Gottfried von Keudell, MD PhD
This study is being done to determine if epcoritamab can be used to treat participants with previously treated Waldenstrom Macroglobulinemia (WM). The names of the study drug involved in this study is: -Epcoritamab (a type of antibody)
This is a prospective phase 2, single arm, open label trial to determine if epcoritamab can be used to treat participants with previously treated Waldenstrom Macroglobulinemia (WM). Epcoritamab is a bispecific antibody, a synthetic protein that activates the immune system to target cancer cells. The U.S. Food and Drug Administration (FDA) has not approved epcoritamab for WM. The research study procedures include screening for eligibility, in-clinic visits, questionnaires, blood tests, electrocardiograms, bone marrow biopsies, and Computerized Tomography (CT) scans. Participants will receive…
Inclusion Criteria: * A diagnosis of lymphoplasmacytic lymphoma/WM that is CD20+ by immunophenotype or immunohistochemistry confirmed by bone marrow biopsy/aspirate (fresh or archival tissue acceptable) at time of most recent progression. All degrees of CD20 positivity will be accepted. * Serum IgM level \>2x upper limit of normal (ULN) * Meeting criteria for initiation of treatment per IWWM2 criteria \[Kyle Semin Oncol 2002\], including but not limited to hyperviscosity syndrome, peripheral neuropathy, cold agglutinin disease, cryoglobulinemia, amyloidosis, cytopenias due to bone marrow infi…
Bispecific antibody, via subcutaneous (under the skin) injection per protocol.
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