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

Waldenström Macroglobulinemia Clinical Trial

Official title:

A Single-Arm, Expanded Access Study of Zanubrutinib (BGB3111) in Participants With B-cell Malignancies

Clinical Trial Details — Status: No longer available

Administrative data

• NCT number: NCT04052854
• Other study ID #: BGB-3111-216
• Status: No longer available

Study information

• Verified date: June 2021
• Source: BeiGene
• Contact: n/a
• Is FDA regulated: No
• Study type: Expanded Access

Clinical Trial 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

Recruitment information / eligibility

• Status: No longer available
• Enrollment: 0
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Waldenstrom Macroglobulinemia
• Waldenström Macroglobulinemia

Intervention

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

Locations

Country	Name	City	State
United States	Texas Oncology, P.A.	Amarillo	Texas
United States	Texas Oncology, P.A.	Austin	Texas
United States	Texas Oncology, P.A.	Bedford	Texas
United States	Dana Farber Cancer Institute	Boston	Massachusetts
United States	Gabrail Cancer Center Research	Canton	Ohio
United States	Charleston Oncology, P.A.	Charleston	South Carolina
United States	Maryland Oncology Hematology, P.A.	Columbia	Maryland
United States	Medical Oncology & Hematology Associates	Des Moines	Iowa
United States	Consultants in Medical Oncology and Hematology, P.C.	Horsham	Pennsylvania
United States	Clinical Research Alliance	Lake Success	New York
United States	Comprehensive Cancer Centers of Nevada (CCCN) - Central Valley	Las Vegas	Nevada
United States	Texas Oncology-McAllen South Second Street	McAllen	Texas
United States	Southern Cancer Center, PC	Mobile	Alabama
United States	Morristown Medical Center	Morristown	New Jersey
United States	Mount Sinai	New York	New York
United States	Medical Oncology Hematology Consultants, PA	Newark	Delaware
United States	Woodlands Medical Specialists, PA	Pensacola	Florida
United States	Eisenhower Health	Rancho Mirage	California
United States	Sansum Clinic	Santa Barbara	California
United States	Texas Oncology - Tyler	Tyler	Texas

Sponsors (1)

Lead Sponsor	Collaborator
BeiGene

Country where clinical trial is conducted

United States,