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

NCT00553943 | Completed Phase 2 DMC

• 1 other identifier: R-C5R 2006
• Study Type: interventional
• Target: 60
• Locations: 2 countries
• Sites: 46

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

Conditions

Lymphoma, Non-Hodgkin; Diffuse Large B-cell Lymphoma

Keywords

lymphoma; cerebral lymphoma; central nervous system; cytarabine; rituximab; Diffuse large B-cell lymphomas, with cerebral or neuromeningeal involvement

Outcome Measures

Primary Outcomes (1)

• Response to treatment (CR/PR)

  End of treatment - 5 months

Secondary Outcomes (1)

• Toxicity, Overall survival, Time to progression

  End of study - 5 years

Study Arms (1)

Rituximab + Cytarabine

EXPERIMENTAL

Drug: Rituximab; Drug: Cytarabine

Interventions

Rituximab DRUG

375 mg/m2 D1

Rituximab + Cytarabine

Cytarabine DRUG

50 mg D3

Rituximab + Cytarabine

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Lymphoma Study Association: lead

Study Sites (46)

ZNA Stuivenberg

Antwerp, 2060, Belgium

Location

Hôpital Saint Joseph

Arlon, Bruges, Belgium

Location

A. Z. Sint-Jan

Bruges, 8000, Belgium

Location

UCL- Saint Luc

Brussels, 1200, Belgium

Location

CH Notre Dame

Charleroi, 6000, Belgium

Location

AZ VUB

Jette, 1090, Belgium

Location

CHR de la Citadelle

Liège, 4000, Belgium

Location

CHU Charleroi-Vésale

Montigny-le-Tilleul, 6110, Belgium

Location

Clinique Saint Pierre

Ottignies, 1340, Belgium

Location

Heilig Hart Ziekenhuis

Roeselare, 8800, Belgium

Location

UCL - Mont-Godinne

Yvoir, 5530, Belgium

Location

CH d'Annecy

Annecy, F-74011, France

Location

Centre Hospitalier d'Avignon

Avignon, F-84902, France

Location

Hôpital de Bayonne

Bayonne, F-64100, France

Location

Hôpital d'Avicenne

Bobigny, F-93009, France

Location

Polyclinique Bordeaux Nord Aquitaine

Bordeaux, F-33300, France

Location

CH de Brive

Brive-la-Gaillarde, F-19190, France

Location

CHU Clemenceau

Caen, F-14033, France

Location

Centre Francois Baclesse

Caen, F-14076, France

Location

CH de Chambery

Chambéry, F-73011, France

Location

CH de Chartres

Chartres, F-28018, France

Location

Hôpital Gilles de Corbeil

Corbeil-Essonnes, F-91108, France

Location

Hôpital Henri Mondor

Créteil, F-94010, France

Location

CHU Le Bocage

Dijon, F-21034, France

Location

Centre Hospitalier de Dunkerque

Dunkirk, F-59385, France

Location

Hôpital Saint Louis

La Rochelle, F-17019, France

Location

Hôpital Andre Mignot

Le Chesnay, F-78157, France

Location

Hôpital Bicêtre

Le Kremlin-Bicêtre, F-94270, France

Location

CHU de Lens

Lens, F-62307, France

Location

Hopital Saint Vincent de Paul

Lille, F-59020, France

Location

CHU Claude Huriez

Lille, F-59037, France

Location

Hôpital Dupuytren

Limoges, F-87000, France

Location

Centre Leon Berard

Lyon, F-69373, France

Location

Hôpital des Chanaux

Mâcon, F-71018, France

Location

CH de Meaux

Meaux, F-77100, France

Location

Hôpital Bon Secours

Metz, F-57038, France

Location

Hôpital Emile Muller

Mulhouse, F-68070, France

Location

Centre Antoine Lacassagne

Nice, F-06054, France

Location

Hôpital Saint Louis

Paris, F-75475, France

Location

Hôpital Necker

Paris, F-75743, France

Location

Centre Hospitalier de Perpigan

Perpignan, F-66046, France

Location

Centre Hospitalier Lyon Sud

Pierre-Bénite, F-69495, France

Location

Centre Henri Becquerel

Rouen, F-76038, France

Location

CH de St Germain

Saint-Germain-en-Laye, F-78108, France

Location

Hôpital Purpan

Toulouse, F-31000, France

Location

Hopital Brabois

Vandœuvre-lès-Nancy, France

Location

Related Links

• Related Info

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin; Lymphoma, Large B-Cell, Diffuse; Lymphoma; Dendritic Cell Sarcoma, Interdigitating

Interventions

Rituximab; Cytarabine

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Lymphoma, B-Cell; Histiocytic Disorders, Malignant; Histiocytosis

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Arabinonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Herve Ghesquieres, MD

  LYmphoma Study Association (LYSA)

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2007
• First Posted: November 6, 2007
• Study Start: July 1, 2007
• Primary Completion: June 1, 2012
• Study Completion: March 1, 2017
• Last Updated: August 23, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

BE (11); FR (35)