Low Grade Lymphoma (EVACC-B)
This study is currently recruiting participants.
Verified July 2012 by Central Hospital, Nancy, France
Sponsor:
Central Hospital, Nancy, France
Information provided by (Responsible Party):
Pierre FEUGIER, Central Hospital, Nancy, France
ClinicalTrials.gov Identifier:
NCT01698866
First received: August 16, 2012
Last updated: October 1, 2012
Last verified: July 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Indolent Lymphoproliferative Disorders |
Biological: Vaccin GenHevac B Pasteur |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | Evaluation of the Immune Response After Vaccination Against Hepatitis B in Patients With Indolent Lymphoproliferative Disorders With no Treatment. |
Resource links provided by NLM:
Further study details as provided by Central Hospital, Nancy, France:
Primary Outcome Measures:
- Describe the seroconversion rates at month 7 (M7) defined for a threshold of HBs Ab> 10 IU / L. [ Time Frame: Month 7 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- - Describe the seroconversion rate in month 2 (M2) defined for a threshold of HBs Ab> 10 IU / L. [ Time Frame: Month 2 ] [ Designated as safety issue: No ]
- Describe the cellular immune response post vaccination at M2 and M7. [ Time Frame: Month 2 and Month 7 ] [ Designated as safety issue: No ]
- To study the influence of age on the rate of seroconversion. [ Time Frame: Month 0, Month 2 and Month 7 ] [ Designated as safety issue: No ]
- Describe vaccine-tolerance at M2 and M7. [ Time Frame: Month 2 and Month 7 ] [ Designated as safety issue: No ]
- To study the influence of sex on the rate of seroconversion. [ Time Frame: Month 0, Month 2 and Month 7 ] [ Designated as safety issue: No ]
- To study the influence of lymphocyte count on the rate of seroconversion. [ Time Frame: Month 0, Month 2 and Month 7 ] [ Designated as safety issue: No ]
- To study the influence of total immunoglobulin on the rate of seroconversion. [ Time Frame: Month 0, Month 2 and Month 7 ] [ Designated as safety issue: No ]
- To study the influence of immunoglobulin M on the rate of seroconversion. [ Time Frame: Month 0, Month 2 and Month 7 ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 40 |
| Study Start Date: | July 2012 |
| Estimated Study Completion Date: | July 2015 |
| Estimated Primary Completion Date: | July 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 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
|
Biological: Vaccin GenHevac B Pasteur |
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01698866
Contacts
| Contact: Pierre FEUGIER, MD, PhD | +33 3 83 15 32 82 | p.feugier@chu-nancy.fr |
| Contact: Jessica MICHEL, MD | +33 3 83 15 53 49 | je.michel@chu-nancy.fr |
Locations
| France | |
| Pôle Hématologie CHU Nancy Brabois | Recruiting |
| Vandoeuvre Les Nancy, France, 54511 | |
| Contact: Pierre FEUGIER, MD, PhD +33 3 83 15 32 82 p.feugier@chu-nancy.fr | |
| Contact: Jessica MICHEL, MD +33 3 83 15 53 49 je.michel@chu-nancy.fr | |
| Principal Investigator: Pierre FEUGIER, MD, PhD | |
Sponsors and Collaborators
Central Hospital, Nancy, France
Investigators
| Principal Investigator: | Pierre FEUGIER, MD, PhD | Pôle Hématologie CHU Nancy Brabois, CHU de Nancy, Vandoeuvre les Nancy, FRANCE |
More Information
No publications provided
| Responsible Party: | Pierre FEUGIER, Professor, M.D. Ph. D, Central Hospital, Nancy, France |
| ClinicalTrials.gov Identifier: | NCT01698866 History of Changes |
| Other Study ID Numbers: | 2011-004968-30 |
| Study First Received: | August 16, 2012 |
| Last Updated: | October 1, 2012 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) |
Keywords provided by Central Hospital, Nancy, France:
|
Low grade lymphoma follicular lymphoma indolent lymphoproliferative disorders Vaccin GenHevac B Pasteur |
Additional relevant MeSH terms:
|
Lymphoma Lymphoproliferative Disorders Lymphoma, Non-Hodgkin Neoplasms by Histologic Type |
Neoplasms Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases |
ClinicalTrials.gov processed this record on June 13, 2013