Call us 24/7

BeiGene BGB-3111-214 (MAGNOLIA): A phase 2, open-label study of zanubrutinib (BGB-3111) in patients with relapsed or refractory marginal zone lymphoma

Description

This is a single arm study to evaluate the efficacy, safety and tolerability of zanubrutinib (BGB-3111) in patients with relapsed/refractory marginal zone lymphoma (R/R MZL)

Status

Accepting new patients

Primary Study Objective(s)

The objective of this study is to determine the overall response rate (ORR) as determined by an independent central review.

Core eligibility

Note: This is only a partial list of eligibility criteria.

Including patients who:

  • Are 18 years of age or older
  • Have histologically confirmed diagnosis of MZL including splenic, nodal, and extranodal subtypes
  • Have 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 PR or documented PD after, the most recent systemic treatment
  • Have a current need for systemic therapy for MZL
  • Have measurable disease by CT or MRI
  • Have ECOG of 0-2
  • Have a life expectancy of six months or more
  • Have adequate bone marrow function
  • Have adequate organ function
  • Use highly effective methods of contraception

Excluding patients who:

  • Have known transformation to aggressive lymphoma, such as large cell lymphoma
  • Have clinically significant cardiovascular disease
  • Have prior malignancy within the past two years, except for curatively treated basal or squamous cell skin cancer, superficial bladder cancer, carcinoma in situ of the cervix or breast, or localized prostate cancer with a Gleason score of 6.
  • Have a 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
  • Have a history of stroke or intracranial hemorrhage
  • Have severe or debilitating pulmonary disease
  • Have an active fungal, bacterial and/or viral infection requiring systemic therapy
  • Have known central nervous system involvement by lymphoma
  • Have known infection with HIV, or serologic status reflecting active viral hepatitis B (HBV) or viral hepatitis C (HCV) infection
  • Had major surgery within four weeks of the first dose of study drug
  • Had prior treatment with a BTK inhibitor
  • Are pregnant or lactating
  • Requires ongoing treatment with a strong CYP3A inhibitor or inducer
  • Are participating concurrently in another therapeutic clinical trial
     

Accepting new patients

 

Learn more at

clinicaltrials.gov