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Recruiting Phase 2 NCT05599256

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

Trial Parameters

Condition Transplant-Related Disorder
Sponsor Institute of Hematology & Blood Diseases Hospital, China
Study Type INTERVENTIONAL
Phase Phase 2
Enrollment 40
Sex ALL
Min Age N/A
Max Age 16 Years
Start Date 2023-02-09
Completion 2024-10-07
Interventions
Ruxolitinib

Brief Summary

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.

Eligibility Criteria

Inclusion Criteria: 1. Patients must be ≤ 16 years of age; 2. Patients receiving human leukocyte antigen mismatched and non-cord blood allogeneic hematopoietic stem cell transplantation; 3. Patients who can take oral medication; 4. Patients or their guardians have to sign an informed consent form before the start of the research procedure. Exclusion Criteria: 1. Tandem transplantation or multiple transplantations; 2. Patients who are allergic to or cannot tolerate ruxolitinib; 3. Mental or other medical conditions that make the patients unable to comply with the research treatment and monitoring requirements; 4. Patients who are pregnant or cannot take appropriate contraceptive measures during treatment; 5. Patients who are ineligible for the study due to other factors, or will bear great risk if participating in the study.

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