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Low Grade Lymphoma (EVACC-B)

This study is currently recruiting participants. (see Contacts and Locations)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Disease
Lymphoproliferative Disorders
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on November 20, 2014