Shayna Sarosiek, MD
This study is being done to examine the safety and effectiveness of pacritinib as a possible treatment for participants with Waldenström macroglobulinemia (WM). The name of the study drug involved in this study is: -Pacritinib (a type of kinase inhibitor)
This is a single-arm, open-label, Phase II study to evaluate the safety and efficacy of pacritinib in participants with symptomatic Waldenström macroglobulinemia (WM). Pacritinib is a targeted therapy that blocks a protein called JAK2 that helps cells live and grow. It also inhibits IRAK1, which is important for the survival of WM cells. By blocking JAK2 \& IRAK1, pacritinib may kill abnormal cells or stop them from growing. The U.S. Food and Drug Administration (FDA) has not approved pacritinib for WM but it has been approved for Myelofibrosis. The research study procedures include screeni…
Inclusion Criteria: * Age ≥18 years * ECOG performance status ≤2 * Clinicopathological diagnosis of Waldenström Macroglobulinemia * Symptomatic disease meeting criteria for treatment using consensus panel criteria from the Second International Workshop on Waldenström macroglobulinemia. At least one of the following: * constitutional symptoms: recurrent fever, night sweats, fatigue or weight loss * progressive or symptomatic lymphadenopathy or splenomegaly * hemoglobin ≤10 g/dL * platelet count ≤100 k/uL * hyperviscosity syndrome * symptomatic peripheral neuropathy * systemic am…
Kinase inhibitor, capsule, taken orally per protocol.
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