Ignite Creation Date:
2025-12-25 @ 2:45 AM
Ignite Modification Date:
2025-12-26 @ 1:24 AM
Study NCT ID:
NCT06364033
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-09
First Post:
2024-04-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Biological and Clinical Efficacy of Shingrix in Patients With CLL
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015451', 'term': 'Leukemia, Lymphocytic, Chronic, B-Cell'}], 'ancestors': [{'id': 'D015448', 'term': 'Leukemia, B-Cell'}, {'id': 'D007945', 'term': 'Leukemia, Lymphoid'}, {'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 312}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-08', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2028-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-05-08', 'studyFirstSubmitDate': '2024-04-09', 'studyFirstSubmitQcDate': '2024-04-09', 'lastUpdatePostDateStruct': {'date': '2024-05-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Serologic response evaluation', 'timeFrame': 'at 1 month', 'description': 'Rate of positive serologic response to Shingrix in different subsets of patients as determined by antibody response to varicella-zoster virus (≥4-fold increase in anti-gE titer from baseline)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Chronic Lymphocytic Leukemia', 'Small Lymphocytic Lymphoma', 'CLL-like MBL', 'Varicella-zoster Virus Reactivation']}, 'descriptionModule': {'briefSummary': 'This is a biological study. Patients who are eligible to receive Shingrix through the Italian National Health System will be invited to participate in the study. According to AIFA indication, the two doses of vaccine will be administered 4-8 weeks apart. Blood samples will be collected prior to the first vaccine dose (i.e. within the time frame of 3 months prior to the first dose) and 1, 6, 12, 24 and 36 months after the second vaccine dose to evaluate the serological response of Shingrix.', 'detailedDescription': 'This is a multi-centre, prospective study, performed on biological samples only. Patients who are eligible to receive Shingrix through the Italian National Health System will be invited to participate in the study.\n\nAccording to AIFA indication, the two doses of vaccine will be administered 4-8 weeks apart.\n\nBlood samples will be collected prior to the first vaccine dose (i.e. within the time frame of 3 months prior to the first dose) and 1, 6, 12, 24 and 36 months after the second vaccine dose to evaluate the serological response of Shingrix. All protocol procedures (including clinical assessment and blood draws) will be performed during regular follow-up visits according to clinical practice. No additional invasive/dangerous/painful procedures will be required by the study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of CLL or small lymphocytic lymphoma (SLL) or CLL-like MBL according to IWCLL guidelines. Patients must belong to one of the following subgroups:\n\n * Group A: Patients with MBL or previously untreated early-phase CLL/SLL (Binet stage A or RAI stage 0), with no clear signs of disease progression;\n * Group B: Patients with active or symptomatic disease according to IWCLL guidelines or with advanced Binet or Rai stages receiving both the first and second vaccine doses before treatment initiation;\n * Group C: Patients with CLL/SLL receiving targeted drugs (i.e. ibrutinib/acalabrutinib-based treatment or venetoclax-based treatment) for at least 6 months prior to the administration of the first vaccine dose.\n* Age 18 years or older\n* Eligible to receive Shingrix according to clinical indication and free of charge through the Italian National Health System\n* Life expectancy \\>6 months\n* No active, symptomatic herpes zoster infection or varicella-zoster virus reactivation within 12 months prior to vaccination\n* No prior exposure to Shingrix\n* Able and willing to provide written informed consent and to comply with the study protocol procedures\n\nExclusion Criteria:\n\n* Female patients who are currently in pregnancy or are willing to be pregnant\n* Any uncontrolled active systemic infection\n* Intravenous immunoglobulin (IVIG) administration within 3 months prior to vaccination\n* Concomitant use of radiotherapy or chemotherapy\n* Hereditary or acquired immunodeficiency syndrome unrelated to CLL\n* Chronic use of immunosuppressive medications given for indications that are not CLL-related'}, 'identificationModule': {'nctId': 'NCT06364033', 'briefTitle': 'Biological and Clinical Efficacy of Shingrix in Patients With CLL', 'organization': {'class': 'OTHER', 'fullName': "Gruppo Italiano Malattie EMatologiche dell'Adulto"}, 'officialTitle': 'Biological and Clinical Efficacy of Recombinant Zoster Vaccine (Shingrix) in Patients With Chronic Lymphocytic Leukemia', 'orgStudyIdInfo': {'id': 'CLL2624'}}, 'armsInterventionsModule': {'interventions': [{'name': 'serologic response evaluation', 'type': 'BIOLOGICAL', 'description': 'Blood samples collection'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Varese', 'country': 'Italy', 'contacts': [{'name': 'Marta Coscia', 'role': 'CONTACT'}], 'facility': 'UOC Ematologia ASST dei Sette Laghi', 'geoPoint': {'lat': 45.82058, 'lon': 8.82511}}], 'centralContacts': [{'name': 'Paola Fazi', 'role': 'CONTACT', 'email': 'p.fazi@gimema.it', 'phone': '0670390528'}, {'name': 'Enrico Crea', 'role': 'CONTACT', 'email': 'e.crea@gimema.it', 'phone': '0670390514'}], 'overallOfficials': [{'name': 'Marta Coscia', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UOC Ematologia ASST Sette Laghi Varese'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Gruppo Italiano Malattie EMatologiche dell'Adulto", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}