[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100553457":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":25,"locations":19,"responsibleParty":31,"collaborators":19,"id":33,"slug":34,"hasResults":35,"nctId":36,"briefTitle":37,"officialTitle":38,"acronym":19,"eligibilityCriteria":39,"healthyVolunteers":35,"sex":40,"minAge":41,"maxAge":42,"enrollmentInfo":43,"targetDuration":19,"studyType":46,"phases":47,"briefSummary":49,"conditions":50,"keywords":52,"overallStatus":55,"whyStopped":19,"lastUpdateSubmitDate":56,"lastUpdatePostDateStruct":57,"startDateStruct":60,"completionDateStruct":62,"leadSponsor":64,"locationsCount":19},{"fullName":5,"class":6},"The First Affiliated Hospital of Soochow University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"CMOP±R","EXPERIMENTAL","All enrolled patients. All patient who signed the consent form for participation to the study.",[13],"Drug: CMOP±R",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":19},"DRUG","Drug: Mitoxantrone hydrochloride liposome Mitoxantrone hydrochloride liposome (18 mg\u002Fm\\^2) on day 1, every 4 weeks; Drug: Cyclophosphamide Cyclophosphamide(750 mg\u002Fm\\^2) on day 1, every 4 weeks; Drug: Vincristine Vincristine (1.4mg\u002F m2，Max dose 2mg) will be administered on day 1(Or at the discretion of the investigator, use other vinblastine drugs with the same mechanism, such as vindesine 2-3 mg\u002Fm2 on day 1), every 4 weeks; Drug: Prednisone Prednisone (100 mg) will be taken orally from day 1-5(Or equivalent dose of dexamethasone at 15mg), every 4 weeks; Drug: Rituximab Rituximab (375mg\u002Fm\\^2) on day 0, every 4 weeks, only with CD20-positive lymphomas are evaluated by the investigator.",[9],null,[21],{"name":22,"affiliation":23,"role":24},"Haiwen Huang","The First Affiliated Hospital of Soochow University, Suzhou, China","PRINCIPAL_INVESTIGATOR",[26,30],{"name":22,"role":27,"phone":28,"phoneExt":19,"email":29},"CONTACT","13962154846","huanghaiwen@suda.edu.cn",{"name":22,"role":27,"phone":19,"phoneExt":19,"email":19},{"type":32,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR","100553457","phase-2-cmopr-in-the-treatment-of-untreated-non-hodgkins-lymphoma-100553457",false,"NCT06486337","CMOP±R in the Treatment of Untreated Non-Hodgkin's Lymphoma","A Single-arm, Multi-center, Prospective Clinical Study of Mitoxantrone Hydrochloride Liposome Injection-based CMOP±R Regimen in the Treatment of Newly Diagnosed Non-Hodgkin's Lymphoma","Inclusion Criteria:\n\n* Patients fully understand this study, voluntarily participate and sign the informed consent (ICF);\n* Age: 18-75 years old;\n* Expected survival time ≥ 3 months;\n* Histopathologically diagnosed newly diagnosed non-Hodgkin's lymphoma;\n* Must have at least one evaluable or measurable lesion that meets the Lugano 2014 criteria: lymph node lesions, measurable lymph nodes must have a long diameter \\>1.5cm; non-lymph node lesions, measurable extranodal lesions must have a long diameter \\>1.0cm;\n* Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-2.\n* Bone marrow function: Absolute neutrophil count (ANC) ≥1.5×10\\^9\u002FL, Platelet count (PLT) ≥75×10\\^9\u002FL, Hemoglobin(HB)≥ 80 g\u002FL(Restriction may be relaxed in patients with bone marrow involvement, Absolute neutrophil count (ANC) ≥1.0×10\\^9\u002FL, Platelet count (PLT) ≥50×10\\^9\u002FL, Hemoglobin(HB)≥ 75g\u002FL);\n* 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 (for patients with liver invasion ≤ 5 times the upper limit of normal value); total bilirubin ≤ 1.5 times the upper limit of normal value (for patients with liver invasion ≤ 3 times the upper limit of normal value);\n\nExclusion Criteria:\n\n* Subjects have previously received anthracyclic drug pretreatment;\n* Hypersensitivity to any study drug or its components;\n* Uncontrollable systemic diseases (such as advanced infection, uncontrollable hypertension, diabetes, etc.);\n* Heart function and disease meet one of the following conditions: a) long QTc syndrome or QTc interval \\>480 ms; b) complete left bundle branch block, grade II or III atrioventricular block; c) Serious and uncontrolled arrhythmias requiring drug treatment; d) New York Heart Association grade ≥ III; e) Cardiac ejection fraction (LVEF) lower than 50%;f) A history of myocardial infarction, unstable angina pectoris, severe unstable ventricular arrhythmia or any other arrhythmia requiring treatment, a history of clinically serious pericardial disease, or ECG evidence of acute ischemia or active conduction system abnormalities within 6 months before recruitment.\n* Active hepatitis B and C infection (positive hepatitis B virus surface antigen and more than 1x10\\^3 copies\u002FmL of hepatitis B virus DNA; more than 1x10\\^3 copies\u002FmL of hepatitis C virus RNA);\n* Human immunodeficiency virus (HIV) infection (positive HIV antibody);\n* Suffering from other malignant tumors in the past or at the same time (except for effectively controlled non-melanoma skin basal cell carcinoma, breast\u002Fcervix carcinoma in situ, and other malignant tumors that have been effectively controlled without treatment in the past five years);\n* Suffering from primary or secondary central nervous system (CNS) lymphoma or a history of CNS lymphoma at the time of recruitment;\n* Pregnant and lactating women and patients of childbearing age who are unwilling to take contraceptive measures;\n* Other researchers judge not to Eligibility to participate in this study.","ALL","18 Years","75 Years",{"count":44,"type":45},197,"ESTIMATED","INTERVENTIONAL",[48],"PHASE2","This is a prospective, single arm, multicenter study to evaluate the safety and efficacy of CMOP±R in patients with newly diagnosed non-Hodgkin's lymphoma.",[51],"NHL",[53,54],"newly diagnosed non-Hodgkin's lymphoma","Mitoxantrone hydrochloride liposome","NOT_YET_RECRUITING","2024-06-30",{"date":58,"type":59},"2024-07-03","ACTUAL",{"date":61,"type":45},"2024-07-10",{"date":63,"type":45},"2027-08-31",{"name":5,"class":6}]