Ignite Creation Date:
2025-12-24 @ 10:23 PM
Ignite Modification Date:
2025-12-31 @ 5:55 AM
Study NCT ID:
NCT06549335
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-10-15
First Post:
2024-08-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Zanubrutinib, Obinutuzumab and Lenalidomide (ZGR) in High-risk Treatment-naive Patients with Follicular Lymphoma (FL)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008224', 'term': 'Lymphoma, Follicular'}, {'id': 'D008223', 'term': 'Lymphoma'}], 'ancestors': [{'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}, {'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': 'C543332', 'term': 'obinutuzumab'}, {'id': 'D000077269', 'term': 'Lenalidomide'}], 'ancestors': [{'id': 'D010797', 'term': 'Phthalimides'}, {'id': 'D010795', 'term': 'Phthalic Acids'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D010881', 'term': 'Piperidones'}, {'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D054833', 'term': 'Isoindoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 66}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-12-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-10-08', 'studyFirstSubmitDate': '2024-08-08', 'studyFirstSubmitQcDate': '2024-08-08', 'lastUpdatePostDateStruct': {'date': '2024-10-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Objective response rate (ORR)', 'timeFrame': 'At the end of Cycle 6 (each cycle is 28 days)', 'description': 'Percentage of participants with overall response was determined on the basis of investigator assessments according to 2014 Lugano criteria'}], 'secondaryOutcomes': [{'measure': 'Complete response rate (CR)', 'timeFrame': 'At the end of Cycle 6 (each cycle is 28 days)', 'description': 'Percentage of participants with complete response was determined on the basis of investigator assessments according to 2014 Lugano criteria.'}, {'measure': 'Partial response rate (PR)', 'timeFrame': 'At the end of Cycle 6 (each cycle is 28 days)', 'description': 'Percentage of participants with complete response was determined on the basis of investigator assessments according to 2014 Lugano criteria.'}, {'measure': 'Duration of response', 'timeFrame': 'Baseline up to data cut-off (up to approximately 2 years)', 'description': 'Time from first occurrence of documented CR or PR to disease progression/relapse, or death from any cause for participants with a response of CR or PR. Tumor assessments were performed with PET-CT.'}, {'measure': '2-year progression free survival rate', 'timeFrame': 'Baseline up to data cut-off (up to approximately 2 years)', 'description': 'progression-free survival was defined as the time from the date of first treatment until the date of the first documented day of disease progression or relapse, using 2014 Lugano criteria, or death from any cause, whichever occurred first.'}, {'measure': '2-year overall survival rate', 'timeFrame': 'Baseline up to data cut-off (up to approximately 2 years)', 'description': 'progression-free survival was defined as the time from the date of first treatment until the date of the first documented day of death from any cause.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Zanubrutinib', 'Lymphoma'], 'conditions': ['Follicular Lymphoma']}, 'descriptionModule': {'briefSummary': 'This is a prospective, multiple-centers, open-label, single-arm clinical study designed to evaluate the efficacy and safety of Zanubrutinib, Obinutuzumab, and Lenalidomide (ZGR) in high-risk treatment-naive patients with follicular lymphomas'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Pathologically confirmed CD20 positive follicular lymphoma grade 1, 2, or 3A based on 2016 WHO classification\n2. Treatment naive\n3. Age ≥ 18 years\n4. Indications for treatment confirmed\n5. Identified as high-risk group by Follicular Lymphoma International Prognostic Index 2 (FLIPI2) at enrollment\n6. Must has measurable lesion in CT or PET-CT prior to treatment\n7. Considered suitable for ZGR regimens\n8. Informed consented\n\nExclusion Criteria:\n\n* Transformed follicular lymphoma or 3B follicular lymphoma;\n* HBsAg positive and / or HBcAb positive with HBV DNA titer; HCV antibody positive with HCV-RNA; or HIV positive\n* Any drug contraindication in the treatment plan\n* Pregnant or lactating women\n* Patients judged by other researchers to be unsuitable for inclusion in the study'}, 'identificationModule': {'nctId': 'NCT06549335', 'briefTitle': 'Zanubrutinib, Obinutuzumab and Lenalidomide (ZGR) in High-risk Treatment-naive Patients with Follicular Lymphoma (FL)', 'organization': {'class': 'OTHER', 'fullName': 'Ruijin Hospital'}, 'officialTitle': 'The Efficacy and Safety of Zanubrutinib, Obinutuzumab and Lenalidomide (ZGR) Regimen in High-risk Treatment-naive Patients with Follicular Lymphoma', 'orgStudyIdInfo': {'id': 'FL-ZGR'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental: Zanubrutinib, Obinutuzumab and Lenalidomide (ZGR)', 'interventionNames': ['Drug: Zanubrutinib, Obinutuzumab and Lenalidomide (ZGR)']}], 'interventions': [{'name': 'Zanubrutinib, Obinutuzumab and Lenalidomide (ZGR)', 'type': 'DRUG', 'description': 'Induction therapy:\n\nThe ZGR regimen will be given from day 1 of each cycle of treatment. Each cycle will last for 28 days. Participants will receive a total of 6 cycles.\n\nDosage:\n\n1. Zanubrutinib, 160 mg bid, po, day 1-28;\n2. Obinutuzumab, 1000mg, ivgtt, day 1/8/15 (C1), day1 (C2-6);\n3. Lenalidomide, 25 mg qd, po, day 2-11.\n\nMaintenance therapy:\n\n1. Obinutuzumab, ivgtt,1000mg, every 3 months for 2 years;\n2. Lenalidomide, 25mg, PO, during 1-10 days in every 28 days for 6 cycles.', 'armGroupLabels': ['Experimental: Zanubrutinib, Obinutuzumab and Lenalidomide (ZGR)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Shanghai', 'country': 'China', 'facility': 'Ruijin Hospital, Shanghai Jiao Tong University School of Medicine', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Weili Zhao, M.D. and Ph.D', 'role': 'CONTACT', 'email': 'zwl_trial@163.com', 'phone': '+862164370045', 'phoneExt': '610707'}, {'name': 'Pengpeng Xu, M.D. and Ph.D', 'role': 'CONTACT', 'email': 'pengpeng_xu@126.com', 'phone': '+862164370045', 'phoneExt': '610707'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ruijin Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'First Deputy Director, Hematology Department', 'investigatorFullName': 'Zhao Weili', 'investigatorAffiliation': 'Ruijin Hospital'}}}}