The primary objective of this study is to evaluate the safety of zanubrutinib (also known as BGB-3111) in chronic lymphocytic leukemia/small lymphocytic lymphoma, Waldenström macroglobulinemia, mantle cell lymphoma, or marginal zone lymphoma patients who have become intolerant of prior ibrutinib and/or acalabrutinib treatment, by comparing intolerance to adverse event profile as assessed by the recurrence and the change in severity of adverse events.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
96
Zanubrutinib (BGB-3111) will be orally administered at a dose of 160 mg twice daily or 320mg once daily until disease progression, unacceptable toxicity, treatment consent withdrawal, or study termination.
Rocky Mountain Cancer Centers (Williams) Usor
Aurora, Colorado, United States
Christiana Care
Newark, Delaware, United States
Scri Florida Cancer Specialists South
Fort Myers, Florida, United States
St Century Oncology
Jacksonville, Florida, United States
Scri Florida Cancer Specialists North
St. Petersburg, Florida, United States
Healthcare Research Network Iii, Llc
Flossmoor, Illinois, United States
Minnesota Oncology Burnsville Clinic
Burnsville, Minnesota, United States
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, United States
Summit Medical Group
Florham Park, New Jersey, United States
Morristown Medical Center
Morristown, New Jersey, United States
...and 14 more locations
Recurrence and change in severity of treatment-emergent Adverse Events (AEs) of interest.
Time frame: 24 months
Overall response as determined by investigator
Time frame: 24 months
Progression free survival (PFS) as determined by investigator
Time frame: 24 months
Patient reported outcomes as measured by EuroQol five dimension scale (EQ-5D)
Time frame: 24 months
Patient reported outcomes as measured by European Organisation for Research and Treatment of Cancer (EORTC)
Time frame: 24 months
Disease control rate as determined by investigator
Time frame: 24 months
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