ACTRN12611000085976
进行中（未招募）
3 期
Double blind randomized phase III study ofLenalidomide (Revlimid Registered Trademark) maintenance versusPlacebo in responding elderly patients withdiffuse large B cell lymphoma (DLBCL) and treated with Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) in first line
Australasian Leukaemia and Lymphoma Group0 个研究点目标入组 54 人2011年1月24日
概览
- 阶段
- 3 期
- 干预措施
- 未指定
- 疾病 / 适应症
- Diffuse large B cell lymphoma (DLBCL) in elderly patients
- 发起方
- Australasian Leukaemia and Lymphoma Group
- 入组人数
- 54
- 状态
- 进行中（未招募）
- 最后更新
- 6年前
概览
简要总结
暂无简介。
研究者
入排标准
入选标准
- •For patients registered at the time of initial diagnosis
- •initial diagnosis of histologically confirmed CD20\+ DLBCL
- •previously untreated with chemo\- or radiotherapy
- •For patients registered after response evaluation to first line treatment with R\-CHOP:
- •Diagnosis of histologically confirmed CD20\+ diffuse large B\-Cell Lymphoma
- •Have reached a CR or PR after first line treatment with at least 6 cycles of R\-CHOP 14 regimen or up to 8 cycles of R\-CHOP21
- •Previously untreated with Radiotherapy
- •For all patients:
- •aged from 60 to 80 years at time of initial diagnosis
- •Ann Arbor stages II\-IV at time of initial diagnosis
排除标准
- •Any other histological type of lymphoma, Burkitt included.
- •Any history of treated or non\-treated small B\-cell lymphoma
- •Central nervous system or meningeal involvement by lymphoma
- •Contraindication to any drug contained in the chemotherapy regimen.
- •Myocardial infarction during last 3 months or unstable coronary disease or uncontrolled chronic
- •symptomatic congestive heart insufficiency New York Heart Association III\-IV
- •Uncontrolled hypertension
- •Uncontrolled diabetes mellitus as defined by the investigator
- •Active systemic infection requiring treatment.
- •Previously known human immunodeficiency virus (HIV) positive serology
结局指标
主要结局
未指定
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