NCT00199017已完成4 期
Multicenter Trial for Treatment Optimization in T-lymphoblastic Lymphoma in Adults and Adolescents Older Than 15 Years (GMALL T-LBL 1/2004) (Amend 1)
Johann Wolfgang Goethe University Hospital2 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2004年4月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 75
- 试验地点
- 2
- 主要终点
- remission rate, remission duration, disease free survival, overall survival
研究概览
简要总结
This study evaluates the efficacy and tolerability of treatment for T-lymphoblastic lymphoma (T-LBL) according to a protocol for acute lymphoblastic leukemia. Patients receive one year of intensive cyclical chemotherapy with additional prophylaxis for central nervous system (CNS) relapse by intrathecal therapy and cranial irradiation and mediastinal irradiation after induction chemotherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 15 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •T-lymphoblastic lymphoma (bone marrow [BM] involvement < 25%)
- •Aged 15-65 years (55-65 years if biologically younger)
- •Written informed consent
排除标准
- •Severe complications due to lymphoma or secondary disease
- •T-LBL as second malignancy or other active second malignancy
- •Cytostatic pretreatment of LBL (exception of emergency treatments)
- •Pregnancy
- •Severe psychiatric illness or other circumstances which may compromise cooperation of the patient or informed consent
- •Participation in other study interfering with study treatment
结局指标
主要结局
remission rate, remission duration, disease free survival, overall survival
次要结局
- time and dose compliance, toxicity according to World Health Organization (WHO)
研究者
研究点 (2)
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