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Closed (no longer recruiting)Last updated: 7 May 2024

The purpose of this study is to evaluate the long-term safety of treatment regimens with the targeted therapy drug zanubrutinib in people with B-cell malignancies who have participated in a previous clinical trial for zanubrutinibAn Open-label, Multi-center, Long-term Extension Study of Zanubrutinib (BGB-3111) Regimens in Patients With B-cell Malignancies

Clinical summary

Summary

Eligible participants will receive zanubrutinib (160mg twice daily or the last dose level received in the BeiGene parent study).

Participants in Australia who participated in a parent study that involved combination therapy of zanubrutinib and tislelizumab will receive zanubrutinib (160mg twice daily, or the last dose level received in the BeiGene parent study) plus tislelizumab (200mg every three weeks).

Conditions

This trial is treating patients with B-cell malignancies who are either currently participating, or recently participated, in a BeiGene parent study

Cancer

Blood Cancers Haematological

Age

People18+

Phase

III

More information

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

Trial sponsor

BeiGene

Scientific Title

An Open-label, Multi-center, Long-term Extension Study of Zanubrutinib (BGB-3111) Regimens in Patients With B-cell Malignancies

Eligibility

Inclusion

  1. Currently participating or participated recently in a BeiGene parent study
  2. Intent to continue or start zanubrutinib treatment after any of the following:

    1. At time of final analysis or study closure of the eligible BeiGene parent study
    2. At time of progressive disease (PD); and investigator, patient and medical monitor agree it is in the patient's best interest
    3. At an alternative timepoint for an alternative reason
  3. 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

  4. Zanubrutinib-naive patient:

    Must meet the following criteria ≤ 15 days before first dose of study drug:

    1. Platelets ≥ 50,000/mm3
    2. Absolute neutrophil count ≥ 750/mm3
    3. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 x upper limit of normal
    4. Serum total bilirubin ≤ 3 x upper limit of normal (not required for Gilbert Syndrome)
    5. QT interval corrected for heart rate using Fridericia's formula (QTcF) ≤ 480 msec
    6. No known New York Heart Association (NYHA) Class III or IV congestive heart failure
    7. Creatinine clearance ≥ 30 mL/min
  5. Female participants of childbearing potential and nonsterile males must be willing to use a highly effective method of birth control.

Exclusion

  1. Permanently discontinued from zanubrutinib treatment in the BeiGene parent study due to unacceptable toxicity, non-compliance with study procedures, or withdrawal of consent
  2. Uncontrolled active systemic infection or recent infection requiring parenteral anti-microbial therapy
  3. 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
  4. Concomitant chemotherapy, targeted therapy, radiation therapy, antibody-based therapies, or any prohibited concomitant therapy outlined in the protocol
  5. Pregnant or lactating woman
  6. Inability to comply with study procedures
  7. Concurrent participation in another therapeutic clinical study
  8. History of progressive disease (PD) while receiving a BTK inhibitor (excluding zanubrutinib)

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply

Inclusion

  • You have previously participated in a certain specific trial.
  • You are currently receiving treatment for your cancer.

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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