Relapsed and refractory diffuse large B-cell lymphoma
Conditions
Interventions
Experimental group:Different doses of mitoxantrone hydrochloride liposome injection and fixed doses of rituximab, bendamustine
Sponsors
Chongqing University Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Patients fully understand the study, voluntarily participate and sign an informed consent form (ICF); 2. Age: 18~70 years old (including upper and lower limits); 3. Expected survival time =3 months; 4. Recurrent/refractory diffuse large B-cell lymphoma confirmed by histopathology; Recurrent DLBCL: Lymphoma that recur after achieving complete response (CR) with initial chemotherapy Refractory DLBCL: Patients who have not responded to a first-line RCHOP regimen at an interim assessment 5.ECOG score 0-2 points; 6. There must be at least one evaluable or measurable lesion that meets Lugano2014 standards: lymph node lesion, the length of the measurable lymph node must be greater than 1.5cm; For non-lymph node lesions, the measured extra-nodal lesions should be > 1.0cm in length; 7. Bone marrow function: neutrophil count =1.5×109/L, platelet count =75×109/L, hemoglobin =80g/L (neutrophil count =1.0×109/L, platelet count =50×109/L, hemoglobin =75 g/L in patients with bone marrow involvement); 8. 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 (=5 times the upper limit of normal for patients with liver metastasis); Total bilirubin =1.5 times the upper limit of normal (=3 times the upper limit of normal for patients with liver metastasis);
Exclusion criteria
Exclusion criteria: 1. Previous recipients of mitoxantrone or mitoxantrone liposomes; 2. Received doxorubicin or other anthracyclines in the past, with a total cumulative dose of doxorubicin > 350mg/m2 (other anthracyclines equivalent to 1 mg doxorubicin is equivalent to 2mg epirubicin, 2mg doxorubicin, 2mg daunorubicin, 0.5 mg desoxydaunorubicin, or 0.45mg mitoxantrone); 3. Received anti-tumor therapy (including chemotherapy, targeted therapy, hormone therapy, taking Chinese medicine with anti-tumor activity, etc.) or participated in other clinical trials and received clinical trial drugs within 2 weeks before the first use of the drug in this study; 4. Patients who have received autologous hematopoietic stem cell transplantation or have received allogeneic hematopoietic stem cell transplantation within 100 days of the first medication; 5. Hypersensitivity to any investigational drug or its ingredients; 6. Uncontrolled systemic diseases (such as advanced infections), uncontrolled hypertension, diabetes, etc.); 7. Heart function and disease meet one of the following conditions: a) Long QTc syndrome or QTc interphase > 480 ms; b) Complete left bundle branch block, degree II or III atrioventricular block; c) severe, uncontrolled arrhythmias requiring medical treatment; d) New York College of Cardiology grade = III; e) Cardiac ejection fraction (LVEF) less than 50%; f) 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 electrocardiographic evidence of acute ischemic or active conduction system abnormalities within the 6 months prior to recruitment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| maximum tolerated dose; | — |
Secondary
| Measure | Time frame |
|---|---|
| Dose-Limiting Toxicity;recommended phaseII dose;Complete response;Objective remission rate;Disease Control Rate;Safety; | — |
Countries
China
Contacts
Public ContactLiu Yao
Chongqing University Cancer Hospital
Outcome results
None listed