NCT05640102 Observational Study Evaluating the Efficacy and Safety of Zanubrutinib in Participants With Waldenström Macroglobulinemia
| NCT ID | NCT05640102 |
| Status | Recruiting |
| Phase | — |
| Sponsor | BeiGene |
| Condition | Waldenstrom Macroglobulinemia |
| Study Type | OBSERVATIONAL |
| Enrollment | 111 participants |
| Start Date | 2023-03-03 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 111 participants in total. It began in 2023-03-03 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Study Director
STUDY DIRECTOR
BeiGene
Frequently Asked Questions
Who can join the NCT05640102 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Waldenstrom Macroglobulinemia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05640102 currently recruiting?
Yes, NCT05640102 is actively recruiting participants. Contact the research team at clinicaltrials@beigene.com for enrollment information.
Where is the NCT05640102 trial being conducted?
This trial is being conducted at Huntsville, United States, Mobile, United States, Duarte, United States, Glendale, United States and 4 additional locations.
Who is sponsoring the NCT05640102 clinical trial?
NCT05640102 is sponsored by BeiGene. The principal investigator is Study Director at BeiGene. The trial plans to enroll 111 participants.