Clinical trial NCT00553943: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Lymphoma, Non-Hodgkin
Diffuse Large B-cell Lymphoma
Keywords: lymphoma
cerebral lymphoma
central nervous system
cytarabine
rituximab
Diffuse large B-cell lymphomas, with cerebral or neuromeningeal involvement
Lead sponsor: Lymphoma Study Association
Sponsor class: OTHER
First posted: 2007-11-06
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility 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.

Primary outcomes:
measure: Response to treatment (CR/PR)
timeFrame: End of treatment - 5 months
Secondary outcomes:
measure: Toxicity, Overall survival, Time to progression
timeFrame: End of study - 5 years
Other outcomes:
Locations:
city: Antwerpen
country: Belgium
facility: ZNA Stuivenberg
city: Arlon
country: Belgium
facility: Hôpital Saint Joseph
city: Bruges
country: Belgium
facility: A. Z. Sint-Jan
city: Bruxelles
country: Belgium
facility: UCL- Saint Luc
city: Charleroi
country: Belgium
facility: CH Notre Dame
city: Jette
country: Belgium
facility: AZ VUB
city: Liège
country: Belgium
facility: CHR de la Citadelle
city: Montigny-Le-Tilleul
country: Belgium
facility: CHU Charleroi-Vésale
city: Ottignies
country: Belgium
facility: Clinique Saint Pierre
city: Roeselare
country: Belgium
facility: Heilig Hart Ziekenhuis
city: Yvoir
country: Belgium
facility: UCL - Mont-Godinne
city: Annecy
country: France
facility: CH d'Annecy
city: Avignon
country: France
facility: Centre Hospitalier d'Avignon
city: Bayonne
country: France
facility: Hôpital de Bayonne
city: Bobigny
country: France
facility: Hôpital d'Avicenne
city: Bordeaux
country: France
facility: Polyclinique Bordeaux Nord Aquitaine
city: Brive la Gaillarde
country: France
facility: CH de Brive
city: Caen
country: France
facility: CHU Clemenceau
city: Caen
country: France
facility: Centre Francois Baclesse
city: Chambery
country: France
facility: CH de Chambery
city: Chartres
country: France
facility: CH de Chartres
city: Corbeil-Essonnes
country: France
facility: Hôpital Gilles de Corbeil
city: Creteil
country: France
facility: Hôpital Henri Mondor
city: Dijon
country: France
facility: CHU Le Bocage
city: Dunkerque
country: France
facility: Centre Hospitalier de Dunkerque
city: La Rochelle
country: France
facility: Hôpital Saint Louis
city: Le Chesnay
country: France
facility: Hôpital Andre Mignot
city: Le Kremlin-Bicêtre
country: France
facility: Hôpital Bicêtre
city: Lens
country: France
facility: CHU de Lens
city: Lille
country: France
facility: Hopital Saint Vincent de Paul
city: Lille
country: France
facility: CHU Claude Huriez
city: Limoges
country: France
facility: Hôpital Dupuytren
city: Lyon
country: France
facility: Centre Leon Berard
city: Macon
country: France
facility: Hôpital des Chanaux
city: Meaux
country: France
facility: CH de Meaux
city: Metz
country: France
facility: Hôpital Bon Secours
city: Mulhouse
country: France
facility: Hôpital Emile Muller
city: Nice
country: France
facility: Centre Antoine Lacassagne
city: Paris
country: France
facility: Hôpital Saint Louis
city: Paris
country: France
facility: Hôpital Necker
city: Perpignan
country: France
facility: Centre Hospitalier de Perpigan
city: Pierre Benite
country: France
facility: Centre Hospitalier Lyon Sud
city: Rouen
country: France
facility: Centre Henri Becquerel
city: St Germain en Laye
country: France
facility: CH de St Germain
city: Toulouse
country: France
facility: Hôpital Purpan
city: Vandoeuvre les Nancy
country: France
facility: Hopital Brabois
Study officials:
affiliation: LYmphoma Study Association (LYSA)
name: Herve Ghesquieres, MD
role: STUDY_CHAIR
References: