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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2010 by Lymphoma Study Association.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Lymphoma Study Association
ClinicalTrials.gov Identifier:
NCT00553943
First received: November 5, 2007
Last updated: October 22, 2010
Last verified: October 2010
  Purpose

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

Condition Intervention Phase
Lymphoma, Non-Hodgkin
Diffuse Large B-cell Lymphoma
Drug: Rituximab, Cytarabine
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Lymphoma Study Association:

Primary Outcome Measures:
  • Response to treatment (CR/PR) [ Time Frame: End of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Toxicity, Overall survival, Time to progression [ Time Frame: End of study ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 106
Study Start Date: July 2007
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Rituximab, Cytarabine
    Intravenous chemotherapy associated with IV rituximab and intrathecal cytarabine
  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00553943

Contacts
Contact: HERVE GHESQUIERES, MD 33 (0)4 78 78 28 28 ghesquie@lyon.fnclcc.fr
Contact: Christelle DA-CRUZ 33 (0)4 72 66 93 33 christelle.da-cruz@gelarc.org

Locations
France
CH d'Annecy Not yet recruiting
Annecy, France, F-74011
Contact: Bernadette Corront, MD    33 (0)4 50 88 33 28      
Principal Investigator: Bernadette Corront, MD         
Centre Hospitalier d'Avignon Not yet recruiting
Avignon, France, F-84902
Contact: Hacene ZERAZHI, MD       hzerazhi@ch-avignon.fr <hzerazhi@ch-avignon.fr>   
Principal Investigator: Hacene ZERAZHI, MD         
Hôpital de Bayonne Not yet recruiting
Bayonne, France, F-64100
Contact: Frederic BAUDUER, MD    33 (0)5 59 44 38 32    fbauduer001@chcb.rss.fr <fbauduer001@chcb.rss.fr>   
Principal Investigator: Frederic Bauduer, MD         
Hôpital d'Avicenne Recruiting
Bobigny, France, F-93009
Contact: Olivier Fain, PhD    33 (0)1 48 02 63 80    olivier.fain@jvr.ap-hop-paris.fr <olivier.fain@jvr.ap-hop-paris.fr>   
Principal Investigator: olivier Fain, PhD         
Polyclinique Bordeaux Nord Aquitaine Not yet recruiting
Bordeaux, France, F-33300
Contact: Olivier Fitoussi, MD    33 (0)5 56 43 73 54    o.fitoussi@bordeauxnord.com   
CH de Brive Not yet recruiting
Brive la Gaillarde, France, F-19190
Contact: Sophie Lefort, MD    33 (0)5 55 92 60 52      
Principal Investigator: Sophie Lefort, MD         
CHU Clemenceau Not yet recruiting
Caen, France, F-14033
Contact: Margarete Macro, MD    33 (0)2 31 27 25 39    macro-m@chu-caen.fr   
Principal Investigator: Margarete Macro, MD         
Centre Francois Baclesse Not yet recruiting
Caen, France, F-14076
Contact: Christophe Fruchart, MD    33 (0)2 31 45 50 12    c.fruchart@baclesse.fr   
Principal Investigator: Chritophe Fruchart, MD         
CH de Chambery Not yet recruiting
Chambery, France, F-73011
Contact: Michel Blanc, MD    33 (0)4 79 96 51 05    michel.blanc@ch-chambery.fr   
Principal Investigator: Moichel Blanc, MD         
CH de Chartres Not yet recruiting
Chartres, France, F-28018
Contact: Lina ALJASSEM, MD    33 (0)2 37 30 33 47    aljassem@ch-chartres.fr   
Principal Investigator: Lina ALJASSEM, MD         
Hôpital Gilles de Corbeil Recruiting
Corbeil Essone, France, F-91108
Contact: Alain Devidas       alain.devidas@ch-sud-francilien.fr   
Principal Investigator: Alain Devidas, MD         
Hôpital Henri Mondor Not yet recruiting
Creteil, France, F-94010
Contact: Corinne Haioun, PhD    33(0)1 49 81 20 51    corinne.haioun@hmn.ap-hop-paris.fr   
Principal Investigator: Corinne Haioun, PhD         
CHU Le Bocage Recruiting
Dijon, France, F-21034
Contact: Rene-Olivier Casasnovas, MD    33 (0)3 80 29 50 41    olivier.casasnovas@chu-dijon.fr   
Principal Investigator: Rene-Olivier Casasnovas, MD         
Centre Hospitalier de Dunkerque Not yet recruiting
Dunkerque, France, F-59385
Contact: Marc Wetterwald, MD    33 (0)3 28 28 56 33    marc.wetterwald@ch-dunkerque.fr   
Principal Investigator: Marc Wetterwald, MD         
Hôpital Bicêtre Not yet recruiting
Kremlin Bicêtre, France, F-94270
Contact: Caroline Besson, MD    33 (0)1 45 21 20 16    caroline.besson@bct.ap-hop-paris.fr   
Principal Investigator: Caroline Besson, MD         
Hôpital Saint Louis Not yet recruiting
La Rochelle, France, F-17019
Contact: Emmanuel Fleck, MD       emmanuel.fleck@ch-larochelle.fr   
Principal Investigator: Emmanuel Fleck, md         
Hôpital Andre Mignot Not yet recruiting
Le Chesnay, France, F-78157
Contact: Sylvie Csataigne, PhD    33 (0)1 39 63 89 09    scastaigne@ch-versailles.fr   
