Clinical trial NCT01698866: Low Grade Lymphoma
Official title: Evaluation of the Immune Response After Vaccination Against Hepatitis B in Patients With Indolent Lymphoproliferative Disorders With no Treatment.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Indolent Lymphoproliferative Disorders
Keywords: Low grade lymphoma
follicular lymphoma
indolent lymphoproliferative disorders
Vaccin GenHevac B Pasteur
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2012-10-03
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: 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.

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 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.

Primary outcomes:
measure: Describe the seroconversion rates at month 7 (M7) defined for a threshold of HBs Ab> 10 IU / L.
timeFrame: Month 7
Secondary outcomes:
measure: - Describe the seroconversion rate in month 2 (M2) defined for a threshold of HBs Ab> 10 IU / L.
timeFrame: Month 2
measure: Describe the cellular immune response post vaccination at M2 and M7.
timeFrame: Month 2 and Month 7
measure: To study the influence of age on the rate of seroconversion.
timeFrame: Month 0, Month 2 and Month 7
measure: Describe vaccine-tolerance at M2 and M7.
timeFrame: Month 2 and Month 7
measure: To study the influence of sex on the rate of seroconversion.
timeFrame: Month 0, Month 2 and Month 7
measure: To study the influence of lymphocyte count on the rate of seroconversion.
timeFrame: Month 0, Month 2 and Month 7
measure: To study the influence of total immunoglobulin on the rate of seroconversion.
timeFrame: Month 0, Month 2 and Month 7
measure: To study the influence of immunoglobulin M on the rate of seroconversion.
timeFrame: Month 0, Month 2 and Month 7
Other outcomes:
Locations:
city: Vandoeuvre Les Nancy
country: France
facility: Pôle Hématologie CHU Nancy Brabois
Study officials:
affiliation: Pôle Hématologie CHU Nancy Brabois, CHU de Nancy, Vandoeuvre les Nancy, FRANCE
name: Pierre FEUGIER, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: