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

Launched by HENAN CANCER HOSPITAL · May 19, 2024

Keywords

ClinConnect Summary

This clinical trial is testing a new treatment called Zanubrutinib for patients who have recently been diagnosed with mantle cell lymphoma, a type of non-Hodgkin lymphoma. It aims to see how effective Zanubrutinib-containing regimens are in helping patients manage their condition. The trial is currently not recruiting participants, but it will involve both older adults aged 65 and above and younger adults aged 18 to under 65 who have never received treatment for this type of lymphoma.

To participate in the study, individuals must understand the trial and agree to take part by signing a consent form. They should have a confirmed diagnosis of mantle cell lymphoma and be in reasonably good health, with functioning major organs. Participants will need to have at least one measurable tumor and be expected to live for at least three months. However, those with certain health conditions or other cancers, pregnant or breastfeeding women, and individuals with severe organ issues or certain infections may not be eligible. If you join the trial, you can expect to follow specific steps outlined by the researchers, which will help them understand how well this new treatment works.

Gender

ALL

Eligibility criteria

• 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.