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

Sponsor
Institute of Hematology & Blood Diseases Hospital, China
Study ID
NCT05599256
Phase
PHASE2
Status
Unknown

Conditions

  • Transplant-Related Disorder

Eligibility Criteria

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

Interventions

  • Ruxolitinib — DRUG
    Model-predicted high-risk patients: weight ≤ 25 kg, ruxolitinib, 2.5mg bid po until at least day 60 post-transplant and terminated after day 100; weight \> 25 kg, ruxolitinib, 5mg bid po until at least day 60 post-transplant and terminated after day 100. If 'azoles' are taken concomitantly, ruxolitinib will start at half dose. If the patient tolerates ruxolitinib, the dose can be increased to 10mg bid po. Model-predicted low risk: regular aGVHD prophylactic regimens.

Study Details

To evaluate the efficacy and safety of ruxolitinib for prophylactic therapy of child 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
Feb 9, 2023
Status verified
Mar 2024
Primary completion
Oct 7, 2024
Completion
Dec 1, 2025

Study Design

Enrollment
40 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION

Arms

  • Experimental: The group of daGOAT model prevention
    Model-predicted high-risk patients: weight ≤ 25 kg, ruxolitinib, 2.5mg bid po until at least day 60 post-transplant and terminated after day 100; weight \> 25 kg, ruxolitinib, 5mg bid po until at least day 60 post-transplant and terminated after day 100. If 'azoles' are taken concomitantly, ruxolitinib will start at half dose. If the patient tolerates ruxolitinib, the dose can be increased to 10mg bid po. 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 ]

Central Contacts

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