Modified R-MINE Regimen vs. R-GemOx Regimens on the Treatment of Late Relapsed DLBCL

Exclusion Criteria

• •Previous history of antitumor therapy meeting any of the following conditions:
• •1. Prior treatment with mitoxantrone or liposomal mitoxantrone;
• •2. Prior treatment with doxorubicin or other anthracyclines, with a total cumulative doxorubicin dose \>360 mg/m² (for other anthracyclines, 1 mg of doxorubicin is equivalent to 2 mg of epirubicin);
• •3. Prior autologous hematopoietic stem cell transplantation within 100 days before the first dose, or a history of allogeneic hematopoietic stem cell transplantation;
• •4. Prior antitumor therapy (including chemotherapy, targeted therapy, hormone therapy, traditional Chinese medicine with antitumor activity, etc.) or participation in other clinical trials involving investigational drugs within 4 weeks or 5 half-lives (whichever is shorter) before the first dose of the study drug.
• •Hypersensitivity to any study drug or its components;
• •Uncontrolled systemic diseases (e.g., progressive infections, uncontrolled hypertension, diabetes, etc.);
• •Cardiac function and diseases meeting any of the following conditions:
• •1. Long QTc syndrome or QTc interval \>480 ms;
• •2. Complete left bundle branch block, complete right bundle branch block with left anterior fascicular block, type II second-degree or third-degree atrioventricular block;
• •3. Severe, uncontrolled arrhythmia requiring medication;
• •4. New York Heart Association Class ≥ III;
• •5. History of acute myocardial infarction, unstable angina, severe unstable ventricular arrhythmia, or any other arrhythmia requiring treatment within 6 months before enrollment; history of clinically significant pericardial disease; or electrocardiographic evidence of acute ischemic or active conduction system abnormalities.
• •Active hepatitis B or C infection (hepatitis B surface antigen positive with HBV DNA \>1×10³ copies/mL; HCV RNA \>1×10³ copies/mL);
• •Human immunodeficiency virus (HIV) infection (HIV antibody positive);
• •History or concurrent presence of other malignancies (except for effectively controlled non-melanoma skin basal cell carcinoma, in situ carcinoma of the breast/cervix, and other malignancies effectively controlled without treatment in the past five years);
• •Presence of primary or secondary central nervous system (CNS) lymphoma or a history of CNS lymphoma at enrollment;
• •Pregnant or lactating women, and patients of childbearing potential unwilling to use contraception;
• •Requirement for systemic corticosteroid therapy or other immunosuppressive therapy due to a medical condition within 14 days before the start of study treatment \[topical use (ocular, intra-articular, intranasal, and inhaled corticosteroids with minimal systemic absorption) is permitted; short-term (≤7 days) corticosteroid use for prophylaxis (e.g., contrast agent allergy) or treatment of non-autoimmune conditions (e.g., delayed hypersensitivity due to contact allergens) is permitted\];
• •Other conditions deemed by the investigator to be unsuitable for participation in this study.