Ignite Creation Date:
2025-12-25 @ 1:47 AM
Ignite Modification Date:
2025-12-26 @ 12:05 AM
Study NCT ID:
NCT06363994
Status:
RECRUITING
Last Update Posted:
2024-12-27
First Post:
2024-04-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Global Phase 3 Study of Orelabrutinib+BR Vs.BR in Pts with TN MCL
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020522', 'term': 'Lymphoma, Mantle-Cell'}], 'ancestors': [{'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': 'C000729508', 'term': 'orelabrutinib'}, {'id': 'D000069461', 'term': 'Bendamustine Hydrochloride'}, {'id': 'D000069283', 'term': 'Rituximab'}], 'ancestors': [{'id': 'D002087', 'term': 'Butyrates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D009588', 'term': 'Nitrogen Mustard Compounds'}, {'id': 'D009150', 'term': 'Mustard Compounds'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D001562', 'term': 'Benzimidazoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'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': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 476}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-05-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2032-06-25', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-20', 'studyFirstSubmitDate': '2024-04-09', 'studyFirstSubmitQcDate': '2024-04-09', 'lastUpdatePostDateStruct': {'date': '2024-12-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2031-06-25', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Dose-limiting toxicity (DLT)', 'timeFrame': '28 days'}, {'measure': 'Progression-free Survival (PFS) for Arm A vs. Arm B', 'timeFrame': 'Approximately 7 years'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Mantle Cell Lymphoma']}, 'descriptionModule': {'briefSummary': 'Compare the efficacy and safety of Orelabrutinib plus bendamustine+ rituximab versus bendamustine + rituximab in previously untreated patients with mantle cell lymphoma (MCL)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Subjects ≥ 65 of age, or ≥ 60 and \\< 65 years old who are ineligible for stem cell transplant or have refused stem cell transplantation due to reason(s) including: Have not received prior systemic therapies for MCL.\n2. Modified Ann Arbor stage II-IV. Patients with stage II require systemic treatment to be eligible, at the discretion of the investigator.\n3. Histopathological confirmed MCL, expression of Cyclin D1 and/or t (11; 14) chromosomal translocation. Either fresh tissue or FFPE for diagnosis must be sent to central lab for final confirmation after randomization.\n4. At least one measurable site of disease (the longest axis of the lymph node lesion is \\> 1.5 cm, or the longest diameter of the extranodal lesion is \\> 1.0 cm).\n5. ECOG PS score of 0 to 2.\n\nExclusion Criteria:\n\n1. Existing or prior history of other malignant tumor and no evidence of recurrence and metastasis within 2 years before screening.\n2. Subjects with evident gastrointestinal dysfunction that may affect drug intake, transport or absorption, or subjects who have undergone total gastrectomy.\n3. Subjects for whom the goal of therapy is tumor debulking prior to stem cell transplant.\n4. Use of strong inhibitors or strong inducers of cytochrome P450 3A within 14 days or 5 half-lives, whichever is longer, before the first dose of study treatment; or plan to use strong inhibitors or strong inducers of CYP3A during the study.\n5. Known central nervous system lymphoma.'}, 'identificationModule': {'nctId': 'NCT06363994', 'briefTitle': 'A Global Phase 3 Study of Orelabrutinib+BR Vs.BR in Pts with TN MCL', 'organization': {'class': 'INDUSTRY', 'fullName': 'InnoCare Pharma Inc.'}, 'officialTitle': 'A Randomized, Double-Blind, Multicenter, Placebo-Controlled Phase 3 Study of Orelabrutinib in Combination with Rituximab and Bendamustine (BR) Vs. BR in Subjects with Treatment-Naїve Mantle Cell Lymphoma', 'orgStudyIdInfo': {'id': 'ICP-CL-00128'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Arm A', 'interventionNames': ['Drug: Orelabrutinib', 'Drug: Bendamustine Injection', 'Drug: Rituximab']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Arm B', 'interventionNames': ['Drug: Bendamustine Injection', 'Drug: Rituximab', 'Drug: Orelabrutinib Placebo']}], 'interventions': [{'name': 'Orelabrutinib', 'type': 'DRUG', 'description': 'Eligible patients will receive Orelabrutinib orally as per the protocol，until disease progression or other reasons for treatment discontinuation，whichever comes first.', 'armGroupLabels': ['Arm A']}, {'name': 'Bendamustine Injection', 'type': 'DRUG', 'description': 'Eligible patients will receive