Newmarket

Researchers are evaluating nemtabrutinib compared with the investigator's choice of ibrutinib or acalabrutinib in adults with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who have not received any prior therapy. This Phase 3 study aims to determine if nemtabrutinib is not worse than ibrutinib or acalabrutinib in terms of objective response rate and if it is better regarding progression-free survival, both assessed using standardized disease criteria by independent review. Participants will be randomly assigned to receive one of the three oral treatments: nemtabrutinib, ibrutinib, or acalabrutinib. The study compares the effectiveness of nemtabrutinib against the other two drugs chosen by the investigator to treat first-line CLL/SLL. Treatment continues with monitoring over months to assess response and disease progression. During the study, participants will undergo evaluations based on the International Workshop on Chronic Lymphocytic Leukemia criteria, including blinded independent central reviews of their disease status. Researchers will track objective response rates up to about 33 months and progression-free survival up to around 104 months. Participants will also be monitored for safety and treatment adherence throughout the trial period.

This research aims to evaluate the long-term safety of pirtobrutinib in adults who have previously been treated for chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). It focuses on participants who completed a prior study (J2N-MC-JZNN/LOXO-BTK-20020) and offers them continued access to the study drug or follow-up visits. The study is in Phase 4 and targets assessing safety outcomes over an extended period. Participants will receive pirtobrutinib orally every four weeks. The study includes treatment administration and ongoing follow-up for about five years, allowing researchers to monitor the long-term effects of the drug. Idelalisib is also listed as an intervention but the study primarily assesses pirtobrutinib. Throughout the study, researchers will monitor participants for any treatment-emergent adverse events of grade 3 or higher from the first dose until 30 days after the last dose or start of new anticancer therapy, whichever occurs first. Participants will be regularly assessed during their visits to ensure safety and collect necessary data over the duration of the study.

Researchers are evaluating the safety and effectiveness of nemtabrutinib (formerly ARQ 531) in adults with various blood cancers including chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), Richter's transformation, marginal zone lymphoma (MZL), mantle cell lymphoma (MCL), follicular lymphoma (FL), and Waldenström's macroglobulinemia (WM). This Phase 2 study is designed to better understand how well nemtabrutinib works and how safe it is for these conditions. The study is conducted in two parts: Part 1 focuses on dose escalation and confirmation to find the recommended Phase 2 dose, while Part 2 involves expanding the study to include eight disease-specific groups. Participants receive nemtabrutinib tablets once daily by mouth. Different cohorts in Part 2 are defined based on specific diagnoses and prior treatments, such as those with relapsed or refractory disease after certain therapies. Each participant will receive treatment according to their cohort's criteria. Participants will be closely monitored throughout the study, with assessments including the number of participants experiencing dose-limiting toxicities and adverse events, response rates according to established lymphoma criteria, and treatment discontinuations due to side effects. The study includes detailed evaluations like biopsies for biomarker analysis, imaging scans, and laboratory tests. Safety and treatment effects will be followed for up to several years, allowing researchers to gather comprehensive data on nemtabrutinib's impact.