Ignite Creation Date:
2025-12-25 @ 2:16 AM
Ignite Modification Date:
2025-12-26 @ 12:45 AM
Study NCT ID:
NCT05075460
Status:
RECRUITING
Last Update Posted:
2024-04-09
First Post:
2021-09-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Tucidinostat, Azacitidine Combined With CHOP Versus CHOP in Patients With Untreated Peripheral T-cell Lymphoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016399', 'term': 'Lymphoma, T-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': 'C547816', 'term': 'N-(2-amino-5-fluorobenzyl)-4-(N-(pyridine-3-acrylyl)aminomethyl)benzamide'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 107}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2024-10-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-04-06', 'studyFirstSubmitDate': '2021-09-22', 'studyFirstSubmitQcDate': '2021-10-09', 'lastUpdatePostDateStruct': {'date': '2024-04-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-10-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-05-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall response rate (ORR)', 'timeFrame': '6 course of treatment (each cycle is 21 days)', 'description': 'the total proportion of patients with complete response (CR) and partial response (PR)'}], 'secondaryOutcomes': [{'measure': '2-year progression-free survival（PFS）', 'timeFrame': '2 years', 'description': 'Time from treatment until disease progression or death'}, {'measure': '2-year overall survival（OS）', 'timeFrame': '2 years', 'description': 'Time from treatment until death from any cause'}, {'measure': 'Incidence and severity of adverse events, serious adverse events and other safety parameters', 'timeFrame': '2 years', 'description': 'Incidence, nature, and severity of adverse events graded according to the NCI CTCAE v5.0'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Tucidinostat', 'Azacitidine', 'CHOP'], 'conditions': ['T-cell Lymphoma']}, 'descriptionModule': {'briefSummary': 'This is a prospective, multicenter, phase III study of Tucidinostat, Azacitidine combined with CHOP versus CHOP in patients with untreated peripheral T-cell lymphoma', 'detailedDescription': 'Tucidinostat, a novel histone deacetylase inhibitor has been approved for the treatment of relapsed or refractory peripheral T-cell lymphoma in China. Azacytidine is a hypomethylating agent. The aim of this study is to compare the efficacy and safety of azacytidine, tucidinostat combined with CHOP regimen and classical CHOP regimen in the treatment of primary PTCL'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with peripheral T-cell lymphoma confirmed by primary pathology;\n* Age 18-70 years;\n* ECOG performance status ≤ 2;\n* Adequate bone marrow hematopoietic function: WBC \\> 3.5 × 10\\*9/L，ANC\\>1.5 × 10\\*9/L，HGB\\>90g/L，PLT\\>80 × 10\\*9/L;\n* Adequate organ function: cardiac function grade 0-2 (NYHA); SpO2 \\> 88% (natural condition); ALT\\<3UNL，TBil\\<2ULN; SCr\\>60ml/min/m2;\n* Patients have signed the Informed Consent Form\n\nExclusion Criteria:\n\n* ALK positive anaplastic T-cell lymphoma;\n* NK / T cell lymphoma, nasal type;\n* Uncontrolled active infection;\n* Acute myocardial infarction or unstable angina pectoris within 6 months; uncontrolled hypertension, symptomatic arrhythmia, etc;\n* Subjects who are known or suspected to be unable to comply with the study protocol;\n* Pregnant or lactating women'}, 'identificationModule': {'nctId': 'NCT05075460', 'briefTitle': 'Tucidinostat, Azacitidine Combined With CHOP Versus CHOP in Patients With Untreated Peripheral T-cell Lymphoma', 'organization': {'class': 'OTHER', 'fullName': 'Peking Union Medical College Hospital'}, 'officialTitle': 'A Prospective, Multicenter, Phase III, Non-randomized Study of Tucidinostat, Azacitidine Combined With CHOP Versus CHOP in Patients With Untreated Peripheral T-cell Lymphoma', 'orgStudyIdInfo': {'id': 'PUMCH-NHL-010'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Tucidinostat, Azacitidine combined with CHOP', 'description': 'Tucidinostat, Azacitidine combined with CHOP', 'interventionNames': ['Drug: Tucidinostat, Azacitidine combined with CHOP']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'CHOP', 'description': 'CHOP', 'interventionNames': ['Drug: Tucidinostat, Azacitidine combined with CHOP']}], 'interventions': [{'name': 'Tucidinostat, Azacitidine combined with CHOP', 'type': 'DRUG', 'description': 'Azacitidine: 200 mg D1200 mg D2100 mg D3 subcutaneous injection Tucidinostat: 20mg / time, D1, 4, 8, 11; Take medicine with 200ml warm boiled water 30 minutes after breakfast.\n\nCHOP chemotherapy:\n\n* Cyclophosphamide (CTX) 750mg / m2 intravenous infusion, day 1;\n* Epirubicin (EPI) 70mg / m2 intravenous infusion, day 1;\n* Vinoresin (VDS) 4mg intravenous infusion, day 1;\n* Prednisone 100mg orally, day 1-5. Every 21 days is a course of treatment', 'armGroupLabels': ['CHOP', 'Tucidinostat, Azacitidine combined with CHOP']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beijing', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Daobin Zhou, Doctor', 'role': 'CONTACT'}], 'facility': 'Peking Union Medical College Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Yan Zhang', 'role': 'CONTACT', 'email': 'zhangyan10659@pumch.cn', 'phone': '+861069156874'}, {'name': 'Daobin Zhou', 'role': 'CONTACT', 'email': 'zhoudb@pumch.cn', 'phone': '+861069156874'}], 'overallOfficials': [{'name': 'Daobin Zhou', 'role': 'STUDY_CHAIR', 'affiliation': 'Department of Hematology, Peking University First Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peking Union Medical College Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Deputy Chief Physician', 'investigatorFullName': 'Yan Zhang, MD', 'investigatorAffiliation': 'Peking Union Medical College Hospital'}}}}