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).
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.
This study is sponsored by ADC Therapeutics S.A.
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.