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

Properties

1. Intervention

   Placebo

2. Intervention

   High-dose citarabine and midostaurin

3. Intervention

   Daunorubicin/Cytarabine

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