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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
106

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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 - Hôtel 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
        • Universitatsklinikum Munster
  • 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 Carità
      • 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
        • Fundacion Jimenez Diaz
      • 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 Clínico 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Event-free survival (EFS)
Time Frame: 3 years
3 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Arog Pharmaceuticals, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 16, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 3, 2026

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 3, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 11, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 14, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 15, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 9, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 8, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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