Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Daunorubicin · 1 trial · 1 indication
| 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...
Daunorubicin is an investigational small molecule being studied for the treatment of Acute Myeloid Leukemia (AML). It is currently in Phase 3 clinical development as part of a study evaluating standard intensive chemotherapy versus intensive chemotherapy with CPX-351 in adult patients with newly diagnosed AML and intermediate- or adverse genetics.
Daunorubicin is being developed by Jazz Pharmaceuticals plc, which trades under the ticker JAZZ. The company is conducting a Phase 3 clinical trial of the drug in patients with Acute Myeloid Leukemia.
Daunorubicin is in Phase 3 clinical development. It is an investigational drug, not yet approved, and is being studied in an active, not recruiting clinical trial for Acute Myeloid Leukemia.
Daunorubicin is being studied in clinical trial NCT03897127, a Phase 3 study of standard intensive chemotherapy versus intensive chemotherapy with CPX-351 in adult patients with newly diagnosed Acute Myeloid Leukemia and intermediate- or adverse genetics. The trial is active but not recruiting, with an enrollment of 882 participants.
Daunorubicin is not the same as CPX-351. In the clinical trial NCT03897127, CPX-351 is the investigational agent being compared to standard intensive chemotherapy, and Daunorubicin is a component of that standard chemotherapy regimen.