Loncastuximab Tesirine for B-Cell Lymphoma
Trial Summary
What is the purpose of this trial?
This trial is testing a new treatment called loncastuximab tesirine for patients whose B-cell cancers have returned or don't respond to other treatments. The treatment uses a special protein to find cancer cells and deliver a chemotherapy drug directly to them. Patients receive this treatment periodically and are monitored for several years after treatment. Loncastuximab tesirine has been previously tested in an earlier study for similar conditions.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. However, it mentions that you should not have major surgery, radiotherapy, chemotherapy, or other anti-cancer treatments within 14 days before starting the study drug, and you should not use any experimental medication within 14 days prior to starting the study.
What data supports the effectiveness of the drug Loncastuximab Tesirine for B-Cell Lymphoma?
Loncastuximab Tesirine has been shown to be effective in treating relapsed or refractory diffuse large B-cell lymphoma, with a study showing an overall response rate of 48.3% and a complete response rate of 24.1%. It has been approved by the US FDA for this use, and ongoing trials are evaluating its safety and effectiveness in other types of non-Hodgkin lymphoma.12345
What is known about the safety of Loncastuximab Tesirine for B-Cell Lymphoma?
Loncastuximab Tesirine has been shown to have a tolerable safety profile in clinical trials for B-cell lymphomas, with common side effects including low white blood cell counts (neutropenia), low platelet counts (thrombocytopenia), and elevated liver enzymes. It has been safely used in patients with severe liver dysfunction, although specific dose adjustments are not clearly defined.12345
What makes the drug Loncastuximab Tesirine unique for treating B-cell lymphoma?
Loncastuximab Tesirine is unique because it is an antibody-drug conjugate that specifically targets CD19 on B cells, delivering a potent toxin directly to the cancer cells. This targeted approach helps to minimize damage to healthy cells, making it a novel option for patients with relapsed or refractory diffuse large B-cell lymphoma who have not responded to other treatments.12356
Research Team
Stephen Smith
Principal Investigator
Fred Hutch/University of Washington Cancer Consortium
Eligibility Criteria
Adults with certain B-cell malignancies that have returned or are treatment-resistant can join this trial. They must be over 18, in fairly good health (ECOG PS 0-2), and have normal-ish liver/blood tests. Specific groups include those with CD19+ lymphoma post-transplant, relapsed/refractory non-Hodgkin's excluding some types, or after CAR T-cell therapy/allogeneic transplant. Women/men of childbearing potential must agree to contraception.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Patients receive loncastuximab tesirine IV over 30 minutes on day 1 of each cycle. Treatment repeats every 21 days for 6 cycles in the absence of disease progression or unacceptable toxicity.
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Loncastuximab Tesirine
Loncastuximab Tesirine is already approved in United States, European Union for the following indications:
- Diffuse large B-cell lymphoma (DLBCL)
- DLBCL arising from low-grade lymphoma
- High-grade B-cell lymphoma
- Diffuse large B-cell lymphoma (DLBCL)
- DLBCL arising from low-grade lymphoma
- High-grade B-cell lymphoma
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Washington
Lead Sponsor