EUCTR2015-000591-97-CZ进行中（未招募）1 期
Study evaluating relapses in central nervous system in patients with diffuse large B-cell lymphoma treated with chemotherapy with or without CNS prophylaxis. Multicentric, prospective randomized phase III study - CNS relapse prophylaxis in DLBC
Kooperativní lymfomová skupina, o.s.0 个研究点目标入组 200 人开始时间: 2015年5月22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
- 200
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 untreated DLBCL
- •2/age 18-72 years
- •3/signed informed consent with the study
- •4/planned first-line treatment 6 cycles of R CHOP +2x R or 6 cycles of DA EPOCH R+ 2xR
- •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 160
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 40
排除标准
- •1/ patients with DLBCL and concomitant initial CNS involvement
- •2/ patients with PMBL
- •3/ DLBCL patients with planned another chemotherapy than R CHOP or DA EPOCH R
- •4/ HIV positive, or active hepatitis B or C
- •5/ other serious disease (based on the decision of the physician-investigator)
- •6/ non-compliance of a patient
- •7/ every containdication for administration of antracyclin regimen or high dose methotrexat
- •8/ pregnancy or breast-feeding
研究者
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