A Phase II Study Evaluating Loncastuximab Tesirine in Patients With Previously Treated Waldenström Macroglobulinemia
Shayna Sarosiek, MD
Summary
This study is being done to examine the safety and effectiveness of loncastuximab tesirine as a possible treatment for participants with Waldenström Macroglobulinemia (WM). The name of the study drug involved in this study is: * Loncastuximab tesirine
Description
This is a single-arm, open-label, phase II study to evaluate the safety and efficacy of loncastuximab tesirine in patients with Waldenström Macroglobulinemia (WM) who have received at least 2 prior treatments, including an anti-CD20 antibody such as rituximab and a BTK inhibitor such as ibrutinib. The U.S. Food and Drug Administration (FDA) has not approved loncastuximab tesirine for Macroglobulinemia (WM) but it has been approved for other uses. Loncastuximab tesirine is a type of therapy called an antibody drug conjugate. This type of treatment is an antibody to CD19, a protein that is typi…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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 2 prior lines of treatment, including an anti-CD20 monoclonal antibody-containing regimen and a BTK inhibitor. * Age 18 years or older * Measurable disease, defined as presence of immunoglobulin M (IgM) paraprotein with a minimum serum IgM level of \> 2 times the upper limit normal. * ECOG performance status ≤2 (Karnofsky ≥60%, see Appendix A)…
Interventions
- DrugLoncastuximab Tesirine
Administered by intravenous infusion
- DrugDexamethasone
Taken orally or administered by intravenous infusion
Locations (4)
- Dana Farber Cancer InstituteBoston, Massachusetts
- Beth Israel Deaconess Medical CenterBoston, Massachusetts
- Mayo ClinicRochester, Minnesota
- Fred HutchSeattle, Washington