Cytarabine, Daunorubicin, and Midostaurin induction therapy for acute myeloid leukemia (AML)
Regimen in use at
|Stone et al. 2017 (RATIFY)||Phase III (E-RT-esc)||7+3d (intermediate-dose)||Superior OS|
- Cytarabine (Ara-C) 200 mg/m2/day IV continuous infusion on days 1 to 7 (total dose: 1400 mg/m2)
- Daunorubicin (Cerubidine) 60 mg/m2 IV once per day on days 1 to 3
- Midostaurin (Rydapt) 50 mg PO twice per day on days 8 to 21
- Hydroxyurea (Hydrea) (no dosage specified) was allowed to be used for up to 5 days before the start of therapy while waiting for results of FLT3 mutation testing
21-day course; retreatment with a second course was allowed if day 21 bone marrow biopsy showed residual AML.
- Patients who achieved complete remission (CR): HiDAC & Midostaurin consolidation. Stem cell transplantation was allowed.
- RATIFY: Stone RM, Mandrekar SJ, Sanford BL, Laumann K, Geyer S, Bloomfield CD, Thiede C, Prior TW, Döhner K, Marcucci G, Lo-Coco F, Klisovic RB, Wei A, Sierra J, Sanz MA, Brandwein JM, de Witte T, Niederwieser D, Appelbaum FR, Medeiros BC, Tallman MS, Krauter J, Schlenk RF, Ganser A, Serve H, Ehninger G, Amadori S, Larson RA, Döhner H. Midostaurin plus chemotherapy for acute myeloid leukemia with a FLT3 mutation. N Engl J Med. 2017 Aug 3;377(5):454-464. Epub 2017 Jun 23. link to original article link to PMC article contains verified protocol PubMed