Low Grade Lymphoma (EVACC-B)

Central Hospital, Nancy, France

Status and phase: Unknown; Phase 4

Conditions: Indolent Lymphoproliferative Disorders

Treatments: Biological: Vaccin GenHevac B Pasteur

Study type: Interventional

Funder types: Other

Identifiers

NCT01698866

2011-004968-30

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

vaccin GenHevac B Pasteur

Experimental group

Description:

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

Treatment:

Biological: Vaccin GenHevac B Pasteur