Phase II Study to Evaluate the Combination of Rituximab and DepoCyte® 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 Neurom

• Status: Completed
• Trial end date: 2017-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is 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 Toxicity of the protocol Overall survival Survival without relapse Long-term incidence of neurocognitive toxicity

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Lymphoma Study Association
• Treatments: Cytarabine; Rituximab

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.

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.