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

ConditionsLarge 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
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorMayo Clinic

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 volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

  • Biospecimen Collection

    Procedure/Surgery

    Undergo blood sample collection

  • Bone Marrow Aspiration

    Procedure/Surgery

    Undergo bone marrow aspiration and biopsy

  • Bone Marrow Biopsy

    Procedure/Surgery

    Undergo bone marrow aspiration and biopsy

  • Chimeric Antigen Receptor T-Cell Therapy

    Biological/Vaccine

    Undergo standard of care CAR-T therapy

  • Computed Tomography

    Procedure/Surgery

    Undergo CT or PET/CT

  • Golcadomide

    Drug

    Given PO

  • Leukapheresis

    Procedure/Surgery

    Undergo leukapheresis

  • Positron Emission Tomography

    Procedure/Surgery

    Undergo PET/CT

  • Rituximab

    Biological/Vaccine

    Given IV

Treatment groups

41 Participants
are divided into 1 treatment group
Group A: Treatment (golcadomide, rituximab)Experimental treatment 9 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
2 cycles (cycle length = 28 days)

Secondary outcomes

1

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.

Time frame
Up to 2 years
2

Complete response rate

Will be assessed by the total number of patients who achieve a CMR by Lugano 2014 PET/CT.

Time frame
Up to 2 years
3

Overall response rate

Will be assessed by the total number of patients who achieve a CMR or PMR by Lugano 2014 PET/CT divided.

Time frame
Up to 2 years
4

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.

Time frame
Up to 2 years

Other outcomes

Sponsors and contacts

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