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)
Age greater than or equal to 18 years
Histologically confirmed treatment naive WM/LPL (participants with non-IgM LPL are NOT eligible for the study)
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 glomerulonephritis or renal disease, bulky disease, or constitutional symptoms
Prior/Concomitant Therapy: Participants must not have had prior systemic therapy.
Medical Conditions
Major surgery within 4 weeks prior to start of treatment
History of bleeding diathesis
Single group
Pirtobrutinib
DrugPO QD
Venetoclax
DrugPO QD
Rituximab
DrugIV or SC
Number of participants with Very Good Partial Response Rate or Better
To evaluate the rate of very good partial response (VGPR) rate or better in previously untreated participants with WM / LPL who are treated upfront with this regimen.
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Memorial Sloan Kettering Cancer Center
Lead sponsor
AbbVie
Collaborator
Eli Lilly and Company
Collaborator
