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| Name | Class |
|---|---|
| The Children's Hospital of Zhejiang University School of Medicine | OTHER |
| Yinzhou Hospital Affiliated to Medical School of Ningbo University | OTHER |
| Ruijin Hospital | OTHER |
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Low Dose Ruxolitinib with Calcineurin Inhibitor and Methotrexate vs. Calcineurin Inhibitor plus Methotrexate and Mycophenolate mofetil as Graft Versus Host Disease prophylaxis for HLA-haploidentical hematopoietic stem cell transplantation in low-dose antithymocyte globulin (ATG) system.
The is a prospective, randomized two-arm, and multicenter study. To compare the efficacy and safety of low-dose ruxolitinib combined with calcineurin inhibitor and methotrexate vs. calcineurin inhibitor plus methotrexate and mycophenolate mofetil as graft versus host disease prophylaxis for HLA-haploidentical hematopoietic stem cell transplantation in low-dose antithymocyte globulin (ATG) system.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RUX group | Experimental |
| |
| Control group | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ruxolitinib+Calcineurin inhibitor+Methotrexate | Drug | low-dose ruxolitinib combine with calcineurin inhibitor and short course of methotrexate. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 100-day cumulative II-IV aGVHD incidence after HSCT | Cumulative incidence of grade II-IV acute GVHD occurring within the first 100 days following transplantation. | From the date of transplantation to the first occurrence of grade II-IV acute GVHD, assessed up to 100 days. |
| Measure | Description | Time Frame |
|---|---|---|
| Cumulative Incidence of Chronic GVHD | The cumulative incidence of chronic GVHD following transplantation.n | From the date of transplantation to the first diagnosis of chronic GVHD, assessed up to 3 years. |
| Overall Survival |
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Inclusion Criteria:
8) left ventricular ejection fraction (LVEF) ≥ 50% on echocardiography (ECHO). 9) life expectancy >12 weeks. 10) Voluntarily signed the consent form and could understand and comply with the requirements of the study.
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Hospital of Zhejiang Medical Colleage Zhejiang University | Hangzhou | Zhejiang | 310006 | China |
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| The First Affiliated Hospital of Zhengzhou University |
| OTHER |
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| Calcineurin Inhibitor+Methotrexate+Mycophenolate mofetil | Drug | calcineurin inhibitor and short course of methotrexate and mycophenolate mofetil |
|
Overall survival following is defined as the time from transplantation to death from any cause.
| From the date of transplantation until death from any cause, assessed up to 3 years. |
| Adverse Events | Incidence and type adverse events following transplantation. | From the date of transplantation to day 180 post-transplantation. |
| Cumulative Incidence of Relapse | Cumulative incidence of disease relapse following transplantation is defined as the time from transplantation to the first documented disease recurrence. | From the date of transplantation to the first documented relapse, assessed up to 3 years. |
| GVHD-Free, Relapse-Free Survival | GVHD-free, relapse-free survival is defined as the time from transplantation to the first occurrence of grade III-IV acute GVHD, chronic GVHD requiring systemic therapy, disease relapse, or death from any cause. | From the date of transplantation to the first occurrence of grade III-IV acute GVHD, systemic therapy-requiring chronic GVHD, relapse, or death, assessed up to 3 years. |
| Non-Relapse Mortality | Non-relapse mortality is defined as death without evidence of relapse or progression of the primary disease following transplantation. | From the date of transplantation to death without prior relapse or disease progression, assessed up to 3 years. |
| Relapse-Free Survival | Relapse-free survival is defined as the time from transplantation to the first documented relapse of the underlying disease or death from any cause. | From the date of transplantation to the first documented relapse or death from any cause, assessed up to 3 years. |
| ID | Term |
|---|---|
| D006086 | Graft vs Host Disease |
| ID | Term |
|---|---|
| D007154 | Immune System Diseases |
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