{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"7"},{"groupId":"OG001","value":"42"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"7"},{"groupId":"OG001","value":"59"}],"units":"Participants"}],"description":"A Response is defined as: Complete response (CR) + Complete response without platelet recovery (CRp) + CR with insufficient hematological recovery (platelets or neutrophils (CRi). CR is Neutrophil count 2: 1.0 x 10\\^9/L, platelet count 2: 100 x 10\\^9/L and bone marrow aspirate and biopsy: S5% blasts. CRp is same as CR but with Platelets \\< 100 x 10\\^/L. CRi is same as CR but platelets \\< 100 x 10(/L or neutrophils \\< 1 x 10\\^9.","groups":[{"description":"The first 7 patients on study (first cohort) receive 1 or 2 induction cycles of therapy according to the following starting schedule: Vosaroxin administered intravenously on days 1 and 4 at a dose of 90 mg/m2 in the first cycle (induction 1) for a total dose of 180 mg/m2/cycle in combination with Decitabine at a dose of 20 mg/m2 intravenously daily for 5 consecutive days (Days 1 to 5).","id":"OG000","title":"Phase I MTD Vosaroxin"},{"description":"The first 7 patients on study (first cohort) receive 1 or 2 induction cycles of therapy according to the following starting schedule: Vosaroxin administered intravenously on days 1 and 4 at a dose of 90 mg/m2 in the first cycle (induction 1) for a total dose of 180 mg/m2/cycle in combination with Decitabine at a dose of 20 mg/m2 intravenously daily for 5 consecutive days (Days 1 to 5).\n\nFollowing the phase I portion, patients in phase II receive the following induction:\n\n1. Vosaroxin intravenously on days 1 and 4 at a dose of 70 mg/m2 for a total dose of 140 mg/m2/cycle (days 1 and 4), or the final induction dose (MTD) determined in phase I.\n2. Decitabine intravenously at a dose of 20 mg/m2 for 5 consecutive days (days 1 to 5), or the final induction dose (MTD) determined in phase I.\n\nVosaroxin: Phase I Starting Dose: 90 mg/m2 by vein on Days 1 and 4 of each cycle.\n\nPhase II Starting Dose: 70 mg/m2 by vein on Days 1 and 4 of each cycle, or maximum tolerated dose from Phase I.\n\nDecitabine: Phase I and II: 20 mg/m2 by vein daily for 5 consecutive days (Days 1 to 5).","id":"OG001","title":"Vosaroxin + Decitabine"}],"paramType":"COUNT_OF_PARTICIPANTS","reportingStatus":"POSTED","timeFrame":"21 days","title":"Participants With a Response","type":"SECONDARY","unitOfMeasure":"Participants"}