Overview

MTX and Steroid for III-IV aGVHD Treatment

Status:
Recruiting
Trial end date:
2022-09-30
Target enrollment:
0
Participant gender:
All
Summary
The aim of the study is to identify the efficacy and safety of methotrexate (MTX) combined corticosteroid treatment for grade III-IV acute graft-versus-host disease (aGVHD) after allogeneic hematopoietic stem cell transplantation (allo-HSCT).
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Peking University People's Hospital
Treatments:
Methotrexate
Criteria
Inclusion Criteria:

1. Patients who are fully informed and sign informed consent by themselves or their
guardians;

2. Patients receiving allogeneic hematopoietic stem cell transplantation;

3. Patients with acute graft-versus-host disease of grade III-IV were diagnosed after
transplantation;

4. Patients with stable implantation of granulocytes and platelets.

Exclusion Criteria:

1. Patients who have received more than one transplant;

2. Patients with overlap syndrome;

3. Patients within six months after the failure of the first transplantation;

4. Patients with uncontrollable active infection;

5. Patients with recurrence of primary malignant hematopathy;

6. Patients with donor lymphocyte infusion induced graft-versus-host disease after first
intervention;

7. Patients with serious respiratory diseases;

8. Patients with severe renal insufficiency;

9. Patients with serious and uncontrolled heart disease;

10. Patients with severe hepatobiliary diseases unrelated to graft-versus host disease;

11. Within one week patients who need to use more than 1mg/kg/d methylprednisolone for
reasons other than graft-versus-host disease;

12. patients who have participated in other clinical trials within 1 month;

13. The researcher judges that there are other factors that are not suitable for
participating