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

Lymphoma, Non-Hodgkin Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00553943
• Other study ID #: R-C5R 2006
• Status: Completed
• Phase: Phase 2
• Start date: July 2007
• Est. completion date: March 2017

Study information

• Verified date: August 2018
• Source: Lymphoma Study Association
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: March 2017
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diffuse Large B-cell Lymphoma
• Lymphoma
• Lymphoma, B-Cell
• Lymphoma, Large B-Cell, Diffuse
• Lymphoma, Non-Hodgkin

Intervention

Drug:
• Rituximab
375 mg/m2 D1
• Cytarabine
50 mg D3

Locations

Country	Name	City	State
Belgium	ZNA Stuivenberg	Antwerpen
Belgium	Hôpital Saint Joseph	Arlon
Belgium	A. Z. Sint-Jan	Bruges
Belgium	UCL- Saint Luc	Bruxelles
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
France	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	Centre Francois Baclesse	Caen
France	CHU Clemenceau	Caen
France	CH de Chambery	Chambery
France	CH de Chartres	Chartres
France	Hôpital Gilles de Corbeil	Corbeil-Essonnes
France	Hôpital Henri Mondor	Creteil
France	CHU Le Bocage	Dijon
France	Centre Hospitalier de Dunkerque	Dunkerque
France	Hôpital Saint Louis	La Rochelle
France	Hôpital Andre Mignot	Le Chesnay
France	Hôpital Bicêtre	Le Kremlin-Bicêtre
France	CHU de Lens	Lens
France	CHU Claude Huriez	Lille
France	Hopital Saint Vincent de Paul	Lille
France	Hôpital Dupuytren	Limoges
France	Centre Leon Berard	Lyon
France	Hôpital des Chanaux	Macon
France	CH de Meaux	Meaux
France	Hôpital Bon Secours	Metz
France	Hôpital Emile Muller	Mulhouse
France	Centre Antoine Lacassagne	Nice
France	Hôpital Necker	Paris
France	Hôpital Saint Louis	Paris
France	Centre Hospitalier de Perpigan	Perpignan
France	Centre Hospitalier Lyon Sud	Pierre Benite
France	Centre Henri Becquerel	Rouen
France	CH de St Germain	St Germain en Laye
France	Hôpital Purpan	Toulouse
France	Hopital Brabois	Vandoeuvre les Nancy

Sponsors (1)

Lead Sponsor	Collaborator
Lymphoma Study Association

Countries where clinical trial is conducted

Belgium,  France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response to treatment (CR/PR)		End of treatment - 5 months
Secondary	Toxicity, Overall survival, Time to progression		End of study - 5 years

External Links

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