Title: Study to Evaluate Loncastuximab Tesirine With Rituximab Versus Immunochemotherapy in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (LOTIS 5)
Study Director: ADC Therapeutics S.A.
Description: Researchers are conducting a phase 3 trial to compare the combination of loncastuximab tesirine plus rituximab (Lonca-R) with standard immunochemotherapy in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL).
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The trial has 2 parts. Part 1 consists of a non-randomized safety run-in period evaluating loncastuximab tesirine for the first 20 participants. In part 2, participants are randomly assigned to receive Lonca-R or standard immunochemotherapy with rituximab, gemcitabine, and oxaliplatin (R-GemOx).
Lonca-R is administered via an intravenous infusion on day 1 of each 3-week cycle for up to 8 cycles. R-GemOx is administered intravenously on day 1 of each 2-week cycle for up to 8 cycles.
The primary endpoint is progression-free survival. Key secondary endpoints include overall survival, response rates, and safety.
To be eligible for this study, patients must have a pathologic diagnosis of DLBCL or high-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements. For a complete list of eligibility criteria, please refer to the reference.
Status: Recruiting
This study is sponsored by ADC Therapeutics S.A.
Reference
Clinicaltrials.gov. Study to evaluate loncastuximab tesirine with rituximab versus immunochemotherapy in participants with relapsed or refractory diffuse large B-cell lymphoma (LOTIS 5). NCT04384484. Accessed December 15, 2021.
