A Phase 4, Observational Study Evaluating the Efficacy and Safety of the Bruton Tyrosine Kinase (BTK) Inhibitor Zanubrutinib in Patients With Waldenström Macroglobulinemia
Summary
This is a hybrid (retrospective and prospective) non-interventional registry study to further describe the clinical profile of zanubrutinib in Waldenström macroglobulinemia (WM) participants with and without specific mutations and from racial and ethnic minority groups. Data collected from this registry study will be used to better understand the clinical benefit and safety of zanubrutinib for the treatment of participants in these populations.
Arms & interventions
- DrugZanubrutinib
Dosing and treatment duration are at the discretion of the prescribing physician and in accordance with local labeling
Outcome measures
Primary
Major Response Rate (MRR)
MRR is defined as the proportion of participants achieving either complete response (CR), very good partial response (VGPR), or partial response (PR) as determined by the investigator using an adaptation of the response criteria updated at the Sixth International Workshop on WM (IWWM)
Time frame: Up to approximately 4 years
Secondary
VGPR+ Rate
Time frame: Up to approximately 5 years
Overall Response Rate (ORR)
Time frame: Up to approximately 5 years
Duration of Response (DOR)
Time frame: Up to approximately 5 years
Number of Participants with Treatment-emergent Adverse Events
Time frame: Up to approximately 5 years
Eligibility criteria
Study locations (7)
Clearview Cancer Institute
Huntsville, Alabama, 35805-2606
South Alabama Medical Science Foundation Mitchell Cancer Institute
Mobile, Alabama, 36604-1405
City of Hope National Medical Center
Duarte, California, 91010-3012
Los Angeles Cancer Network (Lacn)
Glendale, California, 91204-3640
Eisenhower Medical Center, Lucy Curci Cancer Center
Rancho Mirage, California, 92270-3221
Hattiesburg Hematology and Oncology Clinic
Hattiesburg, Mississippi, 39401-7233
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, 89169-3321