Pirtobrutinib and Venetoclax in Waldenström Macroglobulinemia

Waldenstrom Macroglobulinemia Clinical Trial

Official title: A Phase II Study Evaluating Venetoclax and Pirtobrutinib in Previously Treated Waldenström Macroglobulinemia

Status Recruiting

Clinical Trial Summary

This study is being done to examine the safety and effectiveness of pirtobrutinib combined with venetoclax as a possible treatment for participants with Waldenström Macroglobulinemia (WM).

The names of the study drugs involved in this study are:

• Pirtobrutinib (a Noncovalent Bruton Tyrosine Kinase (BTK) inhibitor)

• Venetoclax (a BCL2 inhibitor)

Clinical Trial Description

This is a single-arm, open-label, Phase II study to evaluate the safety and efficacy of venetoclax combined with pirtobrutinib (VEN-P) in participants with symptomatic Waldenström Macroglobulinemia (WM) with previously treated disease. Pirtobrutinib blocks a type of protein called Bruton Tyrosine Kinase (BTK) that helps cells live and grow. Venetoclax blocks BCL-2, a protein essential for WM cells' survival.

The U.S. Food and Drug Administration (FDA) has not approved pirtobrutinib for Waldenström Macroglobulinemia (WM), but it has been approved for other uses.

The FDA has not approved venetoclax for Waldenström Macroglobulinemia (WM), but it has been approved for other uses.

The FDA has not approved the combination of pirtobrutinib and venetoclax as a treatment for any disease.

Study procedures include screening for eligibility, treatment visits, CT scans, blood tests, and bone marrow aspirates and biopsies.

Participants will receive study treatment for up to 2 years and will be followed for up to 4 years or until they start a new therapy.

It is expected that about 42 people will take part in this research study.

Eli Lilly supports this research study by providing study drug pirtobrutinib and funding. ;

Related Conditions & MeSH terms

• Waldenstrom Macroglobulinemia

• NCT number: NCT05734495
• Study type: Interventional
• Source: Dana-Farber Cancer Institute
• Contact: Jorge Castillo, MD
• Phone: 617-632-6045
• Email: jorgej_castillo@dfci.harvard.edu
• Status: Recruiting
• Phase: Phase 2
• Start date: May 2, 2023
• Completion date: January 25, 2033