The goal of this clinical trial was to evaluate whether zanubrutinib can effectively treat adults with CD79B-mutant relapsed or refractory diffuse large B-cell lymphoma (DLBCL). Participants received zanubrutinib as monotherapy, underwent regular disease assessments to evaluate treatment response, and were monitored for safety and side effects throughout the study.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
65
Administered orally as capsules at a dose of 160 mg twice daily on a continuous dosing schedule.
Overall Response Rate (ORR)
Defined as the percentage of participants who achieved complete response (CR) or partial response (PR) by investigator assessment according to the Lugano classification for Non-Hodgkin's Lymphoma (NHL).
Time frame: Response was assessed every 12 weeks for the first 24 months and every 24 weeks thereafter. Maximum time on study was 36.4 months
Complete Response Rate (CRR)
CRR was defined as the percentage of participants who achieved a complete response as their best overall response, as determined by investigator assessment according to the Lugano classification for NHL.
Time frame: Response was assessed every 12 weeks for the first 24 months and every 24 weeks thereafter. Maximum time on study was 36.4 months
Duration of Response (DOR)
DOR was defined as the time from the date that a confirmed response (CR or PR) was first observed to the date of first documented disease progression or death, whichever occurred first. Median DOR was estimated using the Kaplan-Meier method.
Time frame: From the date of first documented response until to the data cutoff date (31MAR2025). Maximum time on study was 36.4 months
Progression-free Survival (PFS)
PFS is defined as time from start of treatment to the first documentation of disease progression or death, whichever occurs first as determined by investigator assessment according to the Lugano classification for NHL. Median PFS was estimated using the Kaplan-Meier method.
Time frame: From first dose until the data cutoff date (31MAR2025). Maximum time on study was 36.4 months
Time to Response (TTR)
TRR was defined as the time from randomization to the first date that response criteria (CR or PR) were met, as determined by investigator assessment per the Lugano classification for NHL. Only participants who achieved an overall response were included in the analysis.
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Anhui Provincial Cancer Hospital Aka West Branch of Anhui Province Hospital
Hefei, Anhui, China
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Fujian Cancer Hospital
Fuzhou, Fujian, China
Sun Yat Sen University Cancer Center
Guangzhou, Guangdong, China
Guangdong Provincial Peoples Hospital Huifu Branch
Guangzhou, Guangdong, China
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
The First Affiliated Hospital of Shantou University Medical College
Shantou, Guangdong, China
Hainan Cancer Hospital
Haikou, Hainan, China
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, China
Henan Cancer Hospital
Zhengzhou, Henan, China
...and 15 more locations
Time frame: From first dose until disease progression or death, assessed up to the data cutoff date (31MAR2025). Maximum time on study was 36.4 months
Overall Survival (OS)
OS was defined as the time from randomization to the date of death from any cause. Median OS was estimated using the Kaplan-Meier method.
Time frame: From first dose until the data cutoff date (31MAR2025). Maximum time on study was 36.4 months
Number of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
An adverse event refers to any unintended or unfavorable sign, symptom, or condition (including abnormal lab results) that occurs during the study, regardless of whether it was linked to the study drug.
Time frame: From the first dose until 30 days after the last dose of zanubrutinib, death, or initiation of new anticancer therapy, whichever occurred first, assessed up to the data cutoff date (31MAR2025). Maximum treatment duration was 36.4 months