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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
215
low-dose ruxolitinib combine with calcineurin inhibitor and short course of methotrexate.
calcineurin inhibitor and short course of methotrexate and mycophenolate mofetil
The First Hospital of Zhejiang Medical Colleage Zhejiang University
Hangzhou, Zhejiang, China
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.
Time frame: From the date of transplantation to the first occurrence of grade II-IV acute GVHD, assessed up to 100 days.
Cumulative Incidence of Chronic GVHD
The cumulative incidence of chronic GVHD following transplantation.n
Time frame: From the date of transplantation to the first diagnosis of chronic GVHD, assessed up to 3 years.
Overall Survival
Overall survival following is defined as the time from transplantation to death from any cause.
Time frame: From the date of transplantation until death from any cause, assessed up to 3 years.
Adverse Events
Incidence and type adverse events following transplantation.
Time frame: 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.
Time frame: 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.
Time frame: 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.
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Non-Relapse Mortality
Non-relapse mortality is defined as death without evidence of relapse or progression of the primary disease following transplantation.
Time frame: 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.
Time frame: From the date of transplantation to the first documented relapse or death from any cause, assessed up to 3 years.