Other Clinical Trial - MAP-guided Preemptive Therapy of aGvHD

Status Recruiting

Clinical Trial Summary

Acute graft versus host disease (aGvHD) is a severe and potentially fatal complication of allogeneic hematopoietic stem cell transplantation (HCT). The Mount Sinai Acute GVHD International Consortium (MAGIC) algorithm probability (MAP) identifies patients who are at high risk for severe aGvHD as early as 7 days after HCT based on 2 serum biomarkers, suppressor of tumorigenesis 2 (ST2) and regenerating islet-derived 3α (Reg3α). Patients who consent to this study will have their blood tested weekly up to four times within the first month post HCT to determine if they are at high risk for severe GVHD based on MAP. Patients who are at high risk at any of these four tests will be treated with methylprednisolone to see if it prevents the development of severe aGvHD. Methylprednisolone starts with the dose of 2 mg/kg for 5 days. If no signs of aGvHD, the dose of methylprednisolone is gradually tapered within the following 16 days. Patients will be followed for the development of severe aGvHD for up to 3 months from the HCT and will continue to be followed at routine clinic visits for up to one year after HCT.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

GVHD,Acute
Stem Cell Transplant Complications

Clinical Trial Details

NCT number	NCT05368181
Study type	Interventional
Source	Sichuan University
Contact	Jie Ji, MD
Phone	86-28-85422373
Email	jieji@scu.edu.cn
Status	Recruiting
Phase	Phase 2
Start date	May 1, 2022
Completion date	December 31, 2024

View Details

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