A Single-arm, Multicenter, Prospective Clinical Study of Mitoxantrone Liposome Combined With Chidamide and Azacitidine in the Treatment of Relapsed and Refractory Peripheral T-cell Lymphoma

Exclusion Criteria

• •1. The subject's previous history of anti-tumor therapy meets one of the following conditions:
• •1. Those who have received mitoxantrone or mitoxantrone liposome in the past;
• •2. Have received doxorubicin or other anthracycline therapy in the past, and the total cumulative dose of doxorubicin is more than 360 mg/m2 (1 mg doxorubicin equivalent to 2 mg epirubicin converted from other anthracyclines);
• •3. Patients who have received autologous hematopoietic stem cell transplantation within 100 days of the first medication, or have received allogeneic hematopoietic stem cell transplantation;
• •4. Received anti-tumor therapy (including chemotherapy, targeted therapy, hormone therapy, taking traditional Chinese medicine with anti-tumor activity, etc.) or participated in other clinical trials and received clinical trial drugs within 4 weeks before the first use of the study drug;
• •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 disease meet one of the following conditions:
• •1. Long QTc syndrome or QTc interval \>480 ms;
• •2. Complete left bundle branch block, second or third degree atrioventricular block;
• •3. severe, uncontrolled arrhythmia requiring medical treatment;
• •4. New York College of Cardiology classification ≥ grade III;
• •5. Cardiac ejection fraction (LVEF) less than 50%;
• •6. History of myocardial infarction, unstable angina, severe unstable ventricular arrhythmia, or any other arrhythmia requiring treatment, clinically significant pericardial disease within 6 months prior to recruitment, or acute ischemic or active ECG evidence of conduction system abnormalities.
• •5. Active infection of hepatitis B and C (HBV surface antigen positive and hepatitis B virus DNA more than 1x103 copies/mL; hepatitis C virus RNA more than 1x103 copies/mL);
• •6. Human immunodeficiency virus (HIV) infection (HIV antibody positive);
• •7. Past or present with other malignant tumors (except for effectively controlled non-melanoma skin basal cell carcinoma, breast/cervical carcinoma in situ, and other malignant tumors that have been effectively controlled without treatment within 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. There are obvious gastrointestinal diseases at the time of screening, which may affect the intake, transport or absorption of drugs (such as inability to swallow, chronic diarrhea, intestinal obstruction, etc.);
• •10. Pregnant, lactating women and patients of childbearing age who are unwilling to take contraceptive measures;
• •11. Subjects with lymphoma and leukemia (proportion of malignant tumor cells in bone marrow examination\> 20%) Circumstances judged by other investigators to be inappropriate to participate in this study. -