eagle-i University of Hawaii at ManoaUniversity of Hawaii at Manoa
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Daunorubicin/cytarabine, high-dose cytarabine + midostaurin or placebo in newly diagnosed patients over 60 years with acute myeloid leukemia (AML)

eagle-i ID


Resource Type

  1. Clinical trial


  1. Intervention
  2. Intervention
    High-dose citarabine and midostaurin
  3. Intervention
  4. Additional Topic(s)
    antineoplastic combined chemotherapy
  5. Contact
    Berenberg, Jeffrey
  6. PI
    Berenberg, Jeffrey
  7. Topic
    acute myeloid leukemia
  8. Study Population
    Non-pregnant and non-nursing patients 18 to 16 years old with unequivocal diagnosis of AML (>20% blasts in the bone marrow based on the WHO classification, excluding M3 (acute promyelocytic leukemia), with no prior treatment for leukemia, and documented FLT3 mutation (ITD or point mutation), determined by analysis in a protocol-designated FLT3 screening laboratory. AML patients with a history of antecedent myelodysplasia (MDS) must not have had prior cytotoxic (including azacitidine or decitabine) therapy for MDS. Total bilirubin < 2.5 x upper limit of normal.
  9. Funded by
    Cancer Trials Support Unit
  10. Phase
    Phase 3 clinical trial
  11. Performed by
    Clinical Protocol & Data Management Shared Resource
Provenance Metadata About This Resource Record
Copyright © 2016 by the President and Fellows of Harvard College
The eagle-i Consortium is supported by NIH Grant #5U24RR029825-02 / Copyright 2016