A Single-Arm, Expanded Access Study of Zanubrutinib in Participants With B-cell Malignancies
Primary Purpose
Waldenström Macroglobulinemia
Status
No longer available
Phase
Locations
United States
Study Type
Expanded Access
Intervention
Zanubrutinib
Sponsored by
About this trial
This is an expanded access trial for Waldenström Macroglobulinemia focused on measuring WM, Treatment naive, Relapsed/refractory
Eligibility Criteria
Key Inclusion Criteria:
- 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 Criteria:
- 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.
Sites / Locations
- Southern Cancer Center, PC
- Eisenhower Health
- Sansum Clinic
- Medical Oncology Hematology Consultants, PA
- Woodlands Medical Specialists, PA
- Medical Oncology & Hematology Associates
- Maryland Oncology Hematology, P.A.
- Dana Farber Cancer Institute
- Comprehensive Cancer Centers of Nevada (CCCN) - Central Valley
- Morristown Medical Center
- Clinical Research Alliance
- Mount Sinai
- Gabrail Cancer Center Research
- Consultants in Medical Oncology and Hematology, P.C.
- Charleston Oncology, P.A.
- Texas Oncology, P.A.
- Texas Oncology, P.A.
- Texas Oncology, P.A.
- Texas Oncology-McAllen South Second Street
- Texas Oncology - Tyler
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04052854
Brief Title
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
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
No longer available
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
BeiGene
4. Oversight
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Waldenström Macroglobulinemia
Keywords
WM, Treatment naive, Relapsed/refractory
7. Study Design
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Zanubrutinib
Other Intervention Name(s)
BGB-3111
Intervention Description
Zanubrutinib will be orally administered in participants with treatment naive or R/R WM
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Eligibility Criteria
Key Inclusion Criteria:
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 Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rainer Brachmann
Organizational Affiliation
BeiGene
Official's Role
Study Director
Facility Information:
Facility Name
Southern Cancer Center, PC
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36608
Country
United States
Facility Name
Eisenhower Health
City
Rancho Mirage
State/Province
California
ZIP/Postal Code
92270
Country
United States
Facility Name
Sansum Clinic
City
Santa Barbara
State/Province
California
ZIP/Postal Code
93105
Country
United States
Facility Name
Medical Oncology Hematology Consultants, PA
City
Newark
State/Province
Delaware
ZIP/Postal Code
19713
Country
United States
Facility Name
Woodlands Medical Specialists, PA
City
Pensacola
State/Province
Florida
ZIP/Postal Code
32503
Country
United States
Facility Name
Medical Oncology & Hematology Associates
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50309
Country
United States
Facility Name
Maryland Oncology Hematology, P.A.
City
Columbia
State/Province
Maryland
ZIP/Postal Code
21044
Country
United States
Facility Name
Dana Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Comprehensive Cancer Centers of Nevada (CCCN) - Central Valley
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89169
Country
United States
Facility Name
Morristown Medical Center
City
Morristown
State/Province
New Jersey
ZIP/Postal Code
07960
Country
United States
Facility Name
Clinical Research Alliance
City
Lake Success
State/Province
New York
ZIP/Postal Code
11042
Country
United States
Facility Name
Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Gabrail Cancer Center Research
City
Canton
State/Province
Ohio
ZIP/Postal Code
44718
Country
United States
Facility Name
Consultants in Medical Oncology and Hematology, P.C.
City
Horsham
State/Province
Pennsylvania
ZIP/Postal Code
19044
Country
United States
Facility Name
Charleston Oncology, P.A.
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29414
Country
United States
Facility Name
Texas Oncology, P.A.
City
Amarillo
State/Province
Texas
ZIP/Postal Code
79106
Country
United States
Facility Name
Texas Oncology, P.A.
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
Texas Oncology, P.A.
City
Bedford
State/Province
Texas
ZIP/Postal Code
76022
Country
United States
Facility Name
Texas Oncology-McAllen South Second Street
City
McAllen
State/Province
Texas
ZIP/Postal Code
78503
Country
United States
Facility Name
Texas Oncology - Tyler
City
Tyler
State/Province
Texas
ZIP/Postal Code
75702
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Single-Arm, Expanded Access Study of Zanubrutinib in Participants With B-cell Malignancies
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