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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 Dec 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

  • 25 Oct 2024 According to a Actinium Pharmaceuticals media release, data from an exploratory analysis of the Phase 3 SIERRA trial of Iomab-B was presented in a poster presentation at the 2024 European Association of Nuclear Medicine (EANM) Congress, held in Hamburg from October 19-23.
  • 25 Oct 2024 According to a Actinium Pharmaceuticals media release, data from the Phase 3 SIERRA trial of Iomab-B was presented in an oral presentation (Modeling-based Assessment of Exposure Measurements After High-Dose Targeted 131I-apamistamab: Results and Analyses from the Phase III SIERRA Trial) at the 2024 European Association of Nuclear Medicine (EANM) Congress, held in Hamburg from October 19-23.
  • 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.

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