Low Grade Lymphoma

Central Hospital, Nancy, France40 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Indolent Lymphoproliferative Disorders

Interventions

Vaccin GenHevac B PasteurBIOLOGICAL

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Pôle Hématologie CHU Nancy Brabois

Vandœuvre-lès-Nancy, France

RECRUITING

Outcomes

Primary Outcomes

Describe the seroconversion rates at month 7 (M7) defined for a threshold of HBs Ab> 10 IU / L.

Time frame: Month 7

Secondary Outcomes

- Describe the seroconversion rate in month 2 (M2) defined for a threshold of HBs Ab> 10 IU / L.

Time frame: Month 2

Describe the cellular immune response post vaccination at M2 and M7.

Time frame: Month 2 and Month 7

To study the influence of age on the rate of seroconversion.