PTCL,DLBCL
Conditions
Interventions
research group. : mitoxantrone hydrochloride liposome injection-based CMOP±R regimen
Sponsors
Soochow Hopes Hematology Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Patients fully understand this study, voluntarily participate and sign the informed consent (ICF); 2. Age: 18-75 years old; 3. Expected survival time = 3 months; 4. Histopathologically diagnosed newly diagnosed PTCL, One of the following subtypes: (1) Peripheral T-cell lymphoma not specified (PTCL-NOS) (2) Angioimmunoblastic T-cell lymphoma (AITL) (3) Anaplastic large T-cell lymphoma (ALCL) ), ALK+ (4) Anaplastic large T-cell lymphoma (ALCL), ALK- (5) Other subtypes of PTCL that the investigators think can be included; 5. Newly treated DLBCL confirmed by histopathology; 6. Must have At least one evaluable or measurable lesion that meets the Lugano2014 criteria: lymph node lesions, measurable lymph nodes must have a long diameter > 1.5cm; non-lymph node lesions, measurable extranodal lesions must have a long diameter > 1.0cm; 7. ECOG score 0-2 8. Bone marrow function: neutrophil count =1.5×109/L, platelet count =75×109/L, hemoglobin =80g/L (neutrophil count in patients with bone marrow involvement can be relaxed to =1.0×109/L L, platelet count can be relaxed to =50×109/L, hemoglobin can be relaxed to =75 g/L); 9. 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 liver invasion = 3 times the upper limit of normal value);.
Exclusion criteria
Exclusion criteria: 1. The subject's previous history of anti-tumor treatment meets one of the following conditions: a) Previously received mitoxantrone or mitoxantrone liposome; b) Previously received doxorubicin or other anthracyclines , the total cumulative dose of doxorubicin> 360 mg/m2 (1 mg doxorubicin converted to other anthracyclines is equivalent to 2 mg epirubicin); c) Received autologous hematopoietic stem cell transplantation within 100 days of the first medication, or received Patients with allogeneic hematopoietic stem cell transplantation; 2. Hypersensitivity to any study drug or its components; 3. Uncontrollable systemic diseases (such as advanced infection, uncontrollable hypertension, diabetes, etc.); 4. Cardiac function And the disease meets one of the following conditions: a) long QTc syndrome or QTc interval>480 ms; b) complete left bundle branch block, second-degree or third-degree atrioventricular block; c) need drug treatment Severe, uncontrolled arrhythmia; d) New York Society of Cardiology classification = III; e) Cardiac ejection fraction (LVEF) lower than 50%; f) Myocardial infarction, instability within 6 months before recruitment Angina, history of severe unstable ventricular arrhythmia or any other arrhythmia requiring treatment, history of clinically serious pericardial disease, or ECG evidence of acute ischemia or active conduction system abnormalities. 5. Active hepatitis B and C infection (positive hepatitis B virus surface antigen and more than 1x103 copies/mL of hepatitis B virus DNA; more than 1x103 copies/mL of hepatitis C virus RNA); 6. Human immunodeficiency virus (HIV) infection (positive HIV antibody); 7. Suffering from other malignant tumors in the past or at the same time (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); 8. 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 do not want to take contraceptive measures; other researchers judge not to Eligibility to participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| CRR;PFS;OS;Safety; | — |
Countries
China
Contacts
Public ContactHuang Haiwen
Soochow Hopes Hematology Hospital
Outcome results
None listed