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A Randomized Phase II/III Trial of "Novel Therapeutics" Versus Azacitidine in Newly Diagnosed Patients With Acute Myeloid Leukemia (AML) or High-Risk Myelodysplastic Syndrome (MDS), Age 60 or Older LEAP: Less-Intense AML Platform Trial.

Trial Profile

A Randomized Phase II/III Trial of "Novel Therapeutics" Versus Azacitidine in Newly Diagnosed Patients With Acute Myeloid Leukemia (AML) or High-Risk Myelodysplastic Syndrome (MDS), Age 60 or Older LEAP: Less-Intense AML Platform Trial.

Status: Suspended
Phase of Trial: Phase II/III

Latest Information Update: 24 Jan 2020

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At a glance

  • Drugs Azacitidine (Primary) ; Azacitidine (Primary) ; Cytarabine (Primary) ; Decitabine (Primary) ; Midostaurin (Primary) ; Nivolumab (Primary)
  • Indications Acute myeloid leukaemia; Myelodysplastic syndromes
  • Focus Therapeutic Use
  • Most Recent Events

    • 10 Dec 2019 Trial design of Accrual Barriers and Detection of Early Toxicity Signal in Newly Diagnosed Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome patients treated with Azacitidine and Nivolumab presented at the 61st Annual Meeting and Exposition of the American Society of Hematology.
    • 02 Nov 2018 Status changed from recruiting to suspended as Safety data review, unscheduled
    • 31 Aug 2018 Biomarkers information updated
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