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

Inclusion Criteria:

• They voluntarily participated in the study and signed the informed consent.
• Age 18 or higher;
• Expected survival time for 3 months or more;
• The histopathological diagnosed late relapsed (> 12 months) diffuse large B cell lymphoma;
• Must have at least a Lugano 2014 standard can be evaluation or measurable lesions: lymph node lesions, measurable lymph nodes should be diameter > 1.5 cm; Non-lymph node lesions, measurable extranodal lesions should be diameter > 1.0 cm;
• ECOG score 0 to 2 points;
• Bone marrow function: neutrophil count >= 1.5 x 10^9 / L, platelet count >= 75 x 10^9 / L, and hemoglobin >= 80 g/L (neutrophil count may be extended to >= 1.0 x 10^9 / L, the platelet count can be extended to >= 50 x 10^9 / L, and hemoglobin can be extended to >= 75 g/L in patients with bone marrow involvement);
• Liver and kidney function: serum creatinine acuities were <= 1.5 times the upper limit of normal (ULN) value; AST and ALT <= 2.5 times the ULN(<= 5 times the upper limit of normal in patients with liver invasion); Total bilirubin <= 1.5 times the ULN (<= 3 times the upper limit of normal in patients with liver invasion);
• Blood coagulation function: International standardization Ratio (International Normalized thewire, INR) <= 1.5 x ULN; Prothrombin Time (PT), Activated PartialThromboplastin Time (APTT) <= 1.5×ULN (unless receiving anticoagulant therapy, And PT and APTT at screening were within the expected range for anticoagulant therapy).

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.