daGOAT-Guided Prevention of Severe aGVHD After Allo-HSCT

NCT07588945 | Not Yet Recruiting Phase 3

• 1 other identifier: IIT2026031
• Study Type: interventional
• Target: 438
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Transplant-Related Disorder

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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

Study Arms (2)

Intervention group

EXPERIMENTAL

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

Control group

NO INTERVENTION

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.

Interventions

Ruxolitinib DRUG

1. 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. 2. 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. 3. 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.

Intervention group

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

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

MeSH Terms

Interventions

ruxolitinib

Central Study Contacts

Yahui Feng

CONTACT

022-23608045; fengyahui@ihcams.ac.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2026
• First Posted: May 15, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): June 1, 2028
• Last Updated: May 15, 2026

Record last verified: 2026-05