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The goal of this observation study is to test in patients undergoing allogeneic hemopoietic stem-cell transplantation (allo-HSCT). The main question it aims to answer is:
• Effect of MAGIC algorithm probability guided preemption of aGVHD with ruxolitinib on prevention of severe aGVHD.
Participants will take ruxolitinib with the dose of 5mg bid for 28 days. If no signs of aGvHD, the dose of ruxolitinib is gradually tapered within the following 16 days.
Researchers will compare patients who don't receive preemption of aGVHD with ruxolitinib to see if there is an improvement in severe aGVHD.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ruxolitinib | Experimental | Ruxolitinib is asministrated with the dose of 5mg bid for 28 days. If no signs of aGvHD, the dose of ruxolitinib is gradually tapered within the following 16 days. |
|
| Control | No Intervention | Patients assigned to the control group are treated based on symptom-triggered aGvHD therapy. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ruxolitinib | Drug | Ruxolitinib is asministrated with the dose of 5mg bid for 28 days. If no signs of aGvHD, the dose of ruxolitinib is gradually tapered within the following 16 days. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of High Risk Patients Who Develop Grade III or IV aGvHD | Number of High Risk Patients Who Develop Grade III or IV aGvHD by day 100 post HCT | Day 100 post HCT |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Non-relapse Mortality (NRM) | Number of participants with NRM - deaths which could not be attributed to disease relapse or progression. Nonrelapse mortality defined as death without prior relapse at 6 months | 6 months |
| Number of Participants With Chronic GVHD Requiring Systemic Steroid Treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jie Ji, MD | Contact | 86-28-85422373 | jieji@scu.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| West China Hospital, Sichuan University | Chengdu | Sichuan | 610041 | China |
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| ID | Term |
|---|---|
| C540383 | ruxolitinib |
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Number of participants with chronic GVHD requiring systemic steroid treatment. Chronic GVHD Requiring Systemic Steroid Treatment: defined as the development of symptoms of chronic GVHD according to NIH Consensus Criteria that require treatment with oral or intravenous corticosteroids at the end of 1 year and 2 years |
| 1 year and 2 years |
| GvHD free and relapse free survival | Survival of patients without grade 3 or 4 aGvHD or disseminated cGvHD or relapse of disease at end of 1 year post HCT at the end of 1 year and 2 years | 1 year and 2 years |
| Progression-free survival | Progression-free survival of this group of patients at the end of 1 year and 2 years | 1 year and 2 years |
| Overall survival | Overall survival of this group of patients at the end of 1 year and 2 years | 1 year and 2 years |
| Number of Participants With Relapse | Number of participants with relapse at one year and 2 years. Relapse defined as recurrence of disease that required transplant. | 1 year and 2 years |
| Number of Participants With Serious Infections | Number of participants with serious infections (defined as grade 3 by the Blood and Marrow Transplant Clinical Trials Network). Serious Infection: Defined as bacterial, fungal, viral or parasitic infections that required oral or intravenous treatments such as antibiotics | 1 year and 2 years |
| cytomegalovirus (CMV) reactivation | Number of participants with cytomegalovirus (CMV) reactivation at the end of 1 year and 2 years. CMV reactivation was defined as the presence of DNA copies exceeding 10^3/ml in plasma. | 1 year and 2 years |
| grade 2 or higher hemorrhagic cystitis | Number of participants with grade 2 or higher hemorrhagic cystitis at the end of 1 year and 2 years, which was assessed according to the Common Terminology Criteria for Adverse Events (CTCAE, Version 5.0). | 1 year and 2 years |
| MAGIC algorithm probability (MAP) change | The change in the patient's MAGIC algorithm probability (MAP) at each time | Day 28 post HCT |