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CompletedNCT00553943Updated Aug 23, 2018

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

A Phase 2 interventional study of Rituximab and Cytarabine in Lymphoma, Non-Hodgkin and Diffuse Large B-cell Lymphoma, sponsored by Lymphoma Study Association. Completed at 46 sites in 2 countries. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2018-08-23.

Sponsored by Lymphoma Study Association · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Registered 4 months after the study started (first participant enrolled Jul 2007, registered Nov 2007).
Phase
Phase 2
Study type
Interventional
Enrollment
60
Allocation
Not applicable
Ages
18 Years to 60 Years
Sex
All
01

Study 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
02

Conditions studied

  • 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
03

In context

Lymphoma

5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.

This study's enrollment of 60 is above the median of 40 across 4,508 interventional studies indexed under Lymphoma.

Browse Lymphoma studies →

Lead sponsor

Lymphoma Study Association is the lead sponsor of 26 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
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Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
60 participants (actual)

Study arms

  • Experimental
    Rituximab + Cytarabine

    Drug: Rituximab · Drug: Cytarabine

Interventions

  • DrugRituximab

    375 mg/m2 D1

  • DrugCytarabine

    50 mg D3

06

What researchers measure

Primary outcomes

  1. Response to treatment (CR/PR)

    Time frame: End of treatment - 5 months

Secondary outcomes

  1. Toxicity, Overall survival, Time to progression

    Time frame: End of study - 5 years

07

Study locations

46 sites
  • ZNA Stuivenberg
    Antwerpen, 2060, Belgium
  • Hôpital Saint Joseph
    Arlon, Bruges, Belgium
  • A. Z. Sint-Jan
    Bruges, 8000, Belgium
  • UCL- Saint Luc
    Bruxelles, 1200, Belgium
  • CH Notre Dame
    Charleroi, 6000, Belgium
  • AZ VUB
    Jette, 1090, Belgium
  • CHR de la Citadelle
    Liège, 4000, Belgium
  • CHU Charleroi-Vésale
    Montigny-Le-Tilleul, 6110, Belgium
  • Clinique Saint Pierre
    Ottignies, 1340, Belgium
  • Heilig Hart Ziekenhuis
    Roeselare, 8800, Belgium
  • UCL - Mont-Godinne
    Yvoir, 5530, Belgium
  • CH d'Annecy
    Annecy, F-74011, France
  • Centre Hospitalier d'Avignon
    Avignon, F-84902, France
  • Hôpital de Bayonne
    Bayonne, F-64100, France
  • Hôpital d'Avicenne
    Bobigny, F-93009, France
  • Polyclinique Bordeaux Nord Aquitaine
    Bordeaux, F-33300, France
  • CH de Brive
    Brive la Gaillarde, F-19190, France
  • CHU Clemenceau
    Caen, F-14033, France
  • Centre Francois Baclesse
    Caen, F-14076, France
  • CH de Chambery
    Chambery, F-73011, France
  • CH de Chartres
    Chartres, F-28018, France
  • Hôpital Gilles de Corbeil
    Corbeil-Essonnes, F-91108, France
  • Hôpital Henri Mondor
    Creteil, F-94010, France
  • CHU Le Bocage
    Dijon, F-21034, France
  • Centre Hospitalier de Dunkerque
    Dunkerque, F-59385, France
  • Hôpital Saint Louis
    La Rochelle, F-17019, France
  • Hôpital Andre Mignot
    Le Chesnay, F-78157, France
  • Hôpital Bicêtre
    Le Kremlin-Bicêtre, F-94270, France
  • CHU de Lens
    Lens, F-62307, France
  • Hopital Saint Vincent de Paul
    Lille, F-59020, France
  • CHU Claude Huriez
    Lille, F-59037, France
  • Hôpital Dupuytren
    Limoges, F-87000, France
  • Centre Leon Berard
    Lyon, F-69373, France
  • Hôpital des Chanaux
    Macon, F-71018, France
  • CH de Meaux
    Meaux, F-77100, France
  • Hôpital Bon Secours
    Metz, F-57038, France
  • Hôpital Emile Muller
    Mulhouse, F-68070, France
  • Centre Antoine Lacassagne
    Nice, F-06054, France
  • Hôpital Saint Louis
    Paris, F-75475, France
  • Hôpital Necker
    Paris, F-75743, France
  • Centre Hospitalier de Perpigan
    Perpignan, F-66046, France
  • Centre Hospitalier Lyon Sud
    Pierre Benite, F-69495, France
  • Centre Henri Becquerel
    Rouen, F-76038, France
  • CH de St Germain
    St Germain en Laye, F-78108, France
  • Hôpital Purpan
    Toulouse, F-31000, France
  • Hopital Brabois
    Vandoeuvre les Nancy, France
08

References and documents

Related links

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 23, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00553943
Lead sponsor
Lymphoma Study Association
Responsible party
Sponsor
First posted
Nov 6, 2007
Start date
Jul 2007
Primary completion
Jun 2012
Completion
Mar 2017
Last update
Aug 23, 2018

Study contacts

Herve Ghesquieres, MD
study chair · LYmphoma Study Association (LYSA)

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2018. You cannot join it, but the record below documents what was studied.

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