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NCT Number: NCT07588945

daGOAT-Guided Prevention of Severe aGVHD After Allo-HSCT

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.

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Key information

Conditions

Transplant-Related Disorder

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Ruxolitinib

Drug
  • 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.

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. Severe aGVHD during 180 days after transplantation according to the MAGIC criteria

    Time frame: 180 days after transplantation

  2. aGVHD in various target organs according to the MAGIC criteria

    Time frame: 180 days after transplantation

  3. Overall survival

    Time frame: 1.5 year after transplantation

  4. Relapse-free survival rate

    Time frame: 1.5 year after transplantation

  5. Relapse rate

    Time frame: 1.5 year after transplantation

Study contacts

Contact information is provided by the study sponsor or research team.

Yahui Feng

CONTACT

[email protected]

022-23608045

Sponsors and collaborators

Lead sponsor

Institute of Hematology & Blood Diseases Hospital, China

Other

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
May 15, 2026
Registry last updated
May 15, 2026

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.

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