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

StatusRecruiting
PhasePhase 2
Started

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Trial flagged as At Risk
Primary completion moved at least 3 months later Mar 3, 2027 → Jun 10, 2027
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Record History

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  1. Minor Primary completion pushed from Mar 3, 2027 to Jun 10, 2027 Show 4 more changesShow less
    • Study completion pushed from Mar 3, 2027 to Sep 9, 2028
    • Eligibility criteria expanded, about 84 words
    • Secondary endpoints: details revised at 6 of 9 entries
    • Study description revised
  2. Minor Site contacts updated at 1 of 7 sitesv5
  3. Minor Re-verified, no change to tracked fieldsv4
  4. Notable Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Mar 3, 2025 to Apr 2, 2025
    • Site details revised at 7 of 7 sites
    v3
  5. Minor Re-verified, no change to tracked fieldsv2
  6. Minor Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
1,024 trials monitored
See 128 trials at risk
706 trials monitored
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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.
Trial Details
NCT Number NCT06834373
Lead Sponsor Mayo Clinic
Conditions
(from sponsor)
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 +23 more
Related terms Lymphoma, Large B-Cell, Diffuse
Enrollment 41 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov