Patiens with 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 MedDRA version: 9.1 Level: LLT Classification code 10012820 Term: Diffuse large B-cell lymphoma NOS
Conditions
Interventions
Trade Name: DepoCyte
Product Name: DepoCyte
Pharmaceutical Form: Concentrate for solution for injection
Trade Name: Mabthera
Pharmaceutical Form: Solution for infusion
Trade Name: Vincristine
Produ
Sponsors
Groupe d’Etude des Lymphomes de l’Adulte (GELA)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -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
Exclusion criteria
Exclusion criteria: -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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To measure the rate of complete response (CR and UCR) at the end of a course of immuno-chemotherapy: -before cerebral radiotherapy for PCL -after the course of immuno-chemotherapy for aggressive lymphomas with neuromeningeal involvement ;Secondary Objective: Toxicity of the protocol Overall survival Survival without relapse Long-term incidence of neurocognitive toxicity ;Primary end point(s): To evaluate the complete response rate after the immuno-chemotherapy. A 50% response rate is expected. | — |
Countries
Belgium, France
Outcome results
None listed