Ignite Creation Date:
2025-12-25 @ 12:34 AM
Ignite Modification Date:
2026-01-05 @ 7:07 PM
Study NCT ID:
NCT06190067
Status:
RECRUITING
Last Update Posted:
2024-01-30
First Post:
2023-12-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Azacitidine Plus PD-1 Therapy for R/R Hodgkin Lymphoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D001374', 'term': 'Azacitidine'}], 'ancestors': [{'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': 40}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-10-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2028-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-01-28', 'studyFirstSubmitDate': '2023-12-19', 'studyFirstSubmitQcDate': '2023-12-19', 'lastUpdatePostDateStruct': {'date': '2024-01-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-01-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall Response Rate (ORR)', 'timeFrame': '1 year', 'description': 'ORR was defined as the proportion of patients who achieved CR or PR as their best response'}], 'secondaryOutcomes': [{'measure': 'Overall Survival (OS)', 'timeFrame': 'through study completion, an average of 2 year', 'description': 'OS was defined as time from diagnosis to death from any cause or the last follow-up'}, {'measure': 'Progression Free Survival (PFS)', 'timeFrame': '18 months', 'description': 'PFS using local assessment of progressive disease according to Lugano Response Criteria (2014)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Relapsed Classic Hodgkin Lymphoma', 'Refractory Classic Hodgkin Lymphoma']}, 'descriptionModule': {'briefSummary': 'The goal of this phase 2 trial is to test the safety and efficacy of azacitidine when given together with PD-1 therapy in treating patients with relapsed/refractory classic Hodgkin lymphoma.', 'detailedDescription': 'The investigators will evaluate response rate, progression free survival (PFS), overall survival (OS), and toxicity of azacytidine combined with PD-1 therapy in classic relapsed/refractory Hodgkin lymphoma.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pathologically confirmed Hodgkin Lymphoma according World Health Organization (WHO) classification.\n* Patient is ≥ 18 years of age at the time of signing the informed consent form (ICF).\n* Patient must understand and voluntarily sign an ICF prior to any study-specific assessments/procedures being conducted.\n* Patient is willing and able to adhere to the study visit schedule and other protocol requirements.\n* Relapsed (after partial or complete response) or refractory AITL after at least one line of systemic therapy (there is no mandatory resting period after the previous treatment as long as the biochemistry and hematology labs meet the inclusion criteria as below).\n* Meet the following lab criteria: Absolute Neutrophil Count (ANC) ≥ 1,5 x 10\\^9/L (≥ 1 x 10\\^9/L if bone marrow (BM) involvement by lymphoma); Platelet ≥ 75 x 10\\^9/L (≥ 50 x 10\\^9/L if BM involvement by lymphoma); Hemoglobin ≥ 8 g/dL.\n* Anticipated life expectancy at least 3 months.\n\nExclusion Criteria:\n\n* Active or uncontrolled infections requiring systemic treatment within 14 days before enrollment.\n* Any instability of systemic disease, including but not limited to severe cardiac, liver, kidney, or metabolic disease need therapy.\n* Pregnant or lactating women.'}, 'identificationModule': {'nctId': 'NCT06190067', 'briefTitle': 'Azacitidine Plus PD-1 Therapy for R/R Hodgkin Lymphoma', 'organization': {'class': 'OTHER', 'fullName': 'Navy General Hospital, Beijing'}, 'officialTitle': 'Azacitidine Plus PD-1 Therapy for Relapsed/Refractory Hodgkin Lymphoma', 'orgStudyIdInfo': {'id': 'PA2023'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Azacitidine Plus PD-1 therapy', 'description': 'Patients were treated by Azacitidine plus PD-1 therapy', 'interventionNames': ['Drug: Azacitidine Plus PD-1 therapy']}], 'interventions': [{'name': 'Azacitidine Plus PD-1 therapy', 'type': 'DRUG', 'otherNames': ['Azacitidine Plus PD-1 antibody'], 'description': 'Patients were treated by Azacytidine(75 mg/m2 subcutaneous injection qd on days 1-7) plus PD-1 therapy(200mg iv qd d8)', 'armGroupLabels': ['Azacitidine Plus PD-1 therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100048', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Liren Qian, M.D.', 'role': 'CONTACT', 'email': 'qlr2007@126.com', 'phone': '+861066957676'}], 'facility': 'Navy General Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Liren Qian, PhD', 'role': 'CONTACT', 'email': 'qlr2007@126.com', 'phone': '+861066947192'}], 'overallOfficials': [{'name': 'Liren Qian, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Navy General Hospital, Beijing'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Navy General Hospital, Beijing', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Vice Director', 'investigatorFullName': 'Liren Qian', 'investigatorAffiliation': 'Navy General Hospital, Beijing'}}}}