CPX-351 vs Intensive Chemotherapy in Patients With de Novo Intermediate or Adverse Risk AML Stratified by Genomics

PHASE2RecruitingINTERVENTIONAL
Enrollment

210

Participants

Timeline

Start Date

May 3, 2023

Primary Completion Date

October 31, 2027

Study Completion Date

October 31, 2027

Conditions
Acute Myeloid Leukemia
Interventions
DRUG

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"

DRUG

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"

Trial Locations (30)

Unknown

RECRUITING

CHU Amiens Picardie site Sud, Amiens

RECRUITING

CH Avignon, Avignon

RECRUITING

CHRU Jean Minjoz, Besançon

RECRUITING

Centre Hospitalier de Béziers, Béziers

RECRUITING

Hôpital Avicenne APHP, Bobigny

RECRUITING

Institut d'hématologie de Basse Normandie (IHBN), Caen

RECRUITING

Hôpital d'Instruction des Armée (HIA), Clamart

RECRUITING

CHU Estaing, Clermont-Ferrand

RECRUITING

Centre Hospitalier Sud Francilien (CHSF), Corbeil-Essonnes

RECRUITING

CHU Henri Mondor, Créteil

RECRUITING

Centre Hospitalier de Versailles, Site André Mignot, Le Chesnay

RECRUITING

Hôpital Claude HURIEZ, CHU Lille, Lille

RECRUITING

CHU de Limoges, Limoges

RECRUITING

Hoptial de la Conception APHM, Marseille

RECRUITING

CHR Metz-Thionville Site Mercy, Metz

RECRUITING

Groupe hospitalier de la région de Mulhouse et Sud-Alsace, Hôpital Emile Muller, Mulhouse

NOT_YET_RECRUITING

Centre Antoine Lacassagne, Nice

RECRUITING

CHU de Nice, Nice

RECRUITING

Institut de cancérologie du Gard, Nîmes

RECRUITING

CHR Orléans, Orléans

RECRUITING

Hopital Necker, Paris

RECRUITING

Hôpital de la Pitié Salpêtrière, Paris

RECRUITING

Hôpital Saint-Antoine, Paris

RECRUITING

Hôpital Saint-Louis, Paris

RECRUITING

Hopital Lyon Sud, Pierre-Bénite

RECRUITING

CH de Roubaix, Roubaix

RECRUITING

Centre Henri Becquerel, Rouen

RECRUITING

CHU de Saint Etienne, Saint-Priest-en-Jarez

RECRUITING

Hopital Bretonneau, Tours

NOT_YET_RECRUITING

Institut Gustave Roussy, Villejuif

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Jazz Pharmaceuticals

INDUSTRY

collaborator

Acute Leukemia French Association

OTHER

lead

Centre Hospitalier Universitaire de Nice

OTHER