Early treatment of aggressive non-Hodgkin lymphoma in the elderly
Conditions
Interventions
test group:Medication regimen for DLBCL patients:
60-80 years old: Rituximab 375 mg/m2, d0, Cyclophosphamide 750 mg/m2, d1, Mitoxantrone liposome 18 mg/m2 d1, Vincristine 1.4 mg/m2, d1 (max Dosage 2m
>80 years old: Rituximab 375mg/m2, d0, cyclophosphamide 400mg/m2, d1, mitoxantrone liposome 12mg/m2, d1, vincristine 1mg, d1, Prednisone 40mg/m2, d1-5
Medication regimen for PTCL patients: Cyclophosphamide 750mg/m2, d1, mitoxantrone liposome 18mg/m2 on d1, Vincristine 1.4mg/m2, d1 (maximum dose 2mg), Prednisone 100mg, d1-5
21 days is a medication cycle, a total of 6-8 cycles.
Sponsors
Shanxi Hospital of Cancer Hospital of Chinese Academy of Medical Sciences/Shanxi Provincial Cancer Hospital
Eligibility
Sex/Gender
All
Age
60 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Subjects fully understand and voluntarily participate in this study; 2. Patients with diffuse large B-cell lymphoma (DLBCL) and peripheral T-cell lymphoma (PTCL) confirmed by histopathology or cytology, NK/T-cell lymphoma ( Except NKTCL); 3. Aged =60 years old, regardless of gender; 4. Patients with untreated DLBCL or PTCL; 5. There must be at least 1 evaluable or measurable lesion that meets Lugano2014 standards: lymph node lesions, measurable lymph nodes The long diameter must be >1.5cm; non-lymph node lesions, measurable extranodal lesions must have a long diameter >1.0cm; 6. ECOG score 0-2 points; 7. Bone marrow function: neutrophil count =1.5×10^9/L, platelets Count =75×10^9/L, hemoglobin =80g/L (in patients with bone marrow involvement, the neutrophil count can be relaxed to =1.0×10^9/L, the platelet count can be relaxed to =50×10^9/L, and the hemoglobin can be relaxed to =75 g/L); 8. Liver and kidney function: serum creatinine =1.5 times the upper limit of normal; AST and ALT =2.5 times the upper limit of normal (for patients with liver invasion =5 times the upper limit of normal); total bilirubin =1.5 times Upper limit of normal value (=3 times the upper limit of normal value for patients with liver invasion); 9. Complete at least one tumor assessment
Exclusion criteria
Exclusion criteria: 1. 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, II or III degree atrioventricular block; c ) Severe, uncontrolled arrhythmia requiring medical treatment; d) New York Heart Association classification = III; e) Cardiac ejection fraction (LVEF) less than 50%; f) Myocardial infarction within 6 months before recruitment History of infarction, unstable angina, severe unstable ventricular arrhythmia or any other arrhythmia requiring treatment, history of clinically severe pericardial disease, or ECG evidence of acute ischemia or active conduction system abnormalities 2. Regarding study drugs The ingredients of similar drugs and excipients have a known history of immediate or delayed hypersensitivity reactions; 3. Uncontrollable systemic diseases (such as advanced infections, uncontrollable hypertension, diabetes, etc.); 4. Participate in other interventional clinical trials at the same time Patients in the study; 5. Patients with other malignant tumors who require treatment; 6. Patients judged by the researcher to be unfit to participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| complete response rate;progression free survival;duration of remission;2-year OS rate;safety; | — |
Countries
China
Contacts
Public ContactLiping Su
Shanxi Hospital of Cancer Hospital of Chinese Academy of Medical Sciences/Shanxi Provincial Cancer Hospital
Outcome results
None listed