drugset / Trial / NCT07796620

Sirolimus+Ruxolitinib+Mycophenolate Mofetil for Prophylaxis of aGVHD in Patients Receiving Haplo-HSCT Who Are Intolerant to CNI

NCT07796620 ↗

Phase 1/2 Not yet recruiting 40 enrolled Peking University People's Hospital
NaSingle-groupOpen-labelPrevention

Summary

Graft-versus-host disease (GVHD) is an important complication after transplantation, with an incidence of 40-60%, which can increase non-relapse mortality if poorly controlled. At present, the standard prophylaxis for GVHD is cyclosporine combined with methotrexate. However, calcineurin inhibitors (CNI) can cause some vital side effects, which are not tolerated by some patients. Therefore, this study aims to explore the safety and efficacy of Sirolimus in combination with Ruxolitinib and Mycophenolate Mofetil for the prophylaxis of GVHD in patients with haplo-HSCT who are intolerant to calcineurin inhibitors.

Timeline

Start
2026-10-01
Primary completion
2027-09-30
Completion
2028-09-30

Drugs

EvaluationDrugModalityDoseRoute
Subject ANTILYMPHOCYTE IMMUNOGLOBULIN (HORSE) Protein / enzyme biologic 2.5 mg/kg —
Subject Mycophenolate Mofetil Small molecule 500 mg —
Subject Ruxolitinib Small molecule 5 mg —
Subject Sirolimus Small molecule 2 mg —