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
Sites (24)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Texas Oncology - Amarillo Coordinator of this site? Confirm its status | Amarillo | United States | Unknown status |
| Rocky Mountain Cancer Centers (Williams) - USOR Coordinator of this site? Confirm its status | Aurora | United States | Unknown status |
| Texas Oncology Tyler Longview Coordinator of this site? Confirm its status | Austin | United States | Unknown status |
| Minnesota Oncology Burnsville Clinic Coordinator of this site? Confirm its status | Burnsville | United States | Unknown status |
| Baylor Research Institute Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
| Oncology Associates of Oregon Willamette Valley Cancer Center Coordinator of this site? Confirm its status | Eugene | United States | Unknown status |
| Us Oncology Virginia Cancer Specialists, Pc Coordinator of this site? Confirm its status | Fairfax | United States | Unknown status |
| Summit Medical Group Coordinator of this site? Confirm its status | Florham Park | United States | Unknown status |
| Healthcare Research Network Iii, Llc Coordinator of this site? Confirm its status | Flossmoor | United States | Unknown status |
| SCRI Florida Cancer Specialists South Coordinator of this site? Confirm its status | Fort Myers | United States | Unknown status |
| St Lukes University Health Network Coordinator of this site? Confirm its status | Fountain Hill | United States | Unknown status |
| Abington Hematology Oncology Associates Coordinator of this site? Confirm its status | Horsham | United States | Unknown status |
| St Century Oncology Coordinator of this site? Confirm its status | Jacksonville | United States | Unknown status |
| Comprehensive Cancer Centers of Nevada Coordinator of this site? Confirm its status | Las Vegas | United States | Unknown status |
| Ssm Health Cancer Care Dean Medical Center Coordinator of this site? Confirm its status | Madison | United States | Unknown status |
| Texas Oncology McAllen South Second Street Coordinator of this site? Confirm its status | McAllen | United States | Unknown status |
| Morristown Medical Center Coordinator of this site? Confirm its status | Morristown | United States | Unknown status |
| Tennessee Oncology, Pllc Nashville Coordinator of this site? Confirm its status | Nashville | United States | Unknown status |
| Christiana Care Coordinator of this site? Confirm its status | Newark | United States | Unknown status |
| Virginia Oncology Associates Coordinator of this site? Confirm its status | Norfolk | United States | Unknown status |
| Fred Hutchinson Cancer Research Center Coordinator of this site? Confirm its status | Seattle | United States | Unknown status |
| Medical Oncology Associates Coordinator of this site? Confirm its status | Spokane | United States | Unknown status |
| SCRI Florida Cancer Specialists North Coordinator of this site? Confirm its status | St. Petersburg | United States | Unknown status |
| Clinical Research Alliance Inc Coordinator of this site? Confirm its status | Westbury | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.