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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
438
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.
Severe aGVHD during 100 days after transplantation according to the MAGIC criteria
Incidence of severe aGVHD after transplantation within 100 days. The medical records for each case wil be reviewed by two or three physicians to confirm the aGVHD diagnosis and grading (according to the MAGIC criteria)
Time frame: 100 days after transplantation
Severe aGVHD during 180 days after transplantation according to the MAGIC criteria
Time frame: 180 days after transplantation
aGVHD in various target organs according to the MAGIC criteria
Time frame: 180 days after transplantation
Overall survival
Time frame: 1.5 year after transplantation
Relapse-free survival rate
Time frame: 1.5 year after transplantation
Relapse rate
Time frame: 1.5 year after transplantation
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