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Low Grade Lymphoma (EVACC-B)

Primary Purpose

Indolent Lymphoproliferative Disorders

Status
Unknown status
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
Vaccin GenHevac B Pasteur
Sponsored by
Central Hospital, Nancy, France
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Indolent Lymphoproliferative Disorders focused on measuring Low grade lymphoma, follicular lymphoma, indolent lymphoproliferative disorders, Vaccin GenHevac B Pasteur

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Pôle Hématologie CHU Nancy BraboisRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

vaccin GenHevac B Pasteur

Arm 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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
August 16, 2012
Last Updated
June 15, 2016
Sponsor
Central Hospital, Nancy, France
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1. Study Identification

Unique Protocol Identification Number
NCT01698866
Brief Title
Low Grade Lymphoma
Acronym
EVACC-B
Official Title
Evaluation of the Immune Response After Vaccination Against Hepatitis B in Patients With Indolent Lymphoproliferative Disorders With no Treatment.
Study Type
Interventional

2. Study Status

Record Verification Date
June 2016
Overall Recruitment Status
Unknown status
Study Start Date
July 2012 (undefined)
Primary Completion Date
July 2017 (Anticipated)
Study Completion Date
February 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Central Hospital, Nancy, France

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Indolent Lymphoproliferative Disorders
Keywords
Low grade lymphoma, follicular lymphoma, indolent lymphoproliferative disorders, Vaccin GenHevac B Pasteur

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
vaccin GenHevac B Pasteur
Arm Type
Experimental
Arm 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
Intervention Type
Biological
Intervention Name(s)
Vaccin GenHevac B Pasteur
Primary Outcome Measure Information:
Title
Describe the seroconversion rates at month 7 (M7) defined for a threshold of HBs Ab> 10 IU / L.
Time Frame
Month 7
Secondary Outcome Measure Information:
Title
- Describe the seroconversion rate in month 2 (M2) defined for a threshold of HBs Ab> 10 IU / L.
Time Frame
Month 2
Title
Describe the cellular immune response post vaccination at M2 and M7.
Time Frame
Month 2 and Month 7
Title
To study the influence of age on the rate of seroconversion.
Time Frame
Month 0, Month 2 and Month 7
Title
Describe vaccine-tolerance at M2 and M7.
Time Frame
Month 2 and Month 7
Title
To study the influence of sex on the rate of seroconversion.
Time Frame
Month 0, Month 2 and Month 7
Title
To study the influence of lymphocyte count on the rate of seroconversion.
Time Frame
Month 0, Month 2 and Month 7
Title
To study the influence of total immunoglobulin on the rate of seroconversion.
Time Frame
Month 0, Month 2 and Month 7
Title
To study the influence of immunoglobulin M on the rate of seroconversion.
Time Frame
Month 0, Month 2 and Month 7

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pierre FEUGIER, MD, PhD
Phone
+33 3 83 15 32 82
Email
p.feugier@chu-nancy.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Jessica MICHEL, MD
Phone
+33 3 83 15 53 49
Email
je.michel@chu-nancy.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pierre FEUGIER, MD, PhD
Organizational Affiliation
Pôle Hématologie CHU Nancy Brabois, CHU de Nancy, Vandoeuvre les Nancy, FRANCE
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pôle Hématologie CHU Nancy Brabois
City
Vandoeuvre Les Nancy
ZIP/Postal Code
54511
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pierre FEUGIER, MD, PhD
Phone
+33 3 83 15 32 82
Email
p.feugier@chu-nancy.fr
First Name & Middle Initial & Last Name & Degree
Jessica MICHEL, MD
Phone
+33 3 83 15 53 49
Email
je.michel@chu-nancy.fr
First Name & Middle Initial & Last Name & Degree
Pierre FEUGIER, MD, PhD

12. IPD Sharing Statement

Learn more about this trial

Low Grade Lymphoma

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