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RecruitingNCT06834373

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)

Status
Recruiting
Phase
Phase 2
Study type
Interventional
Enrollment
41 (estimated)
Sponsor
Mayo Clinic · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Detailed description

PRIMARY OBJECTIVE: I. Evaluate efficacy as measured by the disease control rate (complete metabolic response \[CMR\], partial metabolic response \[PMR\], and no metabolic response \[NMR\]) by Lugano 2014 positron emission tomography (PET)-computed tomography (CT) based assessment after 2 cycles of therapy. SECONDARY OBJECTIVES: I. To further evaluate clinical efficacy as measured by overall response rate (ORR), complete response (CMR) rate, disease control rate by Lugano PET-CT based criteria. II. To evaluate the safety and tolerability of golcadomide + rituximab combination therapy as measured by the incidence and severity of treatment related adverse events (TRAE). III. To evaluate efficacy as a bridging therapy as measured by the number of patients proceeding to CAR-T and response to CAR-T. IV. To evaluate duration of response, progression-free survival, and overall survival. EXPLORATORY OBJECTIVES: I. Improvement of symptoms (compressive, pain, B symptoms \[fever, night sweats, weight loss\]) associated with the disease as determined by the investigator. II. To evaluate the diversity of CAR-T products received in patients proceeding to CAR-T. OUTLINE: Patients receive golcadomide orally (PO) once daily (QD) on days 1-14 of each cycle and rituximab intravenously (IV) on days 1, 8, 15 and 22 of cycle 1 and then on day 1 of all subsequent cycles. Cycles repeat every 28 days for up to 2 cycles in the absence of disease progression or unacceptable toxicity. ELIGIBLE FOR CAR-T: After 2 cycles, patients undergo leukapheresis and may receive 1-2 additional cycles of golcadomide and rituximab prior to undergoing standard of care CAR-T therapy. INELIGIBLE FOR CAR-T: After 2 cycles, patients receive golcadomide PO QD on days 1-14 of each cycle and rituximab IV on day 1 of each cycle. Cycles repeat every 28 days for up to 10 additional cycles of golcadomide (cycles 3-12) and up to 3 additional cycles of rituximab (cycles 3-5) in the absence of disease progression or unacceptable toxicity. Patients also undergo blood sample collection and PET/CT or CT throughout the study. Additionally, patients may undergo bone marrow aspiration and biopsy as clinically indicated. After completion of study treatment, patients are followed up at 28 days. CAR-T ineligible patients are followed up every 3 months until progression or subsequent treatment, then every 6 months for up to 2 years. CAR-T eligible patients are followed up at 180 days after CAR-T then every 6 months for up to 2 years.

Conditions

Interventions

TypeNameDescription
PROCEDUREBiospecimen CollectionUndergo blood sample collection
PROCEDUREBone Marrow AspirationUndergo bone marrow aspiration and biopsy
PROCEDUREBone Marrow BiopsyUndergo bone marrow aspiration and biopsy
BIOLOGICALChimeric Antigen Receptor T-Cell TherapyUndergo standard of care CAR-T therapy
PROCEDUREComputed TomographyUndergo CT or PET/CT
DRUGGolcadomideGiven PO
PROCEDURELeukapheresisUndergo leukapheresis
PROCEDUREPositron Emission TomographyUndergo PET/CT
BIOLOGICALRituximabGiven IV

Timeline

Start date
2025-04-02
Primary completion
2027-03-03
Completion
2027-03-03
First posted
2025-02-19
Last updated
2026-01-28

Locations

7 sites across 1 country: United States

Regulatory

Source: ClinicalTrials.gov record NCT06834373. Inclusion in this directory is not an endorsement.