Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03897127 | Study of Standard Intensive Chemotherapy Versus Intensive Chemotherapy With CPX-351 in Adult Patients With Newly Diagnosed AML and Intermediate- or Adverse Genetics | PHASE3 | ACTIVE NOT_RECRUITING | 882 | — | — | Sep 4, 2019 | Jun 1, 2027 | Jul 17, 2025 | 62 | Austria, Germany |
| Arm | Type | Description |
|---|---|---|
| Standard arm | ACTIVE_COMPARATOR | - |
| Investigational arm | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Cytarabine | DRUG | 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 |
| Daunorubicin | DRUG | Induction therapy: 60 mg/m2 i.v. (1 hr) d1-3 |
| CPX-351 | DRUG | 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 |
Patient Inclusion Criteria: 1. Patients with newly diagnosed AML and intermediate- or adverse-risk genetics (according to 2017 ELN criteria \[Appendix B\]), including AML with myelodysplasia-related changes (AML-MRC) and therapy-related AML according to the World Health Organization (WHO) classific...