Ignite Creation Date:
2025-12-25 @ 5:08 AM
Ignite Modification Date:
2025-12-26 @ 4:12 AM
Study NCT ID:
NCT06176027
Status:
RECRUITING
Last Update Posted:
2024-10-29
First Post:
2023-08-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Azacytidine Plus CAOLD Regimen in Relapsed/Refractory Peripheral T-Cell Lymphomas
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016411', 'term': 'Lymphoma, T-Cell, Peripheral'}], 'ancestors': [{'id': 'D016399', 'term': 'Lymphoma, T-Cell'}, {'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': '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': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 52}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2030-09-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-10-26', 'studyFirstSubmitDate': '2023-08-05', 'studyFirstSubmitQcDate': '2023-12-18', 'lastUpdatePostDateStruct': {'date': '2024-10-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-12-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-09-01', '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 Peripheral T-Cell Lymphomas', 'Refractory Peripheral T-Cell Lymphomas']}, 'descriptionModule': {'briefSummary': 'This is a multicenter prospective single arm phase II study. The purpose of this study is to evaluate the safety and efficiency of azacytidine combined with CAOLD Regimen in the treatment of relapsed/refractory peripheral t-cell lymphomas.', 'detailedDescription': 'The investigators will evaluate response rate, progression free survival (PFS), overall survival (OS), and toxicity of azacytidine combined with CAOLD Regimen in relapsed/refractory peripheral t-cell lymphomas.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatients must satisfy all following criteria to be enrolled in the study:\n\n* Pathologically confirmed angioimmunoblastic T-cell 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:\n\n * Absolute Neutrophil Count (ANC) ≥ 1,5 x 10\\^9/L (≥ 1 x 10\\^9/L if bone marrow (BM) involvement by lymphoma)\n * Platelet ≥ 75 x 10\\^9/L (≥ 50 x 10\\^9/L if BM involvement by lymphoma)\n * 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': 'NCT06176027', 'briefTitle': 'Azacytidine Plus CAOLD Regimen in Relapsed/Refractory Peripheral T-Cell Lymphomas', 'organization': {'class': 'OTHER', 'fullName': 'Navy General Hospital, Beijing'}, 'officialTitle': 'Therapeutic Effect of Chemotherapy Azacytidine Plus CAOLD Regimen on Patients With Relapsed/Refractory Peripheral T-Cell Lymphomas', 'orgStudyIdInfo': {'id': 'NavyGHB-008'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Azacytidine plus CAOLD regimen', 'description': 'Patients were treated by Azacytidine plus CAOLD regimen', 'interventionNames': ['Drug: Azacytidine plus CAOLD regimen']}], 'interventions': [{'name': 'Azacytidine plus CAOLD regimen', 'type': 'DRUG', 'description': 'Patients were treated by Azacytidine(75 mg/m2 on days 1-7) plus CAOLD regimen (cyclophosphamide 400mg/m2 qd d1; cytarabine 30mg/m2 qd d1-d4; vindesine 2mg/m2 qd d1; pegaspargase 2500iu/m2 qd d2; dexamethasone 7.5mg/m2 qd d1-d5)', 'armGroupLabels': ['Azacytidine plus CAOLD regimen']}]}, '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': '+861066957676'}], 'overallOfficials': [{'name': 'Liren Qian, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Navy General Hospital, Beijing'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Navy General Hospital, Beijing', 'class': 'OTHER'}, 'collaborators': [{'name': 'Chinese PLA General Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Chief Physician, Associate Professor', 'investigatorFullName': 'Liren Qian', 'investigatorAffiliation': 'Navy General Hospital, Beijing'}}}}