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

Sponsor
Institute of Hematology & Blood Diseases Hospital, China
Study ID
NCT05600855
Phase
PHASE2
Status
Completed

Conditions

  • Transplant-Related Disorder

Eligibility Criteria

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

Interventions

  • Ruxolitinib — DRUG
    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.

Study Details

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.

Key Dates

Start date
Jan 15, 2023
Status verified
Dec 2024
Primary completion
Oct 10, 2024
Completion
Dec 1, 2024

Study Design

Enrollment
115 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION

Arms

  • Experimental: The group of daGOAT model prevention
    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.

Primary Outcome Measure

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

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