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

NCT04052854 | Unknown

• 1 other identifier: BGB-3111-216
• Study Type: expanded_access
• Target: N/A
• Locations: 1 country
• Sites: 10

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

Conditions

Waldenström Macroglobulinemia

Keywords

WM; Treatment naive; Relapsed/refractory

Interventions

Zanubrutinib DRUG

Zanubrutinib will be orally administered in participants with treatment naive or R/R WM

Also known as: BGB-3111

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• BeiGene: lead

Study Sites (10)

Eisenhower Desert Cardiology Center

Rancho Mirage, California, 92270, United States

Location

Sansum Clinic and Ridley Tree Cancer Center

Santa Barbara, California, 93105, United States

Location

Maryland Oncology Hematology, Pa

Columbia, Maryland, 21044, United States

Location

Dana Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

Comprehensive Cancer Centers of Nevada

Las Vegas, Nevada, 89169, United States

Location

Morristown Medical Center

Morristown, New Jersey, 07960, United States

Location

Icahn School of Medicine At Mount Sinai

New York, New York, 10029, United States

Location

Clinical Research Alliance, Inc

Westbury, New York, 11590, United States

Location

Texas Oncology Austin Midtown

Round Rock, Texas, 78681, United States

Location

Texas Oncology Tyler Longview

Tyler, Texas, 75702, United States

Location

MeSH Terms

Conditions

Waldenstrom Macroglobulinemia; Recurrence

Interventions

zanubrutinib

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Rainer Brachmann

  BeiGene

  STUDY DIRECTOR

Study Design

• Study Type: expanded access
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2019
• First Posted: August 12, 2019
• Last Updated: October 23, 2024

Record last verified: 2024-10

Locations

US (10)