Phase 3 Study Comparing Two Cycles of R-mini-CHOP Followed by AZD0486 Versus Six Cycles of R-mini-CHOP in Older or Unfit Patients with Newly Diagnosed Large B-cell Lymphoma

What this Trial Is About

Researchers are evaluating the efficacy and safety of a treatment regimen involving R-mini-CHOP followed by AZD0486 compared to the standard approach of R-mini-CHOP alone in elderly or unfit participants newly diagnosed with large B-cell lymphoma LBCL. This Phase III, open-label, randomized study aims to determine whether the combination therapy provides better outcomes than the usual six cycles of R-mini-CHOP. The trial focuses on participants aged 65 and older who are either unfit or elderly and not candidates for full-dose treatment. Participants will receive one of three treatment approaches two cycles of R-mini-CHOP followed by multiple cycles of AZD0486 at the recommended Phase III dose, six cycles of R-mini-CHOP per standard care, or two cycles of R-mini-CHOP followed by multiple cycles of AZD0486 at a different recommended dose during the safety run-in phase. The drugs include R-mini-CHOP, administered intravenously and orally, and AZD0486, a bispecific monoclonal antibody. Treatments are given according to assigned groups to compare their effects. During the study, participants will be closely monitored for treatment-related adverse events, tolerability, and the recommended dose determination over up to one year. The research team will assess various outcomes including response rates, duration of response, progression-free survival, overall survival, and pharmacokinetics of AZD0486 for up to seven years. Regular evaluations of blood and organ function, disease measurements, and safety monitoring will be part of participant involvement throughout the trial.

AZD0486 1L Therapy for Elderly or Unfit Participants With LBCL