Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT05260528
PHASE2

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

Sponsor: Centre Hospitalier Universitaire de Nice

View on ClinicalTrials.gov

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

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

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