Skip to main content
OpenTrials
Completed

NCT Number: NCT05600855

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

To evaluate the efficacy and safety of ruxolitinib for prophylactic therapy of adult 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Transplant-Related Disorder

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Institute of Hematology & Blood Diseases Hospital

Tianjin, Tianjin Municipality, 300020, China

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients must be > 16 years of age;
  • Patients receiving human leukocyte antigen mismatched and non-cord blood allogeneic hematopoietic stem cell transplantation;
  • Patients who can take oral medication;
  • Patients have to sign an informed consent form before the start of the research procedure.

Exclusion criteria

  • Tandem transplantation or multiple transplantations;
  • Patients who are allergic to or cannot tolerate ruxolitinib ;
  • Mental or other medical conditions that make the patients unable to comply with the research treatment and monitoring requirements ;
  • Patients who are pregnant or cannot take appropriate contraceptive measures during treatment;
  • Patients who are ineligible for the study due to other factors, or will bear great risk if participating in the study.

Treatment and study plan

Ruxolitinib

Drug

Model-predicted high-risk patients: ruxolitinib 5mg bid po until at least day 60 post-transplant and terminated after day 100. If severe hematological signs occur such as when there is severe neutropenia (<0.1×10^9/L), ruxolitinib can be used at half dose or discontinued as appropriate, and can continue to be used after hematology recovery.

Model-predicted moderate-risk patients: ruxolitinib 2.5mg bid p po until at least day 60 post-transplant and terminated after day 100. If severe hematological signs occur such as when there is severe neutropenia (<0.1×10^9/L), ruxolitinib can be used at half dose or discontinued as appropriate, and can continue to be used after hematology recovery.

Model-predicted low risk: regular aGVHD prophylactic regimens.

Primary outcomes

  1. Severe aGVHD during 100 days after transplantation according to the MAGIC criteria

    Time frame: 100 days after transplantation

    Incidence of severe aGVHD after transplantation within 100 days. The medical records for each case wil be reviewed by two or three physicians to confirm the aGVHD diagnosis and grading (according to the MAGIC criteria)

Secondary outcomes

  1. aGVHD in various target organs during 100 days after transplantation according to the MAGIC criteria

    Time frame: 100 days after transplantation

    Incidence of aGVHD (any grade) in various target organs. The medical records for each case wil be reviewed by two or three physicians to confirm the aGVHD diagnosis and grading (according to the MAGIC criteria)

  2. Overall survival during 1.5 year after transplantation

    Time frame: Days 14, 28, 42, 60, 90, 180, 270, 360 and 540 after transplantation

    Patients will be followed up at days 14, 28, 42, 60, 90, 180, 270, 360 and 540 after transplantation; data on survival will be collected.

  3. Relapse-free survival rate and relapse rate during 1.5 year after transplantation

    Time frame: Days 14, 28, 42, 60, 90, 180, 270, 360 and 540 after transplantation

    Patients will be followed up at days 14, 28, 42, 60, 90, 180, 270, 360 and 540 after transplantation; data on relapse will be collected.

  4. Incidence of infections during 1.5 year after transplantation

    Time frame: 1.5 year after transplantation

    Infection was defined as meeting one of the following criteria: culture-confirmed presence of bacteria or fungi in a sample collected from a sterile site; polymerase chain reaction-confirmed viremia at ≥ 5000 copies/ml for the cytomegalovirus or ≥ 10000 copies/ml for the Epstein-Barr virus; or body temperature ≥ 38 ℃ with culture-confirmed presence of pathogens from a non-sterile site.

  5. Safety of treatment during 100 days after transplantation according to the Common Terminology Criteria for Adverse Events version 5.0

    Time frame: 100 days after transplantation

    Data on adverse events of treatment will be collected.

  6. Total cost of treatment during 1.5 year after transplantation

    Time frame: 1.5 year after transplantation

    Data on total cost of treatment will be collected from the medical records.

Sponsors and collaborators

Lead sponsor

Institute of Hematology & Blood Diseases Hospital, China

Other

Registry information

Official study title

A Prospective, Single-arm Clinical Trial of Prevention of Severe Acute Graft-versus-host Disease After Adult Patients Receiving Allogeneic Hematopoietic Stem Cell Transplantation Using a daGOAT Model

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Nov 1, 2022
Registry last updated
Dec 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.