drugset / Trial / NCT05260528
CPX-351 vs Intensive Chemotherapy in Patients With de Novo Intermediate or Adverse Risk AML Stratified by Genomics
Phase 2
Recruiting
248 enrolled
Centre Hospitalier Universitaire de Nice
Acute Leukemia French Association · collabJazz Pharmaceuticals · collab
RandomizedParallel-groupOpen-labelTreatment
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
Timeline
- Start
- 2023-05-03
- Primary completion
- 2028-08-02
- Completion
- 2030-02-02
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | CPX-351 | Other / unclassified | 29 mg/m2 | Intravenous |
| Subject | CPX-351 | Other / unclassified | 44 mg/m2 | Intravenous |
| Subject | CPX-351 | Other / unclassified | 65 mg/m2 | Intravenous |
| Subject | CPX-351 | Other / unclassified | 100 mg/m2 | Intravenous |
| Comparator | Cytarabine | Small molecule | 200 mg/m2 | Intravenous |
| Comparator | Cytarabine | Small molecule | 1500 mg/m2 | Intravenous |
| Comparator | Idarubicin | Small molecule | 12 mg/m2 | Intravenous |