r-cmop in patients with primary diffuse large b-cell lymphoma

Conditions: Diffuse Large B-cell Lymphoma

Summary: 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

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.

Eligibility criteria:
inclusion criteria: 1. to participate in the study voluntarily and sign the informed consent (icf); 2. 18 years ≤ age ≤80 years; 3. expected survival time ≥3 months; 4. initial dlbcl confirmed by histopathology; 5. 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; 6. ecog score 0\~2; 7. 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); 8. 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); 9. 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.). exclusion criteria: 1. hypersensitivity to any study drug or its components; 2. uncontrollable systemic diseases (such as progressive infection, uncontrollable hypertension, diabetes, etc.); 3. cardiac function and disease conform to one of the following conditions: 1. long qtc syndrome or qtc interval \>480 ms; 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; 3. new york college of cardiology grade ≥ iii; 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. 4. 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); 5. human immunodeficiency virus (hiv) infection (hiv antibody positive); 6. 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); 7. had primary or secondary central nervous system (cns) lymphoma or had a history of cns lymphoma at the time of recruitment 8. pregnant and lactating women and patients of childbearing age who do not want to take contraceptive measures; 9. other researchers judged that it was not suitable to participate in this study.

Keywords: dlbcl r-cmop mitoxantrone liposome