A Prospective Multicenters Clinical Cohort Study of the Efficacy and Safety of Stratified Risk Factors for Treatment of Chinese Children With Systemic ALK-positive Anaplastic Large Cell Lymphoma
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Event-free survival (EFS)
研究概览
简要总结
With the development of molecular biology and precise medical treatment, new challenges have been raised in the diagnosis and treatment of non-Hodgkin lymphoma (NHL) in children. In recent years, the criteria for clinical staging and efficacy evaluation of NHL in children have been updated. Studies in Germany and the United States have shown that pathological types of systemic anaplastic large cell lymphoma (ALCL) in children and adolescents, minimal disseminated disease (MDD) in peripheral blood or bone marrow and minimal residual disease (MRD) are significantly associated with prognosis, suggesting that these factors need to be combined in risk stratification of ALCL patients. Recent studies have also suggested that PET/CT is helpful in evaluating residual lesions in patients with lymphoma after chemotherapy. In order to keep pace with the times in the diagnosis, clinical staging, risk stratification, efficacy evaluation and treatment of NHL in children. We adjusted the original NHL-BFM-90/95 regimen, mainly in the aspects of clinical staging, efficacy evaluation, risk stratification and treatment regimen，etc.
详细描述
Research purpose:
- To study the efficacy and safety of SCCCG-ALCL-2017 regimen in children with systemic ALK-positive anaplastic large cell lymphoma.
- To explore the correlation between MDD or MRD in peripheral blood or bone marrow and the treat response and survival.
- To explore the feasibility of risk stratification combined with adverse pathological types, dangerous organ invasion and MDD.
- To investigate the effect of vinblastine maintenance chemotherapy on survival of patients with MRD-positive in peripheral blood after treatment.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Age < 18 years old
- •Pathologically confirmed systemic ALK-positive anaplastic large cell lymphoma
- •Newly diagnosed patients
- •Informed consent of guardian of children patients
排除标准
- •Secondary immunodeficiency disease
- •Second neoplasm
- •Primary cutaneous anaplastic large cell lymphoma
- •Recurrent and progressive patients.
结局指标
主要结局
Event-free survival (EFS)
时间窗: through study completion, maximal eight years
EFS is defined as time from start of treatment/randomization up to event or to date of last contact for patients without event. The following occurrences are defined as an event: non-response, progressive disease or relapse, treatment related death, death of any other cause or diagnosis of secondary malignancies
次要结局
- Relapse-free survival (RFS)(through study completion, maximal eight years)
- Response rate (RR)(on an average 3 weeks after finish of treatment)
- Overall survival (OS)(through study completion, maximal eight years)
- Adverse event rate(from the first day of protocol defined treatment until two years after start of protocol defined treatment)
研究者
Xiao-Fei Sun
professor
Sun Yat-sen University