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MTX and Steroid for III-IV aGVHD Treatment

Acute Graft Versus Host Disease Clinical Trial

Official title:
A Single-cohort, Phase II Study of Methotrexate Combined Corticosteroid in Chinese Patients With Grade III-IV Acute Graft vs. Host Disease After Allogeneic Hematopoietic Stem Cell Transplantation

Clinical Trial 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).

Clinical Trial 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 cells is a key event in the development of aGVHD. Corticosteroid is the standard first-line therapy for aGVHD due to their roles in suppressing T cell responses. However, the response rate of corticosteroid was approximate 50%, and the clinical outcomes of patients with corticosteroid refractory GVHD were poor. Thus far, no combination therapy had been prove to be superior to corticosteroid alone as initial therapy for aGVHD. The study hypothesis: MTX combined corticosteroid treatment could help to further ameliorate the activity of T cells and control aGVHD. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04958538
Study type Interventional
Source Peking University People's Hospital
Contact Yu Wang, Dr.
Phone 86-13552647384
Email ywyw3172@sina.com
Status Recruiting
Phase Phase 2
Start date April 21, 2021
Completion date January 30, 2023
View Details
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