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Randomized Phase 3 Trial of Standard Care Plus AV-GBM-1 vs Autologous Monocytes as Adjunctive Therapy Following Primary Surgery Plus Concurrent Radiation-temozolomide in Patients With Newly Diagnosed Glioblastoma

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Randomized Phase 3 Trial of Standard Care Plus AV-GBM-1 vs Autologous Monocytes as Adjunctive Therapy Following Primary Surgery Plus Concurrent Radiation-temozolomide in Patients With Newly Diagnosed Glioblastoma

Status: Not yet recruiting
Phase of Trial: Phase III

Latest Information Update: 01 Mar 2024

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At a glance

  • Drugs AV-GBM-1 (Primary)
  • Indications Glioblastoma
  • Focus Registrational; Therapeutic Use
  • Sponsors AiVita Biomedical

    • Most Recent Events

    • 27 Feb 2024 According to an AiVita Biomedical media release, the company has received US FDA clinical approval to conduct this study.
    • 07 Apr 2023 According to ClinicalTrials.gov record, protocol has been amended to reduced the planned patient number from 726 to 672, time frame of primary endpoint changed from 2.5 years to 2 years. Official title also changed.
    • 07 Apr 2023 Planned number of patients changed from 726 to 672.

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