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

August 21, 2018 updated by: Lymphoma Study Association

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Antwerpen, Belgium, 2060
        • ZNA Stuivenberg
      • Arlon, Belgium, Bruges
        • Hopital Saint Joseph
      • Bruges, Belgium, 8000
        • A. Z. Sint-Jan
      • Bruxelles, Belgium, 1200
        • UCL- Saint Luc
      • Charleroi, Belgium, 6000
        • CH Notre Dame
      • Jette, Belgium, 1090
        • AZ VUB
      • Liège, Belgium, 4000
        • CHR de la Citadelle
      • Montigny-Le-Tilleul, Belgium, 6110
        • CHU Charleroi-Vesale
      • Ottignies, Belgium, 1340
        • Clinique Saint Pierre
      • Roeselare, Belgium, 8800
        • Heilig Hart Ziekenhuis
      • Yvoir, Belgium, 5530
        • UCL - Mont-Godinne
  • France
      • Annecy, France, F-74011
        • CH d'Annecy
      • Avignon, France, F-84902
        • Centre Hospitalier d'Avignon
      • Bayonne, France, F-64100
        • Hopital de Bayonne
      • Bobigny, France, F-93009
        • Hôpital d'Avicenne
      • Bordeaux, France, F-33300
        • Polyclinique Bordeaux Nord Aquitaine
      • Brive la Gaillarde, France, F-19190
        • CH de Brive
      • Caen, France, F-14033
        • CHU Clemenceau
      • Caen, France, F-14076
        • Centre Francois Baclesse
      • Chambery, France, F-73011
        • Ch De Chambery
      • Chartres, France, F-28018
        • CH de Chartres
      • Corbeil-Essonnes, France, F-91108
        • Hôpital Gilles de Corbeil
      • Creteil, France, F-94010
        • Hopital Henri Mondor
      • Dijon, France, F-21034
        • Chu Le Bocage
      • Dunkerque, France, F-59385
        • Centre Hospitalier de Dunkerque
      • La Rochelle, France, F-17019
        • Hôpital Saint Louis
      • Le Chesnay, France, F-78157
        • Hopital Andre Mignot
      • Le Kremlin-Bicêtre, France, F-94270
        • Hopital Bicetre
      • Lens, France, F-62307
        • CHU de Lens
      • Lille, France, F-59020
        • Hopital Saint Vincent de Paul
      • Lille, France, F-59037
        • CHU Claude Huriez
      • Limoges, France, F-87000
        • Hopital Dupuytren
      • Lyon, France, F-69373
        • Centre Leon Berard
      • Macon, France, F-71018
        • Hôpital des chanaux
      • Meaux, France, F-77100
        • CH de Meaux
      • Metz, France, F-57038
        • Hopital Bon secours
      • Mulhouse, France, F-68070
        • Hopital Emile Muller
      • Nice, France, F-06054
        • Centre Antoine Lacassagne
      • Paris, France, F-75475
        • Hôpital Saint Louis
      • Paris, France, F-75743
        • Hopital Necker
      • Perpignan, France, F-66046
        • Centre Hospitalier de Perpigan
      • Pierre Benite, France, F-69495
        • Centre Hospitalier Lyon Sud
      • Rouen, France, F-76038
        • Centre Henri Becquerel
      • St Germain en Laye, France, F-78108
        • CH de St Germain
      • Toulouse, France, F-31000
        • Hopital Purpan
      • Vandoeuvre les Nancy, France
        • Hôpital Brabois

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Rituximab + Cytarabine
Drug: Rituximab
375 mg/m2 D1
Drug: Cytarabine
50 mg D3

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Response to treatment (CR/PR)
Time Frame: End of treatment - 5 months
End of treatment - 5 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Toxicity, Overall survival, Time to progression
Time Frame: End of study - 5 years
End of study - 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lymphoma Study Association

Investigators

  • Study Chair: Herve Ghesquieres, MD, LYmphoma Study Association (LYSA)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 1, 2007

Primary Completion (ACTUAL)

June 1, 2012

Study Completion (ACTUAL)

March 1, 2017

Study Registration Dates

First Submitted

November 5, 2007

First Submitted That Met QC Criteria

November 5, 2007

First Posted (ESTIMATE)

November 6, 2007

Study Record Updates

Last Update Posted (ACTUAL)

August 23, 2018

Last Update Submitted That Met QC Criteria

August 21, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R-C5R 2006

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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