Zanubrutinib (BGB-3111) in Participants With Previously Treated B-Cell Lymphoma Intolerant of Prior Bruton Tyrosine Kinase Inhibitor (BTKi) Treatment
Study Details
Study Description
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 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.
Condition or Disease | Intervention/Treatment | Phase |
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Phase 2 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: Zanubrutinib Cohort 1: Chronic lymphocytic leukemia (CLL)/ small lymphocytic lymphoma (SLL), Waldenström macroglobulinemia (WM), mantle cell lymphoma (MCL), or marginal zone lymphoma (MZL) previously treated with ibrutinib Cohort 2: Chronic lymphocytic leukemia (CLL)/ small lymphocytic lymphoma (SLL), Waldenström macroglobulinemia (WM), mantle cell lymphoma (MCL), or marginal zone lymphoma (MZL) previously treated with acalabrutinib alone/with ibrutinib |
Drug: Zanubrutinib
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.
Other Names:
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Outcome Measures
Primary Outcome Measures
- Recurrence and change in severity of treatment-emergent Adverse Events (AEs) of interest. [24 months]
Secondary Outcome Measures
- Overall response as determined by investigator [24 months]
- Progression free survival (PFS) as determined by investigator [24 months]
- Patient reported outcomes as measured by EuroQol five dimension scale (EQ-5D) [24 months]
- Patient reported outcomes as measured by European Organisation for Research and Treatment of Cancer (EORTC) [24 months]
- Disease control rate as determined by investigator [24 months]
Eligibility Criteria
Criteria
Key Inclusion Criteria:
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Participants must meet protocol defined disease criteria requiring treatment for their respective disease prior to initiation of ibrutinib or acalabrutinib
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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:
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For ibrutinib and acalabrutinib intolerance events:
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1 or more ≥ Grade 2 nonhematologic toxicities for >7 days (with or without treatment)
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1 or more ≥ Grade 3 nonhematologic toxicity of any duration
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1 or more Grade 3 neutropenia with infection or fever of any duration; or
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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;
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1 or more ≥ Grade 1 nonhematologic toxicities of any duration with > 3 recurrent episodes; or
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1 or more ≥ Grade 1 nonhematologic toxicities for > 7 days (with or without treatment); or
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Inability to use acid-reducing agents or anticoagulants (eg, proton pump inhibitors, warfarin) due to concurrent acalabrutinib use
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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.
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Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
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Absolute neutrophil count (ANC) ≥ 1000/mm3 with or without growth factor support and platelet count ≥ 50,000/mm3 (may be post-transfusion), on or prior to C1D1 of zanubrutinib
Key Exclusion Criteria:
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Clinically significant cardiovascular disease including the following:
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Myocardial infarction within 6 months before the Screening
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Unstable angina within 3 months before the Screening
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New York Heart Association class III or IV congestive heart failure
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History of sustained ventricular tachycardia, ventricular fibrillation, and/or Torsades de Pointes
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QT interval corrected by Fridericia's formula > 480 milliseconds
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History of Mobitz II second-degree or third-degree heart block without a permanent pacemaker in place
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History of central nervous system (CNS) hemorrhage
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Documented progressive disease (PD) during ibrutinib and/or acalabrutinib treatment.
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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
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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.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Oncology Specialties, PC | Huntsville | Alabama | United States | 35805 |
2 | Arizona Oncology Associates - Tucson - Rudasill Road | Tucson | Arizona | United States | 85704 |
3 | Innovative Clinical Research Institute | Whittier | California | United States | 90603 |
4 | Rocky Mountain Cancer Centers | Lone Tree | Colorado | United States | 80124 |
5 | Medical Oncology Hematology Consultants, PA | Newark | Delaware | United States | 19713 |
6 | SCRI Florida Cancer Specialists South | Fort Myers | Florida | United States | 33901 |
7 | 21st Century Oncology of Jacksonville - Medical Oncology Division | Jacksonville | Florida | United States | 32256 |
8 | Florida Cancer Specialists | Saint Petersburg | Florida | United States | 33770 |
9 | Healthcare Research Network | Flossmoor | Illinois | United States | 60472 |
10 | Comprehensive Cancer Centers of Nevada(CCCN) | Las Vegas | Nevada | United States | 89169 |
11 | Summit Medical Group (SMG) - Florham Park Campus | Florham Park | New Jersey | United States | 07932 |
12 | Hackensack University Medical Center | Hackensack | New Jersey | United States | 07601 |
13 | Atlantic Health System/Morristown Medical Center | Morristown | New Jersey | United States | 07960 |
14 | Manhattan Hematology Oncology Associates, P.C. | New York | New York | United States | 10016 |
15 | Clinical Research Alliance | New York | New York | United States | 10021 |
16 | Oncology Associates of Oregon - Willamette Valley Cancer | Eugene | Oregon | United States | 97401 |
17 | St. Luke's University Health Network | Bethlehem | Pennsylvania | United States | 18015 |
18 | Alliance Cancer Specialist | Horsham | Pennsylvania | United States | 19044 |
19 | Tennessee Oncology | Nashville | Tennessee | United States | 37203 |
20 | Texas Oncology-Amarillo | Amarillo | Texas | United States | 79106 |
21 | Texas Oncology-Arlington South | Arlington | Texas | United States | 76012 |
22 | Texas Oncology | Austin | Texas | United States | 78705 |
23 | Texas Oncology, P.A. - Baylor Charles A. Sammons Cancer Center | Dallas | Texas | United States | 75246 |
24 | Texas Oncology - Fort Worth Cancer Center | Fort Worth | Texas | United States | 76104 |
25 | Texas Oncology-McAllen South Second Street | McAllen | Texas | United States | 78503 |
26 | Texas Oncology, P.A. - Tyler | Tyler | Texas | United States | 75702 |
27 | Virginia Cancer Specialists | Gainesville | Virginia | United States | 20155 |
28 | Fred Hutchinson Cancer Research Center | Seattle | Washington | United States | 98109 |
29 | Medical Oncology Associates | Spokane | Washington | United States | 99208 |
30 | Green Bay Oncology | Green Bay | Wisconsin | United States | 54301 |
31 | SSM Health Cancer Care | Madison | Wisconsin | United States | 53715 |
Sponsors and Collaborators
- BeiGene
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- BGB-3111-215