Diffuse large B-cell lymphoma
Conditions
Interventions
Experimental Group:Rituximab, cyclophosphamide, mitoxantrone liposome, vindesine, and prednisone (R-CMOP) regimen
Sponsors
The First Affiliated Hospital, College of Medicine, Zhejiang University
Eligibility
Sex/Gender
All
Age
60 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age >=60 years old or with underlying heart diseases; 2. Newly diagnosed diffuse large B-cell lymphoma confirmed by histopathology; 3. There must be at least one lesion that can be evaluated or measured according to Lugano2014 criteria: lymph node lesion, measurable lymph node should be more than 1.5cm in length; Non-lymph node lesions, measurable extranodal lesions should be larger than 1.0cm in length; 4. Bone marrow function: neutrophil count >=1.5×10^9/L, platelet count >=75×10^9/L, hemoglobin >=80g/L (patients with bone marrow involvement were determined by the investigator); 5. Liver and kidney function: serum creatinine<=1.5 times upper limit of normal; AST and ALT <=2.5 times the upper limit of normal (<=5 times the upper limit of normal in patients with liver invasion); Total bilirubin <=1.5 times the upper limit of normal (<=3 times the upper limit of normal in patients with liver invasion); 6. The expected survival time, as judged by the investigator, was at least 3 months; 7. Understand and voluntarily provide written informed consent.
Exclusion criteria
Exclusion criteria: 1.Uncontrollable systemic diseases (such as cardiovascular diseases like unstable angina pectoris, myocardial infarction, congestive heart failure, severe unstable ventricular arrhythmias, and a history of severe pericardial diseases uncontrollable hypertension, diabetes, etc.) 2. A known history of immediate or delayed hypersensitivity to drugs of the same class as the study drug and their excipient ingredients 3. Cardiac function and diseases meeting any of the following conditions: 1) Long QT syndrome or QTc interval > 480 ms 2) Complete left bundle branch block, second-degree or third-degree atrioventricular block 3) Severe, uncontrolled arrhythmias requiring drug treatment 4) New York Heart Association classification >= III 5) Cardiac ejection fraction (LVEF) below 20% 6) A history of myocardial infarction, unstable angina pectoris, severe unstable ventricular arrhythmias, or any other arrhythmias requiring treatment, a history of clinically severe pericardial diseases within 6 months before enrollment, or electrocardiographic evidence of acute ischemic or active conduction system abnormalities 4. Active hepatitis B and hepatitis C infection (positive hepatitis B surface antigen or core antibody, plus HBV-DNA, HBV-DNA more than 1x10^3 copies /mL excluded; positive hepatitis C antibody plus HCV-RNA, HCV-RNA more than 1x10^3 copies /mL excluded); 5. Patients who refuse to take effective contraceptive measures during the study period 6. A past or current history of other malignant tumors (except for effectively controlled non-melanoma basal cell carcinoma of the skin, in situ breast/cervical cancer, and other malignant tumors that have been effectively controlled without treatment in the past five years) 7. Suffering from primary or secondary central nervous system (CNS) lymphoma or having a history of CNS lymphoma at the time of enrollment 8. Pregnant or lactating women, and patients of childbearing age who are unwilling to take contraceptive measures 9. Patients deemed by the researcher as unsuitable to participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete remission rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective remission rate;1-year progression-free survival;1-year overall survival; | — |
Countries
China
Contacts
Public ContactCai Zhen; Zhao Yi
The First Affiliated Hospital of Zhejiang University School of Medicine
Outcome results
None listed