Ignite Creation Date:
2025-12-24 @ 11:02 PM
Ignite Modification Date:
2026-01-02 @ 1:45 PM
Study NCT ID:
NCT05777369
Status:
UNKNOWN
Last Update Posted:
2023-03-21
First Post:
2023-03-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
R-CMOP in Patients With Primary Diffuse Large B-cell Lymphoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016403', 'term': 'Lymphoma, Large B-Cell, Diffuse'}], 'ancestors': [{'id': 'D016393', 'term': 'Lymphoma, B-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': 'D000069283', 'term': 'Rituximab'}, {'id': 'D003520', 'term': 'Cyclophosphamide'}, {'id': 'D014750', 'term': 'Vincristine'}, {'id': 'D014751', 'term': 'Vindesine'}, {'id': 'D011241', 'term': 'Prednisone'}], 'ancestors': [{'id': 'D058846', 'term': 'Antibodies, Monoclonal, Murine-Derived'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}, {'id': 'D010752', 'term': 'Phosphoramide Mustards'}, {'id': 'D009588', 'term': 'Nitrogen Mustard Compounds'}, {'id': 'D009150', 'term': 'Mustard Compounds'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D063088', 'term': 'Phosphoramides'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}, {'id': 'D014748', 'term': 'Vinca Alkaloids'}, {'id': 'D046948', 'term': 'Secologanin Tryptamine Alkaloids'}, {'id': 'D026121', 'term': 'Indole Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D054836', 'term': 'Indolizidines'}, {'id': 'D007212', 'term': 'Indolizines'}, {'id': 'D011244', 'term': 'Pregnadienediols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-03', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2024-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-03-09', 'studyFirstSubmitDate': '2023-03-09', 'studyFirstSubmitQcDate': '2023-03-09', 'lastUpdatePostDateStruct': {'date': '2023-03-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-03-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Objective Response Rate(ORR)', 'timeFrame': 'up to 6 cycles of chemotherapy (each cycle is 21 days)', 'description': 'Objective response rate (ORR) after 6 cycles of R-CMOP chemotherapy'}], 'secondaryOutcomes': [{'measure': 'Complete remission rate(CRR)', 'timeFrame': 'up to 6 cycles of chemotherapy (each cycle is 21 days)', 'description': 'Complete remission rate(CRR) after 6 cycles of R-CMOP chemotherapy'}, {'measure': 'Duration of remission(DOR)', 'timeFrame': 'up to 6 cycles of chemotherapy (each cycle is 21 days)', 'description': 'Time from reaching CR or PR for the first time to disease progression'}, {'measure': 'Progression-Free-Survival rate', 'timeFrame': '1 year', 'description': 'from date of inclusion to date of progression, relapse, or death from any cause'}, {'measure': 'Overall survival rate', 'timeFrame': '1 year', 'description': 'from the date of inclusion to date of death, irrespective of cause'}, {'measure': 'Adverse events (AE)', 'timeFrame': 'From the first day of medication to 28 days after the last dose', 'description': 'The safety of the drug was evaluated by NCI-CTC AE 5.0 standard'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['DLBCL', 'R-CMOP', 'Mitoxantrone liposome'], 'conditions': ['Diffuse Large B-cell Lymphoma']}, 'descriptionModule': {'briefSummary': 'To evaluate the efficacy and safety of R-CMOP regimen based on mitoxantrone hydrochloride liposome injection in the treatment of newly diagnosed diffuse large B-cell lymphoma (DLBCL) based on cardiac function screening', 'detailedDescription': 'Compared with traditional mitoxantrone, mitoxantrone liposomes can significantly prolong the survival time of patients and reduce the cardiotoxicity and non-hematological toxicity of anthracycline drugs. Based on the cardiac safety and efficacy of mitoxantrone liposome, the R-CMOP scheme based on Mitoxantrone liposome for the treatment of initial DLBCL based on cardiac function screening has sufficient theoretical basis and is worth exploring.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. To participate in the study voluntarily and sign the informed consent (ICF);\n2. 