CPX-351 vs Intensive Chemotherapy in Patients With de Novo Intermediate or Adverse Risk AML Stratified by Genomics
Condition(s) studied
Investigational drug(s) / intervention(s)
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
Study 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
Primary outcome measure(s)
- Improvement in the proportion of patients achieving deep remission (CR)/(CRi) with a standardized flow based MRD in the BM aspirate using the LAIP/Dfn method after the 1st induction — 28-56 days
Trial sites (35)
| Facility | City | Region | Status |
|---|---|---|---|
| CHU Amiens Picardie site Sud | Amiens | France | Recruiting |
| CHU d'Angers | Angers | France | Not Yet Recruiting |
| CH Avignon | Avignon | France | Recruiting |
| CHRU Jean Minjoz | Besançon | France | Recruiting |
| Centre Hospitalier de Béziers | Béziers | France | Recruiting |
| Hôpital Avicenne APHP | Bobigny | France | Recruiting |
| Institut d'hématologie de Basse Normandie (IHBN) | Caen | France | Recruiting |
| Hôpital d'Instruction des Armée (HIA) | Clamart | France | Recruiting |
| CHU Estaing | Clermont-Ferrand | France | Recruiting |
| Centre Hospitalier Sud Francilien (CHSF) | Corbeil-Essonnes | France | Recruiting |
| CHU Henri Mondor | Créteil | France | Recruiting |
| Centre Hospitalier de Versailles, Site André Mignot | Le Chesnay | France | Recruiting |
| Hôpital Claude HURIEZ, CHU Lille | Lille | France | Recruiting |
| CHU de Limoges | Limoges | France | Recruiting |
| Hoptial de la Conception APHM | Marseille | France | Recruiting |
| Institut Paoli Calmettes | Marseille | France | Recruiting |
| CHR Metz-Thionville Site Mercy | Metz | France | Recruiting |
| Groupe hospitalier de la région de Mulhouse et Sud-Alsace, Hôpital Emile Muller | Mulhouse | France | Recruiting |
| CHU de Nantes | Nantes | France | Not Yet Recruiting |
| Centre Antoine Lacassagne | Nice | France | Not Yet Recruiting |
| CHU de Nice | Nice | France | Recruiting |
| Institut de cancérologie du Gard | Nîmes | France | Recruiting |
| CHR Orléans | Orléans | France | Recruiting |
| Hopital Necker | Paris | France | Recruiting |
| Hôpital de la Pitié Salpêtrière | Paris | France | Recruiting |
| Hôpital Saint-Antoine | Paris | France | Recruiting |
| Hôpital Saint-Louis | Paris | France | Recruiting |
| CHU de Bordeaux | Pessac | France | Recruiting |
| Hopital Lyon Sud | Pierre-Bénite | France | Recruiting |
| CH de Roubaix | Roubaix | France | Recruiting |
| Centre Henri Becquerel | Rouen | France | Recruiting |
| CHU de Saint Etienne | Saint-Priest-en-Jarez | France | Recruiting |
| CHU de Toulouse | Toulouse | France | Recruiting |
| Hopital Bretonneau | Tours | France | Recruiting |
| Institut Gustave Roussy | Villejuif | France | Recruiting |
More Centre Hospitalier Universitaire de Nice trials in France
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05260528 on ClinicalTrials.gov ↗ ← All trials in France