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A Multicenter, Pivotal Phase 3 Study of Iomab-B Prior to Allogeneic Hematopoietic Cell Transplantation Versus Conventional Care in Older Subjects With Active, Relapsed or Refractory Acute Myeloid Leukemia

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Trial Profile

A Multicenter, Pivotal Phase 3 Study of Iomab-B Prior to Allogeneic Hematopoietic Cell Transplantation Versus Conventional Care in Older Subjects With Active, Relapsed or Refractory Acute Myeloid Leukemia

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 23 Sep 2024

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At a glance

  • Drugs I-131-Apamistamab (Primary) ; Asparaginase; Azacitidine; Carboplatin; Cladribine; Clofarabine; Cyclophosphamide; Cytarabine; Daunorubicin; Decitabine; Doxorubicin; Enasidenib; Etoposide; Fludarabine; Gemtuzumab ozogamicin; Gilteritinib; Idarubicin; Ivosidenib; Midostaurin; Mitoxantrone; Sorafenib; Tioguanine; Topotecan; Venetoclax
  • Indications Acute myeloid leukaemia
  • Focus Registrational; Therapeutic Use
  • Acronyms Iomab-B SIERRA; SIERRA; SIERRA in AML
  • Sponsors Actinium Pharmaceuticals

    • Most Recent Events

    • 20 Sep 2024 According to a Actinium Pharmaceuticals media release, On August 05, 2024, Actinium announced that after concluding both its clinical and Chemistry, Manufacturing and Controls ("CMC") interactions with the FDA regarding the BLA pathway for Iomab-B, the FDA determined that demonstrating an overall survival benefit in a randomized head-to-head trial is required for a BLA filing, and the SIERRA trial alone will not be adequate for BLA filing.
    • 20 Sep 2024 Results presented in a Actinium Pharmaceuticals media release.
    • 20 Sep 2024 According to a Actinium Pharmaceuticals media release, company announced the publication of the Phase 3 SIERRA results of Iomab-B in the peer-reviewed Journal of Clinical Oncology (JCO). The article, titled, "Randomized Phase III SIERRA Trial of 131I-Apamistamab Before Allogeneic Hematopoietic Cell Transplantation vs Conventional Care for Relapsed/Refractory Acute Myeloid Leukemia" and is available online on the ASCO Journal of Clinical Oncology.

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