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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05024552 | Vyxeos Plus Gilteritinib in Relapsed or Refractory, FLT3-Mutated AML | PHASE1 | RECRUITING | 22 | — | — | Feb 25, 2022 | Mar 1, 2027 | Dec 5, 2025 | 1 | United States |
Dose escalation will determine the Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D) of Vyxeos plus Gilteritinib. The MTD is the highest dose of the combination therapy that dose not cause unacceptable side effects.
| Arm | Type | Description |
|---|---|---|
| Dose Escalation Arm | EXPERIMENTAL | Participants will receive intravenous Vyxeos on days 1, 3 and 5 and Gilteritinib will be given on days 6-19 of induction therapy. The induction and reinduction dose of Vyxeos is 44mg/m2 daunorubicin and 100mg/m2 of cytarabine with each infusion. Dose level 1: Vyxeos + 120 mg Gilertinib In the event of a dose-limiting toxicity (DLT) at the initial dose level, a dose level minus (-) 1 is permitted Dose Level -1: Vyxeos + 80 mg Gilertinib |
| Dose Expansion Arm | EXPERIMENTAL | Participants will receive intravenous Vyxeos on days 1, 3 and 5 and Gilteritinib will be given on days 6-19 of induction therapy in the dose determined in the dose escalation arm. |
| Name | Type | Description |
|---|---|---|
| Gilteritinib | DRUG | Gilteritinib is an oral inhibitor of FLT3-ITD and FLT3-TKD. Dose cohort 1 will receive 120mg daily on days 6-19 of induction and days 4-17 of re-induction and consolidation |
| Vyxeos | DRUG | Vyxeos is a liposomal encapsulation of cytarabine and daunorubicin. It is given as an intravenous infusion over 90 minutes on days 1, 3 and 5 of induction and days 1 and 3 of re-induction and consolidation. The induction and reinduction dose is 44mg/m2 daunorubicin and 100mg/m2 of cytarabine with each infusion. The consolidation dose is 29mg/m2 daunorubicin and 65mg/m2 of cytarabine with each dose. |
Inclusion Criteria: * Provision of signed and dated informed consent form * Stated willingness to comply with all study procedures and availability for the duration of the study * Eastern Cooperative Oncology Group (ECOG) performance status ≤2 * FLT3-ITD or FLT3-TKD mutated AML (non-M3) in 1st or g...