{"groups":[{"description":"Decitabine is administered as a 1-hour intravenous (IV) infusion (IVI) daily days 1-5 at 20mg/m2; followed on day 8 by Alvocidib 20mg/m2 (30min bolus) and Alvocidib 20mg/m2 (4 hr IVI)","id":"FG000","title":"ALV-DEC: Cohort 1"},{"description":"Decitabine is administered as a 1-hour intravenous (IV) infusion (IVI) daily days 1-5 at 20mg/m2; followed on day 8 by Alvocidib 20mg/m2 (30min bolus) and Alvocidib 30mg/m2 (4 hr IVI)","id":"FG001","title":"ALV-DEC: Cohort 2"},{"description":"Decitabine is administered as a 1-hour intravenous (IV) infusion (IVI) daily days 1-5 at 20mg/m2; followed on day 8 by Alvocidib 20mg/m2 (30min bolus) and Alvocidib 45mg/m2 (4 hr IVI)","id":"FG002","title":"ALV-DEC: Cohort 3"},{"description":"Decitabine is administered as a 1-hour intravenous (IV) infusion (IVI) daily days 1-5 at 20mg/m2; followed on day 8 by Alvocidib 20mg/m2 (30min bolus) and Alvocidib 60mg/m2 (4 hr IVI)","id":"FG003","title":"ALV-DEC: Cohort 4"},{"description":"Azacitidine (AZA) administered on either a 7-day schedule or a 5-2-2 schedule (once daily for 5 days followed by 2 drug-free days with 2 more days of treatment) at 75mg/m2 per day subcutaneously or via IVI. Alvocidib (ALV) administered on day 10 at 75mg/m2 as a 30-60 minute IVI.","id":"FG004","title":"ALV-AZA: Cohort 5"},{"description":"Azacitidine (AZA) administered on either a 7-day schedule or a 5-2-2 schedule (once daily for 5 days followed by 2 drug-free days with 2 more days of treatment) at 75mg/m2 per day subcutaneously or via IVI. Alvocidib (ALV) administered on day 10 at 90mg/m2 as a 30-60 minute IVI.","id":"FG005","title":"ALV-AZA: Cohort 6"}],"periods":[{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"1"},{"groupId":"FG004","numSubjects":"0"},{"groupId":"FG005","numSubjects":"0"}],"type":"Adverse Event"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"0"},{"groupId":"FG005","numSubjects":"1"}],"type":"Physician Decision"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"3"},{"groupId":"FG001","numSubjects":"3"},{"groupId":"FG002","numSubjects":"3"},{"groupId":"FG003","numSubjects":"4"},{"groupId":"FG004","numSubjects":"3"},{"groupId":"FG005","numSubjects":"4"}],"comment":"Any patient who received at least 1 dose of study drug.","type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"3"},{"groupId":"FG001","numSubjects":"3"},{"groupId":"FG002","numSubjects":"3"},{"groupId":"FG003","numSubjects":"3"},{"groupId":"FG004","numSubjects":"3"},{"groupId":"FG005","numSubjects":"3"}],"comment":"Completed Cycle 1","type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"1"},{"groupId":"FG004","numSubjects":"0"},{"groupId":"FG005","numSubjects":"1"}],"type":"NOT COMPLETED"}],"title":"Overall Study"}],"preAssignmentDetails":"In phase 1b, patients were enrolled in cohorts of 3-6 patients. Escalation of alvocidib (ALV) dose followed standard 3+3 dosing with sequential cohorts of 3 patients treated at incrementally higher doses of alvocidib administered in sequence after fixed doses of decitabine (DEC) or azacitadine (AZA) until MTD is reached.","recruitmentDetails":"Twenty subjects were enrolled between August 2018 and August 2021"}