Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:56 AM
Ignite Modification Date:
2025-12-25 @ 3:56 AM
NCT ID:
NCT05640102
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05640102
Study Brief:
Protocol Section:
NCT05640102