drugset / Trial / NCT04342962

Tagraxofusp in Patients With CD123+ or With BPDCN-IPh-like Acute Myeloid Leukemia

NCT04342962

Phase 2 Terminated 25 enrolled GIMEMA Foundation
NaSingle-groupOpen-labelTreatment

Summary

Non-randomized, open-label, multicenter phase II Study for the treatment of * 25 R/R BPDCN-IF (CD123/CD4/CD56 positive) AML patients and * 25 patients presenting R/R AML CD123+, but negative for either, or both, CD4 and CD56. Patients will be treated with 12 mcg/kg/day of tagraxofusp for 5 days, for at least 4 cicles.

Timeline

Start
2021-02-16
Primary completion
2024-01-18
Completion
2024-01-18

Drugs

EvaluationDrugModalityDoseRoute
Subject Tagraxofusp Protein / enzyme biologic 12 ug/kg Intravenous