Clinical Trials | A Phase 3, Open-label, Randomized Study to Compare the Efficacy and Safety of Nemtabrutinib (MK-1026) Plus Venetoclax versus Venetoclax Plus Rituximab in Participants with Relapsed/Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma Following at Least 1 Prior Therapy (BELLWAVE-010)

The University of Virginia is conducting a clinical research study for adults ages 18 years and over with relapsed/ refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who have received at least 1 prior therapy. The purpose of this trial is to test nemtabrutinib (MK-1026) plus venetoclax. Nemtabrutinib is an experimental drug and has not been approved to treat CLL or SLL. Venetoclax is an approved treatment for untreated and relapsed CLL and SLL. The use of venetoclax in combination with nemtabrutinib in this trial is experimental. This trial will compare nemtabrutinib plus venetoclax to venetoclax plus rituximab (VR). • The trial has 2 groups. A computer will randomly (flip of a coin) decide which group you are put in. You have a 1 in 2 chance of being in either group. o Group 1 will get nemtabrutinib plus venetoclax. Both drugs are a pill administered by mouth daily o Group 2 will get venetoclax plus rituximab (VR). Venetoclax is a pill administered by mouth daily. Rituximab is given via an IV infusion. Rituximab will be given a total of 6 times at treatment weeks 6, 10, 14, 22, and 26. You will receive study treatment for about two years. You will then have additional follow-up visits unless your cancer gets worse or you start a new cancer treatment. You will visit the trial site about 1 time every 12 weeks (3 months) for the first 3 years after your first treatment. After this you will continue to visit the trial site about 1 time every 24 weeks (6 months). 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/NCT05947851 [email protected]