About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥ 18 years
Transformed lymphoma
Germinal center B-cell type
Activated B-cell type
Disqualifiers
Pregnant persons
Nursing persons
Persons of childbearing potential (and persons able to father a child) who are unwilling to employ adequate contraception
For ≥ 28 days before starting treatment, during treatment and dose interruptions, and for ≥ 28 days after the last dose of golcadomide
Trial design
Single group
Treatments tested in this trial
Biospecimen Collection
Procedure/SurgeryUndergo blood sample collection
Bone Marrow Aspiration
Procedure/SurgeryUndergo bone marrow aspiration and biopsy
Bone Marrow Biopsy
Procedure/SurgeryUndergo bone marrow aspiration and biopsy
Chimeric Antigen Receptor T-Cell Therapy
Biological/VaccineUndergo standard of care CAR-T therapy
Computed Tomography
Procedure/SurgeryUndergo CT or PET/CT
Golcadomide
DrugGiven PO
Leukapheresis
Procedure/SurgeryUndergo leukapheresis
Positron Emission Tomography
Procedure/SurgeryUndergo PET/CT
Rituximab
Biological/VaccineGiven IV
Treatment groups
Trial outcomes
Primary outcomes
Disease control
Will be defined as a complete metabolic response (CMR), partial metabolic response (PMR), or no metabolic response (NMR) by Lugano 2014 PET-CT.
Secondary outcomes
Disease control rate
Will be estimated by the total number of patients who achieve a CMR, PMR, or NMR by Lugano 2014 positron emission tomography (PET)/computed tomography (CT) divided by the total number of evaluable patients.
Complete response rate
Will be assessed by the total number of patients who achieve a CMR by Lugano 2014 PET/CT.
Overall response rate
Will be assessed by the total number of patients who achieve a CMR or PMR by Lugano 2014 PET/CT divided.
The proportion of patients proceeding to chimeric antigen receptor T-cell (CART)
Will be assessed by the total number of patients who proceed to CART divided by the total number of evaluable patients.
Sponsors and contacts
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