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Efficacy and Safety of Anti-CD25 rhMAb in the Treatment of Steroid-Refractory cGVHD
Sponsor: Peking University People's Hospital
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.
Official title: 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
Key Details
Gender
All
Age Range
16 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
118
Start Date
2024-04-15
Completion Date
2028-06-30
Last Updated
2024-04-15
Healthy Volunteers
No
Conditions
Interventions
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.
Prednisone
Maintain pre-screening dose
Ruxolitinib
10mg, BID PO
Cyclosporine
1.25mg/kg, BID PO/IV, target:150-250ng/ml