Ignite Creation Date:
2025-12-24 @ 10:22 PM
Ignite Modification Date:
2026-02-09 @ 2:10 AM
Study NCT ID:
NCT06779435
Status:
RECRUITING
Last Update Posted:
2025-02-19
First Post:
2025-01-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Multicenter, Prospective, Real-world Study of a Regimen Containing Tucidinostat for Primary Treatment of DLBCL
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 400}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2028-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-17', 'studyFirstSubmitDate': '2025-01-11', 'studyFirstSubmitQcDate': '2025-01-11', 'lastUpdatePostDateStruct': {'date': '2025-02-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'EFS（Event-free survival）', 'timeFrame': '2-year', 'description': 'The length of time from the start of treatment to the onset of disease progression, recurrence after CR, death from any cause, or the start of new therapy for residual lesions (including conversion therapy for lesions during the trial) after the end of combination therapy, whichever occurs first.'}], 'secondaryOutcomes': [{'measure': 'CRR（Complete response rate）', 'timeFrame': 'End of treatment visit (6-8 weeks after last dose on Day 1 of Cycle 6 [Cycle length=21 days]', 'description': 'The number of subjects who achieved complete response (CR) at the end of combination therapy as a percentage of the total number of participants in the analysis.'}, {'measure': 'PFS（Progression-free survival）', 'timeFrame': '2-year', 'description': 'The length of time from the start of treatment to the onset of disease progression or recurrence or death from any cause, whichever occurs first'}, {'measure': 'OS（Overall survival）', 'timeFrame': '2-year', 'description': 'From the start of treatment to the time of death from any cause.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Tucidinostat', 'DLBCL'], 'conditions': ['DLBCL']}, 'descriptionModule': {'briefSummary': 'This is a prospective, observational, multicenter, cohort study with 400 newly treated DLBCL patients. To evaluate the clinical efficacy and safety of tucidinostat in the real-world treatment of primary diffuse large B-cell lymphoma', 'detailedDescription': 'The study was divided into 2 cohorts. Cohort 1: DLBCL patients diagnosed unfit/ Unfit. A person who is unfit/ unfit is defined as being 80 years or older, or younger than 80 years old but has comorbidities and cannot tolerate a standard dose of chemotherapy as determined by the investigator. Reference options for a combination regimen include C-R2, C-R-mini-CHOP, etc.\n\nCohort 2: Patients diagnosed with DLBCL who cannot be classified as unfit/ Unfit. Reference options for a combination regimen include CR-CHOP, C-Pola-R-CHP, etc.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '400', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 1\\. Age ≥18 years old, male or female;\n* 2\\. No previous treatment for DLBCL, including chemotherapy, targeted therapy and immunotherapy;\n* 3\\. DEL \\[Diffuse large B-cell lymphoma with double expression of MYC and BCL2 (immunohistochemical MYC≥40%, BCL2≥50%)\\] was confirmed by pathology; Or non-double expression but at least one of the following:;\n\n 1. TP53 or other epigenetic gene mutations (as in: ACTB, BCL6, BCOR, CREBBP, EP300, EZH2, HIST1H1C, HIST1H1E, HIST1H2BK, HIST2H2AB, IRF4, KMT2A, KMT2C, KMT2D, MYC, MYD88, NSD2, RAG1, SETD1B SF3B1, SIN3A, TBL1XR1, TET2, TOX, TP53, TRIP12, TRRAP, UBE2A)\n 2. MYC and BCL2 double hit\n* 4\\. Plan to receive or are receiving a treatment regimen containing tucidinostat (if it is permitted to start using tucidinostat after obtaining specific test results due to pending genetic sequencing results);\n* 5\\. Voluntarily sign informed consent.\n\nExclusion Criteria:\n\n* 1\\. Patients currently enrolled or planning to participate in any interventional clinical trial;\n* 2\\. The expected survival time is less than 6 months;\n* 3\\. There are any other reasons that the investigators believe are not suitable for patients to participate in this study.'}, 'identificationModule': {'nctId': 'NCT06779435', 'briefTitle': 'A Multicenter, Prospective, Real-world Study of a Regimen Containing Tucidinostat for Primary Treatment of DLBCL', 'organization': {'class': 'OTHER', 'fullName': 'Ruijin Hospital'}, 'officialTitle': 'A Multicenter, Prospective, Real-world Study of a Regimen Containing Tucidinostat for Primary Treatment of Diffuse Large B-cell Lymphoma', 'orgStudyIdInfo': {'id': 'CSIIT-B42'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cohort 1: DLBCL patients diagnosed unfit/ Unfit.', 'description': 'A person who is unfit/ unfit is defined as being 80 years or older, or younger than 80 years old but has comorbidities and cannot tolerate a standard dose of chemotherapy as determined by the investigator.', 'interventionNames': ['Drug: Low intensity treatment options']}, {'label': 'Cohort 2: Patients diagnosed with DLBCL who cannot be classified as unfit/ Unfit.', 'description': 'Cohort 2: Patients diagnosed with DLBCL who cannot be classified as unfit/ Unfit.', 'interventionNames': ['Drug: Conventional immunochemotherapy regimen']}], 'interventions': [{'name': 'Low intensity treatment options', 'type': 'DRUG', 'description': 'Reference options for a combined regimen include C-R2, C-R-mini-CHOP, etc.\n\nSubjects whose efficacy is assessed as CR after the end of induction therapy will enter consolidation therapy. Tucidinostat maintenance therapy or autologous hematopoietic stem cell transplantation may be an option. Tucidinostat maintenance therapy will be performed every 3 weeks. .Single-drug maintenance is recommended to last 24 weeks', 'armGroupLabels': ['Cohort 1: DLBCL patients diagnosed unfit/ Unfit.']}, {'name': 'Conventional immunochemotherapy regimen', 'type': 'DRUG', 'description': 'Reference options for a combined regimen include CR-CHOP, C-Pola-R-CHP, etc.\n\nSubjects whose efficacy is assessed as CR after the end of induction therapy will enter consolidation therapy. Tucidinostat maintenance therapy or autologous hematopoietic stem cell transplantation may be an option. Tucidinostat maintenance therapy will be performed every 3 weeks. Single-drug maintenance is recommended to last 24 weeks', 'armGroupLabels': ['Cohort 2: Patients diagnosed with DLBCL who cannot be classified as unfit/ Unfit.']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Pengpeng Xu', 'role': 'CONTACT', 'email': 'pengpeng_xu@126.com', 'phone': '13564015001'}], 'facility': 'No. 197 Ruijin 2nd Road, Huangpu District, Shanghai', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Pengpeng Xu, professor', 'role': 'CONTACT', 'email': 'pengpeng_xu@126.com', 'phone': '13564015001'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ruijin Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Zhao Weili', 'investigatorAffiliation': 'Ruijin Hospital'}}}}