Ignite Creation Date:
2025-12-25 @ 4:28 AM
Ignite Modification Date:
2025-12-26 @ 3:31 AM
Study NCT ID:
NCT07233720
Status:
RECRUITING
Last Update Posted:
2025-11-18
First Post:
2025-07-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Zanubrutinib Combined With Rituximab in the Treatment for Patients With Marginal Zone Lymphoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018442', 'term': 'Lymphoma, B-Cell, Marginal Zone'}], 'ancestors': [{'id': 'D016393', 'term': 'Lymphoma, B-Cell'}, {'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000629551', 'term': 'zanubrutinib'}, {'id': 'D000069283', 'term': 'Rituximab'}], 'ancestors': [{'id': 'D058846', 'term': 'Antibodies, Monoclonal, Murine-Derived'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}, 'targetDuration': '24 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-11-18', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2030-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-16', 'studyFirstSubmitDate': '2025-07-08', 'studyFirstSubmitQcDate': '2025-11-16', 'lastUpdatePostDateStruct': {'date': '2025-11-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-11-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2028-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'complete response rate', 'timeFrame': "every 6 weeks from the day of the first cycle of induction chemotherapy treatment (each cycle is 21 days) and every 8 weeks from the day of the first cycle of maintenance treatment (each cycle is 28 days) to 18 months after last patient's enrollment", 'description': 'the total proportion of patients with complete response (CR)'}], 'secondaryOutcomes': [{'measure': 'objective response rate', 'timeFrame': "every 6 weeks from the day of the first cycle of induction chemotherapy treatment (each cycle is 21 days) and every 8 weeks from the day of the first cycle of maintenance treatment (each cycle is 28 days) to 18 months after last patient's enrollment", 'description': 'the total proportion of patients with complete response (CR) and partial response (PR)'}, {'measure': 'progression-free survival', 'timeFrame': "from the day of the first cycle of treatment to the date of confirmed progressive disease or death, whichever occurs first after last patient's enrollment (each cycle is 21 days for induction treatment, and 28 days for maintenance treatment)", 'description': 'the total proportion of patients with no progression from date of the first day of treatment to the date of confirmed progressive disease or death which one occurs first'}, {'measure': 'overall survival', 'timeFrame': 'from date of the first cycle of treatment to the date of death from any cause (each cycle is 21 days for induction treatment, and 28 days for maintenance treatment)', 'description': 'from date of first day of treatment to the date of death by any cause'}, {'measure': 'incidence and relationship with study drugs of grade 3-4 adverse events', 'timeFrame': "from the date of the first cycle of treatment to 24 months after last patient's enrollment (each cycle is 21 days for induction treatment, and 28 days for maintenance treatment)", 'description': 'the incidence and relationship with study drugs of grade 3 or 4 adverse events (based on NCI CTC-AE v5.0)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Marginal Zone Lymphoma', 'Zanubrutinib', 'Rituximab'], 'conditions': ['Marginal Zone Lymphoma']}, 'descriptionModule': {'briefSummary': 'This is a prospective single arm, multi-center, real-world study to observe the efficacy and safety of ZR (Zanubrutinib combined with Rituximab) in the first-line treatment for patients with marginal zone lymphoma (MZL).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with CD20-positive marginal zone lymphoma diagnosed by histopathology for first-line treatment.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients with CD20-positive marginal zone lymphoma diagnosed by histopathology\n2. First-line treatment with the combination regimen of zanubrutinib and rituximab\n3. No receiving systematic treatment before enrollment\n4. Having at least one measurable lesions. Measurable lesions were defined as: the longest diameter of lymph node lesions in CT cross-sectional images \\> 1.5 cm, or the longest diameter of the extranodal lesion is greater than 1.0cm\n5. The patients voluntarily joined this study, signed the informed consent form, had good compliance and cooperated with the follow-up.\n\nExclusion Criteria:\n\n1. Other malignant tumor history or active malignant tumor need be treated\n2. In addition to zanubrutinib and rituximab, other anti-tumor drug treatments were also received simultaneously (except for glucocorticoids aimed at controlling symptoms before formal treatment).'}, 'identificationModule': {'nctId': 'NCT07233720', 'briefTitle': 'Zanubrutinib Combined With Rituximab in the Treatment for Patients With Marginal Zone Lymphoma', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Henan Cancer Hospital'}, 'officialTitle': 'A Multicenter Prospective Real-world Study of Zanubrutinib Combined With Rituximab (ZR) in the First-line Treatment for Patients With Marginal Zone Lymphoma (MZL)', 'orgStudyIdInfo': {'id': 'HNSZLYYNHL10'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Zanubrutinib Combined With Rituximab', 'description': 'Induction treatment:\n\nRituximab, 375mg/m2, Intravenous administration on day 1 (21 days/cycle); Zanubrutinib, 160mg twice daily continuous oral administration from 1 to 8 cycles (21 days/cycle)\n\nMaintenance treatment:\n\nZanubrutinib, 160mg twice daily continuous oral administration for two years (28 days/cycle)', 'interventionNames': ['Drug: Zanubrutinib', 'Drug: Rituximab']}], 'interventions': [{'name': 'Zanubrutinib', 'type': 'DRUG', 'otherNames': ['Zanubrutinib pills'], 'description': '160mg twice daily continuous oral administration.', 'armGroupLabels': ['Zanubrutinib Combined With Rituximab']}, {'name': 'Rituximab', 'type': 'DRUG', 'otherNames': ['RiTUXimab Injection'], 'description': '375mg/m2, Intravenous administration on day 1 of each 3-week cycle', 'armGroupLabels': ['Zanubrutinib Combined With Rituximab']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Zhengzhou', 'state': 'Henan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Zhihua Yao, M.D. Ph.D', 'role': 'CONTACT', 'email': 'zlyyyaozhihua1260@zzu.edu.cn', 'phone': '+8613592622292'}], 'facility': 'Henan Cancer Hospital/The affiliated Cancer Hospital of ZhengZhou university', 'geoPoint': {'lat': 34.75778, 'lon': 113.64861}}], 'centralContacts': [{'name': 'Zhihua Yao, M.D. Ph.D', 'role': 'CONTACT', 'email': 'zlyyyaozhihua1260@zzu.edu.cn', 'phone': '+8613592622292'}], 'overallOfficials': [{'name': 'Zhihua Yao, M.D. Ph.D', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Henan Cancer Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Henan Cancer Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director', 'investigatorFullName': 'Zhihua Yao, PhD', 'investigatorAffiliation': 'Henan Cancer Hospital'}}}}