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.
Study 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.
Eligibility
Sex
ALL
Min age
14 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* Malignant hematologic diseases eligible for allogeneic hematopoietic stem cell transplantation, including MDS-RAEB, acute leukemia, and CML in chronic phase
* Availability of HLA-matched sibling donors, unrelated donors, or haploidentical donors
* Age 14 years and older
* Liver function: ALT and AST ≤ 2.5 times the upper limit of normal, bilirubin ≤ 2 times the upper limit of normal
* Kidney function: creatinine ≤ upper limit of normal
* No uncontrolled infections or severe psychiatric disorders
* Performance status 0-2 (ECOG)
* Signed informed consent
* Patients with acute gastrointestinal GVHD after transplantation (according to MAGIC criteria)
Exclusion Criteria:
* No suitable allogeneic donor
* Non-gastrointestinal GVHD as the main manifestation
* Either donor or recipient is pregnant
* Psychiatric illness or other conditions preventing protocol compliance
Primary outcome measure(s)
28-day overall response rate (ORR) of acute gastrointestinal GVHD — 28-day 28-day gastrointestinal aGVHD ORR: CR+PR rate at Day 28 per MAGIC criteria.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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