Actively Recruiting
Mini-dose MTX Plus Standard-dose Steroid for the Initial Treatment of Acute GVHD
Led by Peking University People's Hospital · Updated on 2025-06-03
218
Participants Needed
2
Research Sites
164 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This trial is a randomized (1:1) phase III open label study of frontline mini-MTX plus methylprednisolone 2mg/kg/day compared to methylprednisolone 2mg/kg in allogeneic stem cell transplant recipients with grade 2-4 aGVHD.
CONDITIONS
Official Title
Mini-dose MTX Plus Standard-dose Steroid for the Initial Treatment of Acute GVHD
Who Can Participate
Eligibility Criteria
You may qualify if you...
-
Patients who are fully informed and sign informed consent by themselves or their guardians;
-
Patients receiving first allogeneic hematopoietic stem cell transplantation;
-
Patients with acute graft-versus-host disease of grade II-IV were diagnosed after transplantation;
-
KPS>60, Estimated survival >3 months;
-
No serious organ damage:
- ANC in peripheral blood is greater than 0.5×109/l
- Creatinine < 1.5mg/dl
- Cardiac ejection index > 55%
You will not qualify if you...
- Patients with severe brain, heart, kidney or liver dysfunction unrelated to graft-versus host disease;
- Patients with uncontrollable active infection;
- Patients with recurrence of primary malignant hematopathy;
- Expected survival is less than 3 months
- Patients who have histories of severe allergic reactions
- Pregnant or lactating women
- The researcher judges that there are other factors that are not suitable for participating
- Patients who received donor lymphocyte infusion
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
Peking University Institute of Hematology,
Beijing, Beijing Municipality, China, 100044
Actively Recruiting
2
Nanfang Hospital, Nanfang Medical University
Guangzhou, Guangdong, China, 510515
Actively Recruiting
Research Team
Y
Yu Wang, M.D.
CONTACT
X
Xiao-Jun Huang, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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