EUCTR2009-015974-36-IT进行中（未招募）1 期
Phase II prospective study on high dose myeloablative therapy, with peripheral stem cell support, in elderly patients (>=65 e <76 years) with aggressive relapsed or refractory non Hodgkin lymphoma - ND
G.I.S.L. - GRUPPO ITALIANO STUDIO LINFOMI0 个研究点开始时间: 2009年10月13日最近更新:
试验速览
- 阶段
- 1 期
- 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)Histological diagnosis of B-cell lymphoma (follicular lymphoma grade IIIb, diffuse large B-cell lymphoma, transformed indolent lymphoma, mantle cell lymphoma) or peripheral T-cell lymphoma; 2)Relapsed or refractory patient after a first line therapy with antracyclines (less than the maxim total dose of 550 mg/m2), not treated with high dose therapy and peripheral stem cell rescue; 3)Age >= 65 and > 76 years; 4)Patient not frail based on the Multidimensional geriatric evaluation; 5)Measurable disease; 6)ANC >=1500/mm3 and platelets >=100.000/106L; 7)Normal renal and hepatic function; 8)LVEF > 50%, DLCO>70% e/o PA O2>70mmHg
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) no
- •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
- •1)HBV, HCV,HIV positivity; 2)CNS involvement by lymphoma; 3)Bone marrow involvement >20%; 4)Other chemotherapy or radiotherapy treatment; 5)Significant cardiovascular pathologies; 6)Hepatic and renal disfunction related to lymphoma; 7)Active infection; 8)Frail patient
研究者
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