Low Grade Lymphoma

Indolent Lymphoproliferative Disorders Clinical Trial

— EVACC-B  

Official title:

Evaluation of the Immune Response After Vaccination Against Hepatitis B in Patients With Indolent Lymphoproliferative Disorders With no Treatment.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01698866
• Other study ID #: 2011-004968-30
• Status: Recruiting
• Phase: Phase 4
• First received: August 16, 2012
• Last updated: June 15, 2016
• Start date: July 2012
• Est. completion date: February 2018

Study information

• Verified date: June 2016
• Source: Central Hospital, Nancy, France
• Contact: Pierre FEUGIER, MD, PhD
• Phone: +33 3 83 15 32 82
• Email: p.feugier[@]chu-nancy.fr
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: February 2018
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Indolent Lymphoproliferative Disorders
• Lymphoproliferative Disorders

Intervention

Biological:
• Vaccin GenHevac B Pasteur

Locations

Country	Name	City	State
France	Pôle Hématologie CHU Nancy Brabois	Vandoeuvre Les Nancy

Sponsors (1)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Describe the seroconversion rates at month 7 (M7) defined for a threshold of HBs Ab> 10 IU / L.		Month 7	No
Secondary	- Describe the seroconversion rate in month 2 (M2) defined for a threshold of HBs Ab> 10 IU / L.		Month 2	No
Secondary	Describe the cellular immune response post vaccination at M2 and M7.		Month 2 and Month 7	No
Secondary	To study the influence of age on the rate of seroconversion.		Month 0, Month 2 and Month 7	No
Secondary	Describe vaccine-tolerance at M2 and M7.		Month 2 and Month 7	No
Secondary	To study the influence of sex on the rate of seroconversion.		Month 0, Month 2 and Month 7	No
Secondary	To study the influence of lymphocyte count on the rate of seroconversion.		Month 0, Month 2 and Month 7	No
Secondary	To study the influence of total immunoglobulin on the rate of seroconversion.		Month 0, Month 2 and Month 7	No
Secondary	To study the influence of immunoglobulin M on the rate of seroconversion.		Month 0, Month 2 and Month 7	No