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NCT04116437CompletedPhase 2

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

A Phase 2, Multicenter, Single-arm Study of Zanubrutinib (BGB-3111) in Patients With Previously Treated B-Cell Lymphoma Intolerant of Prior Treatment With Ibrutinib and/or Acalabrutinib

Source: ClinicalTrials.gov · Last updated 28 Jan 2026

Brief summary (registry, in English)

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.

Status (registry)
Completed
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
96 (actual)
First submitted
1 Oct 2019
Start date
15 Oct 2019
Primary completion date
9 Jan 2026
Lead sponsor
BeiGene
NCT number
NCT04116437

What you commit to

  • Study type: Interventional · Phase 2
  • Participants enrolled: 96
  • From 15 Oct 2019 to the primary completion date, 9 Jan 2026
  • 24 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior 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.

Other illness

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

Lab values

  • 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

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (24)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Texas Oncology - Amarillo
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AmarilloUnited StatesUnknown status
Rocky Mountain Cancer Centers (Williams) - USOR
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AuroraUnited StatesUnknown status
Texas Oncology Tyler Longview
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AustinUnited StatesUnknown status
Minnesota Oncology Burnsville Clinic
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BurnsvilleUnited StatesUnknown status
Baylor Research Institute
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DallasUnited StatesUnknown status
Oncology Associates of Oregon Willamette Valley Cancer Center
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EugeneUnited StatesUnknown status
Us Oncology Virginia Cancer Specialists, Pc
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FairfaxUnited StatesUnknown status
Summit Medical Group
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Florham ParkUnited StatesUnknown status
Healthcare Research Network Iii, Llc
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FlossmoorUnited StatesUnknown status
SCRI Florida Cancer Specialists South
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Fort MyersUnited StatesUnknown status
St Lukes University Health Network
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Fountain HillUnited StatesUnknown status
Abington Hematology Oncology Associates
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HorshamUnited StatesUnknown status
St Century Oncology
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JacksonvilleUnited StatesUnknown status
Comprehensive Cancer Centers of Nevada
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Las VegasUnited StatesUnknown status
Ssm Health Cancer Care Dean Medical Center
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MadisonUnited StatesUnknown status
Texas Oncology McAllen South Second Street
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McAllenUnited StatesUnknown status
Morristown Medical Center
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MorristownUnited StatesUnknown status
Tennessee Oncology, Pllc Nashville
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NashvilleUnited StatesUnknown status
Christiana Care
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NewarkUnited StatesUnknown status
Virginia Oncology Associates
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NorfolkUnited StatesUnknown status
Fred Hutchinson Cancer Research Center
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SeattleUnited StatesUnknown status
Medical Oncology Associates
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SpokaneUnited StatesUnknown status
SCRI Florida Cancer Specialists North
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St. PetersburgUnited StatesUnknown status
Clinical Research Alliance Inc
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WestburyUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.