NCT00488605撤回3 期
H-9926-LCH III: Treatment Protocol of the Third International Study for Langerhans Cell Histiocytosis
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- The proportion of non-responder in risk organs to the initial treatment
研究概览
简要总结
LCH III is an international, multicentric, prospective clinical study comprised of:
- a randomized clinical trial for multisystem "RISK" patients and
- a randomized clinical trial for multisystem "LOW RISK" patients and
- a pilot study for patients with single system MFB and localized "SPECIAL SITES"
详细描述
Therapy for "LOW RISK" Patients:
The decision as to which research program you will be assigned will be made entirely by chance. The overall time of therapy will be 6 or 12 months as randomly assigned. The research program will be with the drugs Vinblastine and Prednisone.
Initial Therapy
- Prednisone given by mouth three times a day daily as a four-week course, then gradually decreased over 2 more weeks.
- Vinblastine will be given IV (into a vein) one day a week for 6 weeks.
- Patients who have no evidence of active disease at this time will proceed to continuation therapy.
Patients whose disease response is stable, mixed or worse will receive additional therapy with:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- — 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All newly diagnosed patients who meet the following criteria are eligible to be enrolled and followed in the study:
- •Definitive diagnosis of LCH
- •Age under 18 years
- •No prior treatment for LCH
排除标准
- •Not specified
研究组 & 干预措施
Treatment Arm A
Active Comparator
干预措施: Prednisone, Vinblastin, 6-mercaptopuroine (Drug)
Treatment Arm B
Experimental
干预措施: Leucovorin, Methotrexate, Vinblastine, Prednisone (Drug)
结局指标
主要结局
The proportion of non-responder in risk organs to the initial treatment
时间窗: 12 months
次要结局
- Overall survival(12 months)
- Proportion of responders (overall and in risk organs)(at week 12)
- Reactivation free survival after response(at week 12)
- Time to NAD(at weeks 6, 12, 7, or 13-23)
研究者
研究点 (1)
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