Clinical Research Directory
Browse clinical research sites, groups, and studies.
daGOAT-Guided Prevention of Severe aGVHD After Allo-HSCT
Sponsor: Institute of Hematology & Blood Diseases Hospital, China
Summary
This study aims to evaluate the efficacy of prophylactic ruxolitinib in adult patients at intermediate-to-high risk of severe acute GvHD, as predicted by the daGOAT model.
Official title: A Multicenter Randomized Controlled Trial of daGOAT Model-guided Prevention of Severe Acute Graft-versus-host Disease in Patients Undergoing Allogeneic Hematopoietic Stem Cell Transplantation
Key Details
Gender
All
Age Range
16 Years - Any
Study Type
INTERVENTIONAL
Enrollment
438
Start Date
2026-06-01
Completion Date
2028-06-01
Last Updated
2026-05-15
Healthy Volunteers
No
Conditions
Interventions
Ruxolitinib
1. Model-predicted high-risk patients: will receive standard prophylaxis plus ruxolitinib 5mg twice daily (bid) orally until at least day 60 post-transplantion and will be terminated after day 100. If severe hematological signs occur such as when there is severe neutropenia (\<0.1×10\^9/L), ruxolitinib can be used at half dose or discontinued until recovery. 2. Model-predicted moderate-risk patients: will receive standard prophylaxis plus ruxolitinib 5mg once daily (qd) orally until at least day 60 post-transplantion and will be terminated after day 100. If severe hematological signs occur such as when there is severe neutropenia (\<0.1×10\^9/L), ruxolitinib can be used at half dose or discontinued until recovery. 3. Model-predicted low-risk patients: will receive standard prophylaxis without additional GvHD prophylactic agents, including mesenchymal cell infusion, anti-CD25 monoclonal antibodies, and ruxolitinib outside the scope specified in the study protocol.