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Closed (no longer recruiting)Last updated: 30 January 2024

BGB-3111-214: This phase II trial is evaluating the safety and response of an investigational therapy (Zanubrutinib) in patients with marginal zone lymphoma that has got worse or not responded to prior treatmentA Phase 2, Open-label Study of Zanubrutinib (BGB-3111) in Patients With Relapsed or Refractory Marginal Zone Lymphoma

Clinical summary

Summary

In this trial, patients will be assigned to a single arm to receive Zanubrutinib at a dose of 160 mg PO BID.

Conditions

This trial is treating patients with Marginal Zone Lymphoma.

Cancer

Blood Cancers Haematological

Age

People18+

Phase

II

Trial Acronym

BGB-3111-214

More information

Trial Identifiers

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

Trial sponsor

BeiGene Australia Pty Ltd

Scientific Title

A Phase 2, Open-label Study of Zanubrutinib (BGB-3111) in Patients With Relapsed or Refractory Marginal Zone Lymphoma

Eligibility

Inclusion

  1. Age 18 years or older
  2. Histologically confirmed diagnosis of MZL including splenic, nodal, and extranodal subtypes
  3. Previously received one or more lines of therapy including at least one CD20-directed regimen (either as monotherapy or as chemoimmunotherapy) with documented failure to achieve at least partial response or documented progressive disease (PD) after, the most recent systemic treatment
  4. Current need for systemic therapy for MZL
  5. Measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI)
  6. Eastern Cooperative Oncology Group (ECOG) of 0-2
  7. Life expectancy ≥ 6 months
  8. Adequate bone marrow function
  9. Adequate organ function
  10. Male and female participants must use highly effective methods of contraception

Exclusion

  1. Known transformation to aggressive lymphoma, eg, large cell lymphoma
  2. Clinically significant cardiovascular disease
  3. Prior malignancy within the past 2 years, except for curatively treated basal or squamous cell skin cancer, superficial bladder cancer, carcinoma in situ of the cervix or breast, or localized Gleason score 6 prostate cancer
  4. History of severe bleeding disorder such as hemophilia A, hemophilia B, von Willebrand disease, or history of spontaneous bleeding requiring blood transfusion or other medical intervention
  5. History of stroke or intracranial hemorrhage
  6. Severe or debilitating pulmonary disease
  7. Active fungal, bacterial and/or viral infection requiring systemic therapy
  8. Known central nervous system involvement by lymphoma
  9. Known infection with HIV, or serologic status reflecting active viral hepatitis B (HBV) or viral hepatitis C (HCV) infection
  10. Major surgery within 4 weeks of the first dose of study drug
  11. Prior treatment with a Bruton's tyrosine kinase (BTK) inhibitor
  12. Pregnant or lactating women
  13. Requires ongoing treatment with a strong Cytochrome P4503A (CYP3A) inhibitor or inducer
  14. Concurrent participation in another therapeutic clinical trial

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

Inclusion

  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.

Exclusion

  • You have been diagnosed with a prior or secondary type of cancer.
  • You have certain types of non-cancer medical conditions.
  • You have previously been treated (or are currently being treated) on a clinical trial.
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Clinical trials have complex eligibility criteria.

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