NCT05600855

Prevention of Severe Acute Graft-versus-host Disease in Adult Patients Using a daGOAT Model

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 115 (actual)
• Sponsor: Institute of Hematology & Blood Diseases Hospital, China · Academic / Other
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This study aims to prospectively evaluate the use of the daGOAT model in real-world clinical settings at the Institute of Hematology, Chinese Academy of Medical Sciences (IHCAMS).

Conditions

• Transplant-Related Disorder

Interventions

Type	Name	Description
DRUG	Ruxolitinib	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.

Timeline

• Start date: 2023-01-15
• Primary completion: 2024-10-10
• Completion: 2024-12-01
• First posted: 2022-11-01
• Last updated: 2024-12-06

Locations

1 site across 1 country: China