A Phase II Study Evaluating Venetoclax and Pirtobrutinib in Previously Treated Waldenström Macroglobulinemia
Dana-Farber Cancer Institute
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)
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 venet…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: Participants must meet the following criteria on screening examination to be eligible to participate. Screening evaluations including consent, physical exam, and laboratory assessments will be done within 30 days prior to Cycle 1 Day 1. Bone marrow biopsy \& aspirate, and CT C/A/P will be done within 90 days prior to Cycle 1 Day 1. * Clinicopathological diagnosis of Waldenström Macroglobulinemia, including MYD88 Wild-Type. * At least 1 prior line of treatment. * Prior covalent BTK inhibitor is allowed even if prior progression documented on this agent. * Prior veneto…
Interventions
- DrugPirtobrutinib
Noncovalent Bruton Tyrosine Kinase (BTK) inhibitor, tablet taken orally.
- DrugVenetoclax
Small-molecule B-cell lymphoma-2 (Bcl-2) family inhibitor, tablet taken orally.
Locations (2)
- Beth Israel Deaconness MedicalBoston, Massachusetts
- Dana Farber Cancer InstituteBoston, Massachusetts