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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. The completion date has passed and the status has not been verified in more than two years.
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   (Adult)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00553943

Locations
France
CH d'Annecy
Annecy, France, F-74011
Centre Hospitalier d'Avignon
Avignon, France, F-84902
Hôpital de Bayonne
Bayonne, France, F-64100
Hôpital d'Avicenne
Bobigny, France, F-93009
Polyclinique Bordeaux Nord Aquitaine
Bordeaux, France, F-33300
CH de Brive
Brive la Gaillarde, France, F-19190
CHU Clemenceau
Caen, France, F-14033
Centre Francois Baclesse
Caen, France, F-14076
CH de Chambery
Chambery, France, F-73011
CH de Chartres
Chartres, France, F-28018
Hôpital Gilles de Corbeil
Corbeil Essone, France, F-91108
Hôpital Henri Mondor
Creteil, France, F-94010
CHU Le Bocage
Dijon, France, F-21034
Centre Hospitalier de Dunkerque
Dunkerque, France, F-59385
Hôpital Bicêtre
Kremlin Bicêtre, France, F-94270
Hôpital Saint Louis
La Rochelle, France, F-17019
Hôpital Andre Mignot
Le Chesnay, France, F-78157
CHU de Lens
Lens, France, F-62307
Hopital Saint Vincent de Paul
Lille, France, F-59020
CHU Claude Huriez
Lille, France, F-59037
Hôpital Dupuytren
Limoges, France, F-87000
Centre Leon Berard
Lyon, France, F-69373
Hôpital des Chanaux
Macon, France, F-71018
CH de Meaux
Meaux, France, F-77100
Hôpital Bon Secours
Metz, France, F-57038
Hôpital Emile Muller
Mulhouse, France, F-68070
Centre Antoine Lacassagne
Nice, France, F-06054
Hôpital Saint Louis
Paris, France, F-75475
Hôpital Necker
Paris, France, F-75743
Centre Hospitalier de Perpigan
Perpignan, France, F-66046
Centre Hospitalier Lyon Sud
Pierre Benite, France, F-69495
Centre Henri Becquerel
Rouen, France, F-76038
CH de St Germain
St Germain en Laye, France, F-78108
Hôpital Purpan
Toulouse, France, F-31000
Hopital Brabois
Vandoeuvre les Nancy, France
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:
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
Rituximab
Cytarabine
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Immunosuppressive Agents

ClinicalTrials.gov processed this record on December 07, 2016