Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
CPX-315 · 1 trial · 1 indication
| 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...
CPX-315 is an investigational small molecule being developed for the treatment of Acute Myeloid Leukemia (AML). It is currently in Phase 2 clinical development and is being studied in patients with de novo intermediate or adverse risk AML.
CPX-315 is being developed by Jazz Pharmaceuticals plc, a biopharmaceutical company listed on the NASDAQ under the ticker symbol JAZZ. The company is conducting a Phase 2 clinical trial of CPX-315 in patients with Acute Myeloid Leukemia.
CPX-315 is currently in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. A Phase 2 trial is actively recruiting participants to evaluate its efficacy and safety in Acute Myeloid Leukemia.
CPX-315 is being evaluated in a Phase 2 clinical trial with the identifier NCT05260528. This randomized, active-controlled study compares CPX-315 to intensive chemotherapy in patients with de novo intermediate or adverse risk AML, stratified by genomics. The trial is recruiting in France and aims to enroll 248 participants aged 18 years and older.
CPX-315 is not the same as CPX-351. CPX-315 is a distinct investigational drug being developed by Jazz Pharmaceuticals. The Phase 2 trial NCT05260528 compares CPX-315 against intensive chemotherapy, which may include CPX-351 as a comparator, but the two are separate agents.