Waldenström MacroglobulinemiaNCT04052854
A Single-Arm, Expanded Access Study of Zanubrutinib in Participants With B-cell Malignancies
A study testing Zanubrutinib in people with Waldenström Macroglobulinemia, run by BeiGene at 10 sites in United States.
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Waldenström Macroglobulinemia
- What is being tested?
- Zanubrutinib
- Type of treatment
- Pill or oral medicine
- How many people
- Not given
- Where
- 10 sitesUnited States
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 15Show fewer
- 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.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
Maryland Oncology Hematology, Pa
Columbia, Maryland, 21044
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, 89169
Morristown Medical Center
Morristown, New Jersey, 07960
Icahn School of Medicine At Mount Sinai
New York, New York, 10029
Eisenhower Desert Cardiology Center
Rancho Mirage, California, 92270
Texas Oncology Austin Midtown
Round Rock, Texas, 78681
Sansum Clinic and Ridley Tree Cancer Center
Santa Barbara, California, 93105
Texas Oncology Tyler Longview
Tyler, Texas, 75702
Clinical Research Alliance, Inc
Westbury, New York, 11590
About this study
Official title: A Single-Arm, Expanded Access Study of Zanubrutinib (BGB3111) in Participants With B-cell Malignancies
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
- Being tested
- Zanubrutinib
- Keywords
- WM, Treatment naive, Relapsed/refractory
- Medical subject headings
- Waldenstrom Macroglobulinemia, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZanubrutinibDrug
Also called BGB-3111
Zanubrutinib will be orally administered in participants with treatment naive or R/R WM
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Waldenström MacroglobulinemiaStudies of the same condition, open and under way.
- More trials run by BeiGeneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Expanded access
Sponsor and investigators
- Lead sponsor
- BeiGene
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Rainer Brachmann, Study director, BeiGene
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04052854
- Sponsor's protocol ID
- BGB-3111-216
- Status last verified
- Oct 2024
- First submitted
- 8 Aug 2019
- Last updated
- 23 Oct 2024
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Arm, Expanded Access Study of Zanubrutinib (BGB3111) in Participants With B-cell Malignancies
- ClinicalTrials.gov ID
- NCT04052854
- Acronym / sponsor ID
- BGB-3111-216
- Conditions
- Waldenström Macroglobulinemia
- Keywords
- WM, Treatment naive, Relapsed/refractory
- Study type
- Expanded access
- Recruitment status
- No Longer Available
- Lead sponsor
- BeiGeneIndustry (pharma, biotech, devices)
- First posted
- 12 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ZanubrutinibAlso: BGB-3111Zanubrutinib will be orally administered in participants with treatment naive or R/R WM | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2024.
Related trials for Waldenström Macroglobulinemia
RecruitingPhase 1/2
Dose Escalation and Dose Expansion Study of MDX2003 in Patients With Different Types of Lymphoma
Lymphoma, Waldenström Macroglobulinemia (WM)
Active, not recruitingPhase 1
Study to Evaluate Adverse Events, Change in Disease Activity, and How Oral ABBV-101 Moves Through the Body in Adult Participants With B-Cell Malignancies
Hematologic Cancer
RecruitingPhase 1/2
Treatment of Chinese Participants With B-Cell Malignancies With BGB-16673, a Bruton Tyrosine Kinase-Targeted Protein-Degrader
B-cell Malignancy, Non-Hodgkin Lymphoma
Active, not recruitingPhase 2
A Study to Investigate Efficacy and Safety of BCL2 Inhibitor Sonrotoclax as Monotherapy and in Combination With Zanubrutinib in Adults With Waldenström Macroglobulinemia
Waldenstrom Macroglobulinemia, Waldenstrom's Macroglobulinemia Recurrent
RecruitingPhase 1
A Study of APG-3288 in Relapsed/Refractory Blood Cancers
Relapsed/Refractory Hematological Malignancies, Relapsed/Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Leukemia (CLL/SLL
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rainer Brachmann study director
BeiGene
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Zanubrutinib in people with Waldenström Macroglobulinemia, run by BeiGene at 10 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2024.