A Prospective Multicenter Cohort Study on the Efficacy and Safety of Stratified Treatment of Chinese Children With Lymphoblastic Lymphoma Based on Risk Factors
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. Recent clinical studies of COG in the United States and LMB in France have confirmed that molecular biological markers such as Notch1, PTEN and LOH6q are significantly associated with the prognosis of T-lymphoblastic lymphoma (T-LBL). These molecular biological markers should be included in the new risk stratification system. High-intensity treatment of high-risk patients will improve survival. 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. SCCCG-LBL-2017 was formulated by South China Children's Cancer Group of Non-Hodgkin lymphoma, which mainly updated in clinical staging, efficacy evaluation, risk stratification, treatment,etc..
详细描述
Research purpose:
- To investigate the efficacy and safety of SCCCG-LBL-2017 in Chinese children with LBL.
- To explore the feasibility of risk stratification of T-LBL by combining genotyping.
- To investigate the correlation between MDD and MRD in lymphoblastic lymphoma and prognosis.
- To investigate the role of PET/CT in the assessment of residual lymphoblastic lymphoma.
- To explore the effect of reducing HD-MTX dosage and shortening maintenance therapy time on the efficacy and survival of low-risk LBL patients.
- To explore the effect of prolonging the duration of maintenance therapy on the efficacy and survival of high-risk LBL patients.
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 lymphoblastic lymphoma
- •Newly diagnosed patients
- •Informed consent of guardian of children patients -
排除标准
- •Age > 18 years old
- •Recurrent lymphoblastic lymphoma
- •Secondary immunodeficiency.
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
- Overall survival (OS)(through study completion, maximal eight years)
- Relapse-free survival (RFS)(through study completion, maximal eight years)
- Response rate (RR)(on an average 3 weeks after finish of treatment)
- Adverse event rate(through study completion, maximal eight years)
研究者
Xiao-Fei Sun
professor
Sun Yat-sen University