Diffuse large B-cell lymphoma
Conditions
Interventions
Group one:The dose of mitoxantrone liposome is 16mg/m2
Group two:The dose of mitoxantrone liposome is 18mg/m2
Group three:The dose of mitoxantrone liposome is 20mg/m2
Group four:The dose of mitoxantrone liposome is 22mg/m2
Stage 1:Rituximab+Cyclophosphamide+Mitoxantrone liposome+Vincristine+Prednisone
Stage 2:Rituximab+Cyclophosphamide+Mitoxantrone liposome+Vincristine+Prednisone
Sponsors
West China Hospital of Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. 18-75 years old; 2. Have not received treatment for DLBCL in the past, including chemotherapy, targeted therapy, immunotherapy, local radiotherapy for lymphoma (except local radiotherapy for relieving tumor-related symptoms), surgical treatment (except tumor or pathological tissue biopsy and Surgical resection not for lymphoma); 3. Subjects with histologically confirmed diagnosis of diffuse large B-cell lymphoma; 4. Subjects must have at least one evaluable or measurable lesion per lugano2014 criteria: for lymph node lesions, the length should be > 1.5cm; For non-lymph node lesions, the length should be > 1.0cm; 5. The longest diameter of the large mass is >=7.5 cm; 6. Bone marrow function: Absolute neutrophil count >=1.5*10^9/L, Platelet count >=75*109/L, Hemoglobin >= 80g/L (Absolute neutrophil can be relaxed to >= 1.0*10^9/L, Platelet count can be relaxed to >=50*10^9/L, Hemoglobin can be relaxed to >=75 g/L in subjects with poor bone-marrow reserve); 7. Liver and kidney function: serum creatinine = 3 months; 9. Subjects fully understand and voluntarily participate in this study and sign the informed consent form (ICF);
Exclusion criteria
Exclusion criteria: 1. The subject had previously received any of the following anti-tumor treatments: (1) Previously received doxorubicin or other anthracycline treatment, and the total cumulative dose of doxorubicin was more than 360 mg/m^2 (1 mg doxorubicin equivalent to 2 mg epirubicin); (2) Subjects who received anti-tumor treatment (including chemotherapy, targeted therapy, glucocorticoid, hormone therapy (the total dose of prednisone in a single course exceeds 500 mg, and the total dose of dexamethasone in a single course exceeds 75 mg with administration for more than 2 weeks) traditional Chinese medicine with anti-tumor activity, etc.) or participated in other clinical trials and received trial drugs within 4 weeks before the first administration of the study drugs; (3) Received autologous hematopoietic stem cell transplantation or allogeneic hematopoietic stem cell transplantationwithin 100 days of the first medication; 2. Hypersensitivity to any study drug or its components; 3. Uncontrolled systemic diseases (such as active infection, uncontrolled hypertension, diabetes, etc.); 4. Heart function and disease meet one of the following conditions: (1) Long QTc syndrome or QTc interval > 480 ms; (2) Complete left bundle branch block, grade II or III atrioventricular block; (3) Serious and uncontrolled arrhythmias requiring drug treatment; (4) New York Heart Association grade >= III; (5) Cardiac ejection fraction (LVEF)< 50%; (6) A history of myocardial infarction, unstable angina pectoris, severe unstable ventricular arrhythmia or any other arrhythmia requiring treatment, a history of clinically serious pericardial disease, or ECG evidence of acute ischemia or active conduction system abnormalities within 6 months before recruitment. 5. Hepatitis B and hepatitis C active infection (plus HBV DNA if one positive for hepatitis B surface antigen or core antibody and HBV DNA more than 1*10^3 copy/mL excluded; plus HCV RNA if hepatitis C antibody positive and HCV RNA more than 1*10^3 copy/mL exclude); 6. Human immunodeficiency virus (HIV) infection (HIV antibody positive); 7. Subjects with other malignant tumors past or present (except for non-melanoma skin basal cell carcinoma, breast/cervical carcinoma in control, and other malignant tumors that have been effectively controlled without treatment within the past five years); 8. Subjects suffering from primary or secondary central nervous system (CNS) lymphoma or a history of CNS lymphoma at the time of recruitment; 9. Pregnant, lactating women and patients of childbearing age who are unwilling to take contraceptive measures; 10. Unsuitable subjects for this study determined by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Recommended Phase II Dose;Objective Response Rate of Phase II; | — |
Secondary
| Measure | Time frame |
|---|---|
| Maximum tolerated dose;Dose-limiting toxicity;Objective Response Rate of Phase I;Complete remission rate;Progression-free survival;Overall survival; | — |
Countries
China
Contacts
Public ContactTing Niu
West China Hospital of Sichuan University
Outcome results
None listed