Zanubrutinib (BGB-3111) in Participants With Previously Treated B-Cell Lymphoma Intolerant of Prior Bruton Tyrosine Kinase Inhibitor (BTKi) Treatment
NCT ID: NCT04116437
Last Updated: 2025-12-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
90 participants
INTERVENTIONAL
2019-10-15
2025-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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
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.
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. 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:
1. 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.
2. 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
3. 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.
4. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
5. 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
Exclusion Criteria
1. Myocardial infarction within 6 months before the Screening
2. Unstable angina within 3 months before the Screening
3. New York Heart Association class III or IV congestive heart failure
4. History of sustained ventricular tachycardia, ventricular fibrillation, and/or Torsades de Pointes
5. QT interval corrected by Fridericia's formula \> 480 milliseconds
6. History of Mobitz II second-degree or third-degree heart block without a permanent pacemaker in place
2. History of central nervous system (CNS) hemorrhage
3. Documented progressive disease (PD) during ibrutinib and/or acalabrutinib treatment.
4. 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
5. 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.
18 Years
ALL
No
Sponsors
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BeiGene
INDUSTRY
Responsible Party
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Locations
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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
Clinical Research Alliance, Inc
Westbury, New York, United States
Oncology Associates of Oregon Willamette Valley Cancer Center
Eugene, Oregon, United States
St Lukes University Health Network
Fountain Hill, Pennsylvania, United States
Abington Hematology Oncology Associates
Horsham, Pennsylvania, United States
Tennessee Oncology, Pllc Nashville
Nashville, Tennessee, United States
Texas Oncology Amarillo
Amarillo, Texas, United States
Texas Oncology Tyler Longview
Austin, Texas, United States
Baylor Research Institute
Dallas, Texas, United States
Texas Oncology McAllen South Second Street
McAllen, Texas, United States
Us Oncology Virginia Cancer Specialists, Pc
Fairfax, Virginia, United States
Virginia Oncology Associates
Norfolk, Virginia, United States
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States
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
Medical Oncology Associates
Spokane, Washington, United States
Ssm Health Cancer Care Dean Medical Center
Madison, Wisconsin, United States
Countries
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References
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Shadman M, Burke JM, Cultrera J, Yimer HA, Zafar SF, Misleh J, Rao SS, Farber CM, Cohen A, Yao H, Idoine A, An Q, Flinn IW, Sharman JP. Zanubrutinib is well tolerated and effective in patients with CLL/SLL intolerant of ibrutinib/acalabrutinib: updated results. Blood Adv. 2025 Aug 26;9(16):4100-4110. doi: 10.1182/bloodadvances.2024015493.
Shadman M, Flinn IW, Levy MY, Porter RF, Burke JM, Zafar SF, Misleh J, Kingsley EC, Yimer HA, Freeman B, Rao SS, Chaudhry A, Tumula PK, Gandhi MD, Manda S, Chen DY, By K, Xu L, Liu Y, Crescenzo R, Idoine A, Zhang X, Cohen A, Huang J, Sharman JP. Zanubrutinib in patients with previously treated B-cell malignancies intolerant of previous Bruton tyrosine kinase inhibitors in the USA: a phase 2, open-label, single-arm study. Lancet Haematol. 2023 Jan;10(1):e35-e45. doi: 10.1016/S2352-3026(22)00320-9. Epub 2022 Nov 16.
Other Identifiers
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BGB-3111-215
Identifier Type: -
Identifier Source: org_study_id