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 - Full Text View

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 II

MedlinePlus related topics:

Lymphoma

ChemIDplus related topics:

Cytarabine Cytarabine hydrochloride Rituximab

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

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

Further study details as provided by Groupe d'Etudes de Lymphomes de L'Adulte:

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 2011

Intervention Details:

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 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
	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
	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 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 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
	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 <caroline.besson@bct.ap-hop-paris.fr
	Principal Investigator: Caroline Besson, 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
	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
	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
	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
	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
	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
	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
	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
	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 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
	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
	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 Saint Louis	Not yet recruiting
	La Rochelle, France, F-17019
	Contact: Emmanuel Fleck, MD emmanuel.fleck@ch-larochelle.fr
	Principal Investigator: Emmanuel Fleck, 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
	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 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 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
	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
	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
	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
	CHU Claude Huriez	Not yet recruiting
	Lille, France, F-59037
	Contact: Franck Morschhauser, MD f-morschhauser@chru-lille.fr
	Principal Investigator: Franck Morschhauser, 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
	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 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
	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
	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 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
	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

Sponsors and Collaborators

Groupe d'Etudes de Lymphomes de L'Adulte

Investigators


Study Chair:	Herve Ghesquieres, MD	Groupe d'Etude des Lymphomes de l'Adulte (GELA)

Responsible Party:	GELA ( Dr Herve Ghesquieres )
Study ID Numbers:	R-C5R 2006, R-C5R
First Received:	November 5, 2007
Last Updated:	May 29, 2008
ClinicalTrials.gov Identifier:	NCT00553943
Health Authority:	France: Afssaps - French Health Products Safety Agency; Belgium: Ministry of Social Affairs, Public Health and the Environment

Sponsored by:	Groupe d'Etudes de Lymphomes de L'Adulte
Information provided by:	Groupe d'Etudes de Lymphomes de L'Adulte
ClinicalTrials.gov Identifier:	NCT00553943