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A Phase 3, Randomized, Open-Label Study Evaluating the Efficacy of Axicabtagene Ciloleucel Versus Standard of Care Therapy in Subjects With Relapsed/Refractory Diffuse Large B Cell Lymphoma

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Trial Profile

A Phase 3, Randomized, Open-Label Study Evaluating the Efficacy of Axicabtagene Ciloleucel Versus Standard of Care Therapy in Subjects With Relapsed/Refractory Diffuse Large B Cell Lymphoma

Status: Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 14 Mar 2024

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At a glance

  • Drugs Axicabtagene ciloleucel (Primary) ; Corticosteroids; Cyclophosphamide; Fludarabine
  • Indications B-cell lymphoma; Diffuse large B cell lymphoma
  • Focus Registrational; Therapeutic Use
  • Acronyms ZUMA-7
  • Sponsors Kite Pharma

    • Most Recent Events

    • 01 Feb 2024 Results of prespecified exploratory analysis examining the association between pretreatment tumor characteristics and the efficacy of axi-cel versus SOC, published in the Nature Medicine
    • 24 Dec 2023 According to a Kite Pharma media release, company announced that the FDA has approved a label update for Yescarta (axicabtagene ciloleucel) to include the overall survival primary analysis from this study showing a statistically significant improvement for Yescarta in OS versus standard of care as second-line treatment with curative intent for V(R/R LBCL) within 12 months of completion of first-line therapy.
    • 20 Dec 2023 Planned End Date changed from 1 Jan 2035 to 1 Oct 2034.
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