NCT03897127

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

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

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 882 (estimated)
• Sponsor: University of Ulm · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Acute Myeloid Leukemia

Interventions

Type	Name	Description
DRUG	Cytarabine	Induction therapy: 200 mg/m2 i.v. (continuously) d1-7 Consolidation therapy: * Patients age 18-60 years o Intermediate-dose cytarabine 1500 mg/m2 i.v. q12h (3 hrs) d1-3 * Patients age \>60 years o Intermediate-dose cytarabine 1000 mg/m2 i.v. q12h (3 hrs) d1-3
DRUG	Daunorubicin	Induction therapy: 60 mg/m2 i.v. (1 hr) d1-3
DRUG	CPX-351	Induction 1: o CPX-351 44 mg/m2 daunorubicin / 100 mg/m2 cytarabine \[100 U/m²\] i.v. (90 min) d1,3,5 Induction 2: o CPX-351 44 mg/m2 daunorubicin / 100 mg/m2 cytarabine \[100 U/m²\] i.v. (90 min) d1,3 Consolidation therapy: o CPX-351 29 mg/m2 daunorubicin / 65 mg/m2 cytarabine \[65 U/m²\] i.v. (90 min) d1,3

Timeline

• Start date: 2019-09-04
• Primary completion: 2027-06-01
• Completion: 2027-06-01
• First posted: 2019-04-01
• Last updated: 2025-07-17

Locations

62 sites across 2 countries: Austria, Germany

Regulatory

• FDA-regulated drug study