The purpose of this study is to measure the efficacy and safety with zanubrutinib in adults with Treatment-Naive (TN) Waldenström Macroglobulinemia (WM). The main objective of this Phase 4 study is to further characterize the efficacy of zanubrutinib in Chinese participants with TN WM in order to fulfill the post-marketing requirements from the National Medical Products Administration (NMPA). Safety data will be collected and evaluated in this study as well.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
18
Administered orally
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
RECRUITINGSun Yat Sen University Cancer Center
Guangzhou, Guangdong, China
RECRUITINGNanfang Hospital, Southern Medical University
Guangzhou, Guangdong, China
RECRUITINGAffiliated Hospital of Hebei University
Baoding, Hebei, China
RECRUITINGUnion Hospital of Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
RECRUITINGYichang Central Peoples Hospital
Yichang, Hubei, China
RECRUITINGXiangya Hospital of Central South University
Changsha, Hunan, China
RECRUITINGThe First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
RECRUITINGPercentage of Participants Achieving a Complete Response (CR) or Very Good Partial Response (VGPR) as Assessed by the Investigator
The percentage of participants who achieve either a complete response or very good partial response (VGPR) as determined by the investigator using an adaptation of the response criteria updated at the Sixth International Workshop on Waldenström's macroglobulinemia (IWWM).
Time frame: Up to approximately 33 Months
Major Response Rate (MRR) as Assessed by the Investigator
MRR is defined as the percentage of participants achieving CR, VGPR, or partial response (PR) as determined by the investigator per the modified IWWM criteria.
Time frame: Up to approximately 33 Months
Duration of Major Response (DOMR) as Assessed by the Investigator
DOMR is defined as the time from first determination of response (CR, VGPR, or PR) (per modified IWWM criteria) until first documentation of disease progression (per modified IWWM criteria) or death, whichever comes first
Time frame: Up to approximately 33 Months
Progression-free Survival (PFS) as Assessed by the Investigator
Progression-free survival (PFS) as assessed by the investigator, defined as time from start of treatment to the first documentation of disease progression (per modified IWWM criteria) or death, whichever occurs first.
Time frame: Up to approximately 33 Months
Number of Participant with Adverse Events (AEs) and Serious Adverse Events (SAEs)
Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs), including laboratory values, vital signs, physical examination findings, and electrocardiogram results.
Time frame: From first dose of study drug until 30 days after the last dose, up to approximately 33 months
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