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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05260528 | CPX-351 vs Intensive Chemotherapy in Patients With de Novo Intermediate or Adverse Risk AML Stratified by Genomics | PHASE2 | RECRUITING | 248 | — | — | May 3, 2023 | Feb 2, 2030 | Mar 27, 2026 | 35 | France |
| Arm | Type | Description |
|---|---|---|
| Standard arm | ACTIVE_COMPARATOR | conventional 7+3 chemotherapy |
| Investigational arm | EXPERIMENTAL | CPX-351 |
| Name | Type | Description |
|---|---|---|
| Cytarabine and Idarubicin | DRUG | Induction 1: Cytarabine 200 mg/m2 i.v. (continuously) d1-7 + Idarubicin 12mg/m2 d1, 2, 3 i.v (60 min) Induction 2: Cytarabine 1500 mg/m2 i.v. q12h d1-3 Consolidation: Cytarabine 1500 mg/m2 i.v. q12h d1-3 |
| CPX-315 | DRUG | Induction 1:CPX-351 44 mg/m2 daunorubicin / 100 mg/m2 cytarabine i.v. (90 min) d1,3,5 Induction 2: CPX-351 44 mg/m2 daunorubicin / 100 mg/m2 cytarabine i.v. (90 min) d1,3 Consolidation therapy:CPX-351 29 mg/m2 daunorubicin / 65 mg/m2 cytarabine i.v. (90 min) d1,3 |
Inclusion Criteria: 1. De novo AML 2. No MRC-defining cytogenetic lesion 3. No t(15;17), t(8;21), inv(16) or t(16;16) 4. No NPM1 gene mutation 5. No FLT3 mutated AML (FLT3 ITD or TKD) 6. Not previously treated except for short course hydroxyurea in patients presenting with high WBC count and/or tum...