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

Overview

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 enrolled in an eligible BeiGene study or recently treated with zanubrutinib in an eligible BeiGene study.
  • Intent to continue or start zanubrutinib treatment after occurrence of any of the following in the eligible BeiGene study:
    • At time of final analysis or study closure;
    • At time of disease progression if:
      • Patient was receiving a non-BTK inhibitor comparator drug on the eligible BeiGene study at the time of progression and both investigator and patient agree that the patient may clinically benefit from zanubrutinib treatment (sponsor agreement required before enrollment);
      • Patient was receiving zanubrutinib on the eligible BeiGene study at the time of progression and both investigator and the patient agree it is in the patient's best interest to continue zanubrutinib (sponsor agreement required before enrollment);
      • Sponsor decision to transfer patient from eligible BeiGene study at an alternative time and confirm eligibility for this current long-term extension study.
  • In the opinion of the investigator, patient will continue to benefit from zanubrutinib treatment.
  • Must meet the following criteria within 15 days before first dose of zanubrutinib:
    • Platelets ≥ 50,000/mm^3;
    • Absolute neutrophil count ≥ 750/mm^3;
    • Aspartate aminotransferase and alanine aminotransferase ≤ 2 x upper limit of normal;
    • Serum total bilirubin < 2.5 x upper limit of normal;
    • QTcF ≤ 480 msec;
    • No known New York Heart Association Class III or IV congestive heart failure;
    • Creatinine clearance ≥ 30 mL/min as estimated by the Cockcroft-Gault equation or estimated glomerular filtration rate [eGFR] from the Modification of Diet in Renal Disease) based on ideal body mass.
  • Female patients of childbearing potential must agree to practice highly effective methods of birth control initiated before the first dose of zanubrutinib, for the duration of the study, and for ≥ 90 days after the last dose of zanubrutinib.
  • Male patients are eligible if abstinent, vasectomized or if they agree to the use of barrier contraception in combination with protocol-approved highly effective methods during the study treatment period and for ≥ 90 days after the last dose of zanubrutinib.
  • Written informed consent obtained before enrolling in this current long-term extension study and receiving study drug.

Inclusion Criteria for Survival Follow-up Patients Only:

  • Currently enrolled in an eligible BeiGene study, or recently treated with zanubrutinib in an eligible BeiGene study.
  • Written informed consent obtained prior to enrolling in this current long-term extension study.

Exclusion Criteria:

  • Permanently discontinued from zanubrutinib treatment in the eligible BeiGene 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.
  • Pregnant or lactating women.
  • Inability to comply with study procedures.
  • Concurrent participation in another therapeutic clinical study.

Exclusion Criteria for Survival Follow-up Patients Only:

  • Permanently discontinued from the eligible BeiGene study.
  • Inability to comply with requests for survival follow-up.

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

Publications

Publications are currently not available

Additional contact information

Cancer-related trials contact form

Phone: 855-776-0015 (toll-free)

International patient clinical studies questions