EUCTR2013-003256-20-IT进行中（未招募）1 期
A PHASE II PROSPECTIVE STUDY OF HIGH-DOSE myeloablative therapy, WITH STEM CELL DEVICES SUPPORT IN ELDERLY PATIENTS (from 65 to 76 years) with relapsed aggressive non-Hodgkin lymphoma OR RESISTANT TO first line THERAPY. - FIL_RecAnz
Fondazione Italiana Linfomi0 个研究点目标入组 115 人开始时间: 2013年9月25日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 115
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
- •Diagnosis of NHL - relapse and refractory pts - age 65 to 75 - ECOG PS <2 - FIT patients (IADL=8, ADL=6, CIRS =0 SCORE=3-4, <3 SCORE=2 ) - evaluable desease - no RT since 3 week - ANC ?1500/mm3 and platelets?100.000/106L - Creatinin ?1.5 mg/dL and clearance >40 ml/min/24 h - bilirubine < ?2 mg/dL - FEV >50% - PA O2 >70 mmHg - no other neoplastic desease - Life expectancy> 3 months - signed informed consense
- •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 115
排除标准
- •HBV+ - HCV+ - HIV+ - SNC involvement - meullar infiltration > 20% - other chemotherapy or radiotherapy - cardiac desease - alteration of liver and kidney function - infections -demented patient - no compliance and depressed pts - Frai and Unfit pts
研究者
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