NCT04723342招募中不适用
Treatment of Children and Adolescents With Primary B-precursor Acute Lymphoblastic Leukemia With Combination Chemotherapy and Immunotherapy
Federal Research Institute of Pediatric Hematology, Oncology and Immunology4 个研究点 分布在 1 个国家目标入组 180 人开始时间: 2020年2月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 180
- 试验地点
- 4
- 主要终点
- Minimal residual disease level
研究概览
简要总结
THE PURPOSE OF THE STUDY is to optimize the therapy of patients with primary B-cell precursor acute lymphoblastic leukemia (BCP-ALL) by including monoclonal bispecific antibodies in post-induction treatment with simultaneous reduction of chemotherapy.
QUESTIONS AND OBJECTIVES OF THE STUDY:
- to determine the efficacy and feasibility of chemotherapy and immunotherapy combination in comparison with standard PCT in children and adolescents with newly diagnosed BCP-ALL;
- to determine the safety and toxicity of chemotherapy and immunotherapy combination in comparison with standard PCT in children and adolescents with newly diagnosed BCP-ALL;
- to determine the possibility of chemotherapy reducing when immunotherapy is included in the treatment regimen without loss of effectiveness;
- to determine the possibility of reducing the maintenance therapy duration to 1 year when immunotherapy is included in the treatment regimen without loss of effectiveness.
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 Year 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •This study included patients with B-cell precursor ALL (BCP-ALL) diagnosed or confirmed in one of the clinics participating in the study. Also following criteria should be considered at the diagnosis for each case:
- •Age at diagnosis at 1 to 18 years.
- •The start of induction therapy within a time interval of study recruitment phase.
- •The diagnosis of BCP-ALL is to be proved by the morphological, cytochemical, and immunological analysis of tumor cells in bone marrow in the reference laboratories of Dmitry Rogachev National Medical Research Center of Pediatric Hematology, Oncology and Immunology (D. Rogachev NMRCPHOI).
- •CD19 expression on tumor cells.
- •Informed consent of the patient parents (guardians)
排除标准
- •Any non-compliance with the inclusion criteria.
- •ALL is a second malignancy.
- •There is severe concomitant disease, which significantly impedes chemotherapy protocol (such as multiple malformations, heart diseases, metabolic disorders, etc.);
- •The patient was treated before for a long time with cytotoxic drugs.
- •Initial CNS (central nervous system) involvement (status CNSII or CNSIII).
- •Initial leukocyte count ≥100×109/L (except for patients with significant translocations).
- •Patients not achieved cytological remission after induction
研究组 & 干预措施
Blinatumomab
Experimental
Consolidation therapy with Blinatumomab administration
干预措施: Blinatumomab (Drug)
结局指标
主要结局
Minimal residual disease level
时间窗: 1 year after starting maintenance therapy
Event-free survival
时间窗: 5 years after study start
次要结局
- Overall survival(5 years after study start)
- Remission death rate(5 years after study start)
- Cumulative incidence of relapse(5 years after study start)
研究者
研究点 (4)
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