NCT04604691招募中1 期
Blinatumomab for Minimal Residual Disease Before Hematopoietic Stem Cell Transplantation With Pediatric B-cell Precursor Acute Lymphoblastic Leukemia
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Safety evaluation including cytokine release syndrome
研究概览
简要总结
This is a single-arm, open-label, multi-center phase I study using blinatumomab for pediatric B-cell acute lymphoblastic leukemia patients with positive of minimal residual disease. 1 Cycle of blinatumomab treatment followed by hematopoietic stem cell transplantation. Blinatumomab has approved to treat adults and children with B-cell precursor ALL who are in remission but still have MRD. However, data on the effects and safety of blinatumomab in children with B-precursor ALL with MRD positive are insufficient.
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
- 0 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Immunophenotypic evidence of Cluster of Differentiation 19 (CD19) positive B precursor ALL
- •Age <18 years at the time of informed consent/assent
- •B cell precursor ALL in first or later hematologic complete remission (CR) defined as less than 5% blasts in bone marrow after at least three intense chemotherapy blocks
- •Persistent or recurrent MRD ≥10^-4 in an assay with a minimum sensitivity of 10^-5 before hematopoietic stem cell transplantation
- •Bone marrow function as defined below: Absolute neutrophil count ≥1,000/μL, Platelets ≥50,000/μL (transfusion permitted), Hemoglobin level ≥9 g/dL (transfusion permitted)
- •Renal and hepatic function as defined below: Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), and alkaline phosphatase (AP) < 2 x upper limit of normal (ULN), Total bilirubin <1.5 x ULN, Creatinine clearance ≥ 50 mL/min
- •Negative HIV test, negative hepatitis B (HBsAg) and hepatitis C virus (anti-HCV) test
- •Negative pregnancy test in women of childbearing potential
排除标准
- •Presence of circulating blasts or current extramedullary involvement by ALL
- •History of relevant central nervous system (CNS) pathology or current relevant CNS pathology (e.g. seizure, epilepsy, paresis, aphasia, stroke, severe brain injuries, dementia, cerebellar disease, organic brain syndrome, psychosis) with the except of CNS leukemia that is well controlled with intrathecal therapy
- •Current infiltration of cerebrospinal fluid by ALL
- •History of or active relevant autoimmune disease
- •Systemic cancer chemotherapy within 2 weeks prior to study treatment (except for intrathecal prophylaxis)
- •Radiotherapy within 4 weeks prior to study treatment
- •Autologous hematopoietic stem cell transplantation (HSCT) within six weeks prior to study treatment
- •Therapy with monoclonal antibodies (rituximab, alemtuzumab) within 4 weeks prior to study treatment
- •Treatment with any investigational product within 4 weeks prior to study treatment
- •Known hypersensitivity to immunoglobulin or to any other component of the study drug formulation
- •Active malignancy other than ALL with the exception of basal cell or squamous cell carcinoma of the skin, or carcinoma "in situ" of the cervix
- •Active infection, any other concurrent disease or medical condition that are deemed to interfere with the conduct of the study as judged by the investigator
研究组 & 干预措施
Blinatumomab Treatment
Experimental
干预措施: Blinatumomab for Injection (Drug)
结局指标
主要结局
Safety evaluation including cytokine release syndrome
时间窗: At the latest possible timepoint prior to the initiation of transplant conditioning or after 30 days of Blinatumomab treatment
The incidence of treatment-emergent and treatment-related adverse events
次要结局
- Overall Survival (OS)(24 Months)
- Hematologic Relapse-Free Survival (RFS)(24 Months)
- Complete MRD response status after 1 cycle of blinatumomab(28 Days)
研究者
研究点 (1)
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