EUCTR2009-017279-77-FR进行中（未招募）1 期
Randomized Phase III study evaluating the non-inferiority of a treatment adapted to the early response evaluated with 18F-FDG PET compared to a standard treatment, for patients aged from 18 to 80 years with low risk (aa IPI = 0) diffuse large B-cells non hodgkin's lymphoma CD 20+
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- GELARC
- 入组人数
- 420
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 with histologically proven CD20+ diffuse large B-cell lymphoma (DLBCL) (WHO classification 2008) including clinical subtypes (primitive mediastinal, intravascular, etc.). Patients with De Novo Transformed DLBCL from low grade lymphoma (Follicular, other...) may also be included.
- •Or CD20+ B-cell lymphoma with intermediate features between DLBCL and Burkitt or with intermediate features between DLBCL and classical Hodgkin lymphoma
- •Or CD20+ Follicular lymphoma grade 3B,
- •Or CD20+ Agressive B-cell lymphoma unclassifiable
- •- Age from18 to 80 years.
- •- Patient not previously treated.
- •- Ann Arbor Stage : I or II
- •- Normal level of LDH.
- •- ECOG performance status (PS) < 2.
- •- Age-adjusted international prognostic index (aaIPI) = 0
- •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
- •- Any other histological type of lymphoma, Burkitt included.
- •- Any history of treated or non-treated small B-cell lymphoma
- •- Central nervous system or meningeal involvement by lymphoma.
- •- Contra-indication to any drug contained in the chemotherapy regimens.
- •- Poor renal function (creatinin level >150 mmol/L), poor hepatic function (total bilirubin level >30 mmol/L, transaminases >2.5 ULN) unless these abnormalities are related to the lymphoma.
- •- Poor bone marrow reserve as defined by Absolute Neutrophils Count (ANC) <1.5 G/L or platelets <100 G/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.
- •-Pregnant or lactating women or women of childbearing potential not currently practicing an adequate method of contraception
- •- Adult patient under tutelage.
研究者
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