An Open-Label, Multicenter Phase 2 Study to Evaluate the Efficacy and Safety of the BCL2 Inhibitor Sonrotoclax (BGB-11417) as Monotherapy and in Combination with Zanubrutinib (BGB-3111) in Patients With Waldenström Macroglobulinemia

ENROLLING
Protocol # :
23-438
Conditions
Waldenstrom Macroglobulinemia
Waldenstrom's Macroglobulinemia Recurrent
Waldenstrom's Macroglobulinemia Refractory
Phase
II
Disease Sites
Other Hematopoietic
Non-Hodgkin's Lymphoma
Principal Investigator
Treon, Steven

Trial Description

This study will evaluate the safety and efficacy of the BCL2 inhibitor sonrotoclax
(BGB-11417) in participants with relapsed/refractory Waldenström's Macroglobulinemia (R/R
WM) and in combination with zanubrutinib in adult participants with previously untreated
WM.

Eligibility Requirements

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).

- For Cohorts 1-3, refractory or relapsed disease 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.

- For Cohort 4, patients must not have received prior therapy for WM (except for
plasmapheresis).

- 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.

23-438