A Study of the Zanubrutinib-containing Regimens in Patients With Newly Diagnosed Mantle Cell Lymphoma

IIT-TN MCL

This is a phase II, open-label, multicentre study of Zanubrutinib-containing regimens in patients with newly diagnosed mantle cell lymphoma.

2024-05-20

2027-12-30

2029-12-30

Not yet recruiting

Early phase I

41

Inclusion Criteria: 1. 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 2. Histopathologically confirmed mantle cell lymphoma according to the 5th edition of the World Health Organization (WHO)，previous untreatment for mantle-cell lymphoma (MCL) 3. The elderly group ≥65 years old;The young group was ≥18 years old and \< 65 years old. 4. ECOG Performance Status 0-3 5. Life expectancy of at least 3 months 6. At least one evaluable lesion according to 2014 Lugano criteria; 7. 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% Exclusion Criteria: 1. The presence of other tumors could affect the study medication or interfere with the results; 2. Patients require treatment with strong or moderate CYP3A inhibitors; 3. Pregnant or lactating women; 4. Known to be allergic to the test drug ingredients; 5. Subjects of childbearing potential who are unwilling to use highly effective contraceptive methods; 6. Live vaccination was administered within 28 days prior to treatment 7. 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; 8. Severe coagulopathy and serious impairment of heart, brain, lung, liver, kidney and other organs 9. History of deep vein thrombosis (DVT) or pulmonary embolism (PE) within the past 12 months; 10. 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.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 41, 'type': 'ESTIMATED'}}

2024-05-23