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

Phase 2

Completed

• Conditions: Lymphoma, Non-Hodgkin; Diffuse Large B-cell Lymphoma
• Interventions: Drug: Rituximab; Drug: Cytarabine

• Registration Number: NCT00553943
• Lead Sponsor: Lymphoma Study Association

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

Detailed Description

Not available

Study Timeline

• Study Start: 2007-07
• Study First Submitted: 2007-11-05
• Study First Submitted QC: 2007-11-05
• Study First Posted: 2007-11-06
• Primary Completion: 2012-06
• Study Completion: 2017-03
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-21
• Last Update Posted: 2018-08-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Rituximab + Cytarabine	Rituximab	-
Rituximab + Cytarabine	Cytarabine	-

Primary Outcome Measures

Name	Time	Method
Response to treatment (CR/PR)	End of treatment - 5 months

Secondary Outcome Measures

Name	Time	Method
Toxicity, Overall survival, Time to progression	End of study - 5 years

Trial Locations

Locations (45)

Hôpital Saint Joseph; 🇧🇪 Arlon, Belgium

A. Z. Sint-Jan; 🇧🇪 Bruges, Belgium

CH Notre Dame; 🇧🇪 Charleroi, Belgium

CHU Charleroi-Vésale; 🇧🇪 Montigny-Le-Tilleul, Belgium

Clinique Saint Pierre; 🇧🇪 Ottignies, Belgium

CH de Brive; 🇫🇷 Brive la Gaillarde, France

Heilig Hart Ziekenhuis; 🇧🇪 Roeselare, Belgium

Centre Francois Baclesse; 🇫🇷 Caen, France

Centre Hospitalier d'Avignon; 🇫🇷 Avignon, France

CH de Chartres; 🇫🇷 Chartres, France

Hôpital Gilles de Corbeil; 🇫🇷 Corbeil-Essonnes, France

CH de Meaux; 🇫🇷 Meaux, France

Centre Antoine Lacassagne; 🇫🇷 Nice, France

Centre Hospitalier de Perpigan; 🇫🇷 Perpignan, France

Centre Hospitalier Lyon Sud; 🇫🇷 Pierre Benite, France

CHR de la Citadelle; 🇧🇪 Liège, Belgium

CHU Clemenceau; 🇫🇷 Caen, France

Centre Hospitalier de Dunkerque; 🇫🇷 Dunkerque, France

Hôpital Saint Louis; 🇫🇷 Paris, France

Hôpital Henri Mondor; 🇫🇷 Creteil, France

Hôpital Andre Mignot; 🇫🇷 Le Chesnay, France

Hopital Saint Vincent de Paul; 🇫🇷 Lille, France

Hôpital Bon Secours; 🇫🇷 Metz, France

Centre Henri Becquerel; 🇫🇷 Rouen, France

ZNA Stuivenberg; 🇧🇪 Antwerpen, Belgium

UCL- Saint Luc; 🇧🇪 Bruxelles, Belgium

AZ VUB; 🇧🇪 Jette, Belgium

UCL - Mont-Godinne; 🇧🇪 Yvoir, Belgium

CH d'Annecy; 🇫🇷 Annecy, France

Hôpital de Bayonne; 🇫🇷 Bayonne, France

Hôpital d'Avicenne; 🇫🇷 Bobigny, France

CH de Chambery; 🇫🇷 Chambery, France

CHU Le Bocage; 🇫🇷 Dijon, France

Polyclinique Bordeaux Nord Aquitaine; 🇫🇷 Bordeaux, France

CHU Claude Huriez; 🇫🇷 Lille, France

Hôpital Bicêtre; 🇫🇷 Le Kremlin-Bicêtre, France

Hôpital Dupuytren; 🇫🇷 Limoges, France

Hôpital des Chanaux; 🇫🇷 Macon, France

Hôpital Emile Muller; 🇫🇷 Mulhouse, France

CHU de Lens; 🇫🇷 Lens, France

Centre Leon Berard; 🇫🇷 Lyon, France

Hôpital Necker; 🇫🇷 Paris, France

CH de St Germain; 🇫🇷 St Germain en Laye, France

Hôpital Purpan; 🇫🇷 Toulouse, France

Hopital Brabois; 🇫🇷 Vandoeuvre les Nancy, France