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A phase Ib/II clinical evaluation of Ponatinib in combination with 5- Azacitidine in patients failing prior therapy for FLT3-ITD positive acute myeloid leukaemia (AMLM21)

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Trial Profile

A phase Ib/II clinical evaluation of Ponatinib in combination with 5- Azacitidine in patients failing prior therapy for FLT3-ITD positive acute myeloid leukaemia (AMLM21)

Status: Recruiting
Phase of Trial: Phase I

Latest Information Update: 18 Apr 2022

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At a glance

  • Drugs Azacitidine (Primary) ; Ponatinib (Primary)
  • Indications Acute myeloid leukaemia
  • Focus Adverse reactions; Therapeutic Use
  • Acronyms PonAZA study

    • Most Recent Events

    • 14 Dec 2021 Results (n=31) presented at the 63rd American Society of Hematology Annual Meeting and Exposition
    • 20 Sep 2021 Phase of the trial is changed from 1/2 to 1. Phase II portion of trial has been removed from the study after enrolment of 20 participants. The removal of the Azacitidine alone arm was done during protocol development, as this was considered an unnecessary control. There are now only 2 arms; Ponatinib alone vs Ponatinib/Azacitidine.
    • 20 Sep 2021 Planned number of patients changed from 60 to 42.
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