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

• Conditions: Waldenström Macroglobulinemia

• Registration Number: NCT04052854
• Lead Sponsor: BeiGene

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-08-08
• Study First Submitted QC: 2019-08-08
• Study First Posted: 2019-08-12
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-21
• Last Update Posted: 2024-10-23

Recruitment & Eligibility

• Status: NO_LONGER_AVAILABLE
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: EXPANDED_ACCESS
• Study Design: Not specified

Trial Locations

Locations (10)

Eisenhower Desert Cardiology Center; 🇺🇸 Rancho Mirage, California, United States

Sansum Clinic and Ridley Tree Cancer Center; 🇺🇸 Santa Barbara, California, United States

Maryland Oncology Hematology, Pa; 🇺🇸 Columbia, Maryland, United States

Comprehensive Cancer Centers of Nevada; 🇺🇸 Las Vegas, Nevada, United States

Icahn School of Medicine At Mount Sinai; 🇺🇸 New York, New York, United States

Clinical Research Alliance, Inc; 🇺🇸 Westbury, New York, United States

Texas Oncology Austin Midtown; 🇺🇸 Round Rock, Texas, United States

Texas Oncology Tyler Longview; 🇺🇸 Tyler, Texas, United States

Dana Farber Cancer Institute; 🇺🇸 Boston, Massachusetts, United States

Morristown Medical Center; 🇺🇸 Morristown, New Jersey, United States