Etude prospective multicentrique de phase II évaluant l’adjonction du rituximab et du DepoCyte® en intrathécal au protocole de chimiothérapie C5R chez les patients âgés de 18 à 60 ans porteurs de lymphomes non hodgkiniens cérébraux primitifs et de lymphomes systémiques diffus à grandes cellules B avec envahissement neuro-méningé au diagnostic.

Groupe d’Etude des Lymphomes de l’Adulte (GELA)0 个研究点目标入组 60 人开始时间: 2007年4月26日最近更新: 2021年12月13日

试验速览

暂无简介。

•-Primary cerebral or oculocerebral NHL not previously treated with chemotherapy or radiotherapy and diffuse large B-cell lymphomas, with cerebral and / or neuromeningeal involvement at diagnosis.
•-Diagnosis proved by histological or cytological examination of cerebral specimens, CSF or vitreous humour.
•-Diffuse large cell CD20+ lymphoma.
•-Men or women between the ages of 18 and 60 years.
•-Presence of a measurable target to evaluate response.
•-Negative serological tests for HIV, hepatitis B (except in cases of vaccination), hepatitis C.
•-Life-expectancy = 3 months
•-Patient having given written consent to participate in this study.
•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

•-CD20- lymphoma.
•-History of indolent lymphoma, treated or untreated.
•-Contraindication for one of the products used in polychemotherapy.
•-Known hypersensitivity to mouse antibodies.
•-Absence of measurable target to evaluate response.
•-History of cancer in the 5 years prior to inclusion except for cutaneous basocellular carcinomas and non-invasive carcinomas of the neck of the uterus.
•-Cardiac contraindication to treatment with anthracyclines or to hyperhydration:
•- SEVERE DISTURBANCE OF HEART RHYTHM
•- VENTRICULAR EJECTION FRACTION BELOW 50%
•- HISTORY OF RECENT MYOCARDIAL INFARCTION
•-Previously known severe renal insufficiency and/or creatinaemia >150 µM/L (apart from invasion of the kidneys by the lymphoma).
•-Total bilirubin >30 µmol/L, ASAT, ALAT >2.5 times the upper normal value (apart from invasion of the liver by the lymphoma).
•-Insufficient medullary reserve: PNL < 1 G/L and platelets <100 G/L (apart from invasion of the medulla by the lymphoma).
•-History of organ transplantation or other causes of severe immunosuppression.
•-Pregnant woman.
•-Patient incapable of keeping to regular monitoring.

发起方

Groupe d’Etude des Lymphomes de l’Adulte (GELA)