Ruxolitinib and Chidamide Intensified Bu/CY Conditioning Regimen for Patients With Acute T Cell Lymphoblast Leukemia/ Lymphoblastic Lymphoma Underwenting Haploidenticl Peripheral Blood Stem Cell Transplantation
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Proportion of participants relapse as assessed by NCCN (National Comprehensive Cancer Network ) criteria
研究概览
简要总结
The purpose of this study is to determine the efficacy and safety of Ruxolitinib and Chidamide intensified conditioning regimen in patients with Acute T cell Lymphoblast leukemia/ lymphoblastic lymphoma Underwenting Haploidenticl Peripheral blood Stem Cell Transplantation.
详细描述
Haploidenticl Peripheral blood Stem Cell Transplantation should be offered to eligible patients with Acute T cell Lymphoblast leukemia/ lymphoblastic lymphoma whenever feasible. To further improve the outcome of transplantation patients with Acute T cell Lymphoblast leukemia/ lymphoblastic lymphoma, we developed a modified Bu/Cy conditioning regimen intensified by Ruxolitinib and Chidamide. In this study, we tested the efficacy and feasibility of the modified Bu/Cy conditioning regimen intensified by Ruxolitinib and Chidamide in patients with Acute T cell Lymphoblast leukemia/ lymphoblastic lymphoma undergoing allogeneic peripheral blood stem cell transplantation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •high risk Acute T cell Lymphoblast leukemia/ lymphoblastic lymphoma with the indications for allogeneic transplantation;
- •Have haploidentical donors
- •All patients should aged 12 to 65 years;
- •Liver function: ALT and AST≤2.5 times the upper limit of normal , bilirubin≤2 times the upper limit of normal;
- •Renal function: creatinine ≤the upper limit of normal;
- •Patients without any uncontrolled infections , without organ dysfunction or without severe mental illness;
- •Eastern Cooperative Oncology Group (ECOG) performance status ≤2;
- •Have signed informed consent.
排除标准
- •pregnant women;
- •Patients with mental illness or other states unable to comply with the protocol;
研究组 & 干预措施
Ruxolitinib combined with Chidamide
All recipients in this arm received the modified Bu/Cy conditioning regimen intensified by Ruxolitinib and Chidamide. The conditioning regimen for allogeneic hematopoietic stem cell transplantation consist of ruxolitinib (35 mg bid [p.o.], days -15 to -10, diminishing to day -1), chidamide (30 mg/day, twice per week from days -15 to -2), cytarabine (4g/m2/day, days -10 to -9), busulfan (0.8mg/kg, Q6h, days -8 to -6), cyclophosphamide (1.8 g/m2/day, days -5 to -4), carmustine(BCNU) (250mg/m2/day, day -3)
干预措施: Modified By/Cy conditioning regimen intensified by Ruxolitinib and Chidamide (Drug)
结局指标
主要结局
Proportion of participants relapse as assessed by NCCN (National Comprehensive Cancer Network ) criteria
时间窗: 365 days after transplantation
Defined as the proportion of participants whose underlying malignancy relapsed.
次要结局
- Proportion of participants with aGVHD as assessed by acute graft versus host disease grading criteria (refer to Glucksberg criteria)(100 days after transplantation)
- OS(overall survival )(365 days after transplantation)
- DFS(disease-free survival )(365 days after transplantation)
- Failure-free survival (FFS)(365 days after transplantation)
- infection rate(365 days after transplantation)
- TRM(treatment-related mortality )(365 days after transplantation)
- Proportion of participants with cGVHD as assessed by chronic graft versus host disease grading criteria (refer to NIH criteria)(365 days after transplantation)
研究者
Daihong Liu
Director
Chinese PLA General Hospital