A Study to Evaluate Zanubrutinib to Treat Patients with B-cell Malignancies


About this study

The purpose of this study is to evaluate the long-term safety and effectiveness of zanubrutinib in participants with B-cell malignancies who were previously enrolled in an eligible BeiGene study.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Currently participating or participated recently in a BeiGene parent study.
  • Intent to continue or start zanubrutinib treatment after any of the following:
    • At time of final analysis or study closure of the eligible BeiGene parent study;
    • At time of progressive disease (PD); and investigator, patient and medical monitor agree it is in the patient's best interest;
    • At an alternative timepoint for an alternative reason.
  • Patient who is currently on zanubrutinib treatment:
    • Does not meet any protocol-specified criteria for zanubrutinib hold or permanent discontinuation, and, in the opinion of the investigator, will continue to benefit From zanubrutinib treatment.
  • Zanubrutinib-naive patient:
  • Must meet the following criteria ≤ 15 days before first dose of study drug:
    • Platelets ≥ 50,000/mm^3;
    • Absolute neutrophil count ≥ 750/mm^3;
    • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 x upper limit of normal;
    • Serum total bilirubin ≤ 3 x upper limit of normal (not required for Gilbert Syndrome);
    • QT interval corrected for heart rate using Fridericia's formula (QTcF) ≤ 480 msec;
    • No known New York Heart Association (NYHA) Class III or IV congestive heart failure;
    • Creatinine clearance ≥ 30 mL/min.
  • Female participants of childbearing potential and nonsterile males must be willing to use a highly effective method of birth control.

Key Exclusion Criteria:

  • Permanently discontinued from zanubrutinib treatment in the BeiGene parent study due to unacceptable toxicity, non-compliance with study procedures, or withdrawal of consent.
  • Uncontrolled active systemic infection or recent infection requiring parenteral anti-microbial therapy.
  • Life-threatening illness, medical condition or organ system dysfunction which, in the investigator's opinion, could compromise the participant's safety, interfere with the absorption or metabolism of zanubrutinib, or put the study outcomes at undue risk.
  • Concomitant chemotherapy, targeted therapy, radiation therapy, antibody-based therapies, or any prohibited concomitant therapy outlined in the protocol.
  • Pregnant or lactating woman.
  • Inability to comply with study procedures.
  • Concurrent participation in another therapeutic clinical study.
  • History of progressive disease (PD) while receiving a BTK inhibitor (excluding zanubrutinib).

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

Eligibility last updated 3/8/23 to match cibicaltrials.gov. Questions regarding updates should be directed to the study team contact.


Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Patrick Johnston, M.D., Ph.D.

Closed for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information


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