Ignite Creation Date:
2025-12-24 @ 10:34 PM
Ignite Modification Date:
2026-01-01 @ 1:18 PM
Study NCT ID:
NCT05453435
Status:
RECRUITING
Last Update Posted:
2024-05-07
First Post:
2022-07-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Entecavir Prophylaxis for Hepatitis B Reactivation for CD20 Positive B-cell Lymphoma Patients With Resolved Hepatitis B (Negative Hepatitis B Surface Antigen, Positive Hepatitis B Core Antibody)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C413685', 'term': 'entecavir'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 84}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-07-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2025-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-05-04', 'studyFirstSubmitDate': '2022-07-02', 'studyFirstSubmitQcDate': '2022-07-10', 'lastUpdatePostDateStruct': {'date': '2024-05-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-07-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cumulative HBV reactivation rate', 'timeFrame': '12 months', 'description': 'Cumulative incidence of hepatitis B virus reactivation'}], 'secondaryOutcomes': [{'measure': 'Incidence of HBV-related liver failure', 'timeFrame': '12 months', 'description': 'Incidence of HBV-related liver failure'}, {'measure': 'Incidence of HBV-related chemotherapy disruption', 'timeFrame': '12 months', 'description': 'Incidence of HBV-related chemotherapy disruption'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Resolved Hepatitis B', 'CD20 Positive B-cell Lymphoma']}, 'descriptionModule': {'briefSummary': 'This phase 2 trial aims to evaluate the efficacy of entecavir prophylacxis for hepatitis B virus (HBV) reactivation that continues until 6 months after completing CD20 monoclonal antibody therapy in patients with CD20-positive B-cell lymphomas and resolved hepatitis B (negative hepatitis B surface antigen, positive hepatitis B core antibody).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Histopathologically confirmed CD20 positive B-cell lymphoma;\n* Plan to receive first-line anti-lymphoma therapy containing CD20 monoclonal antibodies;\n* Negative HBsAg, HBV-DNA lower than the detection limit and positive anti-HBC at baseline;\n* Total bilirubin less than 1.5X the upper limit of normal (ULN), AST and ALT less than 2.5X ULN;\n* ECOG PS: 0\\~2;\n* Estimated survival time \\>3 months.\n\nExclusion Criteria:\n\n* Positive HBsAg or HBV-DNA higher than the detection limit at baseline;\n* Previous chemotherapy or radiotherapy for lymphoma;\n* Other primary liver diseases, such as chronic hepatitis C, hepatitis D, autoimmune hepatitis, Wilson' s disease or primary biliary cirrhosis;\n* Pregnant or lactating women;\n* History of immunodeficiency, including positive HIV, or other acquired congenital immunodeficiency disease, or history of organ transplantation."}, 'identificationModule': {'nctId': 'NCT05453435', 'acronym': 'REHEB', 'briefTitle': 'Entecavir Prophylaxis for Hepatitis B Reactivation for CD20 Positive B-cell Lymphoma Patients With Resolved Hepatitis B (Negative Hepatitis B Surface Antigen, Positive Hepatitis B Core Antibody)', 'organization': {'class': 'OTHER', 'fullName': 'Sun Yat-sen University'}, 'officialTitle': 'Entecavir Prophylaxis for Hepatitis B Reactivation for CD20 Positive B-cell Lymphoma Patients With Resolved Hepatitis B (Negative Hepatitis B Surface Antigen, Positive Hepatitis B Core Antibody) (REHEB)：a Single Arm, Open Label, Multi-center Phase II Study', 'orgStudyIdInfo': {'id': 'B2022-352-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Entecavir prophylaxis', 'description': '0.5mg qd', 'interventionNames': ['Drug: Entecavir']}], 'interventions': [{'name': 'Entecavir', 'type': 'DRUG', 'description': 'All patients enrolled in the study will accept entecavir prophylaxis that initiates within 1 week before the first course of CD20 monoclonal antibody therapy, and continues until 6 months after completing CD20 monoclonal antibody therapy.', 'armGroupLabels': ['Entecavir prophylaxis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510060', 'city': 'Guangzhou', 'state': 'State...', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Qingqing Cai', 'role': 'CONTACT'}], 'facility': 'Sun Yat-sen Universitiy Cancer Center, Sun Yat-Sen University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'centralContacts': [{'name': 'Qingqing Cai, PhD', 'role': 'CONTACT', 'email': 'caiqq@sysucc.org.cn', 'phone': '0086-20-87342823'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sun Yat-sen University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chief physician', 'investigatorFullName': 'Qingqing Cai', 'investigatorAffiliation': 'Sun Yat-sen University'}}}}