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RECRUITING
NCT06834373
PHASE2

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

Sponsor: Mayo Clinic

View on ClinicalTrials.gov

Summary

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.

Official title: Phase 2 Study of Golcadomide With Rituximab as a Bridging Therapy Prior to CAR-T for Patients With Relapsed or Primary Refractory Aggressive B-Cell Non-Hodgkin Lymphoma (NHL)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

41

Start Date

2025-04-02

Completion Date

2027-03-03

Last Updated

2026-01-28

Healthy Volunteers

No

Conditions

Large B-Cell Lymphoma With IRF4 RearrangementRecurrent Aggressive B-Cell Non-Hodgkin LymphomaRecurrent ALK-Positive Large B-Cell LymphomaRecurrent Diffuse Large B-Cell Lymphoma Activated B-Cell TypeRecurrent Diffuse Large B-Cell Lymphoma Associated With Chronic InflammationRecurrent Diffuse Large B-Cell Lymphoma Germinal Center B-Cell TypeRecurrent Diffuse Large B-Cell Lymphoma, Not Otherwise SpecifiedRecurrent EBV-Positive Diffuse Large B-Cell Lymphoma, Not Otherwise SpecifiedRecurrent Grade 3b Follicular LymphomaRecurrent High Grade B-Cell Lymphoma With MYC and BCL2 RearrangementsRecurrent High Grade B-Cell Lymphoma, Not Otherwise SpecifiedRecurrent Intravascular Large B-Cell LymphomaRecurrent Primary Cutaneous Diffuse Large B-Cell Lymphoma, Leg TypeRecurrent Primary Mediastinal Large B-Cell LymphomaRecurrent T-Cell/Histiocyte-Rich Large B-Cell LymphomaRecurrent Transformed Non-Hodgkin LymphomaRefractory Aggressive B-Cell Non-Hodgkin LymphomaRefractory ALK-Positive Large B-Cell LymphomaRefractory Diffuse Large B-Cell Lymphoma Activated B-Cell TypeRefractory Diffuse Large B-Cell Lymphoma Associated With Chronic InflammationRefractory Diffuse Large B-Cell Lymphoma Germinal Center B-Cell TypeRefractory Diffuse Large B-Cell Lymphoma, Not Otherwise SpecifiedRefractory EBV-Positive Diffuse Large B-Cell Lymphoma, Not Otherwise SpecifiedRefractory Grade 3b Follicular LymphomaRefractory High Grade B-Cell Lymphoma With MYC and BCL2 RearrangementsRefractory High Grade B-Cell Lymphoma, Not Otherwise SpecifiedRefractory Intravascular Large B-Cell LymphomaRefractory Primary Cutaneous Diffuse Large B-Cell Lymphoma, Leg TypeRefractory Primary Mediastinal Large B-Cell LymphomaRefractory T-Cell/Histiocyte-Rich Large B-Cell LymphomaRefractory Transformed Non-Hodgkin Lymphoma

Interventions

PROCEDURE

Biospecimen Collection

Undergo blood sample collection

PROCEDURE

Bone Marrow Aspiration

Undergo bone marrow aspiration and biopsy

PROCEDURE

Bone Marrow Biopsy

Undergo bone marrow aspiration and biopsy

BIOLOGICAL

Chimeric Antigen Receptor T-Cell Therapy

Undergo standard of care CAR-T therapy

PROCEDURE

Computed Tomography

Undergo CT or PET/CT

DRUG

Golcadomide

Given PO

PROCEDURE

Leukapheresis

Undergo leukapheresis

PROCEDURE

Positron Emission Tomography

Undergo PET/CT

BIOLOGICAL

Rituximab

Given IV

Locations (7)

Mayo Clinic in Arizona

Scottsdale, Arizona, United States

Mayo Clinic in Florida

Jacksonville, Florida, United States

Mayo Clinic Health System in Albert Lea

Albert Lea, Minnesota, United States

Mayo Clinic Health Systems-Mankato

Mankato, Minnesota, United States

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Mayo Clinic Health System-Eau Claire Clinic

Eau Claire, Wisconsin, United States

Mayo Clinic Health System-Franciscan Healthcare

La Crosse, Wisconsin, United States