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To evaluate the efficacy and safety of ruxolitinib for prophylactic therapy of child 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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| The group of daGOAT model prevention | Experimental | Model-predicted high-risk patients: weight ≤ 25 kg, ruxolitinib, 2.5mg bid po until at least day 60 post-transplant and terminated after day 100; weight > 25 kg, ruxolitinib, 5mg bid po until at least day 60 post-transplant and terminated after day 100. If 'azoles' are taken concomitantly, ruxolitinib will start at half dose. If the patient tolerates ruxolitinib, the dose can be increased to 10mg bid po. Model-predicted low risk: regular aGVHD prophylactic regimens. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ruxolitinib | Drug | Model-predicted high-risk patients: weight ≤ 25 kg, ruxolitinib, 2.5mg bid po until at least day 60 post-transplant and terminated after day 100; weight > 25 kg, ruxolitinib, 5mg bid po until at least day 60 post-transplant and terminated after day 100. If 'azoles' are taken concomitantly, ruxolitinib will start at half dose. If the patient tolerates ruxolitinib, the dose can be increased to 10mg bid po. Model-predicted low risk: regular aGVHD prophylactic regimens. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 100 days after transplantation |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 100 days after transplantation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xueou Liu, PhD | Contact | 022-23909051 | liuxueou@ihcams.ac.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Hematology & Blood Diseases Hospital | Recruiting | Tianjin | Tianjin Municipality | 300020 | China |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 6, 2023 | Mar 22, 2023 | Prot_002.pdf |
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| ID | Term |
|---|---|
| C540383 | ruxolitinib |
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| 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. | 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. | 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. | 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. | 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. | 1.5 year after transplantation |