A Study of the Zanubrutinib Given in Combination With Bendamustine and Rituximab in (Elderly or TP53 Alterations or Chemotherapy Intolerance) Patients With Newly Diagnosed Mantle Cell Lymphoma

Más betegség

• Known Hepatitis B Virus (HBV) and/or Hepatitis C Virus (HCV) infection (HBV infection refers to HBV-DNA \> detectable limit);
• Known to be allergic to the test drug ingredients;
• Diagnosed with or being treated for malignancy other than lymphoma;
• With severe infection;
• Substance abuse, medical, psychological, or social conditions that may interfere with the subjects' participation in the study or evaluation of the study results;

Laborértékek

• With congestive heart failure in 6 months before enrollment, New York Heart Association (NYHA) heart function class III or IV, or LVEF \< 50%;

Egyéb

• Pregnant or lactating women;
• With acquired or congenital immunodeficiency;
• Deemed unsuitable for the group.

• 18 years
  • Histopathologically confirmed mantle cell lymphoma according to the 5th edition of the World Health Organization (WHO)
  • FISH with del(17p)/TP53 mutation or ≥65 years; or\<65 years but chemotherapy intolerance;
  • Life expectancy of \> 3 months (in the opinion of the investigator);
  • Creatinine Clearance Rate (CCR) ≥ 50 mL/min or estimated Glomerular Filtration ●Rate (eGFR) ≥ 60 mL/(min·1.73 m\^2);
  • International Normalized Ratio (INR) ≤ 1.5 and activated Partial Thromboplastin Time (aPTT) ≤ 1.5 times the upper limit of normal;
  • Left Ventricular Ejection Fraction (LVEF) ≥ 50%;
  • Agreeing to provide written informed consent prior to any special examination or procedure for the research on their own or legal representative.