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

Launched by INSTITUTE OF HEMATOLOGY & BLOOD DISEASES HOSPITAL, CHINA · Oct 25, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a medication called ruxolitinib to see if it can help prevent a serious condition known as severe acute graft-versus-host disease (aGVHD) in children who are at high risk after a specific type of stem cell transplant. Graft-versus-host disease happens when the donated cells attack the recipient's body, and this trial aims to find out if ruxolitinib can reduce this risk, helping kids to stay healthier after their transplant.

To be eligible for this trial, children must be 16 years old or younger and must be undergoing a certain type of stem cell transplant where the donor cells do not perfectly match the recipient's cells. Participants must be able to take oral medications and have permission from a parent or guardian to join the study. If accepted, participants will take ruxolitinib and will be monitored closely by the medical team for safety and effectiveness. It's important to know that certain conditions may exclude a child from participating, such as having allergies to the medication or other serious health issues. This study is currently recruiting participants, and it offers a chance to contribute to important research that could improve care for future patients.

Gender

ALL

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.