A Single-Arm, Expanded Access Study of Zanubrutinib in Participants With B-cell Malignancies

Status:

NO_LONGER_AVAILABLE

A Single-Arm, Expanded Access Study of Zanubrutinib in Participants With B-cell Malignancies

Lead Sponsor:

BeiGene

Conditions:

Waldenström Macroglobulinemia

Eligibility:

All Genders

18+ years

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

Inclusion

Key
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
Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
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
Creatinine clearance of ≥ 30 mL/min
Aspartate aminotransferase (AST)/serum glutamic-oxaloacetic transaminase (SGOT) and alanine aminotransferase (ALT)/serum glutamic pyruvic transaminase (SGPT) ≤ 3 x upper limit of normal (ULN)
Total bilirubin level ≤ 2 x ULN (unless documented Gilbert's syndrome)
Key

Exclusion

Prior exposure to a Bruton tyrosine kinase (BTK) inhibitor
Evidence of disease transformation at the time of study entry
Ongoing requirement for systemic corticosteroid other than systemic adrenal replacement therapy
Chemotherapy given with antineoplastic intent, targeted therapy, radiation therapy or antibody-based therapy within 4 weeks of the start of study drug
Ongoing toxicity of ≥ Grade 2 from prior anticancer therapy
Prior or concurrent active malignancy within the past 2 years
Clinically significant cardiovascular disease
Unable to swallow capsules or disease significantly affecting gastrointestinal function
Active fungal, bacterial and/or viral infection requiring systemic therapy
Known infection with HIV, or serologic status reflecting active viral hepatitis B (HBV) or viral hepatitis C (HCV) infection as follows
Pregnant or lactating women
History of stroke or intracranial hemorrhage within 180 days before first dose of study drug
History of severe bleeding disorder
Active central nervous system (CNS) involvement by WM and/or lymphoma
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Key Trial Info

Start Date :

Trial Type :

EXPANDED_ACCESS

End Date :

Estimated Enrollment :

Patients enrolled

Trial Details

Trial ID

NCT04052854

Last Update

October 23 2024

Active Locations (10)

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Page 1 of 3 (10 locations)

Eisenhower Desert Cardiology Center

Rancho Mirage, California, United States, 92270

Sansum Clinic and Ridley Tree Cancer Center

Santa Barbara, California, United States, 93105

Maryland Oncology Hematology, Pa

Columbia, Maryland, United States, 21044