Phase II Study to Evaluate the Combination of Rituximab and DepoCyte® in the C5R Chemotherapy Pro… (NCT00553943) | Clinical Trial Compass
CompletedPhase 2
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
Belgium60 participantsStarted 2007-07
Plain-language 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
Who can participate
Age range18 Years – 60 Years
SexALL
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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 fro…