This is a Phase II, Open-label, Multicentre Study of Zanubrutinib-containing Regimens in Patients With Newly Diagnosed Mantle Cell Lymphoma

Korábbi kezelés

• The presence of other tumors could affect the study medication or interfere with the results;
• Patients require treatment with strong or moderate CYP3A inhibitors;
• Live vaccination was administered within 28 days prior to treatment

Más betegség

• Known to be allergic to the test drug ingredients;
• Known human immunodeficiency virus (HIV) infection or suggested active B or C infection The following serologic status of hepatitis C virus infection: 1) Hepatitis B virus (HBV) DNA positive. Positive hepatitis B surface antigen (HBsAg) or anti-hepatitis B core antibody (HBcAb) seropositive if HBV DNA is undetectable and willing to accept Monthly surveillance for HBV reactivation was eligible. 2) Hepatitis C virus (HCV) antibody positive. For patients with HCV antibodies present, if undetectable HCV RNA, can be included;
• Severe coagulopathy and serious impairment of heart, brain, lung, liver, kidney and other organs
• History of deep vein thrombosis (DVT) or pulmonary embolism (PE) within the past 12 months;
• Any risk that is considered by the investigator to be likely to affect the safety of the subjects or to pose a risk to the study And vital diseases, medical conditions, or organ system insufficiency.

Egyéb

• Pregnant or lactating women;
• Subjects of childbearing potential who are unwilling to use highly effective contraceptive methods;

• Voluntary participation in clinical study; Fully understand and understand the study and sign the informed consent form (ICF);Willingness to follow and ability to complete all study steps
• Histopathologically confirmed mantle cell lymphoma according to the 5th edition of the World Health Organization (WHO)，previous untreatment for mantle-cell lymphoma (MCL)
• The elderly group ≥65 years old;The young group was ≥18 years old and < 65 years old.
• ECOG Performance Status 0-3
• Life expectancy of at least 3 months
• At least one evaluable lesion according to 2014 Lugano criteria;
• Proper functioning of the major organs, no major heart, lung, liver, kidney, or immunodeficiency (no blood transfusion, granulocyte colony-stimulating factor, or other medical support within 7 days before starting the study) :Hemoglobin (HB)≥60 g/L;Absolute neutrophil count(ANC)≥0.5×10\^9/L;Platelet count（PLT）≥50×10\^9/L;AST and ALT ≤ 2.5 x ULN；Total bilirubin ≤ 1.5 times the ULN;Ccr≥40ml/min（Cockcroft-Gault ）；Left Ventricular Ejection Fraction (LVEF) ≥ 50%