arog Pharmaceuticals, Inc.

Investigators

  • Principal Investigator: Eunice Wang, MD, Roswell Park Cancer Institute, Buffalo, New York, United States, 14263

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 16, 2018

Primary Completion (Actual)

April 3, 2026

Study Completion (Actual)

April 3, 2026

Study Registration Dates

First Submitted

August 11, 2017

First Submitted That Met QC Criteria

August 14, 2017

First Posted (Actual)

August 15, 2017

Study Record Updates

Last Update Posted (Actual)

April 9, 2026

Last Update Submitted That Met QC Criteria

April 8, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ARO-013
  • 2017-001600-29 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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