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临床试验/NCT01761500
NCT01761500已完成2 期

Improve the Survival Rate of Chinese Children and Adolescents With Non-Hodgkin's Lymphoma

Sun Yat-sen University0 个研究点目标入组 200 人开始时间: 1998年3月1日最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
200
主要终点
The event free survival (EFS)

研究概览

简要总结

Non-Hodgkin's lymphoma is an aggressive malignance disease in children and adolescents. This study was designed to evaluate the efficacy and toxicity of the modified NHL-BFM-90 protocol in Chinese children and adolescents with Non-Hodgkin's lymphoma.

详细描述

Non-Hodgkin's Lymphoma (NHL) in children and adolescents include Burkitt's lymphoma (BL), diffuse large B cell lymphoma (DLBL), anaplastic large cell lymphoma (ALCL) and lymphoblastic lymphoma (LBL). These subtypes of NHL are an aggressive group of diseases. At present, in developed countries, 80 to 90% of children with NHL are cured by intensive, risk-adapted chemotherapy.The best protocols include BFM-90, LMB-89 and FAB/LMB/96. However, in developing countries, such as those with low and moderate incomes, the limited availability of resources is an obstacle for using these complicated and intensive protocols.As such, very simple protocols, such as the CHOP protocol, were often used to treat children and adolescents with NHL, thus resulting in poor survival rates. To improve the survival rate of Chinese children and adolescents with NHL, This study was designed to evaluate the efficacy and toxicity of this modified NHL-BFM -90 protocol in Chinese children and adolescents with NHL.

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
6 Months 至 20 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Untreated children and adolescents with Non-Hodgkin's lymphoma
  • Age ≤ 20 years
  • The informed consent of their guardians was obtained.

排除标准

  • Recurrence Non-Hodgkin's lymphoma
  • Age >20 years
  • No abide by the protocol

结局指标

主要结局

The event free survival (EFS)

时间窗: Up to 5 years

The event free survival (EFS) was defined as the time from the start of treatment to one of the following events: death from any cause, disease progression during treatment, relapse, or to the date of the last follow up if patient did not experience any event.

次要结局

  • Number of Participants with Adverse Events(Up to 5 years)

研究者

发起方
Sun Yat-sen University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Xiao-Fei Sun

Professor

Sun Yat-sen University

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