Trial purpose
Cancer treatment
Tumor type
Haematological
Age
18+
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 people with Marginal Zone Lymphoma
Eligibility
Inclusion
- Age 18 years or older
- Histologically confirmed diagnosis of MZL including splenic, nodal, and extranodal subtypes
- 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
- Current need for systemic therapy for MZL
- Measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI)
- Eastern Cooperative Oncology Group (ECOG) of 0-2
- Life expectancy ≥ 6 months
- Adequate bone marrow function
- Adequate organ function
- Male and female participants must use highly effective methods of contraception
Exclusion
- Known transformation to aggressive lymphoma, eg, large cell lymphoma
- Clinically significant cardiovascular disease
- 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
- 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
- History of stroke or intracranial hemorrhage
- Severe or debilitating pulmonary disease
- Active fungal, bacterial and/or viral infection requiring systemic therapy
- Known central nervous system involvement by lymphoma
- Known infection with HIV, or serologic status reflecting active viral hepatitis B (HBV) or viral hepatitis C (HCV) infection
- Major surgery within 4 weeks of the first dose of study drug
- Prior treatment with a Bruton's tyrosine kinase (BTK) inhibitor
- Pregnant or lactating women
- Requires ongoing treatment with a strong Cytochrome P4503A (CYP3A) inhibitor or inducer
- 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 are currently being treated on a clinical trial.
Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:
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
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