Mini-dose MTX Plus Standard-dose Steroid for the Initial Treatment of Acute GVHD

Recruiting now · Phase 3

Conditions studied: Acute Graft Versus Host Disease

In brief

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.

Key facts

Study ID: NCT05921305
Run by: Peking University People's Hospital
People needed: 218
Starts: 2023-08-03
Expected to finish: 2026-09-30
Last updated by the study team: 2025-06-03

Who can join

Age: 15 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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 may not qualify if…

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

Where it is running

Peking University Institute of Hematology, — Beijing, Beijing Municipality, China (enrolling)
Nanfang Hospital, Nanfang Medical University — Guangzhou, Guangdong, China (enrolling)

Full record on ClinicalTrials.gov

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