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NCT03250338CompletedPhase 3

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

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

Source: ClinicalTrials.gov · Last updated 9 Apr 2026

Brief summary (registry, in English)

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.

Status (registry)
Completed
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
106 (actual)
First submitted
11 Aug 2017
Start date
16 Aug 2018
Primary completion date
3 Apr 2026
Lead sponsor
Arog Pharmaceuticals, Inc.
NCT number
NCT03250338
EudraCT number
2017-001600-29

What you commit to

  • Study type: Interventional · Phase 3
  • Participants enrolled: 106
  • From 16 Aug 2018 to the primary completion date, 3 Apr 2026
  • 62 sites in 6 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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.

Other illness

  • Severe liver disease
  • Known, active infection with hepatitis B virus (HBV) or hepatitis C virus (HCV)

Other

  • Known clinically active central nervous system(CNS) leukemia

Who the study is looking for

  • 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

Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (62)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
University of Alberta
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EdmontonCanadaUnknown status
Klinikum Chemnitz gGmbH
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ChemnitzGermanyUnknown status
Technische Universität Dresden
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DresdenGermanyUnknown status
Universitätsklinikum Essen AöR
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EssenGermanyUnknown status
Universitätsklinikum Frankfurt
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FrankfurtGermanyUnknown status
Universitätsklinikum Halle (Saale)
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HalleGermanyUnknown status
Universitätsklinikum Münster
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MünsterGermanyUnknown status
Complejo Hospitalario Universitario A Coruña
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A CoruñaSpainUnknown status
San Pedro de Alcantara Hospital
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CáceresSpainUnknown status
Reina Sofia University Hospital
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CórdobaSpainUnknown status
Hospital Universitario de Donostia
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Donostia / San SebastianSpainUnknown status
Hospital Universitario La Paz
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MadridSpainUnknown status
Hospital Ramón y Cajal
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MadridSpainUnknown status
Hospital 12 de Octubre
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MadridSpainUnknown status
Hospital Gregorio Maranon Servicio de Hematologia y Hemoterapia
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MadridSpainUnknown status
Fundación Jiménez Díaz
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MadridSpainUnknown status
Hospital Universitario Central de Asturias (HUCA)
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OviedoSpainUnknown status
Hospital Clinico Universitario de Salamanca
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SalamancaSpainUnknown status
Hospital U. Marques de Valdecilla
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SantanderSpainUnknown status
Hospital Clínico Universitario de Santiago
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Santiago de CompostelaSpainUnknown status
Hospital U. Virgen del Rocio
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SevilleSpainUnknown status
Hospital Universitario Y Politecnico La Fe
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ValenciaSpainUnknown status
Hospital Avicenne
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BobignyFranceUnknown status
CHU Grenoble Alpes
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GrenobleFranceUnknown status
Hospital Center of Versailles (Le Chesnay)
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Le ChesnayFranceUnknown status
Hospital Claude Huriez - Chru Lille
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LilleFranceUnknown status
Institut Paoli-Calmettes
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MarseilleFranceUnknown status
CHU de Nantes - Hôtel Dieu
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NantesFranceUnknown status
University Hospital Nice L'Archet
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NiceFranceUnknown status
Hopital St-Louis
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ParisFranceUnknown status
CHU de Bordeaux
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PessacFranceUnknown status
Centre Hospitalier Lyon-Sud
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Pierre-BéniteFranceUnknown status
CHU de Poitiers
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PoitiersFranceUnknown status
Institut Universitaire du Cancer Toulouse
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ToulouseFranceUnknown status
AOU Policlinico Sant'Orsola-Malpighi
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BolognaItalyUnknown status
ASST Spedali Civili di Brescia
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BresciaItalyUnknown status
AOU Careggi
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FlorenceItalyUnknown status
IRST - Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
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MeldolaItalyUnknown status
Istituto Europeo di Oncologia
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MilanItalyUnknown status
IRCCS Foundation Ca 'Granda Ospedale Maggiore Policlinico
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MilanItalyUnknown status
IRCCS San Raffaele Hospital
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MilanItalyUnknown status
AOU Federico II
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NaplesItalyUnknown status
Aorn Antonio Cardarelli
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NaplesItalyUnknown status
AOU "Maggiore della Carità"
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NovaraItalyUnknown status
AO Ospedali Riuniti Villa Sofia-Cervello
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PalermoItalyUnknown status
Ao Ospedali Riuniti Marche Nord
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PesaroItalyUnknown status
Ospedale Santa Maria delle Croci di Ravenna
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RavennaItalyUnknown status
Policlinico Tor Vergata
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RomaItalyUnknown status
Fondazione Policlinico Universitario Agostino Gemelli
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RomaItalyUnknown status
A.O.U Città della Salute e della Scienza di Torino
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TorinoItalyUnknown status
AO Ordine Mauriziano di Torino
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TorinoItalyUnknown status
Policlinico GB Rossi, University Hospital Verona
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VeronaItalyUnknown status
AULSS n 8 Berica Ospedale San Bortolo
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VicenzaItalyUnknown status
Roswell Park Cancer Institute
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BuffaloUnited StatesUnknown status
University of Chicago
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ChicagoUnited StatesUnknown status
Karmanos Cancer Center
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DetroitUnited StatesUnknown status
Henry Ford Health System
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DetroitUnited StatesUnknown status
University of Florida
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GainesvilleUnited StatesUnknown status
Kansas University
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Kansas CityUnited StatesUnknown status
City of Hope National Medical Center
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SacramentoUnited StatesUnknown status
UC Davis Comprehensive Cancer Center
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SacramentoUnited StatesUnknown status
Wake Forest Baptist Medical Center
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Winston-SalemUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.