Status:
UNKNOWN
MTX and Steroid for aGVHD Treatment
Lead Sponsor:
Peking University People's Hospital
Conditions:
Acute GVH Disease
Eligibility:
All Genders
16-65 years
Phase:
PHASE2
Brief 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...
Detailed Description
Allo-HSCT is an effective treatment of malignant hematopoietic diseases. However, aGVHD remains a major complication after allo-HSCT and the destruction of recipient tissues by alloantigen-activated T...
Eligibility Criteria
Inclusion
- Patients who are fully informed and sign informed consent by themselves or their guardians;
- Patients receiving allogeneic hematopoietic stem cell transplantation;
- Patients with acute graft-versus-host disease of grade II-IV were diagnosed after transplantation;
- Patients with stable implantation of granulocytes and platelets.
Exclusion
- Patients who have received more than one transplant;
- Patients with overlap syndrome;
- Patients within six months after the failure of the first transplantation;
- Patients with uncontrollable active infection;
- Patients with recurrence of primary malignant hematopathy;
- Patients with DLI or induced graft-versus-host disease after first intervention;
- Patients with serious respiratory diseases;
- Patients with severe renal insufficiency;
- Patients with serious and uncontrolled heart disease;
- Patients with severe hepatobiliary diseases unrelated to graft-versus-host disease;
- Within one week patients who need to use more than 1mg/kg/d methylprednisolone for reasons other than graft-versus-host disease;
- patients who have participated in other clinical trials within 1 month;
- The researcher judges that there are other factors that are not suitable for participating
Key Trial Info
Start Date :
December 23 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2022
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04677868
Start Date
December 23 2020
End Date
June 1 2022
Last Update
September 16 2021
Active Locations (1)
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1
Peking University Institute of Hematology,Beijing
Beijing, Beijing Municipality, China, 100044