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

Last updated: November 4, 2024
Sponsor: Institute of Hematology & Blood Diseases Hospital, China
Overall Status: Active - Recruiting

Phase

2

Condition

N/A

Treatment

Ruxolitinib

Clinical Study ID

NCT05599256
IIT2022034（child）
  • Ages < 16
  • All Genders

Study 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

Inclusion Criteria:

  1. Patients must be ≤ 16 years of age;

  2. Patients receiving human leukocyte antigen mismatched and non-cord blood allogeneichematopoietic stem cell transplantation;

  3. Patients who can take oral medication;

  4. Patients or their guardians have to sign an informed consent form before the startof the research procedure.

Exclusion

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 theresearch treatment and monitoring requirements;

  4. Patients who are pregnant or cannot take appropriate contraceptive measures duringtreatment;

  5. Patients who are ineligible for the study due to other factors, or will bear greatrisk if participating in the study.

Study Design

Total Participants: 40
Treatment Group(s): 1
Primary Treatment: Ruxolitinib
Phase: 2
Study Start date:
February 09, 2023
Estimated Completion Date:
December 01, 2025

Study Description

This study aims to prospectively evaluate the use of the daGOAT model in real-world clinical settings at the Institute of Hematology, Chinese Academy of Medical Sciences (IHCAMS).

Connect with a study center

  • Institute of Hematology & Blood Diseases Hospital

    Tianjin, Tianjin 300020
    China

    Active - Recruiting

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