Study Investigating the Efficacy of Crenolanib With Chemotherapy vs Chemotherapy Alone in R/R FLT3 Mutated AML
- Conditions
- Relapsed/Refractory Acute Myeloid Leukemia With FLT3 Activating Mutations
- Interventions
- Drug: Placebo Oral Tablet
- Registration Number
- NCT03250338
- Lead Sponsor
- Arog Pharmaceuticals, Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 322
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Oral Tablet Placebo following salvage chemotherapy Crenolanib Crenolanib Crenolanib following salvage chemotherapy Crenolanib Cytarabine Crenolanib following salvage chemotherapy Crenolanib Mitoxantrone Crenolanib following salvage chemotherapy Crenolanib G-CSF Crenolanib following salvage chemotherapy Crenolanib Fludarabine Crenolanib following salvage chemotherapy Crenolanib Idarubicin Crenolanib following salvage chemotherapy Placebo Cytarabine Placebo following salvage chemotherapy Placebo Mitoxantrone Placebo following salvage chemotherapy Placebo Fludarabine Placebo following salvage chemotherapy Placebo Idarubicin Placebo following salvage chemotherapy Placebo G-CSF Placebo following salvage chemotherapy
- Primary Outcome Measures
Name Time Method Event-free survival (EFS) 3 years
- Secondary Outcome Measures
Name Time Method MRD negative complete remission rate 3 years Overall Survival 3 years Relapse-free Survival (RFS) 3 years Complete remission rate (CR) 3 years
Trial Locations
- Locations (62)
Kansas University
🇺🇸Kansas City, Kansas, United States
Roswell Park Cancer Institute
🇺🇸Buffalo, New York, United States
University of Alberta
🇨🇦Edmonton, Alberta, Canada
Hospital Center of Versailles (Le Chesnay)
🇫🇷Le Chesnay, France
Hospital Claude Huriez - Chru Lille
🇫🇷Lille, France
CHU de Nantes - Hôtel Dieu
🇫🇷Nantes, France
CHU de Bordeaux
🇫🇷Pessac, France
Institut Universitaire du Cancer Toulouse
🇫🇷Toulouse, France
Centre Hospitalier Lyon Sud
🇫🇷Pierre-Bénite, France
CHU de Poitiers
🇫🇷Poitiers, France
Technische Universität Dresden
🇩🇪Dresden, Germany
Klinikum Chemnitz gGmbH
🇩🇪Chemnitz, Germany
Universitätsklinikum Essen (AöR)
🇩🇪Essen, Germany
Universitätsklinikum Halle (Saale)
🇩🇪Halle, Germany
Universitätsklinikum Frankfurt
🇩🇪Frankfurt, Germany
Universitätsklinikum Münster
🇩🇪Münster, Germany
Policlinico Tor Vergata
🇮🇹Roma, RM, Italy
AOU Policlinico Sant'Orsola-Malpighi
🇮🇹Bologna, Italy
ASST Spedali Civili di Brescia
🇮🇹Brescia, Italy
IRST - Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
🇮🇹Meldola, Italy
AO Ospedali Riuniti Marche Nord
🇮🇹Pesaro, Italy
AO Ordine Mauriziano di Torino
🇮🇹Torino, Italy
Fondazione Policlinico Universitario Agostino Gemelli
🇮🇹Roma, Italy
A.O.U. Città della Salute e della Scienza di Torino
🇮🇹Torino, Italy
Policlinico GB Rossi, University Hospital Verona
🇮🇹Verona, Italy
San Pedro de Alcantara Hospital
🇪🇸Cáceres, Spain
AULSS n 8 Berica Ospedale San Bortolo
🇮🇹Vicenza, Italy
Hospital U. Virgen del Rocio
🇪🇸Sevilla, Andalucia, Spain
Complejo Hospitalario Universitario A Coruna
🇪🇸A Coruña, Spain
Hospital Universitario de Donostia
🇪🇸Donostia San Sebastian, Spain
Reina Sofia University Hospital
🇪🇸Córdoba, Spain
Hospital Ramon y Cajal
🇪🇸Madrid, Spain
Fundacion Jimenez Diaz
🇪🇸Madrid, Spain
Hospital Gregorio Maranon Servicio de Hematologia y Hemoterapia
🇪🇸Madrid, Spain
Hospital Clinico Universitario de Salamanca
🇪🇸Salamanca, Spain
Hospital 12 de Octubre
🇪🇸Madrid, Spain
Hospital Universitario La Paz
🇪🇸Madrid, Spain
Hospital U. Marques de Valdecilla
🇪🇸Santander, Spain
AOU Careggi
🇮🇹Firenze, Italy
IRCCS Foundation Ca 'Granda Ospedale Maggiore Policlinico
🇮🇹Milano, Italy
Istituto Europeo di Oncologia
🇮🇹Milano, Italy
IRCCS San Raffaele Hospital
🇮🇹Milan, Italy
Aorn Antonio Cardarelli
🇮🇹Napoli, Italy
AOU Federico II
🇮🇹Napoli, Italy
AOU Maggiore della Carità
🇮🇹Novara, Italy
AO Ospedali Riuniti Villa Sofia-Cervello
🇮🇹Palermo, Italy
Ospedale Santa Maria delle Croci di Ravenna
🇮🇹Ravenna, Italy
Hospital Avicenne
🇫🇷Bobigny, France
CHU Grenoble Alpes
🇫🇷Grenoble, France
Institut Paoli-Calmettes
🇫🇷Marseille, France
Hôpital St Louis
🇫🇷Paris, France
University Hospital Nice L'Archet
🇫🇷Nice, France
Hospital Clinico Universitario de Santiago
🇪🇸Santiago De Compostela, Spain
Hospital Universitario y Politecnico La Fe
🇪🇸Valencia, Spain
City of Hope National Medical Center
🇺🇸Sacramento, California, United States
UC Davis Comprehensive Cancer Center
🇺🇸Sacramento, California, United States
Karmanos Cancer Center
🇺🇸Detroit, Michigan, United States
Henry Ford Health System
🇺🇸Detroit, Michigan, United States
University of Florida
🇺🇸Gainesville, Florida, United States
University of Chicago
🇺🇸Chicago, Illinois, United States
Wake Forest Baptist Medical Center
🇺🇸Winston-Salem, North Carolina, United States
Hospital Universitario Central de Asturias (HUCA)
🇪🇸Oviedo, Asturias, Spain