Ignite Creation Date:
2025-12-24 @ 4:08 PM
Ignite Modification Date:
2026-01-04 @ 3:48 AM
Study NCT ID:
NCT01698866
Status:
UNKNOWN
Last Update Posted:
2016-06-16
First Post:
2012-08-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Low Grade Lymphoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}, {'id': 'D008224', 'term': 'Lymphoma, Follicular'}], 'ancestors': [{'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2012-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-06', 'completionDateStruct': {'date': '2018-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-06-15', 'studyFirstSubmitDate': '2012-08-16', 'studyFirstSubmitQcDate': '2012-10-01', 'lastUpdatePostDateStruct': {'date': '2016-06-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-10-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Describe the seroconversion rates at month 7 (M7) defined for a threshold of HBs Ab> 10 IU / L.', 'timeFrame': 'Month 7'}], 'secondaryOutcomes': [{'measure': '- Describe the seroconversion rate in month 2 (M2) defined for a threshold of HBs Ab> 10 IU / L.', 'timeFrame': 'Month 2'}, {'measure': 'Describe the cellular immune response post vaccination at M2 and M7.', 'timeFrame': 'Month 2 and Month 7'}, {'measure': 'To study the influence of age on the rate of seroconversion.', 'timeFrame': 'Month 0, Month 2 and Month 7'}, {'measure': 'Describe vaccine-tolerance at M2 and M7.', 'timeFrame': 'Month 2 and Month 7'}, {'measure': 'To study the influence of sex on the rate of seroconversion.', 'timeFrame': 'Month 0, Month 2 and Month 7'}, {'measure': 'To study the influence of lymphocyte count on the rate of seroconversion.', 'timeFrame': 'Month 0, Month 2 and Month 7'}, {'measure': 'To study the influence of total immunoglobulin on the rate of seroconversion.', 'timeFrame': 'Month 0, Month 2 and Month 7'}, {'measure': 'To study the influence of immunoglobulin M on the rate of seroconversion.', 'timeFrame': 'Month 0, Month 2 and Month 7'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Low grade lymphoma', 'follicular lymphoma', 'indolent lymphoproliferative disorders', 'Vaccin GenHevac B Pasteur'], 'conditions': ['Indolent Lymphoproliferative Disorders']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18 years.\n* Lymphoproliferative indolent type of stage A CLL or follicular lymphoma with low tumor burden\n* No indication of chemotherapy during the seven months of the vaccination protocol.\n\nHBV serology negative for HBsAg / Ab HBs / HBc Ab.\n\n* No history of vaccination against hepatitis B.\n\nExclusion Criteria:\n\n* Indication of immediate chemotherapy.\n* At least one HBV positive serologic marker .\n* History of vaccination against HBV.\n* Known neurodegenerative disease.\n* Pregnancy.\n* Febrile infection untreated.\n* Known allergy to any vaccine component.'}, 'identificationModule': {'nctId': 'NCT01698866', 'acronym': 'EVACC-B', 'briefTitle': 'Low Grade Lymphoma', 'organization': {'class': 'OTHER', 'fullName': 'Central Hospital, Nancy, France'}, 'officialTitle': 'Evaluation of the Immune Response After Vaccination Against Hepatitis B in Patients With Indolent Lymphoproliferative Disorders With no Treatment.', 'orgStudyIdInfo': {'id': '2011-004968-30'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'vaccin GenHevac B Pasteur', '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', 'interventionNames': ['Biological: Vaccin GenHevac B Pasteur']}], 'interventions': [{'name': 'Vaccin GenHevac B Pasteur', 'type': 'BIOLOGICAL', 'armGroupLabels': ['vaccin GenHevac B Pasteur']}]}, 'contactsLocationsModule': {'locations': [{'zip': '54511', 'city': 'Vandœuvre-lès-Nancy', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Pierre FEUGIER, MD, PhD', 'role': 'CONTACT', 'email': 'p.feugier@chu-nancy.fr', 'phone': '+33 3 83 15 32 82'}, {'name': 'Jessica MICHEL, MD', 'role': 'CONTACT', 'email': 'je.michel@chu-nancy.fr', 'phone': '+33 3 83 15 53 49'}, {'name': 'Pierre FEUGIER, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Pôle Hématologie CHU Nancy Brabois', 'geoPoint': {'lat': 48.66115, 'lon': 6.17114}}], 'centralContacts': [{'name': 'Pierre FEUGIER, MD, PhD', 'role': 'CONTACT', 'email': 'p.feugier@chu-nancy.fr', 'phone': '+33 3 83 15 32 82'}, {'name': 'Jessica MICHEL, MD', 'role': 'CONTACT', 'email': 'je.michel@chu-nancy.fr', 'phone': '+33 3 83 15 53 49'}], 'overallOfficials': [{'name': 'Pierre FEUGIER, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Pôle Hématologie CHU Nancy Brabois, CHU de Nancy, Vandoeuvre les Nancy, FRANCE'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Central Hospital, Nancy, France', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}