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CPX-351 vs Intensive Chemotherapy in Patients With de Novo Intermediate or Adverse Risk AML Stratified by Genomics
Sponsor: Centre Hospitalier Universitaire de Nice
Summary
The trial is a randomized, open-label phase II study comparing CPX-351 vs conventional intensivechemotherapy in patients with newly diagnosed de novo AML and intermediate- or adverse-risk genetics
Official title: An ALFA 2101 Multicenter Randomized Phase II Study: CPX-351 Versus Intensive Chemotherapy in Patients With de Novo Intermediate or Adverse Risk AML Stratified by Genomics
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
248
Start Date
2023-05-03
Completion Date
2030-02-02
Last Updated
2026-03-27
Healthy Volunteers
No
Conditions
Interventions
Cytarabine and Idarubicin
Induction 1: Cytarabine 200 mg/m2 i.v. (continuously) d1-7 + Idarubicin 12mg/m2 d1, 2, 3 i.v (60 min) Induction 2: Cytarabine 1500 mg/m2 i.v. q12h d1-3 Consolidation: Cytarabine 1500 mg/m2 i.v. q12h d1-3
CPX-315
Induction 1:CPX-351 44 mg/m2 daunorubicin / 100 mg/m2 cytarabine i.v. (90 min) d1,3,5 Induction 2: CPX-351 44 mg/m2 daunorubicin / 100 mg/m2 cytarabine i.v. (90 min) d1,3 Consolidation therapy:CPX-351 29 mg/m2 daunorubicin / 65 mg/m2 cytarabine i.v. (90 min) d1,3
Locations (35)
CHU Amiens Picardie site Sud
Amiens, France
CHU d'Angers
Angers, France
CH Avignon
Avignon, France
CHRU Jean Minjoz
Besançon, France
Centre Hospitalier de Béziers
Béziers, France
Hôpital Avicenne APHP
Bobigny, France
Institut d'hématologie de Basse Normandie (IHBN)
Caen, France
Hôpital d'Instruction des Armée (HIA)
Clamart, France
CHU Estaing
Clermont-Ferrand, France
Centre Hospitalier Sud Francilien (CHSF)
Corbeil-Essonnes, France
CHU Henri Mondor
Créteil, France
Centre Hospitalier de Versailles, Site André Mignot
Le Chesnay, France
Hôpital Claude HURIEZ, CHU Lille
Lille, France
CHU de Limoges
Limoges, France
Hoptial de la Conception APHM
Marseille, France
Institut Paoli Calmettes
Marseille, France
CHR Metz-Thionville Site Mercy
Metz, France
Groupe hospitalier de la région de Mulhouse et Sud-Alsace, Hôpital Emile Muller
Mulhouse, France
CHU de Nantes
Nantes, France
Centre Antoine Lacassagne
Nice, France
CHU de Nice
Nice, France
Institut de cancérologie du Gard
Nîmes, France
CHR Orléans
Orléans, France
Hopital Necker
Paris, France
Hôpital de la Pitié Salpêtrière
Paris, France
Hôpital Saint-Antoine
Paris, France
Hôpital Saint-Louis
Paris, France
CHU de Bordeaux
Pessac, France
Hopital Lyon Sud
Pierre-Bénite, France
CH de Roubaix
Roubaix, France
Centre Henri Becquerel
Rouen, France
CHU de Saint Etienne
Saint-Priest-en-Jarez, France
CHU de Toulouse
Toulouse, France
Hopital Bretonneau
Tours, France
Institut Gustave Roussy
Villejuif, France