Ignite Creation Date:
2025-12-24 @ 6:47 PM
Ignite Modification Date:
2025-12-28 @ 4:07 AM
Study NCT ID:
NCT05182957
Status:
UNKNOWN
Last Update Posted:
2023-01-31
First Post:
2021-12-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Study on Anti-PD-1 Plus Lenalidomide and Azacitidine in Relapsed/Refractory Peripheral T-cell Lymphoma
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': 'C000711728', 'term': 'spartalizumab'}, {'id': 'D000077269', 'term': 'Lenalidomide'}, {'id': 'D007155', 'term': 'Immunologic Factors'}, {'id': 'D001374', 'term': 'Azacitidine'}], 'ancestors': [{'id': 'D010797', 'term': 'Phthalimides'}, {'id': 'D010795', 'term': 'Phthalic Acids'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D010881', 'term': 'Piperidones'}, {'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D054833', 'term': 'Isoindoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D045505', 'term': 'Physiological Effects of Drugs'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D001372', 'term': 'Aza Compounds'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'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': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-12-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2023-12-14', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-01-28', 'studyFirstSubmitDate': '2021-12-16', 'studyFirstSubmitQcDate': '2021-12-21', 'lastUpdatePostDateStruct': {'date': '2023-01-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-01-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-14', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression-free Survival(PFS)', 'timeFrame': 'up to 12 months', 'description': 'To measure the duration of response to Anti-PD-1 antibody plus Lenalidomide and Azacitidine over a follow-up period of 12 months'}, {'measure': 'Overall Response Rate (ORR)', 'timeFrame': 'up to 12 months', 'description': 'To measure the duration of response to Anti-PD-1 antibody plus Lenalidomide and Azacitidine over a follow-up period of 12 months'}], 'secondaryOutcomes': [{'measure': 'Complete Response Rate', 'timeFrame': 'up to 12 months', 'description': 'Number of patients who achieved complete response after treatment by Anti-PD-1 antibody plus Lenalidomide and Azacitidine'}, {'measure': 'Duration of Response', 'timeFrame': 'up to 12 months', 'description': 'Duration of overall response will be assessed from the first Anti-PD-1 antibody plus Lenalidomide and Azacitidine given to progression,death or last follow-up.'}, {'measure': 'Overall Survival', 'timeFrame': 'up to 12 months', 'description': 'OS will be assessed from the first Anti-PD-1 antibody plus Lenalidomide and Azacitidine given to death or last follow-up.'}, {'measure': 'Adverse events profile', 'timeFrame': 'Measured from start of treatment until 28 days after last dose', 'description': 'Number of participants with adverse events. Frequencies of toxicities based on the NCI Common Terminology Criteria for Adverse Events (CTCAE), version 5.0 will be tabulated'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Anti-PD-1 monoclonal antibody,Lenalidomide,Azacitidine'], 'conditions': ['Relapsed/Refractory Peripheral T-cell Lymphoma']}, 'descriptionModule': {'briefSummary': 'Aim of this study will evaluate the Efficacy and Safety of Anti-PD-1 monoclonal antibody Combined Lenalidomide and Azacitidine in Relapsed/Refractory Peripheral T-cell Lymphoma Patients.', 'detailedDescription': 'Peripheral T-cell lymphomas (PTCLs) are malignancies of immunologically mature T-cells that arise in peripheral lymphoid tissues. Compared with B-cell lymphoma, the treatment methods of PTCL are more limited, the first-line therapy is usually CHOP-like therapy, but the efficacy is poor, 5-year overall survival rate (OS) is only 30%-40%. Anti-PD-1 monoclonal antibody, Lenalidomide and Azacitidine can all have tumor-killing effects, and the three have complementary theoretical basis in the mechanism of action. This study will evaluate the efficacy and safety of Anti-PD-1 monoclonal antibody Combined Lenalidomide and Azacitidine in Relapsed/Refractory Peripheral T-cell Lymphoma patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Pathological immunohistochemistry or flow cytometry confirmed that R/R PTCL with measurable (diameter greater than 1.5cm) lesions meets any of the following conditions: 1\\> After 4 courses of standard first-line therapy or 2 courses of more than two-line therapy, the lesions were reduced by \\<50%; 2\\> PTCL with disease progression after first-line or induction therapy; 3\\> After hematopoietic stem cell transplantation, new lesions appear or the size of previously affected lesions increased by more than 50%.