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.
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);
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 congestive heart failure in 6 months before enrollment, New York Heart Association (NYHA) heart function class III or IV, or LVEF < 50%;
Single group
Zanubrutinib
Drug160 mg bid po, until disease progression, intolerance of drug toxicity or death, otherwise maintaining during the 2 years of follow-up
Rituximab
Drug375 mg/m\^2 ivgtt, D0 of each 28-day cycle
Bendamustin
Drug90mg/m\^2 ivgtt, D0 of each 28-day cycle
2-year Progression-Free Survival
Progression-free survival was defined as the time from the date of first treatment until the date of the first documented day of disease progression or relapse, according to 2014 Lugano criteria, or death from any cause, whichever occurred first.
ORR
Objective Remission Rate (ORR) is defined as the proportion of patients with complete remission (CR) and partial remission (PR)
CRR
Complete Remission Rate (CRR) is defined as the proportion of patients with CR
OS
Overall survival (OS) refers to the time from receiving the first dose to death from any cause
Adverse Events
Any harmful reaction that occurs during the treatment of a disease according to the normal usage and dosage of a drug, which is unrelated to the purpose of treatment.
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