EUCTR2010-019587-36-DE进行中（未招募）1 期
Improvement of outcome and reduction of toxicity in elderly patients with CD20+ aggressive B-cell lymphoma by an optimised schedule of the monoclonal antibody rituximab, substitution of conventional by liposomal vincristine and FDG-PET based reduction of therapy in combination with vitamin D substitution - OPTIMAL>60/DR.CHOP
niversität des Saarlandes0 个研究点目标入组 1,152 人开始时间: 2011年4月19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
- 1,152
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
- •Elderly patients (61-80 years) with newly diagnosed aggressive CD20+ B-NHL. All risk groups with good general condition (ECOG 0-2) without majour accompanying diseases after patient's information and written patient's informed consent
- •Please note: only favourable patients (IPI = 1 (age)) without bulk can be included as recruitment goal for less favourable patients has been reached.
- •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 1152
排除标准
- •Already initiated lymphoma therapy ; Serious accompanying disorder or impaired organ function; Platelets <75 000/mm3, leukocytes <2 500/mm3; Known hypersensitivity to the medications to be used; Known HIV-positivity; Chronic active hepatitis; Poor patient compliance; Simultaneous participation in other treatment studies or in another clinical trial; Prior chemo- or radiotherapy, long-term use of corticosteroids or anti-neoplastic drugs for previous disorder; CNS involvement of lymphoma; Persistent neuropathy grade =2 (unless due to lymphoma involvement) ;Pregnancy or breast-feeding women Persons depending on sponsor or investigator
- •Persons from highly protected groups.
研究者
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