Bendamustine by injection as per the protocol', 'armGroupLabels': ['Arm A', 'Arm B']}, {'name': 'Rituximab', 'type': 'DRUG', 'description': 'Eligible patients will receive Rituximab by injection as per the protocol', 'armGroupLabels': ['Arm A', 'Arm B']}, {'name': 'Orelabrutinib Placebo', 'type': 'DRUG', 'description': 'Eligible patients will receive Orelabrutinib Placebo orally as per the protocol', 'armGroupLabels': ['Arm B']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beijing', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yuqin Song', 'role': 'CONTACT'}], 'facility': 'Beijing Cancer Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Beijing', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Hongmei Jing', 'role': 'CONTACT'}], 'facility': 'Peking University Third Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Bengbu', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yanli Yang', 'role': 'CONTACT'}], 'facility': 'The First Affiliated Hospital of Bengbu Medical University', 'geoPoint': {'lat': 32.94083, 'lon': 117.36083}}, {'city': 'Changchun', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Ou Bai', 'role': 'CONTACT'}], 'facility': 'First Hospital of Jilin University', 'geoPoint': {'lat': 43.88, 'lon': 125.32278}}, {'city': 'Changsha', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Hui Zhou', 'role': 'CONTACT'}], 'facility': 'Hunan Cancer Hospital', 'geoPoint': {'lat': 28.19874, 'lon': 112.97087}}, {'city': 'Changzhou', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Weiying Gu', 'role': 'CONTACT'}], 'facility': "The First People's Hospital of Changzhou", 'geoPoint': {'lat': 31.77359, 'lon': 119.95401}}, {'city': 'Chengdu', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xiaobing Huang', 'role': 'CONTACT'}], 'facility': "Sichuan Provincial People's Hospital", 'geoPoint': {'lat': 30.66667, 'lon': 104.06667}}, {'city': 'Chengdu', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Liqun Zhou', 'role': 'CONTACT'}], 'facility': 'West China Hospital of Sichuan University', 'geoPoint': {'lat': 30.66667, 'lon': 104.06667}}, {'city': 'Chongqing', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yingyu Nan', 'role': 'CONTACT'}], 'facility': 'Chongqinq Cancer Hospital', 'geoPoint': {'lat': 29.56026, 'lon': 106.55771}}, {'city': 'Chongqing', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xiaoqiong Tang', 'role': 'CONTACT'}], 'facility': 'The First Affiliated Hospital of Chongqing Medical University', 'geoPoint': {'lat': 29.56026, 'lon': 106.55771}}, {'city': 'Dalian', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xiuhua Sun', 'role': 'CONTACT'}], 'facility': 'The second Hospital of Dalian Medical University', 'geoPoint': {'lat': 38.91222, 'lon': 121.60222}}, {'city': 'Fuzhou', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Hongming He', 'role': 'CONTACT'}], 'facility': 'Fujing Cancer Hospital', 'geoPoint': {'lat': 26.06139, 'lon': 119.30611}}, {'city': 'Fuzhou', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Tingbo Liu', 'role': 'CONTACT'}], 'facility': 'Union Hospital Affiliated to Fujian Medical University', 'geoPoint': {'lat': 26.06139, 'lon': 119.30611}}, {'city': 'Guangzhou', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Wenyu Li', 'role': 'CONTACT'}], 'facility': "Guangdong Provincial People's Hospital", 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'city': 'Guangzhou', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Zhiming Li', 'role': 'CONTACT'}], 'facility': 'Sun Yat-sen University Cancer Center', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'city': 'Hangzhou', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Wenbin Qian', 'role': 'CONTACT'}], 'facility': 'The Second Affiliated Hospital Zhejiang University School of Medicine', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}, {'city': 'Hangzhou', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Wenjuan Yu', 'role': 'CONTACT'}], 'facility': 'Zhejiang University Medical School affiliated to the first Hospital', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}, {'city': 'Hefei', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jian Ge', 'role': 'CONTACT'}], 'facility': 'The First Affiliated Hospital of Anhui Medical University', 'geoPoint': {'lat': 31.86389, 'lon': 117.28083}}, {'city': 'Jinan', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Zengjun Li', 'role': 'CONTACT'}], 'facility': 'Cancer Hospital of Shandong First Medical University', 'geoPoint': {'lat': 36.66833, 'lon': 116.99722}}, {'city': 'Jinan', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xiaosheng Fang', 'role': 'CONTACT'}], 