daGOAT-Guided Prevention of Severe aGVHD After Allo-HSCT

A Multicenter Randomized Controlled Trial of daGOAT Model-guided Prevention of Severe Acute Graft-versus-host Disease in Patients Undergoing Allogeneic Hematopoietic Stem Cell Transplantation

This study aims to evaluate the efficacy of prophylactic ruxolitinib in adult patients at intermediate-to-high risk of severe acute GvHD, as predicted by the daGOAT model.

Study Overview

• Status: Not yet recruiting
• Conditions: Transplant-Related Disorder
• Intervention / Treatment: Drug: Ruxolitinib

• Study Type: Interventional
• Enrollment (Estimated): 438
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Yahui Feng; Phone Number: 022-23608045; Email: fengyahui@ihcams.ac.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Age > 16 years old.
2. HLA-haploidentical transplant.
3. Able to take oral medications.
4. Patients must provide written informed consent before the start of the study procedures.

Exclusion Criteria:

1. Patients who have undergone tandem transplantation or multiple transplantations.
2. Patients who are allergic to or cannot tolerate ruxolitinib.
3. Patients with mental or other medical conditions that make them unable to comply with the study treatment and monitoring requirements.
4. Patients who are ineligible for the study due to other factors, or who will bear great risk if they participate in the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group; For patients in the intervention group, the daGOAT model will be used to predict the occurrence of severe acute GvHD from day 17 to day 23 after transplantation. Each subject will be stratified into low-, intermediate-, and high-risk groups, and corresponding preventive interventions were implemented according to their risk levels.	Drug: Ruxolitinib; Model-predicted high-risk patients: will receive standard prophylaxis plus ruxolitinib 5mg twice daily (bid) orally until at least day 60 post-transplantion and will be 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 until recovery.; Model-predicted moderate-risk patients: will receive standard prophylaxis plus ruxolitinib 5mg once daily (qd) orally until at least day 60 post-transplantion and will be 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 until recovery.; Model-predicted low-risk patients: will receive standard prophylaxis without additional GvHD prophylactic agents, including mesenchymal cell infusion, anti-CD25 monoclonal antibodies, and ruxolitinib outside the scope specified in the study protocol.
No Intervention: Control group; For patients in the control group, they will receive standard prophylaxis without additional GvHD prophylactic agents, including mesenchymal cell infusion, anti-CD25 monoclonal antibodies, and ruxolitinib outside the scope specified in the study protocol.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Severe aGVHD during 100 days after transplantation according to the MAGIC criteria	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)	100 days after transplantation

Secondary Outcome Measures

Outcome Measure	Time Frame
Severe aGVHD during 180 days after transplantation according to the MAGIC criteria	180 days after transplantation
aGVHD in various target organs according to the MAGIC criteria	180 days after transplantation
Overall survival	1.5 year after transplantation
Relapse-free survival rate	1.5 year after transplantation
Relapse rate	1.5 year after transplantation

Collaborators and Investigators

• Sponsor: Institute of Hematology & Blood Diseases Hospital, China

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): June 1, 2028

Study Registration Dates

• First Submitted: April 24, 2026
• First Submitted That Met QC Criteria: May 10, 2026
• First Posted (Actual): May 15, 2026

Study Record Updates

• Last Update Posted (Actual): May 15, 2026
• Last Update Submitted That Met QC Criteria: May 10, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: ruxolitinib
• Other Study ID Numbers: IIT2026031

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No