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临床试验/NCT00276757
NCT00276757已完成不适用

Treatment Protocol of the Third International Study For Langerhans Cell Histiocytosis

Histiocyte Society65 个研究点 分布在 10 个国家目标入组 376 人开始时间: 2001年4月最近更新:
适应症
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
376
试验地点
65

研究概览

简要总结

RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of Langerhans cell histiocytosis, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may be an effective treatment for Langerhans cell histiocytosis.

PURPOSE: This randomized clinical trial is studying combination chemotherapy to see how well it works in treating young patients with Langerhans cell histiocytosis.

详细描述

OBJECTIVES:

Primary

  • Compare the efficacy, in terms of response to initial therapy, of prednisolone, vinblastine, and mercaptopurine with vs without methotrexate and leucovorin calcium in young patients with Langerhans cell histiocytosis.
  • Compare the progression-free survival of patients with low-risk Langerhans cell histiocytosis who responded to initial therapy who are then treated with 6-month vs 12-month continuation therapy comprising prednisolone and vinblastine.

Secondary

  • Compare the acute and long-term toxicity and the incidence of permanent effects.
  • Compare the overall and progression-free survival, response rate, and time until response.

研究设计

研究类型
Interventional
分配方式
Randomized
主要目的
Treatment

入排标准

年龄范围
— 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究者

申办方类型
Other

研究点 (65)

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