Ignite Creation Date:
2025-12-24 @ 3:00 PM
Ignite Modification Date:
2026-01-03 @ 7:37 PM
Study NCT ID:
NCT05498259
Status:
UNKNOWN
Last Update Posted:
2023-02-03
First Post:
2022-08-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Orelabrutinib With R-CHOP-like Regimen for Patients With Newly Diagnosed Untreated Non-GCB DLBCL
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016403', 'term': 'Lymphoma, Large B-Cell, Diffuse'}], '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': 'C000729508', 'term': 'orelabrutinib'}, {'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': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 46}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-07-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2025-01-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-02-01', 'studyFirstSubmitDate': '2022-08-08', 'studyFirstSubmitQcDate': '2022-08-10', 'lastUpdatePostDateStruct': {'date': '2023-02-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-08-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Complete Response Rate', 'timeFrame': 'At the end of Cycle 6（each cycle is 21 days）', 'description': 'The rate of patients who achieved complete response after treatment by OR-CHOP-like'}], 'secondaryOutcomes': [{'measure': 'Overall Response Rate (ORR)', 'timeFrame': 'At the end of Cycle 3 and Cycle 6（each cycle is 21 days）', 'description': 'The rate of patients who achieved CR or PR after treatment by OR-CHOP-like'}, {'measure': 'Progression-free survival（PFS）', 'timeFrame': "up to 24 month after the end of last patient's treatment", 'description': 'PFS will be assessed from the first OR(Orelabrutinib plus Rituximab) given to date of progression, relapse, death or end of follow-up'}, {'measure': 'Incidence of Treatment-Emergent Adverse Events, Treatment-Related Adverse Events and Serious Adverse Events', 'timeFrame': 'initiation of study drug until 30 days after last dose', 'description': 'The safety and tolerability of the therapeutic regimen measured by the incidence of Treatment-Emergent Adverse Events, Treatment-Related Adverse Events and Serious Adverse Events'}, {'measure': 'Mini response rate', 'timeFrame': 'the first 21 days', 'description': 'The rate of patients who achieve ≥25% tumor reduction after OR treatment'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Orelabrutinib'], 'conditions': ['Diffuse Large B-Cell Lymphoma']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the efficacy and safety of orelabrutinib combined with rituximab，followed by orelabrutinib combined with R-CHOP-like regimen for newly diagnosed untreated Non-GCB DLBCL Patients', 'detailedDescription': 'The study will start with an initial 21-days of induction therapy with orelabrutinib and rituximab，following imaging examinations to evaluate response rates. Then treatment with 6 cycles chemoimmunotherapy (R-CHOP-like) either alone or in combination with orelabrutinib will depend on response during induction phase. Each cycle is 21 days.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Histologically confirmed Non-GCB DLBCL\n2. Age ≥18 and ≤70 years\n3. At least one measurable lesion，measurable lymph nodes or masses of at least 15 millimeter (mm)\n4. ECOG performance status 0-2\n5. Lymphoma International Prognostic Score (IPI) ≥ 2\n6. Life expectancy ≥ 6 months\n7. Adequate organ and marrow function\n8. Agreement to practice birth control from the time of enrollment until the follow-up period of the study\n\nExclusion Criteria:\n\n1. Received major surgery within 4 weeks before treatment or existed unhealed wounds or ulcers, except biopsy related to lymphoma diagnosis\n2. All patients with primary central nervous system lymphoma\n3. History of stroke or intracranial hemorrhage within 6 months before screening, require or receive anticoagulant therapy with warfarin or an equivalent antagonist\n4. Requires treatment with strong /moderate CYP3A inhibitors or inducers\n5. Uncontrolled comorbidity or complications, including but not limited to: symptomatic congestive heart failure (New York Heart Association Class III-IV) or symptomatic or poorly controlled arrhythmias and/or significant pulmonary disease\n6. HIV infection and/or active hepatitis B or active hepatitis C infection\n7. Uncontrolled active systemic infection\n8. Known hypersensitivity or contraindications to any drug involved in the study\n9. Pregnant or lactating women'}, 'identificationModule': {'nctId': 'NCT05498259', 'briefTitle': 'Orelabrutinib With R-CHOP-like Regimen for Patients With Newly Diagnosed Untreated Non-GCB DLBCL', 'organization': {'class': 'OTHER', 'fullName': 'The First Affiliated Hospital of Soochow University'}, 'officialTitle': 'A Phase 2 Study of Orelabrutinib With R-CHOP-like Regimen for Patients With Newly Diagnosed Untreated Non-GCB DLBCL', 'orgStudyIdInfo': {'id': 'ORIENT'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Orelabrutinib+R-CHOP-like', 'description': 'Orelabrutinib plus Rituximab for 21 days; Following Imaging examinations, patients with ≥25% tumor reduction, treat with orelabrutinib 150mg qd orally plus R-CHOP-like for 6 cycles; whereas, patients with \\<25% tumor reduction, withdraw from the study，treat with R-CHOP-like alone for 6 cycle', 'interventionNames': ['Drug: Orelabrutinib', 'Biological: Rituximab', 'Drug: CHOP-like Regimen']}], 'interventions': [{'name': 'Orelabrutinib', 'type': 'DRUG', 'description': 'Orelabrutinib 150mg qd PO', 'armGroupLabels': ['Orelabrutinib+R-CHOP-like']}, {'name': 'Rituximab', 'type': 'BIOLOGICAL', 'description': 'Rituximab 375 mg/m2 IV on Day 1 of each 21-day cycle', 'armGroupLabels': ['Orelabrutinib+R-CHOP-like']}, {'name': 'CHOP-like Regimen', 'type': 'DRUG', 'description': 'cyclophosphamide, anthracene nucleus chemotherapeutics（doxorubicin，liposomal doxorubicin, etc.）, vinca alkaloids（vincristine, vindesine, etc.），and glucocorticoid （dexamethasone，prednison, etc.）.', 'armGroupLabels': ['Orelabrutinib+R-CHOP-like']}]}, 'contactsLocationsModule': {'locations': [{'zip': '215006', 'city': 'Suzhou', 'state': 'Jiangsu', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Zhengming Jin', 'role': 'CONTACT'}], 'facility': 'the First Affiliated Hospital of Soochow University', 'geoPoint': {'lat': 31.30408, 'lon': 120.59538}}], 'centralContacts': [{'name': 'Zhengming Jin', 'role': 'CONTACT', 'email': 'jinzhengming519519@163.com', 'phone': '+86 0512 67781856'}, {'name': 'Changju Qu', 'role': 'CONTACT', 'email': 'qcj310@163.com', 'phone': '+86 0512 67781856'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'timeFrame': 'after the end of the study', 'ipdSharing': 'YES', 'description': 'All the data would be available at the First Affiliated Hospital and other researchers after the end of the study'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The First Affiliated Hospital of Soochow University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}