Clinical Trials | A Phase 3 Randomized Double-Blind Multicenter Study of Sonrotoclax Plus Zanubrutinib Versus Placebo Plus Zanubrutinib in Patients With Relapsed/Refractory Mantle Cell Lymphoma

The University of Virginia is conducting a clinical research study for adults ages 18 and over who have been diagnosed with Mantle Cell Lymphoma (MCL). Zanubrutinib is a standard treatment for relapse MCL. The purpose of this study is to test if sonrotoclax in combination with zanubrutinib is safe and if it works better in adult participants with R/R MCL compared to when zanubrutinib is given in combination with placebo (inactive substance). You will be participating in a study where you will definitely receive zanubrutinib, but neither you nor your study doctor, study staff, the sponsor staff or anyone designated will know if you are taking sonrotoclax or placebo. You will have a 50:50 chance, like flipping a coin of receiving one of the following treatments: • Arm A (experimental arm): Participants will receive daily oral zanubrutinib starting on Cycle 1 Day 1. On Cycle 2 Day 1, participants will start sonrotoclax once daily with food and the dose will increase twice a week to the target dose of 320 mg is reached. Thereafter, participants will continue both zanubrutinib and sonrotoclax through Cycle 27 Day 28. Participants may continue on zanubrutinib alone after Cycle 27 if their disease has not worsened, they do not become intolerant to this medication, or do not meet other criteria for ending treatment on the study. • Arm B (control/comparator arm): Participants will receive daily oral zanubrutinib starting on Cycle 1 Day 1. Each study cycle is 28 days. On Cycle 2 Day 1, participant will start placebo once daily with food and dose will increase twice a week to the target dose of 320 mg is reached. Thereafter, participants will continue both zanubrutinib and placebo oral daily dosing through Cycle 27 Day 28. Participants may continue on zanubrutinib alone after Cycle 27 if their disease has not worsened, they do not become intolerant to this medication, or do not meet other criteria for ending treatment on the study. Each study cycle is 28 days on both arms. All participants will be centrally assigned to randomized study treatment using a computer system. You are expected to be in this research study for about 7 ½ years. Study-related procedures that are being done beyond your standard of care will be provided at no cost to you or your insurance. Additional information can be found here: https://clinicaltrials.gov/study/NCT06742996 [email protected]