A Multicenter ,Prospective, Randomized Clinical Trial of Blinatumomab As a Bridge to Allogeneic Hematopoietic Stem Cell Transplantation in High Risk Precursor B-cell Acute Lymphoblastic Leukemia
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Overall survival (OS)
研究概览
简要总结
To explore the efficacy and safty of Blinatumomab as a bridge to Allogeneic Hematopoietic Stem Cell Transplantation in High Risk Precursor B-cell Acute Lymphoblastic Leukemia
详细描述
High Risk Precursor B-cell Acute Lymphoblastic Leukemia is a kind of leukemia with poor prognosis. Here, we want to explore the efficacy and safty of Blinatumomab as a bridge to Allogeneic Hematopoietic Stem Cell Transplantation in High Risk Precursor B-cell Acute Lymphoblastic Leukemia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 14 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patients meet the diagnostic criteria for high risk precursor B-ALL (according to the 2016 WHO classification) and are under hematologic remission.
- •ECOG score is 0-
- •Expecting life span is more than 6 months.
- •Patients are free from severe organ dysfunction.
排除标准
- •Patients are combined with severe organ dysfunction: Organ failure: Cardiac failure: ejection fraction(EF) <30%, NYHA standard, cardiac function not Full Grade II or above; Liver and kidney insufficiency: serum total bile Erythroid ≥2mg/dl, AST or ALT≥ upper limit of normal 2.5-fold, serum creatinine (SCr) >2.5mg/ dL or blood Creatinine clearance rate < 30ml/min.
- •Patients are combined with infection or other complications that can not tolerate chemotherapy.
- •Patients are suffering from central nervous system/solitary extramedullary leukemia.
- •Patients are considered as tumer progression.
- •Patients has undergone allogeneic hematopoietic stem cell transplantation or underwent autologous stem cell transplantation within 6 weeks or other immunotherapy within 4 weeks.
- •Pregnant and lactating women will not be included.
研究组 & 干预措施
Blinatumomab arm
On the 1st to 3rd day, Blinatumomab should be continuous intravenous use for 24 hours with 9ug/ day for those whose weight are equal to or greater than 45kg, and 5ug/ m2 / day for those whose weight are less than 45kg (maximum dosage is 9ug/ day) per 24 hours. On the 4th to 14th day, for the patients who are equal to or greater than 45kg, they will receive Blinatumomab at the dose of 28ug/ day with continuous intravenous administration, and those below 45kg are given a 24h continuous infusion of 15ug/ m2 / day (maximum dose is 28ug/ day). Bucy-based myeloablative conditioning regimen will be performed on the 15th day.
干预措施: Blinatumomab (Drug)
Conventional therapy
Bucy-based myeloablative conditioning regimen will be given to those patients are enrolled into control group.
干预措施: Conventional therapy (Other)
结局指标
主要结局
Overall survival (OS)
时间窗: From the 1st day to the 720th days after enrollment.
The time from randomization to death from any cause.
次要结局
- Cumulative incidence of relapse (CIR)(From the 1st day to the 720th days after enrollment.)
- The proportion of patients with negative minimal residual disease (MRD)(From the 1st day to the 720th days after enrollment.)
- Progression-Free Survival (PFS)(From the 1st day to the 720th days after enrollment.)
研究者
HAN Yue
Director
The First Affiliated Hospital of Soochow University