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

NCT ID: NCT05600855

Last Updated: 2024-12-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 115 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-15
• Study Completion Date: 2024-12-01

Brief Summary

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.

Detailed 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).

Conditions

Transplant-Related Disorder

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

The group of daGOAT model prevention

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.

Group Type: EXPERIMENTAL

Ruxolitinib

Intervention Type: 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.

Interventions

Ruxolitinib

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.

Intervention Type: DRUG

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 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.

• Minimum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institute of Hematology & Blood Diseases Hospital, China

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Institute of Hematology & Blood Diseases Hospital

Tianjin, Tianjin Municipality, China

Countries

China

References

Chen J, Cao Y, Feng Y, Qi S, Yang D, Hu Y, Pang A, Shen Q, Luo J, Gong X, Zhang R, Zhai X, Li X, Yan W, Zhang X, Chen M, Niu M, Wei J, Liang C, Zhai W, Zhao N, Liu X, Liu S, Zhai W, Li R, Shao X, Zhang D, Wang M, Pan P, Xu M, Zhang W, Xu Y, Zhu X, Guo Y, Wang H, Song Z, Gale RP, Han M, Feng S, Jiang E. Autonomous artificial intelligence prescribing a drug to prevent severe acute graft-versus-host disease in HLA-haploidentical transplants. Nat Commun. 2025 Sep 25;16(1):8391. doi: 10.1038/s41467-025-62926-0.

Reference Type: DERIVED

PMID: 40998766 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Other Identifiers

IIT2022034（adult）

Identifier Type: -

Identifier Source: org_study_id