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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
23
160 mg bid po, until disease progression, intolerance of drug toxicity or death, otherwise maintaining during the 2 years of follow-up
375 mg/m\^2 ivgtt, D0 of each 28-day cycle
90mg/m\^2 ivgtt, D0 of each 28-day cycle
Ruijin Hospital
Shanghai, Shanghai Municipality, China
RECRUITING2-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.
Time frame: 2 years
ORR
Objective Remission Rate (ORR) is defined as the proportion of patients with complete remission (CR) and partial remission (PR)
Time frame: End of treatment visit (6-8 weeks after last dose on Day 1 of Cycle 6 [Cycle length=28 days]
CRR
Complete Remission Rate (CRR) is defined as the proportion of patients with CR
Time frame: End of treatment visit (6-8 weeks after last dose on Day 1 of Cycle 6 [Cycle length=28 days]
OS
Overall survival (OS) refers to the time from receiving the first dose to death from any cause
Time frame: Baseline up to data cut-off (up to approximately 2 years)
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.
Time frame: Baseline up to data cut-off (up to approximately 2 years)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.