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
NCT ID: NCT00553943
Last Updated: 2018-08-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
60 participants
INTERVENTIONAL
2007-07-31
2017-03-31
Brief Summary
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* 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
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Rituximab + Cytarabine
Rituximab
375 mg/m2 D1
Cytarabine
50 mg D3
Interventions
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Rituximab
375 mg/m2 D1
Cytarabine
50 mg D3
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
60 Years
ALL
No
Sponsors
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Lymphoma Study Association
OTHER
Responsible Party
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Principal Investigators
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Herve Ghesquieres, MD
Role: STUDY_CHAIR
LYmphoma Study Association (LYSA)
Locations
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ZNA Stuivenberg
Antwerp, , Belgium
Hôpital Saint Joseph
Arlon, , Belgium
A. Z. Sint-Jan
Bruges, , Belgium
UCL- Saint Luc
Brussels, , Belgium
CH Notre Dame
Charleroi, , Belgium
AZ VUB
Jette, , Belgium
CHR de la Citadelle
Liège, , Belgium
CHU Charleroi-Vésale
Montigny-le-Tilleul, , Belgium
Clinique Saint Pierre
Ottignies, , Belgium
Heilig Hart Ziekenhuis
Roeselare, , Belgium
UCL - Mont-Godinne
Yvoir, , Belgium
CH d'Annecy
Annecy, , France
Centre Hospitalier d'Avignon
Avignon, , France
Hôpital de Bayonne
Bayonne, , France
Hôpital d'Avicenne
Bobigny, , France
Polyclinique Bordeaux Nord Aquitaine
Bordeaux, , France
CH de Brive
Brive-la-Gaillarde, , France
CHU Clemenceau
Caen, , France
Centre Francois Baclesse
Caen, , France
CH de Chambery
Chambéry, , France
CH de Chartres
Chartres, , France
Hôpital Gilles de Corbeil
Corbeil-Essonnes, , France
Hôpital Henri Mondor
Créteil, , France
CHU Le Bocage
Dijon, , France
Centre Hospitalier de Dunkerque
Dunkirk, , France
Hôpital Saint Louis
La Rochelle, , France
Hôpital Andre Mignot
Le Chesnay, , France
Hôpital Bicêtre
Le Kremlin-Bicêtre, , France
CHU de Lens
Lens, , France
Hopital Saint Vincent de Paul
Lille, , France
CHU Claude Huriez
Lille, , France
Hôpital Dupuytren
Limoges, , France
Centre Leon Berard
Lyon, , France
Hôpital des Chanaux
Mâcon, , France
CH de Meaux
Meaux, , France
Hôpital Bon Secours
Metz, , France
Hôpital Emile Muller
Mulhouse, , France
Centre Antoine Lacassagne
Nice, , France
Hôpital Saint Louis
Paris, , France
Hôpital Necker
Paris, , France
Centre Hospitalier de Perpigan
Perpignan, , France
Centre Hospitalier Lyon Sud
Pierre-Bénite, , France
Centre Henri Becquerel
Rouen, , France
CH de St Germain
Saint-Germain-en-Laye, , France
Hôpital Purpan
Toulouse, , France
Hopital Brabois
Vandœuvre-lès-Nancy, , France
Countries
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Related Links
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Related Info
Other Identifiers
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R-C5R 2006
Identifier Type: -
Identifier Source: org_study_id
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