Prospective, Single-arm, Multicenter Clinical Study on Haploidentical Hematopoietic Stem Cell Transplantation in Patients With MRD Positive CD19+ALL Treated With Conditioning Regimens Containing Blinatumomab
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- Progress-Free Survival
研究概览
简要总结
A study on the effectiveness and safety of haploidentical hematopoietic stem cell transplantation in patients with MRD positive CD19+ ALL treated with conditioning regimens containing Blinatumomab
详细描述
This is a prospective multicenter clinical study. This study is applicable to CD19+ ALL patients undergoing allogeneic hematopoietic stem cell transplantation. The purpose is to evaluate the effectiveness and safety of haploidentical hematopoietic stem cell transplantation in patients with MRD positive CD19+ ALL treated with conditioning regimens containing Blinatumomab.31 patients will be included in the study. Clinical endpoints include progress-free survival, Overall survival, cumulative incidence of relapse, non-relapse mortality, minimal residual disease, and graft versus host disease.
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
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed as acute B-ALL with CD19+ according to the 2022 WHO classification criteria. After induction and intensified chemotherapy, complete hematological remission was achieved, but MRD was positive by flow cytometry;
- •Age range from 18 to 70 years old, regardless of gender;
- •The Eastern Oncology Collaborative Group (ECOG) physical fitness score is 0-2 points;
- •Female patients of childbearing age who had a negative pregnancy test before the trial and agreed to take effective contraceptive measures during the trial until their last visit;
- •Organ function is normal, and the following laboratory indicators are met within one week of enrollment: creatinine clearance rate ≥ 60 mL/min (according to the Cockcroft Fault formula); AST and ALT ≤ 3 × Upper limit of normal value range (ULN), total bilirubin ≤ 2 × ULN; Echocardiography (ECHO) shows left ventricular ejection fraction (LVEF) ≥ 50%;
- •Life expectancy greater than 8 weeks;
- •Voluntarily sign an informed consent form to understand and comply with the requirements of the study.
排除标准
- •Failure to achieve complete hematological remission, including residual extramedullary infiltration;
- •Previously received hematopoietic stem cell transplantation;
- •Received systemic chemotherapy within 2 weeks;
- •Previously received treatment with Blinatumomab;
- •Have a history of central nervous system leukemia or present with central nervous system leukemia;
- •Active autoimmune diseases, such as SLE, rheumatoid arthritis, etc;
- •Currently suffering from clinically significant active cardiovascular diseases, such as uncontrolled arrhythmia, uncontrolled hypertension, congestive heart failure, any grade 3 or 4 heart disease determined according to the New York Heart Association (NYHA) functional classification (see Appendix 1), or having a history of myocardial infarction within 6 months prior to screening;
- •Chronic obstructive pulmonary disease with whole lung dysfunction;
- •Other serious diseases that may restrict patients from participating in this test (such as advanced infection, uncontrollable diabetes);
- •Concomitant arteriovenous thrombosis or hypercoagulable state;
- •Known human immunodeficiency virus (HIV) infection, or chronic infection of hepatitis B virus (HBsAg positive) or hepatitis C virus (anti-HCV positive) beyond drug control;
- •Pregnant or lactating women;
- •Severe allergies to other monoclonal antibodies in the past;
- •Those who are unable to understand, comply with the research protocol or sign an informed consent form.
研究组 & 干预措施
Blinatumomab Group
Haploidentical hematopoietic stem cell transplantation was performed using a Conditioning regimen containing Blinatumomab. 28ug of Blinatumomab was administered intravenously once a day for a total of 7 days, followed by a routine conditioning regimen and haploid hematopoietic stem cell transplantation.
干预措施: Blinatumomab (Drug)
结局指标
主要结局
Progress-Free Survival
时间窗: At Year 1
Progression-free survival (PFS) is defined as the time from transplantation to disease progression or death from any cause.
次要结局
- chornic graft versus host disease(At Year 1)
- Overall Survival(At Year 1)
- Cumulative Incidence of Relapse(At Year 1)
- acute graft versus host disease(At Day 100)
- Minimal Residual Disease(At Year 1)
- Non-relapse Mortality(At Year 1)
研究者
He Huang
The President of The First Affiliated Hospital, College of Medicine, Zhejiang University
Zhejiang University