Zanubrutinib (BGB-3111) in Participants With Previously Treated B-Cell Lymphoma Intolerant of Prior Bruton Tyrosine Kinase Inhibitor (BTKi) Treatment

Korábbi kezelés

• 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.

Más betegség

• History of central nervous system (CNS) hemorrhage
• Documented progressive disease (PD) during ibrutinib and/or acalabrutinib treatment.

Laborértékek

• 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

• 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