Low Grade Lymphoma (EVACC-B)

This study is currently recruiting participants.
Verified July 2012 by Central Hospital, Nancy, France
Sponsor:
Information provided by (Responsible Party):
Pierre FEUGIER, Central Hospital, Nancy, France
ClinicalTrials.gov Identifier:
NCT01698866
First received: August 16, 2012
Last updated: October 1, 2012
Last verified: July 2012
  Purpose

The purpose of this study is to assess the seroconversion rate and the cellular immune response after vaccination against hepatitis B virus in patients with lymphoproliferative syndrome like chronic lymphocytic leukemia stade A and follicular lymphoma without of treatment criteria.


Condition Intervention Phase
Indolent Lymphoproliferative Disorders
Biological: Vaccin GenHevac B Pasteur
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Evaluation of the Immune Response After Vaccination Against Hepatitis B in Patients With Indolent Lymphoproliferative Disorders With no Treatment.

Resource links provided by NLM:


Further study details as provided by Central Hospital, Nancy, France:

Primary Outcome Measures:
  • Describe the seroconversion rates at month 7 (M7) defined for a threshold of HBs Ab> 10 IU / L. [ Time Frame: Month 7 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • - Describe the seroconversion rate in month 2 (M2) defined for a threshold of HBs Ab> 10 IU / L. [ Time Frame: Month 2 ] [ Designated as safety issue: No ]
  • Describe the cellular immune response post vaccination at M2 and M7. [ Time Frame: Month 2 and Month 7 ] [ Designated as safety issue: No ]
  • To study the influence of age on the rate of seroconversion. [ Time Frame: Month 0, Month 2 and Month 7 ] [ Designated as safety issue: No ]
  • Describe vaccine-tolerance at M2 and M7. [ Time Frame: Month 2 and Month 7 ] [ Designated as safety issue: No ]
  • To study the influence of sex on the rate of seroconversion. [ Time Frame: Month 0, Month 2 and Month 7 ] [ Designated as safety issue: No ]
  • To study the influence of lymphocyte count on the rate of seroconversion. [ Time Frame: Month 0, Month 2 and Month 7 ] [ Designated as safety issue: No ]
  • To study the influence of total immunoglobulin on the rate of seroconversion. [ Time Frame: Month 0, Month 2 and Month 7 ] [ Designated as safety issue: No ]
  • To study the influence of immunoglobulin M on the rate of seroconversion. [ Time Frame: Month 0, Month 2 and Month 7 ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: July 2012
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: vaccin GenHevac B Pasteur
vaccin GenHevac B Pasteur (Suspension for injection in pre-filled syringe / 20 μg microgram(s)Per day). In total, 3 injections at M0, M1 and M6
Biological: Vaccin GenHevac B Pasteur

Detailed Description:

Rituximab is a human-mouse chimeric monoclonal antibody that targets the B-cell CD20. It is an indispensible drug for the treatment of B-cell lymphoproliferative syndrome which induced immunosuppression. So, the infectious complications increase. Reactivation of hepatitis B virus is one such complication that can lead in asymptomatic hepatitis to death. Prevention of hepatitis B reactivation is recommended like using nucleoside analog for patients with chronic hepatitis B or occult hepatitis and vaccination against virus for seronegative patients. The published data about efficacy of hepatitis b vaccination in onco-haematology are rare. therefore, we carried out a prospective study to assess efficacy of hepatitis B vaccination in patients with lymphoproliferative disorder.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age ≥ 18 years.
  • Lymphoproliferative indolent type of stage A CLL or follicular lymphoma with low tumor burden
  • No indication of chemotherapy during the seven months of the vaccination protocol.

HBV serology negative for HBsAg / Ab HBs / HBc Ab.

  • No history of vaccination against hepatitis B.

Exclusion Criteria:

  • Indication of immediate chemotherapy.
  • At least one HBV positive serologic marker .
  • History of vaccination against HBV.
  • Known neurodegenerative disease.
  • Pregnancy.
  • Febrile infection untreated.
  • Known allergy to any vaccine component.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01698866

Contacts
Contact: Pierre FEUGIER, MD, PhD +33 3 83 15 32 82 p.feugier@chu-nancy.fr
Contact: Jessica MICHEL, MD +33 3 83 15 53 49 je.michel@chu-nancy.fr

Locations
France
Pôle Hématologie CHU Nancy Brabois Recruiting
Vandoeuvre Les Nancy, France, 54511
Contact: Pierre FEUGIER, MD, PhD    +33 3 83 15 32 82    p.feugier@chu-nancy.fr   
Contact: Jessica MICHEL, MD    +33 3 83 15 53 49    je.michel@chu-nancy.fr   
Principal Investigator: Pierre FEUGIER, MD, PhD         
Sponsors and Collaborators
Central Hospital, Nancy, France
Investigators
Principal Investigator: Pierre FEUGIER, MD, PhD Pôle Hématologie CHU Nancy Brabois, CHU de Nancy, Vandoeuvre les Nancy, FRANCE
  More Information

No publications provided

Responsible Party: Pierre FEUGIER, Professor, M.D. Ph. D, Central Hospital, Nancy, France
ClinicalTrials.gov Identifier: NCT01698866     History of Changes
Other Study ID Numbers: 2011-004968-30
Study First Received: August 16, 2012
Last Updated: October 1, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Central Hospital, Nancy, France:
Low grade lymphoma
follicular lymphoma
indolent lymphoproliferative disorders
Vaccin GenHevac B Pasteur

Additional relevant MeSH terms:
Lymphoma
Lymphoproliferative Disorders
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on April 17, 2014