Overview

Study of Standard Intensive Chemotherapy Versus Intensive Chemotherapy With CPX-351 in Adult Patients With Newly Diagnosed AML and Intermediate- or Adverse Genetics

Status:
Recruiting

Trial end date:
2024-03-01

Target enrollment:

Participant gender:

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. Event-free survival (EFS) will be the primary endpoint as defined by standard criteria (Döhner 2017).

Phase:

Phase 3

Details

Lead Sponsor:

University of Ulm

Collaborator:

Jazz Pharmaceuticals

Treatments:

Cytarabine
Daunorubicin