Efficacy Study of Blinatumomab Clean Up Early Residual Disease for Newly Diagnosed Pediatric B Lymphoblastic Leukemia
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 90
- 试验地点
- 4
- 主要终点
- The flow cytometric MRD
研究概览
简要总结
The goal of this clinical trial is to evaluate the efficacy of Blinatumomab in pediatric patient with newly diagnosed acute B-Lymphoblastic leukemia with poor response to early chemotherapy, i.e. day 19 MRD ≥ 0.1% (low-risk) or day 19 MRD ≥ 0.01% (intermediate-risk). The main question is:
• If the flow cytometric MRD negative (<0.01%) rate and the NGS- MRD negative (<0.0001%) rate at the end of induction for patients received Blinatumomab will be superior to historical control (D46MRD in the CCCG-ALL2020 protocol).
Participants will:
- Take 14 days full dose Blinatumomab;
- With bone marrow evaluated before and after Blinatumomab treatment.
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
- 1 Month 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age older than 1 month to younger than 18 years.
- •Diagnosis of acute lymphoblastic leukemia by bone marrow morphology.
- •Immunophenotyping: acute B-lymphoblastic leukemia;
- •Meet one of the following situations:
- •A. Provisional low-risk: D19MRD ≥ 0.1%; B. Provisional intermediate-risk: D19MRD ≥ 0.01%;
- •Subjects in the sytudy group or their guardians must be able to understand and accept the informed consent approved by the Ethics Committee
排除标准
- •ALL evolved from chronic myeloid leukemia (CML);
- •Down's syndrome, or major congenital or hereditary disease with organ dysfunction;
- •Other secondary leukemias;
- •CNS involvement;
- •History of epilepsy; or convulsions within the last month;
- •Known underlying congenital immunodeficiency or metabolic disease;
- •Congenital heart disease with cardiac insufficiency;
- •Treated with glucocorticoids for ≥14 days, or ABL kinase inhibitors for > 7 days within one month before enrollment, or any chemotherapy or radiotherapy within 3 months before enrollment (except for emergency radiotherapy to relieve airway compression);
- •Initial diagnosis of high risk;
- •D46MRD ≥1%.
研究组 & 干预措施
Blinatumomab
Patients in this group should receive Blinatumomab
干预措施: Blinatumomab (Drug)
结局指标
主要结局
The flow cytometric MRD
时间窗: From the date of Blinatumomab completion to one week after its treatment course
The flow cytometric MRD negative (\<0.01%) rate at the end of induction for patients received Blinatumomab will superior to historical control (D46MRD in the CCCG-ALL2020 protocol)
The NGS- MRD
时间窗: From the date of Blinatumomab completion to one week after its treatment course
The NGS- MRD negative (\<0.0001%) rate at the end of induction for patients received Blinatumomab will superior to historical control (D46MRD in the CCCG-ALL2020 protocol)
次要结局
- 5-year EFS(5 years since the last recruited patient completed Blinatumomab.)
- Adverse events(From day 19 of induction therapy until the start of the second high-dose methotrexate regimen.)
- Healthcare costs(Six-month since window phase)
研究者
Shuhong Shen
Chair of hematology oncology department of SCMC
Shanghai Jiao Tong University School of Medicine