Ignite Creation Date:
2025-12-25 @ 2:00 AM
Ignite Modification Date:
2025-12-27 @ 6:42 AM
Study NCT ID:
NCT04233294
Status:
RECRUITING
Last Update Posted:
2020-08-14
First Post:
2020-01-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Addition of Chidamide to the Combination Treatment of Decitabine Plus Camrelizumab in Combination Treatment Resistant/Relapsed Patients With Classical Hodgkin Lymphoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006689', 'term': 'Hodgkin Disease'}], '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': 'C000631724', 'term': 'camrelizumab'}, {'id': 'D000077209', 'term': 'Decitabine'}], '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': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-02-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'completionDateStruct': {'date': '2026-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-08-12', 'studyFirstSubmitDate': '2020-01-15', 'studyFirstSubmitQcDate': '2020-01-15', 'lastUpdatePostDateStruct': {'date': '2020-08-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-01-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'ORR', 'timeFrame': '3 years', 'description': 'ORR assess by investigators per the 2014 Lugano classification rate of subjects achieved complete response in all evaluable subjects'}, {'measure': 'Adverse effects', 'timeFrame': '3 years', 'description': 'Adverse effects 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': ['Hodgkin Lymphoma']}, 'referencesModule': {'references': [{'pmid': '39093981', 'type': 'DERIVED', 'citation': 'Nie J, Wang C, Zheng L, Liu Y, Wang C, Chang Y, Hu Y, Guo B, Pan Y, Yang Q, Hu X, Han W. Epigenetic agents plus anti-PD-1 reprogram the tumor microenvironment and restore antitumor efficacy in Hodgkin lymphoma. Blood. 2024 Oct 31;144(18):1936-1950. doi: 10.1182/blood.2024024487.'}]}, 'descriptionModule': {'briefSummary': 'This is a Phase II clinical trial for Decitabine plus Camrelizumab resistant/relapsed patients with Hodgkin Lymphoma. The purpose is to evaluate the efficacy and safety of the combination therapy of Chidamide plus Decitabine Plus Camrelizumab.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Subjects must have histological confirmation of relapsed or refractory Hodgkin lymphoma (HL).\n2. 12 to 75 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 lesion \\>1 cm as defined by lymphoma response criteria.\n6. Subjects must be relapsed or resistant for the treatment of Decitabine plus Camrelizumab. Subjects with autologous hematopoietic stem-cell transplantation are eligible which must be more than 3 months.\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': 'NCT04233294', 'briefTitle': 'Addition of Chidamide to the Combination Treatment of Decitabine Plus Camrelizumab in Combination Treatment Resistant/Relapsed Patients With Classical Hodgkin Lymphoma', 'organization': {'class': 'OTHER', 'fullName': 'Chinese PLA General Hospital'}, 'officialTitle': 'Addition of Chidamide to the Combination Treatment of Decitabine Plus Camrelizumab in Combination Treatment Resistant/Relapsed Patients With Classical Hodgkin Lymphoma: an Open-label, Single Arm, Phase II Trial', 'orgStudyIdInfo': {'id': 'CHN-PLAGH-BT-045'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'chidamide in combination with camrelizumab plus decitabine', 'description': 'chidamide 10mg/day, days 1-4, 20mg/day, day 8, 11, 15, 18; camrelizumab 200mg d6; decitabine 10 mg/day, days 1-5, every 3 weeks', 'interventionNames': ['Drug: Chidamide', 'Drug: Camrelizumab', 'Drug: Decitabine']}], '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.', 'armGroupLabels': ['chidamide in combination with camrelizumab plus decitabine']}, {'name': 'Camrelizumab', 'type': 'DRUG', 'description': 'Camrelizumab is a humanized anti-PD-1 monoclonal antibody.', 'armGroupLabels': ['chidamide in combination with camrelizumab plus 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 camrelizumab plus decitabine']}]}, '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': 'Jing Nie', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Yang Liu', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Qingming Yang', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Chunmeng Wang', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Minhang Zhou', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Qian Mei', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Xiang Li', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Liang Dong', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Jie Bai', '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'}}}}