Status:
COMPLETED
Study of Zanubrutinib (BGB-3111) in Participants With Marginal Zone Lymphoma
Lead Sponsor:
BeiGene
Conditions:
Marginal Zone Lymphoma
MZL
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This is a single arm study to evaluate the efficacy, safety and tolerability of zanubrutinib (BGB-3111) in participants with relapsed/refractory marginal zone lymphoma (R/R MZL).
Eligibility Criteria
Inclusion
- Key
- 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
- Key
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.
Key Trial Info
Start Date :
February 19 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 4 2022
Estimated Enrollment :
68 Patients enrolled
Trial Details
Trial ID
NCT03846427
Start Date
February 19 2019
End Date
May 4 2022
Last Update
October 26 2024
Active Locations (31)
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1
Clinical Research Alliance, Inc
Westbury, New York, United States, 11590
2
The Charlotte Mecklenburg Hospital Authority
Charlotte, North Carolina, United States, 28203
3
Canberra Hospital
Garran, Australian Capital Territory, Australia, 2605
4
Concord Repatriation General Hospital
Concord, New South Wales, Australia, 2139