Phase 2 Study of Golcadomide and Rituximab as Bridging Treatment Before CAR-T Therapy for Relapsed or Refractory Aggressive B-Cell Non-Hodgkin Lymphoma

What this Trial Is About

Researchers are evaluating the use of golcadomide and rituximab as a bridging treatment before chimeric antigen receptor CAR T-cell therapy in patients with aggressive B-cell non-Hodgkin lymphoma that has returned after improvement or has not responded to past treatments. This phase II trial aims to see if this combination can better control the disease and increase the chance of patients qualifying for CAR T-cell therapy, which has potential for cure but is limited to some patients. Golcadomide may block cancer cell growth, while rituximab targets a protein on B cells to help the immune system kill cancer cells. Participants receive golcadomide orally once daily on days 1 to 14 of each 28-day cycle and rituximab intravenously on days 1, 8, 15, and 22 during the first cycle, then on day 1 of subsequent cycles. After two cycles, patients eligible for CAR T-cell therapy undergo leukapheresis and may receive one to two additional cycles before CAR T-cell treatment. Those not eligible continue golcadomide and rituximab for up to 10 and 3 more cycles respectively, unless the disease progresses or side effects occur. Throughout the study, patients have blood samples collected and undergo PETCT or CT scans, with bone marrow tests as needed. Participants are closely monitored with scans and laboratory tests during and after treatment. After completing study treatment, all patients have a follow-up visit at 28 days. Those not receiving CAR T-cell therapy are followed every three months until disease progression or new treatment, then every six months for up to two years. Patients who undergo CAR T-cell therapy are followed at 180 days post-treatment and then every six months for up to two years. The main outcome measured is disease control after two cycles, with additional assessments of response rates, survival, and safety over two years.

Golcadomide and Rituximab as Bridging Therapy for Relapsed or Refractory Aggressive B-cell Non-Hodgkin Lymphoma Before CAR T-cell Therapy