Low Grade Lymphoma

Phase 4

• Conditions: Indolent Lymphoproliferative Disorders
• Interventions: Biological: Vaccin GenHevac B Pasteur

• Registration Number: NCT01698866
• Lead Sponsor: Central Hospital, Nancy, France

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.

Study Timeline

• Study Start: 2012-07
• Study First Submitted: 2012-08-16
• Study First Submitted QC: 2012-10-01
• Study First Posted: 2012-10-03
• Status Verified: 2016-06
• Last Update Submitted: 2016-06-15
• Last Update Posted: 2016-06-16
• Primary Completion: 2017-07
• Study Completion: 2018-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
vaccin GenHevac B Pasteur	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

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
To study the influence of age on the rate of seroconversion.	Month 0, Month 2 and Month 7
Describe the cellular immune response post vaccination at M2 and M7.	Month 2 and Month 7
To study the influence of sex on the rate of seroconversion.	Month 0, Month 2 and Month 7
To study the influence of lymphocyte count on the rate of seroconversion.	Month 0, Month 2 and Month 7
Describe vaccine-tolerance at M2 and M7.	Month 2 and Month 7
To study the influence of total immunoglobulin on the rate of seroconversion.	Month 0, Month 2 and Month 7
To study the influence of immunoglobulin M on the rate of seroconversion.	Month 0, Month 2 and Month 7
- Describe the seroconversion rate in month 2 (M2) defined for a threshold of HBs Ab> 10 IU / L.	Month 2

Trial Locations

Locations (1)

Pôle Hématologie CHU Nancy Brabois; 🇫🇷 Vandoeuvre Les Nancy, France