Brief Title
A Single-Arm, Expanded Access Study of Zanubrutinib in Participants With B-cell Malignancies
Official Title
A Single-Arm, Expanded Access Study of Zanubrutinib (BGB3111) in Participants With B-cell Malignancies
Brief Summary
This is a multicenter expanded access study of zanubrutinib monotherapy for participants with
B-cell malignancies who are ineligible to enroll into any available zanubrutinib clinical
trials
Study Type
Expanded Access
Condition
Waldenström Macroglobulinemia
Intervention
Zanubrutinib
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Eligibility Criteria
Key Inclusion Criteria:
1. Histologically confirmed diagnosis of WM with R/R disease or treatment-naive and
considered by their treating physician to be unsuitable for standard
chemoimmunotherapy regimens
2. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
3. Absolute neutrophil count (ANC) ≥ 0.75 x 109/L, independent of growth factor support;
and Platelet count ≥ 50 x 109/L, independent of growth factor support or transfusion
within 7 days of study entry
4. Creatinine clearance of ≥ 30 mL/min
5. Aspartate aminotransferase (AST)/serum glutamic-oxaloacetic transaminase (SGOT) and
alanine aminotransferase (ALT)/serum glutamic pyruvic transaminase (SGPT) ≤ 3 x upper
limit of normal (ULN)
6. Total bilirubin level ≤ 2 x ULN (unless documented Gilbert's syndrome)
Key Exclusion Criteria:
1. Prior exposure to a Bruton tyrosine kinase (BTK) inhibitor
2. Evidence of disease transformation at the time of study entry
3. Ongoing requirement for systemic corticosteroid other than systemic adrenal
replacement therapy
4. Chemotherapy given with antineoplastic intent, targeted therapy, radiation therapy or
antibody-based therapy within 4 weeks of the start of study drug
5. Ongoing toxicity of ≥ Grade 2 from prior anticancer therapy
6. Prior or concurrent active malignancy within the past 2 years
7. Clinically significant cardiovascular disease
8. Unable to swallow capsules or disease significantly affecting gastrointestinal
function
9. Active fungal, bacterial and/or viral infection requiring systemic therapy
10. Known infection with HIV, or serologic status reflecting active viral hepatitis B
(HBV) or viral hepatitis C (HCV) infection as follows
11. Pregnant or lactating women
12. History of stroke or intracranial hemorrhage within 180 days before first dose of
study drug
13. History of severe bleeding disorder
14. Active central nervous system (CNS) involvement by WM and/or lymphoma
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Gender
All
Ages
18 Years - N/A
Contacts
Rainer Brachmann, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT04052854
Organization ID
BGB-3111-216
Responsible Party
Sponsor
Study Sponsor
BeiGene
Study Sponsor
Rainer Brachmann, Study Director, BeiGene
Verification Date
June 2021