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

This study is currently recruiting participants.
Verified October 2010 by Lymphoma Study Association

First Received on November 5, 2007.  
Last Updated on October 22, 2010  
History of Changes
This Clinical Trial Sponsored By: Lymphoma Study Association
Information provided by: Lymphoma Study Association
ClinicalTrials.gov Identifier: NCT00553943
 

Purpose for Clinical Trial

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 Study Intervention Phase
Lymphoma, Non-Hodgkin
Diffuse Large B-cell Lymphoma
Drug: Rituximab, Cytarabine Phase 2

Study Type: Study Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
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:

MedlinePlus related topics:
Lymphoma
Drug Information available for:
Cytarabine
Rituximab

U.S. FDA Resources

Further study details as provided by Lymphoma Study Association:

Primary Outcome Measures For Clinical Trial:

  • Response to treatment (CR/PR) [ Time Frame: End of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures For Clinical Trial:

  • 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)
Study Intervention Details:

    Drug: Rituximab, Cytarabine

    Intravenous chemotherapy associated with IV rituximab and intrathecal cytarabine

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
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

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

Contacts
Contact: HERVE GHESQUIERES, MD 33 (0)4 78 78 28 28 ghesquie@lyon.fnclcc.fr
Contact: Christelle DA-CRUZ 33 (0)4 72 66 93 33 christelle.da-cruz@gelarc.org

Locations
France
CH d’Annecy Not yet recruiting
Annecy, France, F-74011
Contact: Bernadette Corront, MD     33 (0)4 50 88 33 28        
Principal Investigator: Bernadette Corront, MD            
Centre Hospitalier d’Avignon Not yet recruiting
Avignon, France, F-84902
Contact: Hacene ZERAZHI, MD         hzerazhi@ch-avignon.fr <hzerazhi@ch-avignon.fr>    
Principal Investigator: Hacene ZERAZHI, MD            
Hôpital de Bayonne Not yet recruiting
Bayonne, Fr

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