R-CMOP in Patients With Primary Diffuse Large B-cell Lymphoma
Diffuse Large B-cell Lymphoma
About this trial
This is an interventional treatment trial for Diffuse Large B-cell Lymphoma focused on measuring DLBCL, R-CMOP, Mitoxantrone liposome
Eligibility Criteria
Inclusion Criteria: To participate in the study voluntarily and sign the informed consent (ICF); 18 years ≤ age ≤80 years; Expected survival time ≥3 months; Initial DLBCL confirmed by histopathology; 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; ECOG score 0~2; 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); 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); 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: Hypersensitivity to any study drug or its components; Uncontrollable systemic diseases (such as progressive infection, uncontrollable hypertension, diabetes, etc.); Cardiac function and disease conform to one of the following conditions: Long QTc syndrome or QTc interval >480 ms; Complete left bundle branch block, complete right bundle branch block with left anterior branch block, second degree type II, or third degree atrioventricular block; New York College of Cardiology Grade ≥ III; 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. 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); Human immunodeficiency virus (HIV) infection (HIV antibody positive); 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); Had primary or secondary central nervous system (CNS) lymphoma or had a history of CNS lymphoma at the time of recruitment Pregnant and lactating women and patients of childbearing age who do not want to take contraceptive measures; Other researchers judged that it was not suitable to participate in this study.
Sites / Locations
Arms of the Study
Arm 1
Experimental
R-CMOP
R-CMOP:Rituximab, Cyclophosphamide, Mitoxantrone hydrochloride liposomes, Vincristine or Vindesine, Prednisone