This was a multicenter, open-label, phase 2 study to evaluate efficacy, safety, and tolerability of BGB-3111 (zanubrutinib) 160 milligrams (mg) twice daily (BID) in combination with rituximab in Chinese participants with relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL) (non-GCB \[non-germinal center B-cell-like\] subtype) and R/R indolent lymphoma (follicular lymphoma \[FL\] and marginal zone lymphoma \[MZL\]).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
41
Administered zanubrutinib 160 mg orally (PO) BID continuously
Administered rituximab 375 mg/m\^2 intravenously on Cycle 1 Days 1, 8, 15, 22, and on Day 1 of Cycles 4, 6, 8, 10. Each cycle was 28 days long.
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, China
Tongji Hospital of Tongji Medical College Huazhong University of Science and Technology
Wuhan, Hubei, China
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, China
Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China
Overall Response Rate (ORR) As Measured By The Investigator
The percentage of participants whose best overall response met partial response (PR) or complete response (CR) criteria among all participants. The 95% confidence interval (CI) was calculated with the Clopper-Pearson method.
Time frame: Up to approximately 2.5 years
Duration Of Response (DOR) As Determined By Investigator
The DOR was defined as the time from the date that the response criteria were first met to the date that progressive disease (PD) was objectively documented or death, whichever occurred first. Medians were estimated by the Kaplan-Meier method with 95% CIs estimated using the Brookmeyer and Crowley method.
Time frame: Up to approximately 2.5 years
DOR: Event-free Rate
The DOR was defined as the time from the date that the response criteria were first met to the date that progressive disease (PD) was objectively documented or death, whichever occurred first. The event-free rate was estimated by the Kaplan-Meier method with 95% CIs estimated using Greenwood's formula.
Time frame: Up to approximately 2.5 years
Progression-free Survival (PFS) As Determined By Investigator
The PFS was defined as time from first dose of study treatment until first documentation of progression, assessed per the Lugano Classification, or death, whichever occurred first. Medians were estimated by the Kaplan-Meier method with 95% CIs estimated using the Brookmeyer and Crowley method.
Time frame: Up to approximately 2.5 years
PFS: Event-free Rate
The PFS was defined as time from first dose of study treatment until first documentation of progression, assessed per the Lugano Classification, or death, whichever occurred first. The event-free rate was estimated by the Kaplan-Meier method with 95% CIs estimated using Greenwood's formula.
Time frame: Up to approximately 2.5 years
Overall Survival (OS)
The OS was defined as the time from the date of first dose of study treatment to the date of death due to any cause. Medians were estimated by the Kaplan-Meier method with 95% CIs estimated using the method of Brookmeyer and Crowley.
Time frame: Up to approximately 2.5 years
OS: Survival Rate
The OS was defined as the time from the date of first dose of study treatment to the date of death due to any cause. Survival rates were estimated by the Kaplan-Meier method with 95% CIs estimated using Greenwood's formula.
Time frame: Up to approximately 2.5 years
Time To Response (TTR) As Determined By The Investigator
The TTR was defined as the time from the date of the first dose of study treatment to the date of the first qualifying response (partial response or better).
Time frame: Up to approximately 2.5 years
Median TTR
The TTR was defined as the time from the date of the first dose of study treatment to the date of the first qualifying response (partial response or better).
Time frame: Up to approximately 2.5 years
Complete Response Rate As Determined By The Investigator
The percentage of participants whose best overall response met complete response or complete metabolic response criteria among all participants are reported. The 95% CI was calculated with Clopper-Pearson method.
Time frame: Up to approximately 2.5 years
Number Of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) And Serious TEAEs
A treatment-emergent adverse event was defined as an adverse event with an onset or worsening (if present pretreatment) starting on or after the first dose of study drug up to 30 days after discontinuation of zanubrutinib or 90 days after discontinuation of rituximab, whichever occurred later; or initiation of new anticancer therapy if it occurred prior to the other 2 dates. Worsening of a treatment-emergent adverse event to Grade 5 beyond Day 30 after the last dose of zanubrutinib or Day 90 after the last dose rituximab was also considered a treatment-emergent adverse event if the event occurred prior to initiation of new anticancer therapy.
Time frame: Up to approximately 2.5 years
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