NCT06364319

Efficacy and Safety of Anti-CD25 rhMAb in the Treatment of Steroid-Refractory cGVHD

Study on the Efficacy and Safety of Anti-CD25 rhMAb in the Treatment of Steroid-Refractory Chronic Graft-Versus-Host Disease (cGVHD) of the Liver Following Allogeneic Hematopoietic Stem Cell Transplantatio

• Status: Not Yet Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 118 (estimated)
• Sponsor: Peking University People's Hospital · Academic / Other
• Sex: All
• Age: 16 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The study plan aims to include patients who have been diagnosed with steroid-refractory chronic GVHD in the liver following allogeneic hematopoietic stem cell transplantation. After obtaining informed consent, the patients will be randomly assigned to either the Anti-CD25 rhMAb treatment group or the traditional treatment group. The objective is to assess the effectiveness and safety of Anti-CD25 rhMAb in the treatment of severe chronic GVHD affecting the liver.

Conditions

• cGVHD

Interventions

Type	Name	Description
DRUG	anti-CD25 rhMAb	1 mg/kg/day administered IV day 1, 4, and 8, then weekly for 6 doses. For patients achieving partial remission, an extra dose of Anti-CD25 rhMAb can be given on days 39 and 49.
DRUG	Prednisone	Maintain pre-screening dose
DRUG	Ruxolitinib	10mg, BID PO
DRUG	Cyclosporine	1.25mg/kg, BID PO/IV, target:150-250ng/ml

Timeline

• Start date: 2024-04-15
• Primary completion: 2027-12-31
• Completion: 2028-06-30
• First posted: 2024-04-15
• Last updated: 2024-04-15