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Prospective Randomized Controlled Study: Amimaitosai Injection Combined With Corticosteroids for Gastrointestinal aGVHD
Sponsor: Chinese PLA General Hospital
Summary
This study focuses on patients with gastrointestinal-dominant acute graft-versus-host disease (aGVHD) after allogeneic hematopoietic stem cell transplantation. AmiMetosai Injection combined with corticosteroids is administered as first-line treatment. The objective is to evaluate the efficacy and safety of AmiMetosai Injection combined with corticosteroids for the treatment of gastrointestinal aGVHD.
Official title: Aprospective, Randomized, Controlled Study of Amimaitosai Injection Combined With Corticosteroids for the Treatment Ofgastrointestinal Acute Graft-versus-host Disease
Key Details
Gender
All
Age Range
14 Years - Any
Study Type
INTERVENTIONAL
Enrollment
60
Start Date
2026-05-01
Completion Date
2029-05-01
Last Updated
2026-09-04
Healthy Volunteers
No
Interventions
Amimaitosai injection
Amimaitosai injection (1×10⁶ cells/kg per infusion, twice weekly for 4 weeks; may extend to 8 weeks for partial responders).
Methylprednisolone
Experimental Arm：Methylprednisolone at a daily dose of 1 mg/kg. Active Comparator Arm：Methylprednisolone at a daily dose of 2 mg/kg.
Locations (1)
Chinese PLA General Hospital
Beijing, Beijing Municipality, China