18 years ≤ age ≤80 years;\n3. Expected survival time ≥3 months;\n4. Initial DLBCL confirmed by histopathology;\n5. There must be at least one evaluable or measurable lesion in line with Lugano2014 criteria: lymph node lesion, the length and diameter of detectable lymph node must be greater than 1.5cm; For non-lymph node lesions, the diameter of extrinsic lesions should be \\> 1.0cm;\n6. ECOG score 0\\~2;\n7. Bone marrow function: neutrophil count ≥1.5×10\\^9/L, platelet count ≥75×10\\^9/L, hemoglobin ≥80 g/L (neutrophil count ≥1.0×10\\^9/L, platelet count ≥50×10\\^9/L, hemoglobin ≥75g/L in patients with bone marrow involvement);\n8. Liver and kidney function: serum creatinine ≤1.5 times the upper limit of normal value; AST and ALT ≤2.5 times the upper limit of normal value (≤5 times the upper limit of normal value for patients with liver invasion); Total bilirubin ≤1.5 times the upper limit of normal value (≤3 times the upper limit of normal value for patients with liver invasion);\n9. Cardiac function: 50% ≤ LVEF ≤ 55%, or LVEF\\>55% patients with cardiovascular disease (including left ventricular enlargement (left ventricular diameter: male\\>60mm; female\\>55mm), controllable arrhythmia (first degree atrioventricular block, second degree type I atrioventricular block, atrial fibrillation, atrial flutter, ventricular premature beats (\\<4000 times/24h, mainly single)), myocarditis, pericarditis, structural heart disease, etc.).\n\nExclusion Criteria:\n\n1. Hypersensitivity to any study drug or its components;\n2. Uncontrollable systemic diseases (such as progressive infection, uncontrollable hypertension, diabetes, etc.);\n3. Cardiac function and disease conform to one of the following conditions:\n\n 1. Long QTc syndrome or QTc interval \\>480 ms;\n 2. Complete left bundle branch block, complete right bundle branch block with left anterior branch block, second degree type II, or third degree atrioventricular block;\n 3. New York College of Cardiology Grade ≥ III;\n 4. A history of acute myocardial infarction, unstable angina pectoris, severely unstable ventricular arrhythmias or any other arrhythmia requiring treatment, a history of clinically severe pericardial disease, or electrocardiographic evidence of acute ischemic or active conduction abnormalities within the 6 months prior to treatment.\n4. Hepatitis B and hepatitis C active infection (hepatitis B virus surface antigen positive and hepatitis B virus DNA more than 1x10\\^4 copies /mL; HCV RNA over 1x10\\^4 copies /mL);\n5. Human immunodeficiency virus (HIV) infection (HIV antibody positive);\n6. Past or present co-existing malignancies (other than non-melanoma basal cell carcinoma of the skin, carcinoma in situ of the breast/cervix, and other malignancies that have been effectively controlled without treatment in the past five years);\n7. Had primary or secondary central nervous system (CNS) lymphoma or had a history of CNS lymphoma at the time of recruitment\n8. Pregnant and lactating women and patients of childbearing age who do not want to take contraceptive measures;\n9. Other researchers judged that it was not suitable to participate in this study.'}, 'identificationModule': {'nctId': 'NCT05777369', 'briefTitle': 'R-CMOP in Patients With Primary Diffuse Large B-cell Lymphoma', 'organization': {'class': 'OTHER', 'fullName': 'The First Affiliated Hospital with Nanjing Medical University'}, 'officialTitle': 'An Open, Single-arm, Multicenter Study of R-CMOP Protocol for Primary Treatment of Diffuse Large B-cell Lymphoma Based on Cardiac Function Screening', 'orgStudyIdInfo': {'id': 'CSPC-DED-DLBCL-K08'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'R-CMOP', 'description': 'R-CMOP：Rituximab, Cyclophosphamide, Mitoxantrone hydrochloride liposomes, Vincristine or Vindesine, Prednisone', 'interventionNames': ['Drug: Rituximab', 'Drug: Mitoxantrone hydrochloride liposome', 'Drug: Cyclophosphamide', 'Drug: Vincristine/Vindesine', 'Drug: Prednisone']}], 'interventions': [{'name': 'Rituximab', 'type': 'DRUG', 'description': '375 mg/m2, d0', 'armGroupLabels': ['R-CMOP']}, {'name': 'Mitoxantrone hydrochloride liposome', 'type': 'DRUG', 'description': '18 mg/m2, d1', 'armGroupLabels': ['R-CMOP']}, {'name': 'Cyclophosphamide', 'type': 'DRUG', 'description': '750 mg/m2, d1', 'armGroupLabels': ['R-CMOP']}, {'name': 'Vincristine/Vindesine', 'type': 'DRUG', 'description': 'Vincristine: 1.4 mg/m2, d1(The maximum dose was 2 mg) Vindesine: 3 mg/m2, d1', 'armGroupLabels': ['R-CMOP']}, {'name': 'Prednisone', 'type': 'DRUG', 'description': '60 mg/m2, d1\\~d5', 'armGroupLabels': ['R-CMOP']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'JinHua Liang, M.D', 'role': 'CONTACT', 'email': '1151525490@qq.com', 'phone': '15952032421'}, {'name': 'Wei Xu, PhD& MD', 'role': 'CONTACT', 'email': 'xuwei10000@hotmail.com', 'phone': '862568136034'}], 'overallOfficials': [{'name': 'Wei Xu, PhD& MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The first Affiliated Hospital Of Nanjing Medical University(JiangSu Province Hospital)'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The First Affiliated Hospital with Nanjing Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}