Ignite Creation Date:
2025-12-26 @ 2:42 PM
Ignite Modification Date:
2025-12-26 @ 2:42 PM
Study NCT ID:
NCT04337606
Status:
RECRUITING
Last Update Posted:
2020-04-07
First Post:
2020-04-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Chidamide in Combination With Decitabine in Non-Hodgkin's Lymphoma Relapsed After Chimeric Antigen Receptor
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}], 'ancestors': [{'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'}, {'id': 'D000077209', 'term': 'Decitabine'}, {'id': 'C000631724', 'term': 'camrelizumab'}], 'ancestors': [{'id': 'D001374', 'term': 'Azacitidine'}, {'id': 'D001372', 'term': 'Aza Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'id': 'D012263', 'term': 'Ribonucleosides'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-04-04', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-04', 'completionDateStruct': {'date': '2026-04-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-04-04', 'studyFirstSubmitDate': '2020-04-04', 'studyFirstSubmitQcDate': '2020-04-04', 'lastUpdatePostDateStruct': {'date': '2020-04-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-04-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-04-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'CR rate', 'timeFrame': '2 years', 'description': 'CR rate assess by investigators per the 2014 Lugano classification rate of subjects achieved complete response in all evaluable subjects'}, {'measure': 'Adverse events', 'timeFrame': '2 years', 'description': 'Adverse events were defined according to the National Cancer Institute Common Terminology Criteria for Adverse Events (version 5.0)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Non Hodgkin Lymphoma']}, 'descriptionModule': {'briefSummary': "This is a Phase I/II clinical trial for patients with r/r Non-Hodgkin's Lymphoma relapsed after chimeric antigen receptor T cells infusion. The purpose is to evaluate the safety and efficacy of the treatment with chidamide in combination with decitabine."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Subjects must have histological confirmation of Non-Hodgkin lymphoma (NHL) and relapsed after chimeric antigen receptor T cells infusion.\n2. 18 to 65 years of age.\n3. ECOG performance of less than 2.\n4. Life expectancy of at least 3 months.\n5. Subjects with lymphoma must have at least one measureable new lesion \\>1.5cm as defined by lymphoma response criteria.\n6. Subjects must have relapsed after chimeric antigen receptor T cells infusion without any intervention treatment prior to Day 1.\n7. Subjects must have adequate marrow, live, renal and heart functions.\n\nExclusion Criteria:\n\n1. Subjects with any autoimmune disease or history of syndrome that requires corticosteroids or immunosuppressive medications.\n2. Serious uncontrolled medical disorders or active infections, pulmonary infection especially.\n3. Active alimentary tract hemorrhage or history of alimentary tract hemorrhage in one month .\n4. Prior organ allograft.\n5. Women who are pregnant or breastfeeding.\n6. Women with a positive pregnancy test on enrollment or prior to investigational product administration.\n7. Subjects who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illness'}, 'identificationModule': {'nctId': 'NCT04337606', 'briefTitle': "Chidamide in Combination With Decitabine in Non-Hodgkin's Lymphoma Relapsed After Chimeric Antigen Receptor", 'organization': {'class': 'OTHER', 'fullName': 'Chinese PLA General Hospital'}, 'officialTitle': "Chidamide in Combination With Decitabine in Non-Hodgkin's Lymphoma Relapsed After Chimeric Antigen Receptor : An Open-label Phase I/II Trial", 'orgStudyIdInfo': {'id': 'CHN-PLAGH-BT-046'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'chidamide in combination with decitabine', 'description': 'chidamide 10mg/day, days 1-5, 20mg/day, day 8, 11,15, 18; decitabine 10 mg/day, days 1-5, every 3 weeks', 'interventionNames': ['Drug: Chidamide', 'Drug: Decitabine']}, {'type': 'EXPERIMENTAL', 'label': 'decitabine in combination with Camrelizumab', 'description': 'decitabine 10 mg/day, days 1-5, every 3 weeks; camrelizumab 200mg d6', 'interventionNames': ['Drug: Decitabine', 'Drug: Camrelizumab']}], 'interventions': [{'name': 'Chidamide', 'type': 'DRUG', 'description': 'Chidamide is a novel and orally active benzamide class of HDAC inhibitor that selectively inhibits activity of HDAC1, 2, 3 and 10, which can Induce tumor-cell apoptosis, suppress cell proliferation and enhance immune surveillance; Decitabine is an investigational (experimental) drug that works by depleting DNA methyltransferase 1(DNMT1), which can increase tumor antigens and HLA expression, enhances antigen processing, promotes T cell infiltration, and boosts effector T cell function.', 'armGroupLabels': ['chidamide in combination with decitabine']}, {'name': 'Decitabine', 'type': 'DRUG', 'description': 'Decitabine is an investigational (experimental) drug that works by depleting DNA methyltransferase 1(DNMT1), which can increase tumor antigens and HLA expression, enhances antigen processing, promotes T cell infiltration, and boosts effector T cell function.', 'armGroupLabels': ['chidamide in combination with decitabine', 'decitabine in combination with Camrelizumab']}, {'name': 'Camrelizumab', 'type': 'DRUG', 'description': 'Camrelizumab is a humanized anti-PD-1 monoclonal antibody.', 'armGroupLabels': ['decitabine in combination with Camrelizumab']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100853', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Weidong D Han, Doctor', 'role': 'CONTACT', 'email': 'hanwdrsw@sina.com', 'phone': '+86-10-66937463'}, {'name': 'C, Doctor', 'role': 'CONTACT'}, {'name': 'Weidong Han', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Yajing Zhang', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Yang Liu', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Qingming Yang', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Chunmeng Wang', 'role': 'SUB_INVESTIGATOR'}, {'name': 'zhiqiang Wu', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Qian Mei', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Yao Wang', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Chuan Tong', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Hanren Dai', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Jing Nie', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Biotherapeutic Department of Chinese PLA General Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chinese PLA General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Han weidong', 'investigatorAffiliation': 'Chinese PLA General Hospital'}}}}