Observational Study Evaluating the Efficacy and Safety of Zanubrutinib in Participants With Waldenström Macroglobulinemia

NCT05640102 | Recruiting FDA Drug

• 1 other identifier: BGB-3111-402
• Study Type: observational
• Target: 111
• Locations: 2 countries
• Sites: 8

Brief Summary

This is a hybrid (retrospective and prospective) non-interventional registry study to further describe the clinical profile of zanubrutinib in Waldenström macroglobulinemia (WM) participants with and without specific mutations and from racial and ethnic minority groups. Data collected from this registry study will be used to better understand the clinical benefit and safety of zanubrutinib for the treatment of participants in these populations.

Conditions

Waldenstrom Macroglobulinemia

Outcome Measures

Primary Outcomes (1)

• Major Response Rate (MRR)

  MRR is defined as the proportion of participants achieving either complete response (CR), very good partial response (VGPR), or partial response (PR) as determined by the investigator using an adaptation of the response criteria updated at the Sixth International Workshop on WM (IWWM)

  Up to approximately 4 years

Secondary Outcomes (4)

• VGPR+ Rate

  Up to approximately 5 years

• Overall Response Rate (ORR)

  Up to approximately 5 years

• Duration of Response (DOR)

  Up to approximately 5 years

• Number of Participants with Treatment-emergent Adverse Events

  Up to approximately 5 years

Study Arms (2)

Cohort 1: MYD88 L265P mutation

Arm A: Treatment-naïve (TN); Arm B: Relapsed/refractory (R/R)

Drug: Zanubrutinib

Cohort 2: Non-L265P MYD88 mutation(s) and MYD88 wildtype

Arm C: TN and R/R

Drug: Zanubrutinib

Interventions

Zanubrutinib DRUG

Dosing and treatment duration are at the discretion of the prescribing physician and in accordance with local labeling

Also known as: BGB-3111, Brukinsa

Cohort 1: MYD88 L265P mutation; Cohort 2: Non-L265P MYD88 mutation(s) and MYD88 wildtype

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult participants with WM who are either already receiving or are planned to start treatment with zanubrutinib

You may qualify if:

• Clinical and definitive histologic diagnosis of WM
• Measurable disease, as defined by a serum immunoglobulin M (IgM) level \> 0.5 g/dL at the time of zanubrutinib initiation
• Started treatment with zanubrutinib, has been treated with zanubrutinib, or is planned to be prescribed zanubrutinib for the treatment of WM
• Bone marrow specimens with central MYD88 test results of:
• Cohort 1: MYD88 L265P mutation; enrollment of TN participants will be stopped in each racial and ethnic participant group when the required numbers of participants in the group are met
• Cohort 2: non-L265P MYD88 mutation(s) and MYD88WT

You may not qualify if:

• Evidence of disease transformation before the first dose of zanubrutinib
• Evidence of other non-Hodgkin Lymphoma (NHL) subtypes
• Prior or concurrent active malignancy ≤ 2 years before the first dose of zanubrutinib, except for malignancies that, in the investigator's opinion, will not obscure the interpretation of safety or efficacy results
• Concurrent participation in another therapeutic clinical study while receiving zanubrutinib, although the participant may be eligible depending on the status of the interventional study after discussion with the Medical Monitor or designee on an individual basis

Sponsors & Collaborators

• BeiGene: lead

Study Sites (8)

Clearview Cancer Institute

Huntsville, Alabama, 35805-2606, United States

RECRUITING

South Alabama Medical Science Foundation Mitchell Cancer Institute

Mobile, Alabama, 36604-1405, United States

RECRUITING

City of Hope National Medical Center

Duarte, California, 91010-3012, United States

RECRUITING

Los Angeles Cancer Network (Lacn)

Glendale, California, 91204-3640, United States

RECRUITING

Eisenhower Medical Center, Lucy Curci Cancer Center

Rancho Mirage, California, 92270-3221, United States

RECRUITING

Hattiesburg Hematology and Oncology Clinic

Hattiesburg, Mississippi, 39401-7233, United States

RECRUITING

Comprehensive Cancer Centers of Nevada

Las Vegas, Nevada, 89169-3321, United States

RECRUITING

Pan American Oncology Trials, Llc

Rio Piedras, 00935, Puerto Rico

RECRUITING

MeSH Terms

Conditions

Waldenstrom Macroglobulinemia

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

Study Officials

• Study Director

  BeiGene

  STUDY DIRECTOR

Central Study Contacts

Study Director

CONTACT

1-877-828-5568; clinicaltrials@beigene.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 5 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 28, 2022
• First Posted: December 7, 2022
• Study Start: March 3, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: March 4, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: See plan description
• Access Criteria: See plan description

Locations

PR (1); US (7)