NCT01458730已完成2 期
Immunochemotherapy in Primary Central Nervous System Lymphoma With Rituximab, HD-MTX, HD-Ara C, Cyclophosphamide, Ifosfamide, Vincristine, Vindesine, Temozolomide and DepoCyte Induction Followed by Maintenance Treatment in Elderly Patients With Temozolomide.
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 66
- 试验地点
- 2
- 主要终点
- Overall survival
研究概览
简要总结
The purpose of the study is to test the efficacy and tolerability of a multiagent chemotherapy treatment regimen without radiotherapy in patients with newly diagnosed lymphoma in the brain.
详细描述
The objective of the study is
- To investigate the efficacy and safety of a high-dose methotrexate-based induction polychemotherapy regimen combined with Rituximab and intraspinal DepoCyte followed by temozolomide maintenance treatment in newly diagnosed primary central nervous system lymphoma
- To assess the long term outcome concerning neurotoxicity
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pathologically verified primary central nervous system lymphoma No prior PCNSL treatment.
- •Patients treated with steroids alone are eligible
- •No signs of lymphoma outside the CNS
- •ECOG performance status 0-4
- •Age > 17 and < 76 years
- •Written informed consent from the patient or guardian
排除标准
- •Cardiac failure > 3
- •Pregnancy or lactation. Women of childbearing potential are requested to use an effective method of contraception to avoid pregnancy for a period from entry to the study and at least 3 months after the last study medication
- •Previous malignancy unless disease free for at least five years
- •Active infection.
- •Regarding tuberculosis, patients at risk should be tested for latent TB according local practice at each treating centre.
- •Positive HIV status
- •Organ transplantation
- •Serious psychiatric illness
- •Prior radiotherapy to the brain
- •Concomitant anti-inflammatory medication that cannot be discontinued
- •Creatinine clearance < 60 ml/minute calculated by Cockcroft and Gault formula
- •Peripheral blood count with granulocytes <1.5 x 109L or platelets < 100 x 109L
- •Serum bilirubin >1.5 times or ASAT and alkaline phosphatase >2 times upper limits of normal.
- •Known anaphylaxis or IgE-mediated hypersensitivity to murine protein or any component of Rituximab excludes patients from Rituximab treatment, but not from the remaining part of the study
结局指标
主要结局
Overall survival
次要结局
- response rate(at completion of therapy)
- neurotoxicity(1-10 years after completion of therapy)
研究者
研究点 (2)
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