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 BGB-3111

What's the purpose of this trial?

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.

This trial is currently open and accepting patients.

What will happen during the trial?

You may be able to join this trial if you:

The following criteria is a partial list of reasons why patients may be eligible to participate in this clinical trial. Further evaluation with a medical professional is required.

Key Inclusion Criteria:

1. Participants must meet protocol defined disease criteria requiring treatment for their respective disease prior to initiation of ibrutinib or acalabrutinib
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

Key Exclusion Criteria:

1. Clinically significant cardiovascular disease including the following:

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.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Additional Trial Information

Phase 2

Enrollment: 90 patients (estimated)

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Trial Locations

All Trial Locations

View all clinical trial locations sorted by state.


Oncology Specialties, PC

Huntsville, AL

Open and Accepting


Arizona Oncology - Rudasill Tucson - Rudasill - Medical Oncology

Tucson, AZ

Open and Accepting


Innovative Clinical Research Institute

Whittier, CA

Open and Accepting


Rocky Mountain Cancer Centers (Midtown)

Denver, CO

Open and Accepting



Florida Cancer Specialists - South (Gladiolus) Fort Myers Cancer Center

Fort Myers, FL

Open and Accepting

21st Century Oncology of Jacksonville - Medical Oncology Division

Jacksonville, FL

Open and Accepting

Florida Cancer Specialists - North - St. Petersburg North

St. Petersburg, FL

Open and Accepting


Healthcare Research Network

Flossmoor, IL

Open and Accepting


Comprehensive Cancer Centers of Nevada (Central Valley)

Las Vegas, NV

Open and Accepting

New Jersey

Summit Health

Florham Park, NJ

Open and Accepting

Morristown Medical Center Atlantic Health System

Morristown, NJ

Open and Accepting

New York

Clinical Research Alliance

Lake Success, NY

Open and Accepting


Willamette Valley Cancer Institute (Eugene)

Eugene, OR

Open and Accepting


St. Luke's University Health Network (Bethlehem) Bethlehem Campus

Bethlehem, PA

Open and Accepting

Alliance Cancer Specialist

Horsham, PA

Open and Accepting



Texas Oncology Amarillo Cancer Center

Amarillo, TX

Open and Accepting

Texas Oncology (Arlington South)

Arlington, TX

Open and Accepting

Texas Oncology - Austin Midtown

Austin, TX

Open and Accepting

Baylor Charles A. Sammons Cancer Center Baylor Scott & White Health

Dallas, TX

Open and Accepting

Texas Oncology (Fort Worth)

Fort Worth, TX

Open and Accepting

Texas Oncology (Mcallen)

McAllen, TX

Open and Accepting

Texas Oncology

Tyler, TX

Open and Accepting


Fairfax Northern Virginia Hematology-Oncology, PC-Gainesville

Gainesville, VA

Open and Accepting


Medical Oncology Associates

Spokane, WA

Open and Accepting


Green Bay Oncology (HSHS St. Vincent Hospital) Saint Vincent Hospital

Green Bay, WI

Open and Accepting

SSM Health Cancer Care

Madison, WI

Open and Accepting
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