Study on Zanubrutinib for Patients with B-Cell Lymphoma Who Cannot Tolerate Previous BTK Inhibitor Treatments

Sponsor: BeiGene

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT04116437

This clinical trial is testing the safety of a drug called zanubrutinib in patients with certain types of B-cell lymphoma who have had intolerable side effects from previous treatments with ibrutinib or acalabrutinib.

Patient Parameters

Program Overview

The main goal of this study is to see if zanubrutinib is safe for patients with chronic lymphocytic leukemia, small lymphocytic lymphoma, Waldenström macroglobulinemia, mantle cell lymphoma, or marginal zone lymphoma who could not tolerate previous treatments with ibrutinib or acalabrutinib. Researchers will compare the side effects experienced with zanubrutinib to those from the previous treatments.

Eligibility Criteria

Inclusion Criteria

  • Must have a type of B-cell lymphoma that required treatment before starting ibrutinib or acalabrutinib.
  • Must have experienced intolerable side effects from ibrutinib or acalabrutinib, such as:
    • Non-blood related side effects that are moderate or severe and last more than 7 days.
    • Severe non-blood related side effects of any length.
    • Severe low white blood cell count with infection or fever.
    • Very severe blood-related side effects that led to stopping the treatment.
    • For acalabrutinib only: mild side effects that happen repeatedly or last more than 7 days, or inability to use certain medications due to acalabrutinib.
  • Side effects from previous treatments must have improved to mild or gone back to normal before starting zanubrutinib.
  • Must be in good general health with a performance status score of 0, 1, or 2.
  • Must have adequate blood cell counts before starting zanubrutinib.

Exclusion Criteria

  • Have serious heart problems, such as a recent heart attack, unstable chest pain, severe heart failure, or certain heart rhythm issues.
  • Have a history of bleeding in the brain.
  • Have worsening disease while on ibrutinib or acalabrutinib.
  • Have received other cancer treatments recently, within 7 days for most therapies or 4 weeks for immunotherapy.
  • Need to take more than 10 mg of prednisone or equivalent corticosteroid daily. Must stop systemic corticosteroids at least 5 days before starting the study drug.

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