Ignite Creation Date:
2025-12-25 @ 12:52 AM
Ignite Modification Date:
2026-01-01 @ 3:39 AM
Study NCT ID:
NCT05933967
Status:
RECRUITING
Last Update Posted:
2023-08-15
First Post:
2023-06-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of Orelabrutinib Plus R-CHOP in Treatment-naïve Patients With Double Expression Diffuse Large B-cell Lymphoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 31}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2026-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-08-13', 'studyFirstSubmitDate': '2023-06-16', 'studyFirstSubmitQcDate': '2023-07-03', 'lastUpdatePostDateStruct': {'date': '2023-08-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-07-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'complete response rate', 'timeFrame': 'up to 24 weeks'}], 'secondaryOutcomes': [{'measure': 'ORR', 'timeFrame': 'up to 24 weeks', 'description': 'ORR is defined as the proportion of patients with a best response of CR or PR'}, {'measure': '2 years progression-free survival', 'timeFrame': 'From date of receiving the first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years]', 'description': '2 years progression-free survival was calculated from the date of therapy until death from lymphoma or 2-year follow-up without relapsing'}, {'measure': '2 years overall survival', 'timeFrame': 'From date of receiving the first dose until the date of death from any cause,assessed up to 2 years', 'description': '2 years overall survival was calculated from the date of therapy until death from lymphoma or 2-year follow-up alive'}, {'measure': 'The occurrence of adverse events and serious adverse events', 'timeFrame': 'up to 30 months', 'description': 'Adverse events will be graded by the investigator according to the NCI-CTCAE Version 5.0.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['The First Affiliated Hospital of Nanchang University']}, 'descriptionModule': {'briefSummary': 'This is a multicenter prospective single arm phase II study, and the purpose of this study is to evaluate the safety and efficacy of orelabrutinib combined with R-CHOP in the treatment of treatment-naïve patients with double expression DLBCL.', 'detailedDescription': 'The patients will be treated with 6/8 cycles of orelabrutinib plus R-CHOP regimen（21 days per cycle). The primary objective was the complete response rate (CRR) at end of induction therapy'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Newly diagnosed Double Expression Diffuse Large B-cell Lymphoma\n\n * Age 18-70 years\n * ECOG performance status 0-2\n * Ann Arbor stage II-IV\n * 8.Subjects who in line with the testing standard of the clinical trial laboratory\n * Life expectancy ≥ 3months\n\nExclusion Criteria:\n\n* • systemic lymphoma involved CNS.\n\n * Accompanied by uncontrolled cardiovascular and cerebrovascular diseases, coagulopathy, connective tissue diseases.\n * uncontrolled infections (including HBV, HCV, HIV/AIDS)\n * Subjects who prepared for transplantation\n * Pregnancy or active lactation'}, 'identificationModule': {'nctId': 'NCT05933967', 'briefTitle': 'A Study of Orelabrutinib Plus R-CHOP in Treatment-naïve Patients With Double Expression Diffuse Large B-cell Lymphoma', 'organization': {'class': 'OTHER', 'fullName': 'Shandong Cancer Hospital and Institute'}, 'officialTitle': 'A Phase II, Prospective ,Multicenter Study Evaluating the Efficacy and Safety of Orelabrutinib Plus R-CHOP in Treatment-naïve Patients With Double Expression Diffuse Large B-cell Lymphoma', 'orgStudyIdInfo': {'id': 'SDCHI-NHL-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'orelabrutinib+R-CHOP', 'interventionNames': ['Drug: Orelabrutinib+R-CHOP']}], 'interventions': [{'name': 'Orelabrutinib+R-CHOP', 'type': 'DRUG', 'description': 'Orelabrutinib 150mg qd PO. Rituximab 375 mg/m2 IV on Day 0 of each 21-day cycle. The CHOP include cyclophosphamide, doxorubicin/Epirubicin/liposomal doxorubicin, vincristine/Vindesine, and prednison.', 'armGroupLabels': ['orelabrutinib+R-CHOP']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Nanchang', 'state': 'Jiangxi', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Fei Li', 'role': 'CONTACT'}], 'facility': 'The First Ailliated Hospital of Nanchang University', 'geoPoint': {'lat': 28.68396, 'lon': 115.85306}}, {'city': 'Jinan', 'state': 'Shandong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'zengjun Li', 'role': 'CONTACT'}], 'facility': 'Shandong Cancer Hospital and Institute, Shandong First Medical University and Shandong Academy of Medical Sciences', 'geoPoint': {'lat': 36.66833, 'lon': 116.99722}}], 'centralContacts': [{'name': 'zengjun Li', 'role': 'CONTACT', 'email': 'zengjunli@163.com', 'phone': '13642138692'}, {'name': 'Dan Liu', 'role': 'CONTACT', 'phone': '13256139207'}], 'overallOfficials': [{'name': 'zengjun Li', 'role': 'STUDY_CHAIR', 'affiliation': 'Shandong Cancer Hospital and Institute, Shandong First Medical University and Shandong Academy of Medical Sciences'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shandong Cancer Hospital and Institute', 'class': 'OTHER'}, 'collaborators': [{'name': 'The First Affiliated Hospital of Nanchang University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of the Hematology Department', 'investigatorFullName': 'Zengjun Li', 'investigatorAffiliation': 'Shandong Cancer Hospital and Institute'}}}}