Ignite Creation Date:
2025-12-25 @ 4:05 AM
Ignite Modification Date:
2025-12-26 @ 3:01 AM
Study NCT ID:
NCT06778902
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-01-16
First Post:
2025-01-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
AZA Combined with R-GemOx for Elderly DLBCL Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054739', 'term': 'Dendritic Cell Sarcoma, Interdigitating'}, {'id': 'D016403', 'term': 'Lymphoma, Large B-Cell, Diffuse'}], 'ancestors': [{'id': 'D015620', 'term': 'Histiocytic Disorders, Malignant'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D015614', 'term': 'Histiocytosis'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D016393', 'term': 'Lymphoma, B-Cell'}, {'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}, {'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'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': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-02-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2028-01-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-12', 'studyFirstSubmitDate': '2025-01-07', 'studyFirstSubmitQcDate': '2025-01-12', 'lastUpdatePostDateStruct': {'date': '2025-01-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'The correlation of gene mutations and alterations in relevant signaling pathways with the efficacy and survival in DLBCL', 'timeFrame': 'Through study completion, an average of 2 years', 'description': 'To explore the correlations between gene mutations and response and prognosis'}], 'primaryOutcomes': [{'measure': 'Objective response rate(ORR)', 'timeFrame': 'Up to 8 cycles (each cycle is 21 days)', 'description': 'To investigate the preliminary anti-tumor efficacy'}], 'secondaryOutcomes': [{'measure': 'Complete remission(CR)', 'timeFrame': 'Up to 8 cycles (each cycle is 21 days)', 'description': 'To investigate the preliminary anti-tumor efficacy'}, {'measure': 'Partial remission(PR)', 'timeFrame': 'Up to 8 cycles (each cycle is 21 days)', 'description': 'To investigate the preliminary anti-tumor efficacy'}, {'measure': 'Overall Survival (OS)', 'timeFrame': 'From the date of enrollment until the date of death from ant cause, assessed up to 24 months', 'description': 'To investigate the preliminary anti-tumor efficacy'}, {'measure': 'Progression-free survival (PFS)', 'timeFrame': 'From the date of enrollment until the date of the first documented progression or date of death from any cause, whichever came first, assessed up to 24 months', 'description': 'To investigate the preliminary anti-tumor efficacy'}, {'measure': 'Number of participants with adverse events (AE) and severe adverse events (SAE) as assessed by CTCAE v5.0', 'timeFrame': 'Through study completion, an average of 2 years', 'description': 'To identify the incidence of AE and SAE'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Diffuse large B-cell lymphoma', 'GemOx', 'R', 'AZA'], 'conditions': ['DLBCL - Diffuse Large B Cell Lymphoma']}, 'descriptionModule': {'briefSummary': 'This is a prospective, single-arm, multicenter, phase II clinical trial to evaluate the efficacy and safety of AZA（azacytidine）combined with the R-GemOx (rituximab, gemcitabine and oxaliplatin) regimen as first-line treatment in elderly diffuse large B-cell lymphoma (DLBCL) patients.', 'detailedDescription': 'The purpose of this phase II clinical trial is to evaluate the efficacy and safety of AZA in combination with R-GemOx for untreated elderly DLBCL patients.\n\nThe induction phase consisted of 8 cycles of AZA in combination with R-GemOx for a total of 8 treatment cycles. The efficacy was evaluated every 4 cycles, and if the efficacy was evaluated as complete remission (CR) or partial remission (PR), the original chemotherapy regimen was continued for 4 courses. If efficacy was assessed as stable disease (SD) or progressive disease (PD), the study was withdrawn.After 8 cycles of induction therapy, if the response is assessed as CR or PR, patients may end treatment or receive rituximab maintenance therapy.\n\nThe primary endpoint is the overall response rate (ORR).Secondary efficacy measures included CR and PR,SD, progression-free survival (PFS) and overall survival (OS).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n1. Subjects fully understand and voluntarily participate in this study and sign informed consent.\n2. Aged ≥60 years, both male and female.\n3. Pathologically confirmed DLBCL\n4. There must be at least one measurable or evaluable lesion that meets the evaluation criteria for Lugano 2014 lymphoma.\n5. No previous chemotherapy or radiotherapy for DLBCL has been received.\n6. Expected survival ≥3 months.\n\nKey Exclusion Criteria:\n\n1. DLBCL combined with other types of lymphoma. Transformed DLBCL.\n2. DLBCL with central nervous system invasion.\n3. The patients have contraindications to any drug in the combined treatment.\n4. Patients with the infection of human immunodeficiency virus (HIV) and/or acquired immunodeficiency syndrome.\n5. Mentally ill persons or persons unable to obtain informed consent.\n6. The investigators think that the patient is not suitable for the study.'}, 'identificationModule': {'nctId': 'NCT06778902', 'acronym': 'Dragon', 'briefTitle': 'AZA Combined with R-GemOx for Elderly DLBCL Patients', 'organization': {'class': 'OTHER', 'fullName': 'Daping Hospital and the Research Institute of Surgery of the Third Military Medical University'}, 'officialTitle': 'AZA Combined with R-GemOx for the Initial Treatment of Elderly DLBCL: an Open, Single-arm, Multicenter Clinical Study', 'orgStudyIdInfo': {'id': '2024-322'}, 'secondaryIdInfos': [{'id': 'ZXYZZKY07', 'type': 'OTHER_GRANT', 'domain': 'Army Medical Center Talent Innovation Ability Training Plan'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'AZA+GemOx', 'description': 'Elderly DLBCL patients will receive AZA in combination with R-GemOx for a total of 8 treatment cycles (3 weeks per cycle). The efficacy was evaluated every 4 cycles, and if the efficacy was evaluated as complete remission (CR) or partial remission (PR), the original chemotherapy regimen was continued for 4 courses. If efficacy was assessed as stable disease (SD) or progressive disease (PD), the study was withdrawn.After 8 cycles of induction therapy, if the response is assessed as CR or PR, patients may end treatment or receive rituximab maintenance therapy.', 'interventionNames': ['Drug: azacytidine', 'Drug: R-GemOx']}], 'interventions': [{'name': 'azacytidine', 'type': 'DRUG', 'description': 'Azacytidine: 75mg/m2, d1-d5', 'armGroupLabels': ['AZA+GemOx']}, {'name': 'R-GemOx', 'type': 'DRUG', 'description': 'Rituximab: 375mg/m2, d6; Gemcitabine: 1g/m2, d7 Oxaliplatin: 100mg/m2, d7', 'armGroupLabels': ['AZA+GemOx']}]}, 'contactsLocationsModule': {'locations': [{'zip': '400000', 'city': 'Chongqing', 'country': 'China', 'contacts': [{'name': 'Dongfeng Zeng, PHD', 'role': 'CONTACT', 'email': 'zengdf@tmmu.edu.cn', 'phone': '86+13396081757'}], 'facility': 'Daping Hospital, Third Military Medical University (Army Medical University)', 'geoPoint': {'lat': 29.56026, 'lon': 106.55771}}], 'centralContacts': [{'name': 'Dongfeng Zeng, Pro', 'role': 'CONTACT', 'email': 'zengdf@tmmu.edu.cn', 'phone': '86+18680887505'}, {'name': 'Fanqiao Meng', 'role': 'CONTACT', 'email': '13396081757@163.com', 'phone': '86+13390681757'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Daping Hospital and the Research Institute of Surgery of the Third Military Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}