Mini-dose MTX Plus Standard-dose Steroid for the Initial Treatment of Acute GVHD
Recruiting
Phase 3
Interventional Study
Acute Graft Versus Host Disease
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 15 – 65
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 218 (estimated)
- Sponsor
- Peking University People's Hospital · Other
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About This Trial
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.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. Patients who are fully informed and sign informed consent by themselves or their guardians;
2. Patients receiving first allogeneic hematopoietic stem cell transplantation;
3. Patients with acute graft-versus-host disease of grade II-IV were diagnosed after transplantation;
4.…