Randomized phase II study of two associations of rituximab and chemotherapy, with a pet-driven strategy, in patients from 18 to 59 with DLBCL CD20+ lymphoma and 2 or 3 adverse prognostic factors of the age-adjusted IPI - LNH2007-3B

Hospices Civils de Lyon0 个研究点目标入组 222 人开始时间: 2007年4月23日最近更新: 2012年3月19日

研究概览

暂无简介。

•- Patient with histologically proven CD20+ diffuse large B-cell lymphoma (WHO classification).
•- Age from18 to 59 years, eligible for transplant.
•- Patient not previously treated.
•- Baseline FDG-PET Scan (PET0) performed before any treatment with at least one hypermetabolic lesion.
•- Index prognostic factors (IPI) 2 or 3.
•- With a minimum life expectancy of 3 months.
•- Negative HIV, HBV and HCV serologies £ 4 weeks (except after vaccination).
•- Having previously signed a written informed consent.
•- The subject must be covered by a social security system
•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) no
•F.1.3.1 Number of subjects for this age range

•- Any other histological type of lymphoma.
•- Any history of treated or non-treated indolent lymphoma. However, patients not previously diagnosed and having a diffuse large B-cell lymphoma with some small cell infiltration in bone marrow or lymph node may be included.
•- 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 maximum normal level) unless these abnormalities are related to the lymphoma.
•- Poor bone marrow reserve as defined by neutrophils <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.
•- Any serious active disease (according to the investigator’s decision).
•- Treatment with any investigational drug within 30 days before planned first cycle of chemotherapy and during the study.
•- Pregnant or lactating women or women of childbearing potential not currently practicing an adequate method of contraception
•- Adult patient under tutelage.
•- Impossibility to performed a baseline PET scan (PET0) before randomization and treatment beginning

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