lymphoma
Conditions
Interventions
Experimental group:Mitoxantrone liposome injection + Ifosfamide + Rituximab + etoposide + mesna
Sponsors
37 Guoxue Alley, Wuhou District, Chengdu, Sichuan, China
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Voluntarily join this study and sign the informed consent form; 2. 18 years old = 3 months; 4. Diffuse large B-cell lymphoma confirmed by histopathology; 5. Recurrent lymphoma refers to lymphoma that recurs after the initial chemotherapy achieves complete remission (CR). Refractory lymphoma can be diagnosed when any of the following items are met: (1) After 4 courses of standard chemotherapy, the tumor shrinks 1.5 cm; non-lymph node lesions, measurable extranodal lesions must have a long diameter > 1.0 cm; 8. ECOG score 0-2 points; 9. Bone marrow function: neutrophil count >= 1.5 x 10^9/L, platelet count >= 75 x 10^9/L, hemoglobin >= 80 g/L (neutrophil count in patients with bone marrow involvement can be relaxed to >= 1.0 x 10^9/L, platelet count can be relaxed to >= 50 x 10^9/L, hemoglobin can be relaxed to >= 75 g/L); 10. 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 Patients with liver invasion <= 3 times the upper limit of normal).
Exclusion criteria
Exclusion criteria: 1. Previously received doxorubicin or other anthracycline therapy, and the cumulative dose of doxorubicin exceeded 360 mg/m2 (anthracycline equivalent dose calculation: 1 mg doxorubicin = 2 mg epirubicin; liposomal doxorubicin Accumulative dose of hormone up to 2460 mg/?); 2. Abnormal heart function: (1) Long QTc syndrome or QTc interval > 480 ms; (2) Clinically significant arrhythmias, including but not limited to complete left bundle branch abnormalities, second-degree atrioventricular block, and PR interval > 250 milliseconds; (3) There are any risk factors that increase the prolongation of the QTc interval, such as hypokalemia, hereditary long QT syndrome, currently taking drugs that prolong the QT interval or stopping the drug for less than 15 days; (4) Congestive heart failure grade >= 2 of the New York Society of Cardiology; (5) The cardiac ejection fraction is lower than 50% or lower than the lower limit of the laboratory test value range of the research center; (6) A history of myocardial infarction, unstable angina, severe unstable ventricular arrhythmia or any other arrhythmia requiring treatment, clinically serious pericardial disease history, or acute ischemia or activity within 6 months before recruitment ECG evidence of sex conduction abnormalities; 3. Patients who have received autologous hematopoietic stem cell transplantation within 100 days of the first medication, or patients who have received allogeneic hematopoietic stem cell transplantation; 4. Hypersensitivity to any study drug or its components; 5. Received anti-tumor therapy (including chemotherapy, radiotherapy, targeted therapy, hormone therapy) within 4 weeks before the first use of the drug of this study (the total dose of a single course of prednisone exceeds 500 mg, and the total dose of a single course of dexamethasone exceeds 75 mg, The administration time exceeds 2 weeks), taking anti-tumor active traditional Chinese medicine, etc.) or participating in other clinical trials and accepting clinical trial drugs; 6. Uncontrollable systemic diseases (such as advanced infection, uncontrollable hypertension, diabetes, etc.); 7. Active infection includes hepatitis B (hepatitis B virus surface antigen positive and hepatitis B virus DNA exceeds 1 x 10^3 copies/mL) and hepatitis C (hepatitis C virus RNA exceeds 1 x 10^3 copies/mL); 8. Human immunodeficiency virus (HIV) infection (HIV positive); 9. Previously or currently suffering from other malignant tumors (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); 10. Suffering from primary or secondary central nervous system (CNS) lymphoma or a history of CNS lymphoma at the time of recruitment; 11. Pregnant, lactating women and patients of childbearing age who are unwilling to take contraceptive measures.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Complete response rate;one year Progression-free survival rate;one year Overall Survival rate; Progression-free survival;Overall survival;adverse events; | — |
Countries
China
Contacts
Public ContactTing Niu
West China Hospital, Sichuan University
Outcome results
None listed