Low Grade Lymphoma

NCT ID: NCT01698866

Last Updated: 2016-06-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-07-31

Study Completion Date

2018-02-28

Brief Summary

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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

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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.

Conditions

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Indolent Lymphoproliferative Disorders

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Vaccin GenHevac B Pasteur

Intervention Type BIOLOGICAL

Interventions

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Vaccin GenHevac B Pasteur

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Central Hospital, Nancy, France

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pierre FEUGIER, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Pôle Hématologie CHU Nancy Brabois, CHU de Nancy, Vandoeuvre les Nancy, FRANCE

Locations

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Pôle Hématologie CHU Nancy Brabois

Vandœuvre-lès-Nancy, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Pierre FEUGIER, MD, PhD

Role: CONTACT

+33 3 83 15 32 82

Jessica MICHEL, MD

Role: CONTACT

+33 3 83 15 53 49

Facility Contacts

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Pierre FEUGIER, MD, PhD

Role: primary

+33 3 83 15 32 82

Jessica MICHEL, MD

Role: backup

+33 3 83 15 53 49

Other Identifiers

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2011-004968-30

Identifier Type: -

Identifier Source: org_study_id

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