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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07156435 | Vyxeos® With Clofarabine for Pediatric AML | PHASE1 | RECRUITING | 25 | — | — | Nov 6, 2020 | Dec 31, 2028 | Sep 5, 2025 | 13 | Austria, Denmark +4 |
To establish the recommended phase 2 dose of Vyxeos®/CPX-351 in combination with clofarabine in children with relapsed/refractory AML
| Arm | Type | Description |
|---|---|---|
| Treatment with Vyxeos®/CPX-351 in combination with clofarabine | EXPERIMENTAL | Treatment will consist of 2 courses. An adapted regimen is used to combine Vyxeos®/CPX-351 at a fixed dose given at day 1, 3, 5 with clofarabine at the allocated dose level given at day 2-6 in course one, and only Vyxeos®/CPX-351 in course 2. A maximum of 3 dose levels of clofarabine are expected to be tested in this study. |
| Name | Type | Description |
|---|---|---|
| Vyxeos 44 MG / 100 MG Liposome Injection | DRUG | Vyxeos®/CPX-351 will be infused in 90 minutes on day 1, 3 and 5 only, 3 hours after the end of clofarabine (if administered on the same day). |
| Clofarabine | DRUG | Clofarabine infusion will be given according to the assigned dose level, over 2 hours IV, daily on day 2-6 (for 5 consecutive days). |
We will include pediatric patients ≥1 year and ≤21 years with: * Any ≥ 2nd relapse of AML * Refractory AML (defined as ≥ 20% blasts in the bone marrow after standard (re-) induction therapy) * Early 1st relapse (defined as relapse within one year from initial diagnosis) of AML * Any relapse of AML ...