\n2. Age ≥ 18 years.\n3. ECOG≤2分.\n4. The main organ functions need to meet the following conditions:Hemogram needs to meet HB ≥70\\*1012/L，PLT≥50\\*109/L，NE≥1\\*109/L；LVEF≥50%;CR≤132umol/l or CCr≥60 ml/min;ALT and AST≤2 times normal range；Lung function≤Level 1;dyspnea(CTCAE v5.0),and blood oxygen saturation without oxygen absorption\\> 91%.\n5. Subjects of child-bearing or child-fathering potential must be willing to practice birth control from the time of enrollment on this study until the follow-up one year period of the study.\n6. Estimated survival time ≥3 months.\n7. Voluntary signing of informed consent.\n\nExclusion Criteria:\n\n1. Accepted major surgery within 4 weeks before treatment.\n2. Prior malignancy (other than Relapsed/Refractory Peripheral T-cell Lymphoma), except for cured malignant tumors with no active lesions for 3 years;Adequate treatment of inactive lesions in non-melanoma skin cancer,malignant tonsilloma or carcinoma in situ;\n3. Patients who have previously received failed allogeneic hematopoietic stem cell transplantation.\n4. Have stroke or intracranial hemorrhage within 3 months.\n5. Evidence of complications or medical conditions, including but not limited, that may interfere the conduct of the study or place the patient at serious risk:significant cardiovascular disease(class 3 or 4 cardiac disease as defined by the New York Heart Association Functional Classification、myocardial infarction within 6 months of screening、uncontrolled or symptomatic arrhythmias) and/or significant lung disease.\n6. HIV infection and/or active hepatitis B or active hepatitis C.\n7. Uncontrolled systemic infection.\n8. Pregnant or breasting-feeding women.\n9. According to the researchers' judgment, any life-threatening disease, medical condition or organ system dysfunction which can endanger the patient's safety and Interfer with the absorption or metabolism of anti-PD-1 monoclonal antibody plus Lenalidomide and Azacitidine,may put the results of a study at unnecessary risk."}, 'identificationModule': {'nctId': 'NCT05182957', 'briefTitle': 'Clinical Study on Anti-PD-1 Plus Lenalidomide and Azacitidine in Relapsed/Refractory Peripheral T-cell Lymphoma', 'organization': {'class': 'OTHER', 'fullName': 'The First Affiliated Hospital of Soochow University'}, 'officialTitle': 'Clinical Study on the Efficacy and Safety of Anti-PD-1 Monoclonal Antibody Combined Lenalidomide and Azacitidine in Relapsed/Refractory Peripheral T-cell Lymphoma', 'orgStudyIdInfo': {'id': 'R/R PTCL 01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Anti-PD-1 monoclonal antibody+Lenalidomide+Azacitidine', 'description': 'Anti-PD-1 monoclonal antibody plus Lenalidomide, Azacitidine', 'interventionNames': ['Drug: Anti-PD-1 monoclonal antibody', 'Drug: Lenalidomide', 'Drug: Azacitidine']}], 'interventions': [{'name': 'Anti-PD-1 monoclonal antibody', 'type': 'DRUG', 'otherNames': ['Anti-PD-1 antibody'], 'description': 'Anti-PD-1 monoclonal antibody, 200mg i.v d1 (/21d)', 'armGroupLabels': ['Anti-PD-1 monoclonal antibody+Lenalidomide+Azacitidine']}, {'name': 'Lenalidomide', 'type': 'DRUG', 'otherNames': ['Immunomodulator'], 'description': 'Lenalidomide 25mg qd po d1-d10 (/21d)', 'armGroupLabels': ['Anti-PD-1 monoclonal antibody+Lenalidomide+Azacitidine']}, {'name': 'Azacitidine', 'type': 'DRUG', 'otherNames': ['5-Ladakamycin'], 'description': 'Azacitidine 75mg/m2 i.v d1-d7 (/21d)', 'armGroupLabels': ['Anti-PD-1 monoclonal antibody+Lenalidomide+Azacitidine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '215000', 'city': 'Suzhou', 'state': 'Jiangsu', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Caixia Li, M.D', 'role': 'CONTACT', 'email': 'licaixia@suda.edu.cn', 'phone': '+86 512 67781856'}], 'facility': 'The First Affiliated Hospital of Soochow University', 'geoPoint': {'lat': 31.30408, 'lon': 120.59538}}], 'centralContacts': [{'name': 'Caixia Li, M.D', 'role': 'CONTACT', 'email': 'licaixia@suda.edu.cn', 'phone': '+86 512 67781856'}], 'overallOfficials': [{'name': 'Depei Wu, M.D', 'role': 'STUDY_CHAIR', 'affiliation': 'The First Affiliated Hospital of Soochow University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The First Affiliated Hospital of Soochow University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}