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Clinical phase III trial to compare Treosulfan-based conditioning therapy with Busulfan-based reduced-intensity conditioning (RIC) prior to allogeneic haematopoietic stem cell transplantation in patients with AML or MDS considered ineligible to standard conditioning regimens

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Trial Profile

Clinical phase III trial to compare Treosulfan-based conditioning therapy with Busulfan-based reduced-intensity conditioning (RIC) prior to allogeneic haematopoietic stem cell transplantation in patients with AML or MDS considered ineligible to standard conditioning regimens

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 16 Jan 2023

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At a glance

  • Drugs Treosulfan (Primary) ; Busulfan
  • Indications Acute myeloid leukaemia; Myelodysplastic syndromes
  • Focus Registrational; Therapeutic Use
  • Sponsors Medac

Most Recent Events

  • 12 Jan 2023 According to Medexus media release, the FDA continues to seek supporting information from Medac related to this study.
  • 16 Sep 2022 According to a Medexus media release, the company will provide an update to its shareholders and stakeholders once management knows whether the NDA resubmission has been accepted and is better able to assess the impact of this delay.
  • 16 Sep 2022 According to a Medexus media release, the U.S. Food and Drug Administration (FDA) has delivered to medac a second notice of incomplete response regarding medacs new drug application resubmission for treosulfan (NDA). The FDAs notice requests further supporting information from medac to complete medacs NDA resubmission but does not require submission of new clinical data.

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