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

Part of paid clinical trials in Scottsdale, Arizona.

Sponsor
Mayo Clinic
Study ID
NCT06834373
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Large B-Cell Lymphoma With IRF4 Rearrangement
  • Recurrent ALK-Positive Large B-Cell Lymphoma
  • Recurrent Aggressive B-Cell Non-Hodgkin 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 ALK-Positive Large B-Cell Lymphoma
  • Refractory Aggressive B-Cell Non-Hodgkin 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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Biospecimen Collection — PROCEDURE
    Undergo blood sample collection
  • Bone Marrow Aspiration — PROCEDURE
    Undergo bone marrow aspiration and biopsy
  • Bone Marrow Biopsy — PROCEDURE
    Undergo bone marrow aspiration and biopsy
  • Chimeric Antigen Receptor T-Cell Therapy — BIOLOGICAL
    Undergo standard of care CAR-T therapy
  • Computed Tomography — PROCEDURE
    Undergo CT or PET/CT
  • Golcadomide — DRUG
    Given PO
  • Leukapheresis — PROCEDURE
    Undergo leukapheresis
  • Positron Emission Tomography — PROCEDURE
    Undergo PET/CT
  • Rituximab — BIOLOGICAL
    Given IV

Study Details

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.

Key Dates

Start date
Apr 2, 2025
Status verified
Jan 2026
Primary completion
Mar 3, 2027
Completion
Mar 3, 2027

Study Design

Enrollment
41 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (golcadomide, rituximab)
    Patients receive golcadomide PO QD on days 1-14 of each cycle and rituximab 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.

Primary Outcome Measure

Disease control [ Time Frame: 2 cycles (cycle length = 28 days) ]

Central Contacts

Locations (7)

FacilityCityStateZIPSite coordinators
Mayo Clinic in ArizonaScottsdaleArizona85259
Clinical Trials Referral Office
[email protected]
855-776-0015
Javier L. Munoz, MD, MBA (PRINCIPAL_INVESTIGATOR)
Mayo Clinic in FloridaJacksonvilleFlorida32224-9980
Clinical Trials Referral Office
[email protected]
855-776-0015
Muhamad Alhaj Moustafa, MD, MS (PRINCIPAL_INVESTIGATOR)
Mayo Clinic Health System in Albert LeaAlbert LeaMinnesota56007
Clinical Trials Referral Office
[email protected]
855-776-0015
Mina Hanna, MD (PRINCIPAL_INVESTIGATOR)
Mayo Clinic Health Systems-MankatoMankatoMinnesota56001
Clinical Trials Referral Office
[email protected]
855-776-0015
Amrit B. Singh, MBBS (PRINCIPAL_INVESTIGATOR)
Mayo Clinic in RochesterRochesterMinnesota55905
Clinical Trials Referral Office
[email protected]
855-776-0015
Claire Tiger, MD, PhD (PRINCIPAL_INVESTIGATOR)
Mayo Clinic Health System-Eau Claire ClinicEau ClaireWisconsin54701
Clinical Trials Referral Office
[email protected]
855-776-0015
Eyad S. Al-Hattab, MD (PRINCIPAL_INVESTIGATOR)
Mayo Clinic Health System-Franciscan HealthcareLa CrosseWisconsin54601
Clinical Trials Referral Office
[email protected]
855-776-0015
Scott H. Okuno, MD (PRINCIPAL_INVESTIGATOR)

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