Clinical trial NCT03250338: Study Investigating the Efficacy of Crenolanib With Chemotherapy vs Chemotherapy Alone in R/R FLT3 Mutated AML
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Relapsed/Refractory Acute Myeloid Leukemia With FLT3 Activating Mutations
Lead sponsor: Arog Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2017-08-15
Enrollment: 322
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Event-free survival (EFS)
timeFrame: 3 years
Secondary outcomes:
measure: Overall Survival
timeFrame: 3 years
measure: Relapse-free Survival (RFS)
timeFrame: 3 years
measure: Complete remission rate (CR)
timeFrame: 3 years
measure: MRD negative complete remission rate
timeFrame: 3 years
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: City of Hope National Medical Center
state: California
city: Sacramento
country: United States
facility: UC Davis Comprehensive Cancer Center
state: California
city: Gainesville
country: United States
facility: University of Florida
state: Florida
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Kansas City
country: United States
facility: Kansas University
state: Kansas
city: Detroit
country: United States
facility: Karmanos Cancer Center
state: Michigan
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
city: Buffalo
country: United States
facility: Roswell Park Cancer Institute
state: New York
city: Winston-Salem
country: United States
facility: Wake Forest Baptist Medical Center
state: North Carolina
city: Edmonton
country: Canada
facility: University of Alberta
state: Alberta
city: Bobigny
country: France
facility: Hospital Avicenne
city: Grenoble
country: France
facility: CHU Grenoble Alpes
city: Le Chesnay
country: France
facility: Hospital Center of Versailles (Le Chesnay)
city: Lille
country: France
facility: Hospital Claude Huriez - Chru Lille
city: Marseille
country: France
facility: Institut Paoli-Calmettes
city: Nantes
country: France
facility: CHU de Nantes - Hôtel Dieu
city: Nice
country: France
facility: University Hospital Nice L'Archet
city: Paris
country: France
facility: Hôpital St Louis
city: Pessac
country: France
facility: CHU de Bordeaux
city: Pierre-Bénite
country: France
facility: Centre Hospitalier Lyon Sud
city: Poitiers
country: France
facility: CHU de Poitiers
city: Toulouse
country: France
facility: Institut Universitaire du Cancer Toulouse
city: Chemnitz
country: Germany
facility: Klinikum Chemnitz gGmbH
city: Dresden
country: Germany
facility: Technische Universität Dresden
city: Essen
country: Germany
facility: Universitätsklinikum Essen (AöR)
city: Frankfurt
country: Germany
facility: Universitätsklinikum Frankfurt
city: Halle
country: Germany
facility: Universitätsklinikum Halle (Saale)
city: Münster
country: Germany
facility: Universitätsklinikum Münster
city: Roma
country: Italy
facility: Policlinico Tor Vergata
state: RM
city: Bologna
country: Italy
facility: AOU Policlinico Sant'Orsola-Malpighi
city: Brescia
country: Italy
facility: ASST Spedali Civili di Brescia
city: Firenze
country: Italy
facility: AOU Careggi
city: Meldola
country: Italy
facility: IRST - Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
city: Milano
country: Italy
facility: IRCCS Foundation Ca 'Granda Ospedale Maggiore Policlinico
city: Milano
country: Italy
facility: Istituto Europeo di Oncologia
city: Milan
country: Italy
facility: IRCCS San Raffaele Hospital
city: Napoli
country: Italy
facility: Aorn Antonio Cardarelli
city: Napoli
country: Italy
facility: AOU Federico II
city: Novara
country: Italy
facility: AOU Maggiore della Carità
city: Palermo
country: Italy
facility: AO Ospedali Riuniti Villa Sofia-Cervello
city: Pesaro
country: Italy
facility: AO Ospedali Riuniti Marche Nord
city: Ravenna
country: Italy
facility: Ospedale Santa Maria delle Croci di Ravenna
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario Agostino Gemelli
city: Torino
country: Italy
facility: A.O.U. Città della Salute e della Scienza di Torino
city: Torino
country: Italy
facility: AO Ordine Mauriziano di Torino
city: Verona
country: Italy
facility: Policlinico GB Rossi, University Hospital Verona
city: Vicenza
country: Italy
facility: AULSS n 8 Berica Ospedale San Bortolo
city: Sevilla
country: Spain
facility: Hospital U. Virgen del Rocio
state: Andalucia
city: Oviedo
country: Spain
facility: Hospital Universitario Central de Asturias (HUCA)
state: Asturias
city: A Coruña
country: Spain
facility: Complejo Hospitalario Universitario A Coruna
city: Cáceres
country: Spain
facility: San Pedro de Alcantara Hospital
city: Córdoba
country: Spain
facility: Reina Sofia University Hospital
city: Donostia San Sebastian
country: Spain
facility: Hospital Universitario de Donostia
city: Madrid
country: Spain
facility: Hospital Ramon y Cajal
city: Madrid
country: Spain
facility: Fundacion Jimenez Diaz
city: Madrid
country: Spain
facility: Hospital 12 de Octubre
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Madrid
country: Spain
facility: Hospital Gregorio Maranon Servicio de Hematologia y Hemoterapia
city: Salamanca
country: Spain
facility: Hospital Clinico Universitario de Salamanca
city: Santander
country: Spain
facility: Hospital U. Marques de Valdecilla
city: Santiago De Compostela
country: Spain
facility: Hospital Clinico Universitario de Santiago
city: Valencia
country: Spain
facility: Hospital Universitario y Politecnico La Fe
Study officials:
affiliation: Roswell Park Cancer Institute, Buffalo, New York, United States, 14263
name: Eunice Wang, MD
role: PRINCIPAL_INVESTIGATOR
References: