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.

Research & Trial Information


Protocol #: s1612

Cancer Type: Hematology AML


  1. Patients must be suspected to have previously untreated acute myelogenous leukemia (AML) or myelodysplastic syndrome with excess blasts-2 (MDS-EB-2).
  2. Patients must be ≥ 60 years of age.
  3. Patients must not be known to have AML in the CNS.
  4. Patients must have specimens submitted for FLT3 testing for randomization stratification.
  5. Patients who have received prior therapy with midostaurin, any anti-PD-1 or anti-PD-L1 therapy, any DNA-methyltransferase inhibitor (including hypomethylating agents such as azacitidine, decitabine, or other investigational agent that acts by inhibiting DNA or RNA methylation) for any condition, or prior intensive cytotoxic therapy for MDS, are not eligible.
  6. Prior malignancy is allowed providing it does not require concurrent therapy. Exception: Active hormonal therapy is allowed.


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Hurley Medical Center
Michigan Cancer Consortium


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