A Study of Pirtobrutinib, Venetoclax, and Rituximab in People With Waldenström's Macroglobulinemia (WM)/Lymphoplasmacytic Lymphoma (LPL)

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorMemorial Sloan Kettering Cancer Center

About this trial

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 criteria

Qualifiers

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 glomerulonephritis or renal disease, bulky disease, or constitutional symptoms

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Pirtobrutinib
  • Venetoclax
  • Rituximab

Treatment groups

40 Participants
are divided into 1 treatment group

Locations

9
Beth Israel Deaconess Medical Center (Data Collection Only)02215, BostonMassachusetts, United States
Dana Farber Cancer Institute (Data Collection and Specimen Analysis)02115, BostonMassachusetts, United States
Memorial Sloan Kettering Basking Ridge07920, Basking RidgeNew Jersey, United States
Memoral Sloan Kettering Monmouth07748, MiddletownNew Jersey, United States

Sponsors and collaborators

Memorial Sloan Kettering Cancer Center

Lead sponsor

AbbVie

Collaborator

Eli Lilly and Company

Collaborator