Status:
ACTIVE_NOT_RECRUITING
Zanubrutinib (BGB-3111) in Participants With Previously Treated B-Cell Lymphoma Intolerant of Prior Bruton Tyrosine Kinase Inhibitor (BTKi) Treatment
Lead Sponsor:
BeiGene
Conditions:
Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Mantle Cell Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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...
Eligibility Criteria
Inclusion
- Key
- 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
- 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.
Key Trial Info
Start Date :
October 15 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT04116437
Start Date
October 15 2019
End Date
December 31 2025
Last Update
December 23 2025
Active Locations (24)
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1
Rocky Mountain Cancer Centers (Williams) Usor
Aurora, Colorado, United States, 80012-5405
2
Christiana Care
Newark, Delaware, United States, 19713-2055
3
Scri Florida Cancer Specialists South
Fort Myers, Florida, United States, 33901-8108
4
St Century Oncology
Jacksonville, Florida, United States, 32204-1128