cmop±r in the treatment of untreated non-hodgkin's lymphoma

Conditions: NHL

Summary: 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.

this is a single-arm, open label, multi-center clinical study to evaluate the safety and efficacy of mitoxantrone hydrochloride liposome in combination with cyclophosphamide, vincristine, prednisone and/or rituximab(cmop±r) in patients with newly diagnosed non-hodgkin's lymphoma. mitoxantrone hydrochloride liposome will be given on day 1 at dose of 18 mg/m2 and be combined with cyclophosphamide, vincristine, prednisone and/or rituximab. each cycle consists of 28 days. a maximum of 8 cycles(6×cmop±r+2×r) of therapy are planned.

Eligibility criteria:
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.

Keywords: newly diagnosed non-hodgkin's lymphoma mitoxantrone hydrochloride liposome