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 Neuromeningeal Invasion at Diagnosis

Study Overview
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Brief Summary
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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

Official Title
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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

Conditions
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Lymphoma, Non-Hodgkin, Diffuse Large B-cell Lymphoma

Intervention / Treatment
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* Drug: Rituximab
* Drug: Cytarabine


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Rituximab + Cytarabine<br> | Drug: Rituximab<br>* 375 mg/m2 D1<br>Drug: Cytarabine<br>* 50 mg D3<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response to treatment (CR/PR) |  | End of treatment - 5 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Toxicity, Overall survival, Time to progression |  | End of study - 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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lymphoma, cerebral lymphoma, central nervous system, cytarabine, rituximab, Diffuse large B-cell lymphomas, with cerebral or neuromeningeal involvement