Transplant-Related DisorderPhase 3NCT07588945
daGOAT-Guided Prevention of Severe aGVHD After Allo-HSCT
A Phase 3 study testing Ruxolitinib in people with Transplant-Related Disorder, run by Institute of Hematology & Blood Diseases Hospital, China.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Transplant-Related Disorder
- What is being tested?
- Ruxolitinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 438 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2027to 1 Jun 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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
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
- Being tested
- Ruxolitinib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RuxolitinibDrug
- 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 with no ruxolitinib for GvHD prophylaxis.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Ruxolitinib |
| Control group | No intervention | For patients in the control group, they will receive standard prophylaxis with no ruxolitinib for GvHD prophylaxis. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 100 days after transplantation
Secondary outcomes (5)
Severe aGVHD during 180 days after transplantation according to the MAGIC criteria
Measured: 180 days after transplantation
aGVHD in various target organs according to the MAGIC criteria
Measured: 180 days after transplantation
Overall survival
Measured: 1.5 year after transplantation
Relapse-free survival rate
Measured: 1.5 year after transplantation
Relapse rate
Measured: 1.5 year after transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2026
- Study start1 Jan 2027 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion1 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transplant-Related DisorderStudies of the same condition, open and under way.
- More trials run by Institute of Hematology & Blood Diseases Hospital, ChinaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 438 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07588945
- Sponsor's protocol ID
- IIT2026031
- Status last verified
- May 2026
- First submitted
- 24 Apr 2026
- Last updated
- 21 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07588945
- Acronym / sponsor ID
- IIT2026031
- Conditions
- Transplant-Related Disorder
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 438 participants (estimated)
- Lead sponsor
- Institute of Hematology & Blood Diseases Hospital, ChinaUniversity, hospital or other
- Study start
- 1 Jan 2027 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 1 Jun 2028 (estimated)
- First posted
- 15 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Drug: RuxolitinibFor 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. |
| Control group | No intervention | –For patients in the control group, they will receive standard prophylaxis with no ruxolitinib for GvHD prophylaxis. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ruxolitinib1. 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 with no ruxolitinib for GvHD prophylaxis. | Drug | Intervention group |
Primary outcome
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)
5 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ruxolitinib in people with Transplant-Related Disorder, run by Institute of Hematology & Blood Diseases Hospital, China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yahui Feng (022-23608045, fengyahui@ihcams.ac.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Severe aGVHD during 100 days after transplantation according to the MAGIC criteria (time frame: 100 days after transplantation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2026.