Ruxolitinib and Decitabine Intensified Conditioning Regimen for Patients With High Risk Hematological Malignancies Underwenting Allogeneic Stem Cell Transplantation
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Number 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 Decitabine intensified Conditioning Regimen in Patients with High Risk hematological malignancies undergoing allogeneic peripheral blood stem cell transplantation.
详细描述
Allogeneic hematopoietic stem cell transplantation should be offered to eligible patients with high risk hematological malignancies whenever feasible. To further improve the outcome of transplantation patients with high risk hematological malignancies, the investigators developed a modified Bu/Cy conditioning regimen intensified by Ruxolitinib and Decitabine. In this study, the investigators tested the efficacy and feasibility of the modified Bu/Cy conditioning regimen intensified by Ruxolitinib and Decitabine in Patients with high risk hematological malignancies 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
- •Relapsed/refractory acute leukemia with indications for allogeneic hematopoietic stem cell transplantation; High risk acute leukemia with indications for allogeneic hematopoietic stem cell transplantation;
- •Medium to high risk myelodysplastic syndrome, myeloproliferative disease, myelodysplastic syndrome/myeloproliferative disease, Chronic myelomonocytic leukemia;
- •Have matched sibling donors, ≥8/10 HLA matched unrelated donors or 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;
- •AML patients with t (15;17);
研究组 & 干预措施
Ruxolitinib combined with Decitabine
Ruxolitinib and Decitabine conditioning regimen All recipients in this arm received the modified Bu/Cy conditioning regimen intensified by Ruxolitinib and Decitabine. 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), decitabine (20 mg/m2/day, days -15 to -10), cytarabine (4 g/m2/day, days -10 to -9 (for unrelated donors or haploidentical donors; and 4 g/m2/day, days -9 for sibling donors)), 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 Decitabine (Drug)
结局指标
主要结局
Number 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
- Number of participants with aGVHD as assessed by acute graft versus host disease grading criteria (refer to Glucksberg criteria)(100 days after transplantation)
- DFS(disease-free survival )(365 days after transplantation)
- TRM(treatment-related mortality )(365 days after transplantation)
- OS(overall survival )(365 days after transplantation)
- GRFS (GVHD free, relapse free survival)(365 days after transplantation)
- Number of participants with cGVHD as assessed by chronic graft versus host disease grading criteria (refer to NIH criteria)(365 days after transplantation)
- infection rate(365 days after transplantation)
研究者
Daihong Liu
Director
Chinese PLA General Hospital