Informations générales (source: ClinicalTrials.gov)
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
Interventional
Phase 3
Arog Pharmaceuticals, Inc. (Voir sur ClinicalTrials)
août 2018
avril 2026
09 mai 2026
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.
Etablissements
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| AP-HP - Hôpital Avicenne | Thorsten Braun, MD | Contact (sur clinicalTrials) | |||
| CH DE VERSAILLES SITE ANDRE MIGNOT | Philippe Rousselot, MD | Contact (sur clinicalTrials) | |||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Centre Hospitalier Lyon Sud - 69494 - Pierre-Bénite - France | Xavier Thomas, MD | Contact (sur clinicalTrials) | |||
| CHU de Bordeaux - 33604 - Pessac - France | Arnaud Pigneux, MD | Contact (sur clinicalTrials) | |||
| CHU de Nantes - Hôtel Dieu - 44093 - Nantes - France | Pierre Peterlin, MD | Contact (sur clinicalTrials) | |||
| CHU de Poitiers - 86021 - Poitiers - France | Maria-Pilar Gallego-Hernanz, MD | Contact (sur clinicalTrials) | |||
| CHU Grenoble Alpes - 38043 - Grenoble - France | Jean-Yves Cahn, MD | Contact (sur clinicalTrials) | |||
| Hôpital St Louis - 75010 - Paris - France | Emmanuel Raffoux, MD | Contact (sur clinicalTrials) | |||
| Hospital Claude Huriez - Chru Lille - 59037 - Lille - France | Bruno Quesnel, MD | Contact (sur clinicalTrials) | |||
| Institut Paoli-Calmettes - 13009 - Marseille - France | Norbert Vey, MD | Contact (sur clinicalTrials) | |||
| Institut Universitaire du Cancer Toulouse - 31059 - Toulouse - France | Christian Recher, MD | Contact (sur clinicalTrials) | |||
| University Hospital Nice L'Archet - 06200 - Nice - France | Thomas Cluzeau | Contact (sur clinicalTrials) | |||
Critères
Tous
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.