Trial of Eltrombopag During Consolidation Therapy in Adults With AML in Complete Remission

"Cycle 1= Cytarabine 3 g/m² IV twice daily on Days 1, 3 and 5 (Patients \>60 years of age will receive cytarabine 1.5 g/m² IV per dose). Day 1 must start in AM.~Eltrombopag (Open-Label) by mouth daily until platelet recovery or for 35 consecutive days, whichever occurs first. Phase I will determine the dose and schedule of Eltrombopag to be used in Phase II.~One cycle of consolidation therapy with high-dose cytarabine and eltrombopag will be received on study. Additional chemotherapy may be administered at the investigators discretion without eltrombopag."

"Cytarabine 3 g/m² IV twice daily on Days 1, 3 and 5 (Patients \>60 years of age will receive cytarabine 1.5 g/m² IV per dose). Day 1 must start in AM.~Eltrombopag by mouth daily (dose and schedule as determined in Phase I) with 1st cycle of high-dose consolidation chemotherapy and placebo by mouth daily with 2nd cycle.~Eltrombopag/placebo will continue until platelet recovery or for 35 consecutive days, whichever occurs first.~Additional chemotherapy may be administered at the investigators discretion without eltrombopag."

"Cytarabine 3 g/m² IV twice daily on Days 1, 3 and 5 (Patients \>60 years of age will receive cytarabine 1.5 g/m² IV per dose). Day 1 must start in AM.~Placebo by mouth daily with 1st cycle of high-dose consolidation therapy and Eltrombopag by mouth daily (dose and schedule as determined in Phase I) with 2nd cycle.~Eltrombopag/placebo will continue until platelet recovery or for 35 consecutive days, whichever occurs first.~Additional chemotherapy may be administered at the investigators discretion without eltrombopag."