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A Phase 3 Randomized Study of Loncastuximab Tesirine Combined With Rituximab Versus Immunochemotherapy in Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL) (LOTIS-5)

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Trial Profile

A Phase 3 Randomized Study of Loncastuximab Tesirine Combined With Rituximab Versus Immunochemotherapy in Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL) (LOTIS-5)

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

Latest Information Update: 28 Jan 2025

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At a glance

  • Drugs Loncastuximab tesirine (Primary) ; Rituximab (Primary) ; Dexamethasone; Gemcitabine; Oxaliplatin
  • Indications B-cell lymphoma; Diffuse large B cell lymphoma
  • Focus Registrational; Therapeutic Use
  • Acronyms LOTIS 5
  • Sponsors ADC Therapeutics

    • Most Recent Events

    • 30 Dec 2024 According to an ADC Therapeutics media release, topline results of the primary endpoint analysis are anticipated by the end of 2025 once the required number of pre-specified events is reached followed by regulatory submission to the FDA in Q1 2026 and potential approval in late 2026.
    • 30 Dec 2024 Status changed from recruiting to active, no longer recruiting as per ADC Therapeutics media release
    • 07 Nov 2024 According to an ADC Therapeutics media release, updated data expected in late 2025 once the pre-specified number of events is reached.

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