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 人开始时间: 2011年1月24日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 54
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 60 Years 至 80 Years（—）
- 性别
- All
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
- •age-adjusted International Prognostic Index greater than 1 at time of initial diagnosis
- •Eastern Cooperative Oncology Group performance status 0-2
- •Minimum life expectancy of 3 months
- •Following laboratory values at screening:
- •absoloute neutrophil count greater than or equal to 1000x10^6/Litre and Platelets greater than or equal to 60000x10^6/Litre
- •Aspartate transaminase (AST) less than or equal to 5x Upper limit of normal (ULN), Alanine transaminase (ALT) less than or equal to 5xULN, Total Bilirubin less than or equal to 1.5xULN
- •Creatinine clearance>30mL/min
- •Women of childbearing potential are using effective contraception, are not pregnant and agree not to become pregnant during participation in the trial and after end of study. Men agree to use a condom during sexual contact with a female, even if they have had a vasectomy, and to not donate semen or sperm throughout study drug therapy, during any dose interruption and during the 12 months thereafter.
- •Having previously signed a written informed consent form
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
- •Active hepatitis B or C
- •Prior history of malignancies other than lymphoma within 3 years (except for complete resection of basal cell carcinoma, squamous cell carcinoma of the skin, or in situ malignancy)
- •Serious medical or psychiatric illness likely to interfere with participation in this clinical study
研究者
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