Study to Evaluate the Efficacy and Safety of BGB-11417 in Participants With Waldenström's Macroglobulinemia

Overview

About this study

The purpose of this study is to evaluate the safety and effectiveness of the BCL2 inhibitor BGB-11417 in participants with relapsed/refractory Waldenström's Macroglobulinemia (R/R WM) in 3 cohorts.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

- Clinical and definitive histologic diagnosis of WM.

- Meeting ≥ 1 criterion for treatment according to consensus panel criteria from the 2nd
International Workshop on Waldenström's Macroglobulinemia (IWWM).

- Refractory or relapsed disease to the most recent therapy at study entry unless
participants had intolerance to the most recent therapy. Refractory disease is defined
as not attaining at least a major response, or progressing while on or within 6 months
of completing therapy. Relapsed disease is defined as attaining at least a major
response to therapy and meeting the criteria for disease progression beyond 6 months
after completing therapy.

- Adequate organ function.

Exclusion Criteria:

- Central nervous system (CNS) involvement by WM.

- Transformation to aggressive lymphoma, such as diffuse large B-cell lymphoma.

- History of other malignancies ≤ 2 years before study entry.

- Uncontrolled active systemic infection or recent infection requiring parenteral
antimicrobial therapy that was completed ≤ 14 days before the first dose of the study
drug.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Eligibility last updated 8/29/23. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Prashant Kapoor, M.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information

Publications

Publications are currently not available