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.
- Diseases
- Acute myeloid leukemia
- 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
Sites (62)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Alberta Coordinator of this site? Confirm its status | Edmonton | Canada | Unknown status |
| Klinikum Chemnitz gGmbH Coordinator of this site? Confirm its status | Chemnitz | Germany | Unknown status |
| Technische Universität Dresden Coordinator of this site? Confirm its status | Dresden | Germany | Unknown status |
| Universitätsklinikum Essen AöR Coordinator of this site? Confirm its status | Essen | Germany | Unknown status |
| Universitätsklinikum Frankfurt Coordinator of this site? Confirm its status | Frankfurt | Germany | Unknown status |
| Universitätsklinikum Halle (Saale) Coordinator of this site? Confirm its status | Halle | Germany | Unknown status |
| Universitätsklinikum Münster Coordinator of this site? Confirm its status | Münster | Germany | Unknown status |
| Complejo Hospitalario Universitario A Coruña Coordinator of this site? Confirm its status | A Coruña | Spain | Unknown status |
| San Pedro de Alcantara Hospital Coordinator of this site? Confirm its status | Cáceres | Spain | Unknown status |
| Reina Sofia University Hospital Coordinator of this site? Confirm its status | Córdoba | Spain | Unknown status |
| Hospital Universitario de Donostia Coordinator of this site? Confirm its status | Donostia / San Sebastian | Spain | Unknown status |
| Hospital Universitario La Paz Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| Hospital Ramón y Cajal Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| Hospital 12 de Octubre Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| Hospital Gregorio Maranon Servicio de Hematologia y Hemoterapia Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| Fundación Jiménez Díaz Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| Hospital Universitario Central de Asturias (HUCA) Coordinator of this site? Confirm its status | Oviedo | Spain | Unknown status |
| Hospital Clinico Universitario de Salamanca Coordinator of this site? Confirm its status | Salamanca | Spain | Unknown status |
| Hospital U. Marques de Valdecilla Coordinator of this site? Confirm its status | Santander | Spain | Unknown status |
| Hospital Clínico Universitario de Santiago Coordinator of this site? Confirm its status | Santiago de Compostela | Spain | Unknown status |
| Hospital U. Virgen del Rocio Coordinator of this site? Confirm its status | Seville | Spain | Unknown status |
| Hospital Universitario Y Politecnico La Fe Coordinator of this site? Confirm its status | Valencia | Spain | Unknown status |
| Hospital Avicenne Coordinator of this site? Confirm its status | Bobigny | France | Unknown status |
| CHU Grenoble Alpes Coordinator of this site? Confirm its status | Grenoble | France | Unknown status |
| Hospital Center of Versailles (Le Chesnay) Coordinator of this site? Confirm its status | Le Chesnay | France | Unknown status |
| Hospital Claude Huriez - Chru Lille Coordinator of this site? Confirm its status | Lille | France | Unknown status |
| Institut Paoli-Calmettes Coordinator of this site? Confirm its status | Marseille | France | Unknown status |
| CHU de Nantes - Hôtel Dieu Coordinator of this site? Confirm its status | Nantes | France | Unknown status |
| University Hospital Nice L'Archet Coordinator of this site? Confirm its status | Nice | France | Unknown status |
| Hopital St-Louis Coordinator of this site? Confirm its status | Paris | France | Unknown status |
| CHU de Bordeaux Coordinator of this site? Confirm its status | Pessac | France | Unknown status |
| Centre Hospitalier Lyon-Sud Coordinator of this site? Confirm its status | Pierre-Bénite | France | Unknown status |
| CHU de Poitiers Coordinator of this site? Confirm its status | Poitiers | France | Unknown status |
| Institut Universitaire du Cancer Toulouse Coordinator of this site? Confirm its status | Toulouse | France | Unknown status |
| AOU Policlinico Sant'Orsola-Malpighi Coordinator of this site? Confirm its status | Bologna | Italy | Unknown status |
| ASST Spedali Civili di Brescia Coordinator of this site? Confirm its status | Brescia | Italy | Unknown status |
| AOU Careggi Coordinator of this site? Confirm its status | Florence | Italy | Unknown status |
| IRST - Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori Coordinator of this site? Confirm its status | Meldola | Italy | Unknown status |
| Istituto Europeo di Oncologia Coordinator of this site? Confirm its status | Milan | Italy | Unknown status |
| IRCCS Foundation Ca 'Granda Ospedale Maggiore Policlinico Coordinator of this site? Confirm its status | Milan | Italy | Unknown status |
| IRCCS San Raffaele Hospital Coordinator of this site? Confirm its status | Milan | Italy | Unknown status |
| AOU Federico II Coordinator of this site? Confirm its status | Naples | Italy | Unknown status |
| Aorn Antonio Cardarelli Coordinator of this site? Confirm its status | Naples | Italy | Unknown status |
| AOU "Maggiore della Carità" Coordinator of this site? Confirm its status | Novara | Italy | Unknown status |
| AO Ospedali Riuniti Villa Sofia-Cervello Coordinator of this site? Confirm its status | Palermo | Italy | Unknown status |
| Ao Ospedali Riuniti Marche Nord Coordinator of this site? Confirm its status | Pesaro | Italy | Unknown status |
| Ospedale Santa Maria delle Croci di Ravenna Coordinator of this site? Confirm its status | Ravenna | Italy | Unknown status |
| Policlinico Tor Vergata Coordinator of this site? Confirm its status | Roma | Italy | Unknown status |
| Fondazione Policlinico Universitario Agostino Gemelli Coordinator of this site? Confirm its status | Roma | Italy | Unknown status |
| A.O.U Città della Salute e della Scienza di Torino Coordinator of this site? Confirm its status | Torino | Italy | Unknown status |
| AO Ordine Mauriziano di Torino Coordinator of this site? Confirm its status | Torino | Italy | Unknown status |
| Policlinico GB Rossi, University Hospital Verona Coordinator of this site? Confirm its status | Verona | Italy | Unknown status |
| AULSS n 8 Berica Ospedale San Bortolo Coordinator of this site? Confirm its status | Vicenza | Italy | Unknown status |
| Roswell Park Cancer Institute Coordinator of this site? Confirm its status | Buffalo | United States | Unknown status |
| University of Chicago Coordinator of this site? Confirm its status | Chicago | United States | Unknown status |
| Karmanos Cancer Center Coordinator of this site? Confirm its status | Detroit | United States | Unknown status |
| Henry Ford Health System Coordinator of this site? Confirm its status | Detroit | United States | Unknown status |
| University of Florida Coordinator of this site? Confirm its status | Gainesville | United States | Unknown status |
| Kansas University Coordinator of this site? Confirm its status | Kansas City | United States | Unknown status |
| City of Hope National Medical Center Coordinator of this site? Confirm its status | Sacramento | United States | Unknown status |
| UC Davis Comprehensive Cancer Center Coordinator of this site? Confirm its status | Sacramento | United States | Unknown status |
| Wake Forest Baptist Medical Center Coordinator of this site? Confirm its status | Winston-Salem | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.