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+

YSARC0 个研究点目标入组 650 人开始时间: 2011年2月21日最近更新: 2020年8月3日

适应症

试验速览

暂无简介。

•-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
•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 260
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 390

•- 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 nonmelanoma
•skin tumors or stage 0 (in situ) cervical carcinoma.
•- Positive HIV, HBV and HCV serologies before inclusion (except after
•hepatitis B vaccination or for patients who are HBs Ag negative, anti-
•HBs positive and/or anti-HBc positive but viral DNA negative).
•-Pregnant or lactating women or women of childbearing potential not
•currently practicing an adequate method of contraception
•- Adult patient under tutelage.

发起方

YSARC