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Trial Summary


Protocol No.ARO-021
StatusOPEN TO ACCRUAL
Principal InvestigatorSayar, Hamid
ScopeNational
PhasePhase III
Age GroupAdult
TitlePhase III Randomized Study of Crenolanib versus Midostaurin Administered Following Induction Chemotherapy and Consolidation Therapy in Newly Diagnosed Subjects with FLT3 Mutated Acute Myeloid Leukemia
DescriptionA phase III randomized multi-center study designed to compare the efficacy of crenolanib with that of midostaurin when administered following induction chemotherapy, consolidation chemotherapy and bone marrow transplantation in newly diagnosed AML subjects with FLT3 mutation. About 510 subjects will be randomized in a 1:1 ratio to receive either crenolanib in addition to standard first line treatment of AML (chemotherapy and if eligible, transplantation) (arm A) or midostaurin and standard treatment (arm B). Potentially eligible subjects will be registered and tested for the presence of FLT3 mutation. Once the FLT3 mutation status is confirmed and additional eligibility is established, subject will be randomized and enter into the treatment phase.
Key EligibilityIn order to be eligible to take part in this trial, patients must meet the following criteria:
  • Aged 18 to 60 Years
  • Diagnosis of Acute Myeloid Leukemia
For a full list of participation criteria, please visit clinicaltrials.gov.
Applicable Disease SitesMyeloid and Monocytic Leukemia
Participating InstitutionsIndiana University (IU)
    Treatment TypeTreatment
    ContactPhone: (317) 278-5632
    Email: iutrials@iu.edu