This phase II trial tests whether loncastuximab tesirine works to shrink tumors in patients with B-cell malignancies that have come back (relapsed) or does not respond to treatment (refractory). Loncastuximab tesirine is a monoclonal antibody, called loncastuximab, linked to a chemotherapy drug, called tesirine. Loncastuximab is a form of targeted therapy because it attaches to specific molecules (receptors) on the surface of cancer cells, known as CD19 receptors, and delivers tesirine to kill them.
OUTLINE: Patients receive loncastuximab tesirine intravenously (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. Patients may also undergo bone marrow biopsy and aspiration throughout the study. After completion of study treatment, patients are followed up for 5 years.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
11
Given IV
Undergo bone marrow biopsy and aspiration
Undergo bone marrow biopsy and aspiration
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, United States
Overall response rate (ORR)
According to the 2014 Lugano classification Cheson 20146 as determined by local review; ORR is defined as the proportion of patients with a best overall response of complete response (CR) or partial response (PR).
Time frame: Up to 5 years
Rates of grade 3-5 adverse event
Time frame: Up until 30 days after the last dose of the last study drug
Rate of discontinuation due to adverse events
Time frame: Up until 30 days after the last dose of the last study drug
Clinical benefit rate
Defined as stable disease + partial or complete response.
Time frame: Up to 5 years
Duration or response
Time frame: Time from the first documentation of tumor response to disease progression or death, assessed up to 5 years
Progression free survival
Time frame: Time between start of treatment and the first documentation of recurrence, progression, or death, assessed up to 5 years
Overall survival
Time frame: Time between the start of treatment and death from any cause, assessed up to 5 years
Incidence of grade 3-5 drug-related toxicity
Time frame: Up until 30 days after the last dose of the last study drug
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.