Principal Investigator: Sylvie Castaigne, PhD         
CHU de Lens Recruiting
Lens, France, F-62307
Contact: Pierre Morel, MD    33 (0)3 21 69 13 94    pmorel@ch-lens.fr   
Principal Investigator: Pierre Morel, MD         
Hopital Saint Vincent de Paul Not yet recruiting
Lille, France, F-59020
Contact: Christian Rose, MD       rose.christian@ghicl.net   
Principal Investigator: Christian Rose, MD         
CHU Claude Huriez Not yet recruiting
Lille, France, F-59037
Contact: Franck Morschhauser, MD       f-morschhauser@chru-lille.fr   
Principal Investigator: Franck Morschhauser, MD         
Hôpital Dupuytren Not yet recruiting
Limoges, France, F-87000
Contact: Dominique Bordessoule, PhD    33 (0)5 55 05 66 42    bordesso@unilim.fr   
Principal Investigator: Dominique Bordessoule, PhD         
Centre Leon Berard Recruiting
Lyon, France, F-69373
Contact: Herve Ghesquieres, MD    33 (0)4 78 78 27 37      
Principal Investigator: Herve Ghesquieres, MD         
Hôpital des Chanaux Not yet recruiting
Macon, France, F-71018
Contact: Amine Belhabri, MD    33 (0)3 85 27 53 33    ambelhabri@ch-macon.fr   
Principal Investigator: Amine Belhabry, MD         
CH de Meaux Not yet recruiting
Meaux, France, F-77100
Contact: Wajed ABARAH, MD    33 (0)1 64 35 38 75    w-abarah@ch-meaux.fr   
Principal Investigator: Wajed ABARAH, MD         
Hôpital Bon Secours Not yet recruiting
Metz, France, F-57038
Contact: Bernard Christian, MD    33 (0)3 87 55 33 04    b.christian@chr-metz-thionville.rss.fr   
Principal Investigator: Bernard Christian, MD         
Hôpital Emile Muller Not yet recruiting
Mulhouse, France, F-68070
Contact: Jean-Claude Eisenmann, MD    03 89 64 77 55    eisenmannj@ch-mulhouse.fr   
Principal Investigator: Jean-Claude Eisenmann, MD         
Centre Antoine Lacassagne Not yet recruiting
Nice, France, F-06054
Contact: Antoine Thyss, PhD    33 (0)4 92 03 10 47    antoine.thyss@cal.nice.fnclcc.fr   
Principal Investigator: Antoine Thyss, PhD         
Hôpital Saint Louis Not yet recruiting
Paris, France, F-75475
Contact: Christian Gisselbrecht, PhD    33 (0)1 42 49 92 96    christian.gisselbrecht@sls.ap-hop-paris.fr   
Principal Investigator: Christian Gisselbrecht, PhD         
Hôpital Necker Not yet recruiting
Paris, France, F-75743
Contact: Richard Delarue, MD    33 (0)1 44 49 52 82    richard.delarue@nck.ap-hop-paris.fr   
Principal Investigator: Richard Delarue, MD         
Centre Hospitalier de Perpigan Not yet recruiting
Perpignan, France, F-66046
Contact: Xavier Vallantin, MD    33 (0)4 68 61 64 48    xavier.vallantin@ch-perpignan.fr   
Principal Investigator: xavier Perpignan, MD         
Centre Hospitalier Lyon Sud Recruiting
Pierre Benite, France, F-69495
Contact: Gilles salles, PhD    33 (0)4 78 86 43 02    gilles.salles@chu-lyon.fr   
Principal Investigator: Gilles Salles, PhD         
Centre Henri Becquerel Recruiting
Rouen, France, F-76038
Contact: Herve Tilly, PhD    33 (0)2 32 08 22 23    htilly@rouen.fnclcc.fr   
Principal Investigator: Herve Tilly, PhD         
CH de St Germain Not yet recruiting
St Germain en Laye, France, F-78108
Contact: Mickaël AZAGURY, MD    33 (0)1 39 27 49 51    mazagury@chi-poissy-st-germain.fr <mazagury@chi-poissy-st-germain.fr>   
Principal Investigator: Mickaël Azagury, MD         
Hôpital Purpan Not yet recruiting
Toulouse, France, F-31000
Contact: Guy Laurent, PhD    33 (0)5 61 77 20 78      
Principal Investigator: Guy Laurent, PhD         
Hopital Brabois Not yet recruiting
Vandoeuvre les Nancy, France
Contact: Serge Bologna, MD    33 (o)3 83 15 32 82    s.bologna@chu-nancy.fr   
Principal Investigator: Serge Bologna, MD         
Sponsors and Collaborators
Lymphoma Study Association
Investigators
Study Chair: Herve Ghesquieres, MD Groupe d'Etude des Lymphomes de l'Adulte (GELA)
  More Information

Additional Information:
No publications provided

Responsible Party: Dr Herve Ghesquieres, GELA
ClinicalTrials.gov Identifier: NCT00553943     History of Changes
Other Study ID Numbers: R-C5R 2006, R-C5R
Study First Received: November 5, 2007
Last Updated: October 22, 2010
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Belgium: Ministry of Social Affairs, Public Health and the Environment

Keywords provided by Lymphoma Study Association:
lymphoma
cerebral lymphoma
central nervous system
cytarabine
rituximab
Diffuse large B-cell lymphomas, with cerebral or neuromeningeal involvement

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Non-Hodgkin
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Cytarabine
Rituximab
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents

ClinicalTrials.gov processed this record on April 17, 2014