Chronic Lymphocytic Leukemia Clinical Trial
Zanubrutinib (BGB-3111) in Participants With Previously Treated B-Cell Lymphoma Intolerant of Prior Bruton Tyrosine Kinase Inhibitor (BTKi) Treatment
The primary objective of this study is to evaluate the safety of zanubrutinib (also known as BGB-3111) in leukemia-cll/" >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.
Key Inclusion Criteria:
Participants must meet protocol defined disease criteria requiring treatment for their respective disease prior to initiation of ibrutinib or acalabrutinib
Ibrutinib and acalabrutinib intolerance is defined as an unacceptable toxicity where, in the opinion of the investigator, treatment should be discontinued in spite of optimal supportive care as a result of one of the following:
For ibrutinib and acalabrutinib intolerance events:
1 or more ≥ Grade 2 nonhematologic toxicities for >7 days (with or without treatment)
1 or more ≥ Grade 3 nonhematologic toxicity of any duration
1 or more Grade 3 neutropenia with infection or fever of any duration; or
Grade 4 heme toxicity which persists to the point that the investigator chose to stop therapy due to toxicity NOT progression.
For acalabrutinib intolerance events only;
1 or more ≥ Grade 1 nonhematologic toxicities of any duration with > 3 recurrent episodes; or
1 or more ≥ Grade 1 nonhematologic toxicities for > 7 days (with or without treatment); or
Inability to use acid-reducing agents or anticoagulants (eg, proton pump inhibitors, warfarin) due to concurrent acalabrutinib use
Ibrutinib and/or acalabrutinib-related ≥ Grade 2 toxicities must have resolved to ≤ Grade 1 or baseline prior to initiating treatment with zanubrutinib. Grade 1 acalabrutinib-related toxicities must have resolved to Grade 0 or baseline prior to initiating treatment with zanubrutinib.
Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
Absolute neutrophil count (ANC) ≥ 1000/mm^3 with or without growth factor support and platelet count ≥ 50,000/mm^3 (may be post-transfusion), on or prior to C1D1 of zanubrutinib
Key Exclusion Criteria:
Clinically significant cardiovascular disease including the following:
Myocardial infarction within 6 months before the Screening
Unstable angina within 3 months before the Screening
New York Heart Association class III or IV congestive heart failure
History of sustained ventricular tachycardia, ventricular fibrillation, and/or Torsades de Pointes
QT interval corrected by Fridericia's formula > 480 milliseconds
History of Mobitz II second-degree or third-degree heart block without a permanent pacemaker in place
History of central nervous system (CNS) hemorrhage
Documented progressive disease (PD) during ibrutinib and/or acalabrutinib treatment.
Have received any anticancer therapy (other than immunotherapy) for CLL/SLL, WM, MCL, and MZL < 7 days before any Screening assessments are performed or any immunotherapy treatment, taken alone or as part of a chemoimmunotherapy regimen, < 4 weeks before any Screening assessments are performed
Requires ongoing need for corticosteroid treatment > 10 mg daily of prednisone or equivalent corticosteroid. Note: Systemic corticosteroids must be fully tapered off/discontinued ≥ 5 days before the first dose of study drug is administered.
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
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There are 31 Locations for this study
Huntsville Alabama, 35805, United States
Tucson Arizona, 85704, United States
Whittier California, 90603, United States
Lone Tree Colorado, 80124, United States
Newark Delaware, 19713, United States
Fort Myers Florida, 33901, United States
Jacksonville Florida, 32256, United States
Saint Petersburg Florida, 33770, United States
Flossmoor Illinois, 60472, United States
Las Vegas Nevada, 89169, United States
Florham Park New Jersey, 07932, United States
Hackensack New Jersey, 07601, United States
Morristown New Jersey, 07960, United States
New York New York, 10016, United States
New York New York, 10021, United States
Eugene Oregon, 97401, United States
Bethlehem Pennsylvania, 18015, United States
Horsham Pennsylvania, 19044, United States
Nashville Tennessee, 37203, United States
Amarillo Texas, 79106, United States
Arlington Texas, 76012, United States
Austin Texas, 78705, United States
Dallas Texas, 75246, United States
Fort Worth Texas, 76104, United States
McAllen Texas, 78503, United States
Tyler Texas, 75702, United States
Gainesville Virginia, 20155, United States
Seattle Washington, 98109, United States
Spokane Washington, 99208, United States
Green Bay Wisconsin, 54301, United States
Madison Wisconsin, 53715, United States
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