drugset / Trial / NCT03897127
Study of Standard Intensive Chemotherapy Versus Intensive Chemotherapy With CPX-351 in Adult Patients With Newly Diagnosed AML and Intermediate- or Adverse Genetics
RandomizedParallel-groupOpen-labelTreatment
Summary
The trial is a randomized, open-label phase III study comparing CPX-351 vs conventional intensive induction and consolidation chemotherapy in patients with newly diagnosed AML and intermediate- or adverse-risk genetics (according to 2017 ELN criteria), including AML with myelodysplasia-related changes (AML-MRC) and therapy-related AML according to the World Health Organization (WHO) classification. Overall survival (OS) in the restricted set of de novo patients will be the primary endpoint.
Timeline
- Start
- 2019-09-04
- Primary completion
- 2027-06
- Completion
- 2027-06
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 | 1000 mg/m2 | Intravenous |
| Comparator | Cytarabine | Small molecule | 1500 mg/m2 | Intravenous |
| Comparator | Daunorubicin | Small molecule | 60 mg/m2 | Intravenous |