drugset / Trial / NCT07249346

Dose-Expansion Study of Low Dose Post-Transplant Cyclophosphamide/Tacrolimus/Ruxolitinib for Graft-versus-Host Disease (GVHD) Prophylaxis in Myeloablative Allogeneic Peripheral Blood Stem Cell Transplantation

NCT07249346

Phase 2 Recruiting 124 enrolled Hannah Choe, MD Incyte Corporation · collab
Non-randomizedSequentialOpen-labelTreatment

Summary

This is an open label, non-randomized, multicenter, pilot, dose expansion study of low dose post-transplant cyclophosphamide (25 mg/kg on Days +3 and +4)/tacrolimus/ruxolitinib in the setting of myeloablative conditioning (MAC) allogeneic peripheral blood stem cell transplantation (PBSCT).

Timeline

Start
2026-06-01
Primary completion
2027-06-01
Completion
2027-06-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Ruxolitinib Small molecule 5 mg Oral
Subject Ruxolitinib Small molecule 10 mg Oral
Background Cyclophosphamide Other / unclassified 25 mg/kg Intravenous
Background Tacrolimus Small molecule Oral