A Prospective, Single-arm Clinical Trial of Prevention of Severe Acute Graft-versus-host Disease in Pediatric Patients Using a daGOAT Model

• Status: Not yet recruiting
• Trial end date: 2024-12-01
• Target enrollment: 0
• Participant gender: All

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 daGOAT model.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Institute of Hematology & Blood Diseases Hospital

Criteria

Inclusion Criteria:

1. Patients must be < 18 years of age;

2. Patients receiving HLA-mismatched and non-cord blood allo-HSCT;

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.