Clinical trial NCT04052854: 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
Study type: EXPANDED_ACCESS
Overall status: NO_LONGER_AVAILABLE
Conditions: Waldenström Macroglobulinemia
Keywords: WM
Treatment naive
Relapsed/refractory
Lead sponsor: BeiGene
Sponsor class: INDUSTRY
First posted: 2019-08-12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT

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


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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Rancho Mirage
country: United States
facility: Eisenhower Desert Cardiology Center
state: California
city: Santa Barbara
country: United States
facility: Sansum Clinic and Ridley Tree Cancer Center
state: California
city: Columbia
country: United States
facility: Maryland Oncology Hematology, Pa
state: Maryland
city: Boston
country: United States
facility: Dana Farber Cancer Institute
state: Massachusetts
city: Las Vegas
country: United States
facility: Comprehensive Cancer Centers of Nevada
state: Nevada
city: Morristown
country: United States
facility: Morristown Medical Center
state: New Jersey
city: New York
country: United States
facility: Icahn School of Medicine At Mount Sinai
state: New York
city: Westbury
country: United States
facility: Clinical Research Alliance, Inc
state: New York
city: Round Rock
country: United States
facility: Texas Oncology Austin Midtown
state: Texas
city: Tyler
country: United States
facility: Texas Oncology Tyler Longview
state: Texas
Study officials:
affiliation: BeiGene
name: Rainer Brachmann
role: STUDY_DIRECTOR
References: