A Study to Investigate Efficacy and Safety of BCL2 Inhibitor Sonrotoclax as Monotherapy and in Combination With Zanubrutinib in Adults With Waldenström Macroglobulinemia

Launched by BEIGENE · Jul 18, 2023

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ClinConnect Summary

This clinical trial is studying a new treatment called sonrotoclax for people with Waldenström's Macroglobulinemia (WM), a type of blood cancer. The trial is looking at how safe and effective sonrotoclax is for patients whose disease has come back after treatment or has not responded to previous therapies. It will also explore how well sonrotoclax works when combined with another medication called zanubrutinib for those who have not received any treatment for WM before.

To participate in this trial, individuals need to have a confirmed diagnosis of WM and meet certain treatment criteria. Eligible participants must be adults aged 65 or older and have either relapsed or refractory disease, meaning their cancer has returned or did not respond well to prior treatment. However, those who have never received treatment for WM can also join. Participants can expect to receive the study drug, undergo regular check-ups, and have their health closely monitored throughout the trial. It's important to note that people with certain conditions, like active brain involvement from WM or recent severe infections, may not be eligible.

Gender

ALL

Eligibility criteria

• 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.