MTX and Steroid for aGVHD Treatment

• Status: Recruiting
• Trial end date: 2022-06-01
• 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 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 II-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 DLI or 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