Prospective Multicentre Phase II Study to Evaluate the Combination of Rituximab and DepoCyte® by Intrathecal Injection in the C5R Chemotherapy Protocol in Patients Between the Ages of 18 and 60 Years With Primary Cerebral Non-Hodgkin Lymphoma and Systemic Diffuse Large B-cell Lymphoma With Neuromeningeal Invasion at Diagnosis
- 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),
- Life-expectancy ≥ 3 months
- Patient having given written consent to participate in this study.
- 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.