NCT05024552 - Vyxeos Plus Gilteritinib in Relapsed or Refractory, FLT3-Mutated AML | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

February 25, 2022

Primary Completion Date

February 15, 2027

Study Completion Date

March 31, 2027

Conditions

Acute Myeloid Leukemia With FLT3/ITD Mutation

Interventions

DRUG

Gilteritinib

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

DRUG

Vyxeos

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.

Trial Locations (1)

33612

RECRUITING

Moffitt Cancer Center, Tampa