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

BeiGene111 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

111

Conditions

Waldenstrom Macroglobulinemia

Interventions

ZanubrutinibDRUG

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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: 1. 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 2. Cohort 2: non-L265P MYD88 mutation(s) and MYD88WT Exclusion Criteria: * 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

Locations (8)

Clearview Cancer Institute

Huntsville, Alabama, United States

RECRUITING

South Alabama Medical Science Foundation Mitchell Cancer Institute

Mobile, Alabama, United States

RECRUITING

Outcomes

Primary Outcomes

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)

Time frame: Up to approximately 4 years

Secondary Outcomes

VGPR+ Rate

VGPR+ rate is defined as the proportion of participants achieving either CR or VGPR

Time frame: Up to approximately 5 years

Overall Response Rate (ORR)

ORR is defined as the proportion of participants achieving either CR, VGPR, PR, or minor response (MR)

Time frame: Up to approximately 5 years

Duration of Response (DOR)

DOR is defined as the time from the first determination of response (CR, VGPR, or PR) until first documentation of or death, whichever comes first

Time frame: Up to approximately 5 years

Number of Participants with Treatment-emergent Adverse Events

Time frame: Up to approximately 5 years

Central Contacts

Study Director

CONTACT

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

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.