EUCTR2009-012432-32-IT进行中（未招募）不适用
Randomized phase II trial on primary chemotherapy with high-dose methotrexate and high-dose cytarabine with or without thiotepa, and with or without rituximab, followed by brain irradiation vs. high-dose chemotherapy supported by autologous stem cells transplantation for immunocompetent patients with newly diagnosed primary cns lymphoma. - IELSG 32
IELSG-International Extranodal Lymphoma Study Group0 个研究点目标入组 126 人开始时间: 2009年9月15日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 126
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Histological or cytological assessed diagnosis of non-Hodgkin`s lymphoma. Diagnostic sample obtained by stereotactic or surgical biopsy, CSF cytology examination or vitrectomy. Disease exclusively localized into the central nervous system, CSF, cranial nerves or eyes. At least one measurable lesion. Previously untreated patients (previous or ongoing steroid therapy admitted). Age 18-65 years (with ECOG Performance Status 0-3) or 66-70 (with ECOG Performance Status 0-2). HBsAg- and HCV-negative patients. No known HIV disease or immunodeficiency. Adequate bone marrow (PLT ≥ 100000 mm3, Hb ≥ 9 g/dl, ANC ≥ 2.000 mm3), renal (creatinine clearance ≥ 60 ml/min), cardiac (VEF ≥ 50%), and hepatic function (total serum bilirubin ≤ 3 mg/dL, AST/ALT and γGT ≤ 2 per upper normal limit value). Absence of symptomatic coronary artery disease, cardiac arrhythmias uncontrolled with medication or myocardial infarction within the last 6 months (New York Heart Association Class III or IV heart disease) No previous or concurrent malignancies with the exception of surgically cured carcinoma in-situ of the cervix, carcinoma of the skin or other cancers without evidence of disease at least from 5 years (patients with a previous lymphoma are NOT eligible). Absence of any familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule. Female patients must be non-pregnant and non-lactating. Sexually active patients of childbearing potential must implement adequate contraceptive measures during study participation. No concurrent treatment with other experimental drugs. Patient-signed informed consent obtained before registration (Appendix A).
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Patients with lymphomatous lesions outside the CNS. HBsAg and HCV positivity HIV infection, previous organ transplantation or other clinically evident form of immunodeficiency. Concurrent treatment with other experimental drugs. Concurrent Pregnancy or lactation. Patients not agreeing to take adequate contraceptive measures during the study Patients with a previous non-Hodgkin lymphoma at any time. Symptomatic coronary artery disease, cardiac arrhythmias uncontrolled with medication or myocardial infarction within the last 6 months (New York Heart Association Class III or IV heart disease)
研究者
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