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

CSPC-DED-NHL-K03

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.

2024-07-10

2025-08-31

2027-08-31

Not yet recruiting

Early phase I

197

Inclusion Criteria: * Patients fully understand this study, voluntarily participate and sign the informed consent (ICF); * Age: 18-75 years old; * Expected survival time ≥ 3 months; * Histopathologically diagnosed newly diagnosed non-Hodgkin's lymphoma; * 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; * Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-2. * Bone marrow function: Absolute neutrophil count (ANC) ≥1.5×10\^9/L, Platelet count (PLT) ≥75×10\^9/L, Hemoglobin(HB)≥ 80 g/L(Restriction may be relaxed in patients with bone marrow involvement, Absolute neutrophil count (ANC) ≥1.0×10\^9/L, Platelet count (PLT) ≥50×10\^9/L, Hemoglobin(HB)≥ 75g/L); * 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); Exclusion Criteria: * Subjects have previously received anthracyclic drug pretreatment; * Hypersensitivity to any study drug or its components; * Uncontrollable systemic diseases (such as advanced infection, uncontrollable hypertension, diabetes, etc.); * 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. * Active hepatitis B and C infection (positive hepatitis B virus surface antigen and more than 1x10\^3 copies/mL of hepatitis B virus DNA; more than 1x10\^3 copies/mL of hepatitis C virus RNA); * Human immunodeficiency virus (HIV) infection (positive HIV antibody); * Suffering from other malignant tumors in the past or at the same time (except for effectively controlled non-melanoma skin basal cell carcinoma, breast/cervix carcinoma in situ, and other malignant tumors that have been effectively controlled without treatment in the past five years); * Suffering from primary or secondary central nervous system (CNS) lymphoma or a history of CNS lymphoma at the time of recruitment; * Pregnant and lactating women and patients of childbearing age who are unwilling to take contraceptive measures; * Other researchers judge not to Eligibility to participate in this study.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 197, 'type': 'ESTIMATED'}}

2024-07-03