RecruitingPhase 2NCT06834373

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

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)


Sponsor

Mayo Clinic

Enrollment

41 participants

Start Date

Apr 2, 2025

Study Type

INTERVENTIONAL

Conditions

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

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial tests golcadomide (an oral immune-modulating drug) combined with rituximab as a short "bridging" treatment to keep aggressive B-cell lymphoma under control while patients wait for CAR T-cell therapy — a more intensive immunotherapy that requires preparation time. **You may be eligible if...** - You are 18 or older - You have been diagnosed with a type of aggressive B-cell lymphoma (such as DLBCL, high-grade B-cell lymphoma, or similar) that has come back or stopped responding after 1–2 prior treatments - You are being evaluated or scheduled for CAR T-cell therapy - Your cancer was confirmed by a pathologist using standard classification criteria **You may NOT be eligible if...** - You have received more than 2 prior lines of therapy - You have active brain involvement by lymphoma - You have significant heart, liver, or kidney problems - You are pregnant or unable to use effective contraception Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREBiospecimen Collection

Undergo blood sample collection

PROCEDUREBone Marrow Aspiration

Undergo bone marrow aspiration and biopsy

PROCEDUREBone Marrow Biopsy

Undergo bone marrow aspiration and biopsy

BIOLOGICALChimeric Antigen Receptor T-Cell Therapy

Undergo standard of care CAR-T therapy

PROCEDUREComputed Tomography

Undergo CT or PET/CT

DRUGGolcadomide

Given PO

PROCEDURELeukapheresis

Undergo leukapheresis

PROCEDUREPositron Emission Tomography

Undergo PET/CT

BIOLOGICALRituximab

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

View Full Details on ClinicalTrials.gov

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NCT06834373


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