Study of Golcadomide Treatment After Anti-CD19 CAR T-cell Therapy in Adults with High-Risk Relapsed or Refractory Aggressive Large B-cell Lymphoma

What this Trial Is About

Researchers are evaluating golcadomide as a treatment after anti-CD19 CAR T-cell therapy in patients with aggressive large B-cell lymphoma, including types such as diffuse large B-cell lymphoma, primary mediastinal B-cell lymphoma, transformed follicular or marginal zone lymphoma, and high-grade B-cell lymphoma. This open-label, multicenter phase 2 trial aims to estimate the effectiveness of golcadomide in improving complete metabolic response three months after CAR T-cell infusion in approximately 65 patients with a high risk of relapse. Participants will receive golcadomide orally at a dose of 0.3 mg weekly, starting five days after CAR T-cell infusion, continuing for 24 weeks across six cycles of 28 days. The study includes a safety analysis after the first three patients complete a treatment cycle or discontinue, to decide on continuing enrollment. The trial focuses on patients eligible for authorized anti-CD19 CAR T-cell therapy and monitors treatment effects over a two-year period. During the study, participants will undergo various assessments including imaging with 18FDG-PET before CAR T-cell therapy and evaluations of metabolic response at one month, three months, six months, and up to two years. Researchers will track response rates, duration of response, survival outcomes, and adverse events. The total participation includes treatment and follow-up for two years to evaluate long-term outcomes and safety.

Golcadomide Post-CAR T-cell in R/R Aggressive Large B-cell Lymphoma Patients With High Risk of Relapse