NCT01083342已完成2 期
Open-labeled, Multicenter Phase II Study of High-Dose (HD) Methotrexate (MTX) Induction Chemotherapy Followed by Alternative HD MTX-based and HD Cytarabine-based Combination Consolidation Chemotherapy for Newly Diagnosed Primary CNS Lymphoma; CISL 10-01 Study
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- To evaluate the complete response (CR) after chemotherapy
研究概览
简要总结
The purpose of this study is to evaluate the complete response (CR) rate after HD-MTX induction chemotherapy followed by alternative HD MTX-based and HD Cytarabine-based combination consolidation chemotherapy
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
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed Primary Central Nervous System (CNS) lymphoma
- •Previously untreated. Patients treated with steroid alone are eligible.
- •Performance status: ECOG 0-
- •Adequate renal function: Estimated glomerular filtration rate (GFR) or estimated creatinine clearance (CrCl) ≥ 50 mL/min
- •Adequate liver functions: Transaminase (AST/ALT) < 3 X upper normal value & Bilirubin < 2 X upper normal value
- •Adequate hematological function: hemoglobin ≥ 9 g/dL absolute neutrophil count (ANC) ≥ 1,500/μL and platelet count ≥ 75,000/μL
- •At least one cerebral mass lesion on magnetic resonance imaging (MRI) without involvement beyond the central nervous system (CNS)
- •Life expectancy > 6 months
- •A negative serum or urine pregnancy test prior to treatment must be available both for pre menopausal women and for women who are < 1 years after the onset of menopause.
- •Informed consent
排除标准
- •Other subtypes NHL than Primary Central Nervous System (CNS) lymphoma
- •Systemic involvement of Primary CNS lymphoma except leptomeningeal involvement
- •Intraocular lymphoma
- •Any other malignancies within the past 5 years except curatively treated non-melanoma skin cancer or in situ carcinoma of cervix uteri
- •Pregnant or lactating women, women of childbearing potential not employing adequate contraception
- •Other serious illness or medical conditions
- •Unstable cardiac disease despite treatment, myocardial infarction within 6 months prior to study entry
- •History of significant neurological or psychiatric disorders
- •Active uncontrolled infection (viral, bacterial or fungal infection)
- •Patients who have HBV (+) are eligible. However, primary prophylaxis using antiviral agents (i.e. lamivudine) is recommended for HBV carrier to prevent HBV reactivation during whole treatment period.
- •Concomitant administration of any other experimental drug under investigation, or concomitant chemotherapy, hormonal therapy, or immunotherapy.
结局指标
主要结局
To evaluate the complete response (CR) after chemotherapy
时间窗: 24 months
次要结局
- To evaluate the duration of response(24 months)
- To evaluate the progression-free survival, overall survival(24 months)
- To evaluate the safety profiles(24 months)
研究者
Won Seog Kim
Professor
Samsung Medical Center
研究点 (1)
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