Indolent Lymphoproliferative DisordersPhase 4EVACC-BNCT01698866
Low Grade Lymphoma
A Phase 4 study testing Vaccin GenHevac B Pasteur in people with Indolent Lymphoproliferative Disorders, run by Central Hospital, Nancy, France at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Indolent Lymphoproliferative Disorders
- What is being tested?
- Vaccin GenHevac B Pasteur
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- Jul 2012to Feb 2018
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Pôle Hématologie CHU Nancy Brabois
Vandœuvre-lès-Nancy, 54511
Pierre FEUGIER, MD, PhD, +33 3 83 15 32 82, p.feugier@chu-nancy.fr
Jessica MICHEL, MD, +33 3 83 15 53 49, je.michel@chu-nancy.fr
About this study
Official title: Evaluation of the Immune Response After Vaccination Against Hepatitis B in Patients With Indolent Lymphoproliferative Disorders With no Treatment.
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.
Read the 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.
- Conditions
- Indolent Lymphoproliferative Disorders
- Being tested
- Vaccin GenHevac B Pasteur
- Keywords
- Low grade lymphoma, follicular lymphoma, indolent lymphoproliferative disorders, Vaccin GenHevac B Pasteur
- Medical subject headings
- Lymphoma, Non-Hodgkin, Lymphoma, Follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vaccin GenHevac B PasteurBiological
| Study group | Role | What they receive |
|---|---|---|
| vaccin GenHevac B Pasteur | Experimental | 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 Receives: Biological: Vaccin GenHevac B Pasteur |
What is being measured
The primary outcome is the main question the study is designed to answer.
Describe the seroconversion rates at month 7 (M7) defined for a threshold of HBs Ab> 10 IU / L.
Measured: Month 7
Secondary outcomes (8)
- Describe the seroconversion rate in month 2 (M2) defined for a threshold of HBs Ab> 10 IU / L.
Measured: Month 2
Describe the cellular immune response post vaccination at M2 and M7.
Measured: Month 2 and Month 7
To study the influence of age on the rate of seroconversion.
Measured: Month 0, Month 2 and Month 7
Describe vaccine-tolerance at M2 and M7.
Measured: Month 2 and Month 7
To study the influence of sex on the rate of seroconversion.
Measured: Month 0, Month 2 and Month 7
To study the influence of lymphocyte count on the rate of seroconversion.
Measured: Month 0, Month 2 and Month 7
To study the influence of total immunoglobulin on the rate of seroconversion.
Measured: Month 0, Month 2 and Month 7
To study the influence of immunoglobulin M on the rate of seroconversion.
Measured: Month 0, Month 2 and Month 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2012 (estimated)
- Study startJul 2012
- Primary completionJul 2017 (estimated)
- Study completionFeb 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Indolent Lymphoproliferative DisordersStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pierre FEUGIER, MD, PhD, Principal investigator, Pôle Hématologie CHU Nancy Brabois, CHU de Nancy, Vandoeuvre les Nancy, FRANCE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01698866
- Sponsor's protocol ID
- 2011-004968-30
- Acronym
- EVACC-B
- Status last verified
- Jun 2016
- First submitted
- 16 Aug 2012
- Last updated
- 16 Jun 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Immune Response After Vaccination Against Hepatitis B in Patients With Indolent Lymphoproliferative Disorders With no Treatment.
- ClinicalTrials.gov ID
- NCT01698866
- Acronym / sponsor ID
- EVACC-B / 2011-004968-30
- Conditions
- Indolent Lymphoproliferative Disorders
- Keywords
- Low grade lymphoma, follicular lymphoma, indolent lymphoproliferative disorders, Vaccin GenHevac B Pasteur
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- Jul 2017 (estimated)
- Study completion
- Feb 2018 (estimated)
- First posted
- 3 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| vaccin GenHevac B Pasteur | Experimental | Biological: Vaccin GenHevac B Pasteurvaccin 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- Indication of immediate chemotherapy.
- At least one HBV positive serologic marker .
- History of vaccination against HBV.
- Known neurodegenerative disease.
- Pregnancy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vaccin GenHevac B Pasteur | Biological | vaccin GenHevac B Pasteur |
Primary outcome
Describe the seroconversion rates at month 7 (M7) defined for a threshold of HBs Ab> 10 IU / L.
Time frame: Month 7
8 secondary outcomes
- Describe the seroconversion rate in month 2 (M2) defined for a threshold of HBs Ab> 10 IU / L.
Time frame: Month 2
Describe the cellular immune response post vaccination at M2 and M7.
Time frame: Month 2 and Month 7
To study the influence of age on the rate of seroconversion.
Time frame: Month 0, Month 2 and Month 7
Describe vaccine-tolerance at M2 and M7.
Time frame: Month 2 and Month 7
To study the influence of sex on the rate of seroconversion.
Time frame: Month 0, Month 2 and Month 7
To study the influence of lymphocyte count on the rate of seroconversion.
Time frame: Month 0, Month 2 and Month 7
To study the influence of total immunoglobulin on the rate of seroconversion.
Time frame: Month 0, Month 2 and Month 7
To study the influence of immunoglobulin M on the rate of seroconversion.
Time frame: Month 0, Month 2 and Month 7
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pierre FEUGIER, MD, PhD principal investigator
Pôle Hématologie CHU Nancy Brabois, CHU de Nancy, Vandoeuvre les Nancy, FRANCE
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Vaccin GenHevac B Pasteur in people with Indolent Lymphoproliferative Disorders, run by Central Hospital, Nancy, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pierre FEUGIER, MD, PhD (+33 3 83 15 32 82, p.feugier@chu-nancy.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Describe the seroconversion rates at month 7 (M7) defined for a threshold of HBs Ab> 10 IU / L. (time frame: Month 7). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2016.