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Not yet recruiting NCT07588945

daGOAT-Guided Prevention of Severe aGVHD After Allo-HSCT

Phase III Interventional Transplant-Related Disorder

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Ruxolitinib.
Who it may be relevant to
Registry conditions: Transplant-Related Disorder. Basic parameters: from 16 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Drug Ruxolitinib
    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

Primary outcome measures

  • Severe aGVHD during 100 days after transplantation according to the MAGIC criteria [Time frame: 100 days after transplantation]
Secondary outcome measures (5)
  • Severe aGVHD during 180 days after transplantation according to the MAGIC criteria [Time frame: 180 days after transplantation]
  • aGVHD in various target organs according to the MAGIC criteria [Time frame: 180 days after transplantation]
  • Overall survival [Time frame: 1.5 year after transplantation]
  • Relapse-free survival rate [Time frame: 1.5 year after transplantation]
  • Relapse rate [Time frame: 1.5 year after transplantation]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Prevention

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07588945 · IIT2026031

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