RecruitingWaldenstrom MacroglobulinemiaLymphoplasmacytic Lymphoma
A Study of Pirtobrutinib, Venetoclax, and Rituximab in People With Waldenström's Macroglobulinemia (WM)/Lymphoplasmacytic Lymphoma (LPL)
Eligible age
18+ yrs
Accepts
All genders
Locations
3 states
Healthy volunteers
No
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About this study
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)
Sponsor: Memorial Sloan Kettering Cancer Center
You may qualify if…
- ✓ 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
- ✓ ECOG performance status ≤2
- ✓ Platelet count ≥ 50,000 cells/mm3, independent of transfusions within 7 days of screening assessment
- ✓ Hemoglobin ≥ 8 g/dL, unless due to disease involvement in which case ≥ 7 g/dL, independent of transfusions within 7 days of screening assessment
- ✓ Absolute neutrophil count \>1000 cells/mcL, independent of growth factor support within 7 days of screening assessment
You may not qualify if…
- ✕ 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
- ✕ Patients who experienced a major bleeding event or grade ≥ 3 arrhythmia on prior treatment with a BTK inhibitor.
- ✕ NOTE: Major bleeding is defined as bleeding having one or more of the following features: potentially life-threatening bleeding with signs or symptoms of hemodynamic compromise; bleeding associated with a decrease in the hemoglobin level of at least 2g per deciliter; or bleeding in a critical area or organ (e.g., retroperitoneal, intraarticular, pericardial, epidural, or intracranial bleeding or intramuscular bleeding with compartment syndrome)
- ✕ History of stroke or intracranial hemorrhage within 6 months of start of treatment
- ✕ History of allogeneic or autologous stem cell transplant (SCT) or chimeric antigen receptor-modified T-cell (CAR-T) therapy within 60 days of start of treatment or presence of any of the following, regardless of prior SCT and/or CAR-T therapy timing:
Where it's recruiting
Massachusetts
Boston
New Jersey
Basking Ridge · Middletown · Montvale
New York
Commack · Harrison · New York · Uniondale
Source: ClinicalTrials.gov · NCT07231952 · last updated 2026-09-30