Ruijin Hospital
Shanghai, Shanghai Municipality, 200020, China
Location status: Recruiting
NCT Number: NCT06136351
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Phase 2
Shanghai, Shanghai Municipality, 200020, China
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Time frame: 2 years
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: End of treatment visit (6-8 weeks after last dose on Day 1 of Cycle 6 [Cycle length=28 days]
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]
Complete Remission Rate (CRR) is defined as the proportion of patients with CR
Time frame: Baseline up to data cut-off (up to approximately 2 years)
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)
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.
Ruijin Hospital
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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