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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00553943

Enrollment

Registered

2007-11-06

Start date

2007-07-31

Completion date

2017-03-31

Last updated

2018-08-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

lymphoma, cerebral lymphoma, central nervous system, cytarabine, rituximab, Diffuse large B-cell lymphomas, with cerebral or neuromeningeal involvement

Brief 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

Interventions

DRUGRituximab

375 mg/m2 D1

DRUGCytarabine

50 mg D3

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Response to treatment (CR/PR)	End of treatment - 5 months

Secondary

Measure	Time frame
Toxicity, Overall survival, Time to progression	End of study - 5 years

Countries

Belgium, France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026