At a glance
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A Prospective, Single-arm Clinical Trial of Prevention of Severe Acute Graft-versus-host Disease After Adult Patients Receiving Allogeneic Hematopoietic Stem Cell Transplantation Using a daGOAT Model
In Brief
A Phase 2 clinical trial evaluating Ruxolitinib for Transplant-Related Disorder. Completed, enrolled 115 participants across 1 site.
Detailed Summary
To evaluate the efficacy and safety of ruxolitinib for prophylactic therapy of adult patients who are predicted to have a high risk for developing severe acute graftversus-host disease (aGVHD) by the dynamic aGVHD Onset Anticipation Tianjin (daGOAT) model.
Study Details
Timeline
Interventions
Model-predicted high-risk patients: ruxolitinib 5mg bid po until at least day 60 post-transplant and 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 as appropriate, and can continue to be used after hematology recovery. Model-predicted moderate-risk patients: ruxolitinib 2.5mg bid p po until at least day 60 post-transplant and 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 as appropriate, and can continue to be used after hematology recovery. Model-predicted low risk: regular aGVHD prophylactic regimens.