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A Phase II Study Evaluating Loncastuximab Tesirine in Patients With Previously Treated Waldenström Macroglobulinemia
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
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 typically found on B-cells and plasma cells in patients with Macroglobulinemia (WM). This is a targeted therapy that uses an antibody (immunoglobulin) to deliver a toxin directly to the cancer. The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits. It is expected that about 36 people will take part in this research study. ADC Therapeutics is supporting this research study by providing funding and the study drug.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Mayo Clinic
Rochester, Minnesota, United States
Fred Hutch
Seattle, Washington, United States
Start Date
February 17, 2022
Primary Completion Date
May 1, 2026
Completion Date
August 1, 2028
Last Updated
May 23, 2025
36
ESTIMATED participants
Loncastuximab Tesirine
DRUG
Dexamethasone
DRUG
Lead Sponsor
Shayna Sarosiek, MD
Collaborators
NCT01804686
NCT02269592
Data Source & Attribution
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Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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