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

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.

Conditions

• Large B-Cell Lymphoma With IRF4 Rearrangement
• Recurrent Aggressive B-Cell Non-Hodgkin Lymphoma
• Recurrent ALK-Positive Large B-Cell Lymphoma
• Recurrent Diffuse Large B-Cell Lymphoma Activated B-Cell Type
• Recurrent Diffuse Large B-Cell Lymphoma Associated With Chronic Inflammation
• Recurrent Diffuse Large B-Cell Lymphoma Germinal Center B-Cell Type
• Recurrent Diffuse Large B-Cell Lymphoma, Not Otherwise Specified
• Recurrent EBV-Positive Diffuse Large B-Cell Lymphoma, Not Otherwise Specified
• Recurrent Grade 3b Follicular Lymphoma
• Recurrent High Grade B-Cell Lymphoma With MYC and BCL2 Rearrangements
• Recurrent High Grade B-Cell Lymphoma, Not Otherwise Specified
• Recurrent Intravascular Large B-Cell Lymphoma
• Recurrent Primary Cutaneous Diffuse Large B-Cell Lymphoma, Leg Type
• Recurrent Primary Mediastinal Large B-Cell Lymphoma
• Recurrent T-Cell/Histiocyte-Rich Large B-Cell Lymphoma
• Recurrent Transformed Non-Hodgkin Lymphoma
• Refractory Aggressive B-Cell Non-Hodgkin Lymphoma
• Refractory ALK-Positive Large B-Cell Lymphoma
• Refractory Diffuse Large B-Cell Lymphoma Activated B-Cell Type
• Refractory Diffuse Large B-Cell Lymphoma Associated With Chronic Inflammation
• Refractory Diffuse Large B-Cell Lymphoma Germinal Center B-Cell Type
• Refractory Diffuse Large B-Cell Lymphoma, Not Otherwise Specified
• Refractory EBV-Positive Diffuse Large B-Cell Lymphoma, Not Otherwise Specified
• Refractory Grade 3b Follicular Lymphoma
• Refractory High Grade B-Cell Lymphoma With MYC and BCL2 Rearrangements
• Refractory High Grade B-Cell Lymphoma, Not Otherwise Specified
• Refractory Intravascular Large B-Cell Lymphoma
• Refractory Primary Cutaneous Diffuse Large B-Cell Lymphoma, Leg Type
• Refractory Primary Mediastinal Large B-Cell Lymphoma
• Refractory T-Cell/Histiocyte-Rich Large B-Cell Lymphoma
• Refractory 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

Sponsors & Collaborators

• Mayo Clinic

  lead OTHER

Principal Investigators

• Claire Tiger, MD, PhD · Mayo Clinic

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-04-02

Primary Completion

2027-03-03

Completion

2027-03-03

FDA Drug

Yes

Countries

• United States

Study Locations