EUCTR2006-006999-38-IT进行中（未招募）不适用
HIGH-DOSE SEQUENTIAL CHEMOTHERAPY AND RITUXIMAB (R-HDS) SUPPORTED BY AUTOLOGOUS STEM CELL TRANSPLANTATION IN PATIENTS WITH SYSTEMIC B-CELL LYMPHOMA WITH CENTRAL NERVOUS SYSTEM INVOLVEMENT AT DIAGNOSIS OR RELAPSE - ND
OSPEDALE S. RAFFAELE0 个研究点开始时间: 2007年7月23日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
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
- •1.Histologically confirmed diagnosis of diffuse large-cell, follicular or mantle cell lymphoma
- •2.CNS involvement (brain, meninges, cranial nerves, eyes and/or spinal cord) at diagnosis or relapse after conventional chemotherapy
- •3.Diagnosis of CNS involvement either by brain biopsy or CSF cytology examination; neuroimaging alone is acceptable only when stereotactic biopsy is formally contraindicated
- •4.Age 19-65 years
- •5.ECOG performance status 0-3
- •6.Adequate bone marrow (PLT ?100000 mm3, Hb ?9 gr/dL, ANC ?2000 mm3), renal (creatinine clearance ?60 mL/min), cardiac (VEF > 50%), and hepatic function (total serum bilirubin <=3 mg/dL, AST/ALT and GGT <=2.5 per upper normal limit value), within 1 week prior to study start (unless the abnormality is due to lymphoma involvement)
- •7.Absence of symptomatic coronary artery disease, cardiac arhythmias not well controlled with medication or myocardial infarction within the last 6 months (New York Heart Association Class III or IV heart disease)
- •8.Absence of HIV infection
- •9.No previous or concurrent malignancies with the exception of surgically cured carcinoma in-situ of the cervix and carcinoma of the skin and of other cancers without evidence of disease at least from 5 years
- •10.Absence of any familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
- •11.Female patients must be non-pregnant and non-lactating. Sexually active patients of childbearing potential must implement adequate contraceptive measures during study participation
- •12.No treatment with other experimental drugs within the 6 weeks previous to enrolment
- •13.Given written informed consent prior to any study specific procedures, with the understanding that the patient has the right to withdraw from the study at any time, without prejudice
- •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) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •age under 19 and over 65; pregnancy and breast feeding; patients under treatment with sperimental drugs;..
研究者
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