'facility': 'Shandong Provincial Hospital', 'geoPoint': {'lat': 36.66833, 'lon': 116.99722}}, {'city': 'Jinan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Guifang Ouyang', 'role': 'CONTACT'}], 'facility': 'The First Affiliated Hospital of Ningbo University', 'geoPoint': {'lat': 36.66833, 'lon': 116.99722}}, {'city': 'Luoyang', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Ling Qin', 'role': 'CONTACT'}], 'facility': 'The First Affiliated Hospital of Henan University of Science & Technology', 'geoPoint': {'lat': 34.67345, 'lon': 112.43684}}, {'city': 'Nanchang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Fei Li', 'role': 'CONTACT'}], 'facility': 'The First Affiliated Hospital of Nanchang University', 'geoPoint': {'lat': 28.68396, 'lon': 115.85306}}, {'city': 'Nanjing', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jingyan Xu', 'role': 'CONTACT'}], 'facility': 'Nanjing Drum Tower Hospital Affiliated to Medical School of Nanjing University', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}, {'city': 'Shanghai', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Qunling Zhang', 'role': 'CONTACT'}], 'facility': 'Cancer Hospital Affiliated to Fudan University', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'city': 'Shanghai', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yan Yuan', 'role': 'CONTACT'}], 'facility': 'Huashan Hospital of Fudan University', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'city': 'Shenyang', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Aijun Liao', 'role': 'CONTACT'}], 'facility': 'Shengjing Hospital of China Medical University', 'geoPoint': {'lat': 41.79222, 'lon': 123.43278}}, {'city': 'Shenyang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xiaojing Yan', 'role': 'CONTACT'}], 'facility': 'The First Affiliated Hospital of China Medical University', 'geoPoint': {'lat': 41.79222, 'lon': 123.43278}}, {'city': 'Shijiazhuang', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Lihong Liu', 'role': 'CONTACT'}], 'facility': 'The Fourth Hospital of Hebei Medical University', 'geoPoint': {'lat': 38.04139, 'lon': 114.47861}}, {'city': 'Taiyuan', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Liping Su', 'role': 'CONTACT'}], 'facility': 'Shanxi Cancer Hospital', 'geoPoint': {'lat': 37.86944, 'lon': 112.56028}}, {'city': 'Tianjin', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Zhengzi Qian', 'role': 'CONTACT'}], 'facility': 'Tianjin Cancer Hospital', 'geoPoint': {'lat': 39.14222, 'lon': 117.17667}}, {'city': 'Ürümqi', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Shujuan Wen', 'role': 'CONTACT'}], 'facility': 'The Tumor Hospital Affiliated to Xinjiang Medical University', 'geoPoint': {'lat': 43.80096, 'lon': 87.60046}}, {'city': 'Wuhan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Liling Zhang', 'role': 'CONTACT'}], 'facility': 'Union Hospital Affiliated to Tongji Medical College, Huazhong University of Science and', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}, {'city': 'Wuhan', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jia Kui', 'role': 'CONTACT'}], 'facility': 'Union Hospital Affiliated to Tongji Medical College, Huazhong University of Science and', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}, {'city': "Xi'an", 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Guangxun Gao', 'role': 'CONTACT'}], 'facility': 'The First Affiliated Hospital of the PLA Air Force Military Medical University (Xijing Hospital)', 'geoPoint': {'lat': 34.25833, 'lon': 108.92861}}, {'city': "Xi'an", 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Wanhong Zhao', 'role': 'CONTACT'}], 'facility': "The Second Affiliated Hospital Of Xi'an Jiaotong University", 'geoPoint': {'lat': 34.25833, 'lon': 108.92861}}, {'city': 'Yibin', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Shihua Huang', 'role': 'CONTACT'}], 'facility': "Yibin Second People's Hospital", 'geoPoint': {'lat': 28.7593, 'lon': 104.63994}}, {'city': 'Zhengzhou', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Keshu Zhou', 'role': 'CONTACT'}], 'facility': 'Henan Cancer Hospital', 'geoPoint': {'lat': 34.75778, 'lon': 113.64861}}, {'city': 'Zhengzhou', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Zunmin Zhu', 'role': 'CONTACT'}], 'facility': "Henan Provincial People's Hospital", 'geoPoint': {'lat': 34.75778, 'lon': 113.64861}}], 'centralContacts': [{'name': 'Alexia Lu', 'role': 'CONTACT', 'email': 'CO_HGRAC@innocarepharma.com', 'phone': '010-66609745'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'InnoCare Pharma Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}