A Phase 2 interventional study of Ruxolitinib in Transplant-Related Disorder, sponsored by Institute of Hematology & Blood Diseases Hospital, China. Completed at 1 site in China. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2024-12-06.
Sponsored by Institute of Hematology & Blood Diseases Hospital, China · Phase 2, Interventional, and Prevention
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.
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).
806 studies on the registry are indexed under Graft vs Host Disease; 138 are open to participants now.
This study's enrollment of 115 is above the median of 35 across 637 interventional studies indexed under Graft vs Host Disease.
Browse Graft vs Host Disease studies →Institute of Hematology & Blood Diseases Hospital, China is the lead sponsor of 398 studies on the registry; 293 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Drug: 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.
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)
Time frame: 100 days after transplantation
aGVHD in various target organs during 100 days after transplantation according to the MAGIC criteria
Incidence of aGVHD (any grade) in various target organs. 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)
Time frame: 100 days after transplantation
Overall survival during 1.5 year after transplantation
Patients will be followed up at days 14, 28, 42, 60, 90, 180, 270, 360 and 540 after transplantation; data on survival will be collected.
Time frame: Days 14, 28, 42, 60, 90, 180, 270, 360 and 540 after transplantation
Relapse-free survival rate and relapse rate during 1.5 year after transplantation
Patients will be followed up at days 14, 28, 42, 60, 90, 180, 270, 360 and 540 after transplantation; data on relapse will be collected.
Time frame: Days 14, 28, 42, 60, 90, 180, 270, 360 and 540 after transplantation
Incidence of infections during 1.5 year after transplantation
Infection was defined as meeting one of the following criteria: culture-confirmed presence of bacteria or fungi in a sample collected from a sterile site; polymerase chain reaction-confirmed viremia at ≥ 5000 copies/ml for the cytomegalovirus or ≥ 10000 copies/ml for the Epstein-Barr virus; or body temperature ≥ 38 ℃ with culture-confirmed presence of pathogens from a non-sterile site.
Time frame: 1.5 year after transplantation
Safety of treatment during 100 days after transplantation according to the Common Terminology Criteria for Adverse Events version 5.0
Data on adverse events of treatment will be collected.
Time frame: 100 days after transplantation
Total cost of treatment during 1.5 year after transplantation
Data on total cost of treatment will be collected from the medical records.
Time frame: 1.5 year after transplantation
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Plan to share: Yes
This study is completed, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.
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Institute of Hematology & Blood Diseases Hospital, China