daGOAT-Guided Prevention of Severe aGVHD After Allo-HSCT

Sponsor
Institute of Hematology & Blood Diseases Hospital, China
Study ID
NCT07588945
Phase
PHASE3
Status
Not Yet Recruiting

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Conditions

  • Transplant-Related Disorder

Eligibility Criteria

Sex
ALL
Age
16 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ruxolitinib — DRUG
    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.

Study Details

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.

Key Dates

Start date
Jun 1, 2026
Status verified
May 2026
Primary completion
Dec 31, 2027
Completion
Jun 1, 2028

Study Design

Enrollment
438 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Intervention group
    For patients in the intervention group, the daGOAT model will be used to predict the occurrence of severe acute GvHD from day 17 to day 23 after transplantation. Each subject will be stratified into low-, intermediate-, and high-risk groups, and corresponding preventive interventions were implemented according to their risk levels.
  • No Intervention: Control group
    For patients in the control group, they 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.

Primary Outcome Measure

Severe aGVHD during 100 days after transplantation according to the MAGIC criteria [ Time Frame: 100 days after transplantation ]

Central Contacts

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