Phase II Study of Pirtobrutinib, Venetoclax, and Rituximab Combination Treatment in Adults with Newly Diagnosed Waldenstrms Macroglobulinemia or Lymphoplasmacytic Lymphoma

What this Trial Is About

Researchers are evaluating whether the combination of pirtobrutinib, venetoclax, and rituximab is an effective treatment for people with Waldenstrf6ms macroglobulinemia WM or lymphoplasmacytic lymphoma LPL who have not received prior treatment. This phase II study focuses on treatment-naive patients with measurable disease meeting specific clinical criteria requiring therapy, aiming to understand the response rate after one year of treatment. Participants receive pirtobrutinib and venetoclax orally once daily, along with rituximab given either intravenously or subcutaneously. The treatment is time-limited and designed specifically for participants with newly diagnosed WMLPL. The study does not mention placebo or comparison groups, and all participants receive the combination regimen to assess its effects. During the study, participants will be monitored for their response to treatment, particularly the very good partial response rate after one year. Assessments include clinical evaluations and laboratory tests to measure disease markers like lymph node size and IgM levels. Safety and tolerability will also be monitored throughout the treatment period. The study is expected to continue until April 2028, with participants involved for the duration needed to evaluate the primary outcome.

A Study of Pirtobrutinib, Venetoclax, and Rituximab in People With Waldenström's Macroglobulinemia (WM)/Lymphoplasmacytic Lymphoma (LPL)