Chemotherapy Combined With Targeted Therapy as First-line Treatment for Mantle Cell Lymphoma Based on MRD and PET-CT Assessment

Korábbi kezelés

• Participants with active bleeding within 2 months prior to screening, those currently on anticoagulant therapy, or those deemed by the investigator to have a significant risk of bleeding;
• Major surgery within 6 weeks prior to screening or minor surgery within 2 weeks prior to screening. Major surgery is defined as any surgical procedure requiring general anesthesia; diagnostic endoscopy is not considered major surgery;
• Participants requiring continuous use of drugs with strong inhibition or induction effects on cytochrome P450 CYP3A4;

Más betegség

• Progression to higher-grade disease or central nervous system involvement;
• History of deep vein thrombosis or pulmonary embolism within the past 6 months;
• Active infection or uncontrolled hepatitis B virus (HBV) infection (HBsAg positive and/or HBcAb positive with detectable HBV DNA), hepatitis C virus (HCV) antibody positive, HIV/AIDS, or other severe infectious diseases;
• Participants with pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation-induced lung disease, drug-related lung disease, or other conditions affecting pulmonary function;
• Other conditions deemed unsuitable for participation in this trial by the investigator.

Laborértékek

• Uncontrolled or significant cardiovascular diseases:
  • Within 6 months prior to the first administration of the study drug, there was New York Heart Association (NYHA) class II or higher congestive heart failure, unstable angina pectoris, myocardial infarction, or a need for treatment of arrhythmia at the time of screening, with left ventricular ejection fraction (LVEF) \< 50%;
  • Primary cardiomyopathies (such as dilated cardiomyopathy, hypertrophic cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy, restrictive cardiomyopathy, and unclassified cardiomyopathy);
  • A history of clinically significant QTc interval prolongation, or a QTc interval \>470 ms for females or \>450 ms for males during the screening period;
  • Participants with symptomatic or medication-requiring coronary artery disease;
  • Participants with uncontrolled hypertension, defined as systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg despite adequate therapy with three antihypertensive agents (including a diuretic) for at least one month, or requiring four or more antihypertensive agents to achieve control.

Egyéb

• Pregnant women, breastfeeding women, and fertile participants unwilling to use effective contraception;

• Gender not limited, aged ≥65 years, or aged ≥60 years but \<65 years and unsuitable or unwilling to undergo stem cell transplantation due to the following reasons:
  • Creatinine clearance rate \>30 mL/min, but \<70 mL/min;
  • Presence of other comorbidities that contraindicate high-intensity induction chemotherapy;
  • High-risk patients who are expected to fail stem cell mobilization and collection (such as those with bone marrow infiltration, diabetes, thrombocytopenia). Patients who are unwilling to receive autologous stem cell transplantation, considering potential complications post-transplantation (such as prolonged bleeding, immunodeficiency, hemorrhage, severe infections), and relapse.
• Histologically confirmed mantle cell lymphoma at stages II-IV;
• Patients who have not received prior treatment;
• Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2;
• Adequate organ function:
  • Hematological: Absolute neutrophil count ≥1.5×109/L, platelets ≥75×109/L, hemoglobin ≥75 g/L. If accompanied by bone marrow involvement: Absolute neutrophil count ≥1.0×109/L, platelets ≥50×109/L, hemoglobin ≥50 g/L.
  • Biochemical: Total bilirubin ≤1.5 times the upper limit of normal (ULN), aspartate transaminase (AST) or alanine transaminase (ALT) ≤2 times ULN.
• Coagulation function: International normalized ratio (INR) ≤1.5 times ULN;
• Expected survival time ≥12 months;
• Voluntarily sign a written informed consent form before the trial screening.