Blinatumomab Combined With Reduced-dose Chemotherapy in Treating Precursor B Cell Acute Lymphoblastic Leukemia: a Phase II, Single Arm and Multicenter Study
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Complete remission rate with negative minimal residual disease
研究概览
简要总结
Precursor B cell acute lymphoblastic leukemia (B-ALL) is an aggressive type of leukemia, with high relapse rate and poor long term survival in adults. Traditional treatment regimens mainly include chemotherapy and hematopoietic stem cell transplantation. In the past decade, with the application of molecular targeted drugs and immunotherapy, the survival of B-ALL patients has significantly improved. In this study，we propose a treatment approach that combines Blinatumomab and Reduced-dose Chemotherapy in B-ALL adults. Our study aims to answer the safety and efficacy of this treatment regimen, and further improve the survival for those participants.
详细描述
This is a prospective, single-arm, phase II and open-label study. A total of 20 Ph-negative B-ALL participants will be enrolled. The primary endpoint is MRD-negative CR rate. The induction therapy is a combination of Blinatumomab(Blina), Vindesine(VDS), Cyclophosphamide(CTX) and Dexamethasone(DXM). The second cycle would be the combination of Blina and Venetoclax(VEN). As for consolidation therapy, we suggest the bone marrow transplantation. The purpose of this study is to explore the safety and efficacy of the treatment regimen in the treatment of newly diagnosed young Ph-negative B-ALL patients.
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
- 15 Years 至 59 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Before enrollment, patients must be diagnosed with de novo precursor B-cell acute lymphoblastic leukemia and be negative for Philadelphia chromosome. The diagnostic criteria refer to the 2022 WHO classification;
- •Age≥15 years， ≤59 years;
- •Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2;
- •Expected survival time ≥ 2 months;
- •No organ dysfunction that would restrict the use of this protocol during the screening period;
- •Understand the study and sign the informed consent form.
- •Men, women of childbearing age (only postmenopausal women who have been menopausal for at least 12 months can be considered infertile), and their partners voluntarily take effective contraceptive measures deemed effective by the investigator during the treatment period and for at least 12 months after the last dose of the study drug.
排除标准
- •Patients with known central nervous system (CNS) involvement of ALL;
- •Diseases with abnormal heart, lung, liver, kidney, or other organ functions that may limit the patient's participation in this trial (including but not limited to severe infections, uncontrolled diabetes, severe heart failure or angina, active pulmonary tuberculosis, asthma, COPD, bronchiectasis, etc.);
- •Cardiac ultrasound LVEF < 45%;
- •History of other malignancies within the past 5 years, excluding localized thyroid cancer and in situ skin cancer;
- •Serum total bilirubin > 1.5 ULN (upper limit of normal); ALT or AST > 2.5 ULN; serum creatinine > 1.5 ULN;
- •Known HIV infection;
- •Conditions affecting the use of the study drug as assessed by the investigator;
- •Unable to understand or comply with the study protocol.
研究组 & 干预措施
Treatment arm
Blinatumomab plus Reduced-dose Chemotherapy
干预措施: Blinatumomab plus Reduced-dose Chemotherapy (Drug)
结局指标
主要结局
Complete remission rate with negative minimal residual disease
时间窗: at the end of cycle 1 and 2（each cycle is 28 days）
complete remission and negative MRD detected by flowcytometry
次要结局
- CR/CRi after Cycle 1 and 2(at the end of cycle 1 and 2（each cycle is 28 days）)
- Minimal residual disease(MRD)(At the end of each cycle（each cycle is 28 days）)
- Overall survival (OS)(up to 5 years)
- Event free survival(EFS)(up to 5 years)