A Multicenter, Single-arm, Open-end Study of Reduced-dose Chemotherapy Followed by Blinatumomab in Induction Therapy of Newly Diagnosed Non-elderly Philadelphia Chromosome Negative Acute B Lymphoblastic Leukemia
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Overall response rate (ORR)
研究概览
简要总结
Blinatumomab, a CD3/CD19 bisespecific T-cell conjugative antibody, has shown high efficacy in phase I/II studies of relapsed/refractory B-lymphoblastic leukemia (B-ALL), particularly in the context of low tumor burden.Meanwhile, Blinatumomab also plays an important role in rapid and efficient clearance of MRD in patients. Therefore, its use in combination with less intensive chemotherapy for initial induction therapy in newly diagnosed patients may result in favorable response rates, greater depth of remission, and lower treatment-related toxic effects.
In this study, newly diagnosed non-elderly patients with Philadelphia chromosomal negative (PH-) B-ALL were enrolled and treated with reduced-intensity chemotherapy followed by Blinatumomab as the basis of induction therapy. The clinical remission rate, MRD negative rate and treaty-related adverse reactions were evaluated in newly diagnosed non-elderly PH-B-ALL patients during induction therapy.
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 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ph-(BCR-ABL1 negative)B-ALL was diagnosed according to WHO diagnostic criteria
- •Newly diagnosed patients without prior induction therapy (except hydroxyurea and glucocorticoids ≦5 days)
- •ECOG score 0-3
- •Liver function: total bilirubin ≦ 3 times the upper limit of normal; Alanine aminotransferase ≦ 3 times upper limit of normal motion; Aspartate aminotransferase ≦ 3 times upper limit of normal motion; (except considering leukemia infiltration)
- •Renal function: endogenous creatinine clearance ≧30ml/min
- •Patients must be able to understand and willing to participate in the study and must sign the informed consent form.
排除标准
- •Ph+ (BCR-ABL1 positive) ALL and known ABL class Ph-Like ALL
- •T cells ALL
- •Mature B-cell leukemia/lymphoma, B-cell lymphoma, isolated extramedullary disease
- •Acute mixed-cell leukemia
- •Central nervous system leukemia
- •HIV infection
- •HBV-DNA or HCV-RNA positive
- •Patients with grade 2 or higher heart failure and other patients deemed inappropriate for inclusion by the investigator
- •Pregnant or breastfeeding patients
- •The study patient was refused enrollment
研究组 & 干预措施
reduced-intensity chemotherapy followed by berintuzumab
Induction therapy was performed with reduced intensity chemotherapy (including 1 dose of Idarubicin 8 mg/m2, 1 dose of Vindesine 3 mg/m2, and 7 days of Dexamethasone 9 mg/m2/d) followed by 2 weeks of Blinatumomab (9 ug/d d8-14, 28 ug/d d15-21) immediately. Bone marrow evaluation was performed on day 22±2, and consolidation therapy was performed after achieving bone marrow remission (CR/CRh/CRi). If CR/CRh/CRi was not achieved in the first course of induction therapy, Blinatumomab (28ug/d×14d) should be continued and bone marrow evaluation should be evaluated again.
The regimen of consolidation therapy is recommended as multidrug combination chemotherapy (including high-dose Methotrexate or Cytarabine combined with Asparaginase) or alternating with Blinatumomab (28 ug/d×28d). If Allogeneic Hematopoietic Stem Cell Transplantation (Allo-HSCT) is not performed, consolidation therapy needs at least 4 courses before 2 years maintenance therapy.
干预措施: Blinatumomab (Drug)
结局指标
主要结局
Overall response rate (ORR)
时间窗: Induction therapy phase: The time of bone marrow evaluation is day 22 or 37±2.
Overall response rate (ORR), including complete response (CR)/ complete response rate with partial hematologic recovery (CRh)/ complete response rate with incomplete hematologic recovery (CRi).
次要结局
- Event-free survival (EFS)(1 year after study completion)
- Overall survival (OS)(1 year after study completion)
- The negative rate of minimal residual lesion (MRD)(Induction therapy phase: The time of bone marrow evaluation is day 22 or 37±2.)
- Time of hematopoietic recovery(From the beginning of induction therapy to the beginning of consolidation therapy.)
- Treatment-related SAE(From the beginning of induction therapy to the beginning of consolidation therapy.)
研究者
Chen Suning
Physician
The First Affiliated Hospital of Soochow University