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
2 other identifiers
interventional
106
6 countries
62
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Aug 2018
Longer than P75 for phase_3
62 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 11, 2017
CompletedFirst Posted
Study publicly available on registry
August 15, 2017
CompletedStudy Start
First participant enrolled
August 16, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 3, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
April 3, 2026
CompletedApril 9, 2026
April 1, 2026
7.6 years
August 11, 2017
April 8, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Event-free survival (EFS)
3 years
Secondary Outcomes (4)
Overall Survival
3 years
Relapse-free Survival (RFS)
3 years
Complete remission rate (CR)
3 years
MRD negative complete remission rate
3 years
Study Arms (2)
Crenolanib
EXPERIMENTALCrenolanib following salvage chemotherapy
Placebo
PLACEBO COMPARATORPlacebo following salvage chemotherapy
Interventions
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (62)
City of Hope National Medical Center
Sacramento, California, 95817, United States
UC Davis Comprehensive Cancer Center
Sacramento, California, 95817, United States
University of Florida
Gainesville, Florida, 32610, United States
University of Chicago
Chicago, Illinois, 60637, United States
Kansas University
Kansas City, Kansas, 666160, United States
Karmanos Cancer Center
Detroit, Michigan, 48201, United States
Henry Ford Health System
Detroit, Michigan, 48202, United States
Roswell Park Cancer Institute
Buffalo, New York, 14263, United States
Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, 27104, United States
University of Alberta
Edmonton, Alberta, T6G 2R3, Canada
Hospital Avicenne
Bobigny, 93000, France
CHU Grenoble Alpes
Grenoble, 38043, France
Hospital Center of Versailles (Le Chesnay)
Le Chesnay, 78157, France
Hospital Claude Huriez - Chru Lille
Lille, 59037, France
Institut Paoli-Calmettes
Marseille, 13009, France
CHU de Nantes - Hôtel Dieu
Nantes, 44093, France
University Hospital Nice L'Archet
Nice, 06200, France
Hôpital St Louis
Paris, 75010, France
CHU de Bordeaux
Pessac, 33604, France
Centre Hospitalier Lyon Sud
Pierre-Bénite, 69494, France
CHU de Poitiers
Poitiers, 86021, France
Institut Universitaire du Cancer Toulouse
Toulouse, 31059, France
Klinikum Chemnitz gGmbH
Chemnitz, 09116, Germany
Technische Universität Dresden
Dresden, Germany
Universitätsklinikum Essen (AöR)
Essen, 45147, Germany
Universitätsklinikum Frankfurt
Frankfurt, Germany
Universitätsklinikum Halle (Saale)
Halle, Germany
Universitätsklinikum Münster
Münster, 48149, Germany
Policlinico Tor Vergata
Roma, RM, 00133, Italy
AOU Policlinico Sant'Orsola-Malpighi
Bologna, 40138, Italy
ASST Spedali Civili di Brescia
Brescia, 25123, Italy
AOU Careggi
Florence, 50134, Italy
IRST - Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
Meldola, 47014, Italy
IRCCS San Raffaele Hospital
Milan, 20132, Italy
IRCCS Foundation Ca 'Granda Ospedale Maggiore Policlinico
Milan, 20122, Italy
Istituto Europeo di Oncologia
Milan, 20141, Italy
Aorn Antonio Cardarelli
Naples, 80131, Italy
AOU Federico II
Naples, 80131, Italy
AOU Maggiore della Carità
Novara, 28100, Italy
AO Ospedali Riuniti Villa Sofia-Cervello
Palermo, Italy
AO Ospedali Riuniti Marche Nord
Pesaro, 61122, Italy
Ospedale Santa Maria delle Croci di Ravenna
Ravenna, 48121, Italy
Fondazione Policlinico Universitario Agostino Gemelli
Roma, 00168, Italy
A.O.U. Città della Salute e della Scienza di Torino
Torino, 10126, Italy
AO Ordine Mauriziano di Torino
Torino, 10128, Italy
Policlinico GB Rossi, University Hospital Verona
Verona, 37134, Italy
AULSS n 8 Berica Ospedale San Bortolo
Vicenza, 36100, Italy
Hospital U. Virgen del Rocio
Seville, Andalusia, 41013, Spain
Hospital U. Marques de Valdecilla
Santander, Cantabria, 39008, Spain
Hospital Universitario Central de Asturias (HUCA)
Oviedo, Principality of Asturias, 33011, Spain
Complejo Hospitalario Universitario A Coruna
A Coruña, 15006, Spain
San Pedro de Alcantara Hospital
Cáceres, 10003, Spain
Reina Sofia University Hospital
Córdoba, 14004, Spain
Hospital Universitario de Donostia
Donostia / San Sebastian, 20014, Spain
Hospital Ramon y Cajal
Madrid, 28034, Spain
Fundacion Jimenez Diaz
Madrid, 28040, Spain
Hospital 12 de Octubre
Madrid, 28041, Spain
Hospital Universitario La Paz
Madrid, 28046, Spain
Hospital Gregorio Maranon Servicio de Hematologia y Hemoterapia
Madrid, Spain
Hospital Clinico Universitario de Salamanca
Salamanca, 37007, Spain
Hospital Clinico Universitario de Santiago
Santiago de Compostela, 15706, Spain
Hospital Universitario y Politecnico La Fe
Valencia, 46026, Spain
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Eunice Wang, MD
Roswell Park Cancer Institute, Buffalo, New York, United States, 14263
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 11, 2017
First Posted
August 15, 2017
Study Start
August 16, 2018
Primary Completion
April 3, 2026
Study Completion
April 3, 2026
Last Updated
April 9, 2026
Record last verified: 2026-04