ACTRN12610000908033进行中（未招募）3 期
Rituximab in Primary Central Nervous system Lymphoma.A randomized Dutch/Belgian Hemato-Oncology Cooperative Group (HOVON) / Australasian Leukaemia and Lymphoma Group (ALLG) intergroup study
HOVO0 个研究点目标入组 45 人开始时间: 2010年10月25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
- 45
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
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 70 Years（—）
- 性别
- All
入选标准
- •1. Patients with a histologically confirmed diagnosis of CD20 positive diffuse large B cell lymphoma (DLBCL) based upon a representative histology specimen of brain biopsy according to the world health organisation (WHO) classification;
- •2. Patients with a diagnosis of PCNSL based on magnetic resonance imaging (MRI) evidence of brain parenchymal lesion showing homogeneous contrast enhancement suspect for lymphoma;
- •3. Unequivocal morphological and/or immunophenotypical evidence of cerebrospinal fluid (CSF) CD20 + large cell lymphoma;
- •4. AND/OR Unequivocal morphological and/or immunophenotypical evidence of CD20 + large cell lymphoma in vitreous fluid;
- •5. Patients with unequivocal morphological and/or immunophenotypical evidence of CD20 + large cell lymphoma in vitreous fluid AND CSF but without a brain parenchymal lesion;
- •6. Age 18-70 years inclusive;
- •7. Performance status with or without administration of steroids WHO/Eastern cooperative group (ECOG) 0-3;
- •8. Written informed consent.
排除标准
- •1. Evidence of systemic lymphoma;
- •2. History of intolerance of exogenous protein administration;
- •3. Severe cardiac dysfunction (NYHA classification III-IV, , or Left Ventricular Ejection Fraction < 45%) Congestive heart failure or symptomatic coronary artery disease or cardiac arythmias not well controlled with medication ;
- •4. Severe pulmonary dysfunction (vital capacity or diffusion capacity < 50% of predicted value);
- •5. Significant hepatic dysfunction (bilirubin or transaminase greater or equal to 2.5 x upper normal limit) at Screening;
- •6. Significant renal dysfunction (serum creatinine greater than or equal to 150 micromol/l or clearance < 60 ml/min) at Screening;
- •7. Presence of third space fluid, such as pleural effusion or ascites;
- •8. Prior cranial radiotherapy;
- •9. Active uncontrolled infection;
- •10. Human immunodeficiency virus (HIV)-positivity;
- •11. Epstein barr virus (EBV) positive post-transplant lymphoproliferative disorder;
- •12. Untreated hepatitis B infection (inclusion is possible if adequate antiviral medication e.g. lamivudine or alternative is started and continued for the duration of the trial);
- •13. Positive pregnancy test in women of reproductive potential;
- •14. Lactating women;
- •15. Unable or unwilling to use adequate contraceptive methods (all men, pre-menopausal women) until 12 months after last chemotherapy treatment;
- •16. Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.
研究者
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