EUCTR2005-002344-26-BE进行中（未招募）1 期
GEMCITABINE-OXALIPLATINE PLUS RITUXIMAB (R-GEMOX) IN REFRACTORY/RELAPSED PATIENTS WITH CD20 POSITIVE DIFFUSE LARGE B-CELL LYMPHOMA, NON ELIGIBLE FOR HIGH-DOSE CHEMOTHERAPY FOLLOWED BY AUTOTRANSPLANTATION - R-GEMOX
GELA0 个研究点目标入组 0 人开始时间: 2005年12月14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
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
- •-Patient diagnosed with histologically or cytologically proven, CD20+, Diffuse Large B-cell Lymphoma
- •- Relapsed after first or second CR, PR or less than PR for first-line treatment for the rituximab-naïve patients OR relapsed after first or second CR with a minimum delay of 12 months between the last rituximab infusion and the inclusion for rituximab-experienced patients
- •- aged 18-75 years
- •- Not eligible for autologous transplantation
- •- Previously treated with chemotherapy containing anthracyclin, with or without rituximab
- •- ECOG performance status 0 to 2
- •- With a minimum life expectancy of 3 months
- •- Having signed informed consent form prior to enrollement
- •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
排除标准
- •- Burkitt's, mantle cell, T-cell lymphomas
- •- CD20-negative lymphoma
- •- HIV or HBV related disease
- •- Central nervous system or meningeal involvement by the lymphoma
- •- Not previously treated with anthracyclin-containing regimens
- •- Any radiotherapy during the four weeks before inclusion
- •- Contraindication to any drug contained in the R-GEMOX chemotherapy regimen
- •- Any serious active disease or co-morbid medical condition (according to the investigator's decision)
- •- Poor renal function, poor hepatic function unless these abnormalities are related to the lymphoma
- •- Poor bone marrow reserve as defined <1.5G/l or platelets<100G/l, unless related to bone marrow infiltration
- •- Any history of cancer during the last 5 years, with the exception of non-melanoma skin tumors or stage 0 (in situ) cervical carcinoma
- •- Treatment with any investigational drug within 30 days before planned first cycle of chemotherapy and during the study
- •- Pregnant or lactatingwoman
- •- Adult patient unable to give informed consent because of intellectual impairement.
研究者
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