RecruitingPhase 2NCT05260528

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

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

Sponsor

Centre Hospitalier Universitaire de Nice

Enrollment

248 participants

Start Date

May 3, 2023

Study Type

INTERVENTIONAL

Conditions

Acute Myeloid Leukemia

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

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two different chemotherapy approaches for older adults with a newly diagnosed type of blood cancer called acute myeloid leukemia (AML). One arm uses a standard treatment (7+3 chemotherapy) and the other uses a newer formulation called CPX-351, to see which works better for patients without certain high-risk genetic features. **You may be eligible if...** - You are 50 years or older - You have been newly diagnosed with AML and have not received prior treatment (except for a short course of a drug called hydroxyurea) - Your AML does not have certain specific genetic abnormalities (your doctor will check for these) - You are in reasonably good physical condition (ECOG 0–2) - Your organ function is adequate based on lab tests - You are not pregnant or breastfeeding **You may NOT be eligible if...** - You have previously been treated for AML - Your AML has certain genetic mutations (such as NPM1, FLT3, or specific chromosome changes) - You have serious heart, liver, or kidney problems - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCytarabine 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

DRUGCPX-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

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NCT05260528

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