A Phase II Study of Time-limited Combination of Pirtobrutinib, Venetoclax, and Rituximab in Treatment Naïve Patients With Waldenström's Macroglobulinemia (WM) / Lymphoplasmacytic Lymphoma (LPL) (PRoVen)
Memorial Sloan Kettering Cancer Center
Summary
The purpose of this study is to find out if the combination of pirtobrutinib, venetoclax, and rituximab is an effective treatment for participants with Waldenström's macroglobulinemia (WM)/lymphoplasmacytic lymphoma (LPL)
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Age greater than or equal to 18 years * Histologically confirmed treatment naive WM/LPL * Patients must have measurable disease as defined by at least one lymph node ≥1.5 cm and/ or IgM levels \> 0.5gm/dl quantified by using densitometry on serum protein electrophoresis (SPEP) or quantitative nephelometry. * Participants must have at least one of the established criteria to require therapy for WM, including anemia, thrombocytopenia, neuropathy related to WM, symptomatic hyperviscosity or serum viscosity levels greater than 4.0 centipoises, WM-associated glomerulonephriti…
Interventions
- DrugPirtobrutinib
PO QD
- DrugVenetoclax
PO QD
- DrugRituximab
IV or SC
Locations (8)
- Beth Israel Deaconess Medical Center (Data Collection Only)Boston, Massachusetts
- Memorial Sloan Kettering Basking RidgeBasking Ridge, New Jersey
- Memoral Sloan Kettering MonmouthMiddletown, New Jersey
- Memorial Sloan Kettering BergenMontvale, New Jersey
- Memorial Sloan Kettering Suffolk - CommackCommack, New York
- Memorial Sloan Kettering WestchesterHarrison, New York