Mayo Clinic
This phase II trial tests the effectiveness of golcadomide and rituximab as bridging treatment before chimeric antigen receptor (CAR) T-cell therapy in patients with aggressive B-cell non-Hodgkin lymphoma that has come back after a period of improvement (relapsed) or that has not responded to previous treatment (refractory). Patients that are able to receive CAR T-cell therapy have a potential for cure, however, many will not be qualified to receive therapy due to relapse. Bridging therapy is therapy intended to transition a patient from one therapy or medication to another or maintain their health or status until they are a candidate for a therapy or have decided on a therapy. Golcadomide may help block the formation, growth or spread of cancer cells. Rituximab is a monoclonal antibody. It binds to a protein called CD20, which is found on B cells (a type of white blood cell) and some types of cancer cells. This may help the immune system kill cancer cells. Giving golcadomide and rituximab as bridging therapy before CAR T-cell therapy may kill more tumor cells and may improve the chance of proceeding to CAR T-cell therapy in patients with relapsed or refractory aggressive B-cell non-Hodgkin lymphoma.
PRIMARY OBJECTIVE: I. Evaluate efficacy as measured by the disease control rate \[complete metabolic response (CMR), partial metabolic response (PMR), and no metabolic response (NMR)\] by Lugano 2014 positron emission tomography (PET)-computed tomography (CT) based assessment after 2 cycles of therapy. SECONDARY OBJECTIVES: I. To further evaluate clinical efficacy as measured by overall response rate (ORR), complete response (CMR) rate, disease control rate by Lugano PET-CT based criteria. II. To evaluate the safety and tolerability of golcadomide + rituximab combination therapy as measure…
Inclusion Criteria: * Age ≥ 18 years * Confirmed pathology diagnosis according to 2016 World Health Organization (WHO) classification including patients with diseases listed below with relapsed, progressive and/or refractory disease (Cheson et al. 2014) following treatment with one or two prior lines of standard therapy, no more than two lines of therapy are permitted: * Diffuse large B-cell lymphoma not otherwise specified (NOS) including: * Transformed lymphoma * Germinal center B-cell type * Activated B-cell type * High-grade B-cell lymphoma (HGBCL), NOS * High grade B-…
Undergo blood sample collection
Undergo bone marrow aspiration and biopsy
Undergo bone marrow aspiration and biopsy
Undergo standard of care CAR-T therapy
Undergo CT or PET/CT
Given PO
Undergo leukapheresis
Undergo PET/CT
Given IV