← Back to Clinical Trials
Recruiting Phase 2 NCT06136351

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

Trial Parameters

Condition Lymphoma, Mantle-Cell
Sponsor Ruijin Hospital
Study Type INTERVENTIONAL
Phase Phase 2
Enrollment 23
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2023-11-15
Completion 2027-11-01
Interventions
ZanubrutinibRituximabBendamustin

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of Zanubrutinib given in combination with bendamustine and rituximab in (elderly or TP53 alterations or chemotherapy intolerance) patients with newly diagnosed mantle cell lymphoma.

Eligibility Criteria

Inclusion Criteria: * 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. Exclusion Criteria: * Pregnant or lactating women; * Known Hepatitis B Virus (HBV) and/or Hepatitis C Virus (HCV) infection (HBV infection refers to HBV-DNA \> detectable limit); * With acquired or congenital immunodeficiency; * With

Related Trials