{"classes":[{"categories":[{"measurements":[{"comment":"The maximum tolerated dose in phase I was not reached. insufficient number of participants with events, study terminated early.","groupId":"OG000","value":"NA"},{"comment":"The maximum tolerated dose in phase I was not reached. insufficient number of participants with events, study terminated early.","groupId":"OG001","value":"NA"},{"comment":"The maximum tolerated dose in phase I was not reached. insufficient number of participants with events, study terminated early.","groupId":"OG002","value":"NA"},{"comment":"The maximum tolerated dose in phase I was not reached. insufficient number of participants with events, study terminated early.","groupId":"OG003","value":"NA"},{"comment":"The maximum tolerated dose in phase I was not reached. insufficient number of participants with events, study terminated early.","groupId":"OG004","value":"NA"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"4"},{"groupId":"OG001","value":"4"},{"groupId":"OG002","value":"5"},{"groupId":"OG003","value":"3"},{"groupId":"OG004","value":"1"},{"groupId":"OG005","value":"0"},{"groupId":"OG006","value":"0"},{"groupId":"OG007","value":"0"}],"units":"Participants"}],"description":"This will be selected based upon the cumulative safety, efficacy and PK data at the end of the Phase 1 portion when the maximum tolerated dose is found. This will be One dose level below the RP2D of DS-1594b from Phase 1.","groups":[{"description":"Patients receive DS-1594b PO BID on days 1-28 in the absence of disease progression or unacceptable toxicity.\n\n70 mg twice daily.\n\nDS-1594b: Given DS-1594b PO","id":"OG000","title":"Phase I (DS-1594b) Cohort 1"},{"description":"Patients receive DS-1594b PO BID on days 1-28 in the absence of disease progression or unacceptable toxicity.\n\n50 mg twice daily.\n\nDS-1594b: Given DS-1594b PO","id":"OG001","title":"Phase I (DS-1594b) Cohort 2"},{"description":"Patients receive DS-1594b PO BID on days 1-28 in the absence of disease progression or unacceptable toxicity.\n\n20 mg daily.\n\nDS-1594b: Given DS-1594b PO","id":"OG002","title":"Phase I (DS-1594b) Cohort 3"},{"description":"Patients receive DS-1594b PO BID on days 1-28 in the absence of disease progression or unacceptable toxicity.\n\n50 mg daily.\n\nDS-1594b: Given DS-1594b PO","id":"OG003","title":"Phase I (DS-1594b) Cohort 4"},{"description":"Patients receive DS-1594b PO BID on days 1-28 in the absence of disease progression or unacceptable toxicity.\n\n100 mg daily.\n\nDS-1594b: Given DS-1594b PO","id":"OG004","title":"Phase I (DS-1594b) Cohort 5"},{"description":"Patients with MLLr or NPM1m receive DS-1594b PO BID on days 1-28. Cycles repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity.\n\nDS-1594b: Given DS-1594b PO","id":"OG005","title":"Phase 2 Cohort A and B (DS-1594b)"},{"description":"Patients receive DS-1594b PO BID on days 1-28, venetoclax PO QD on days 1-28, and azacitidine IV or SC on days 1-7. Cycles repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity.\n\nDS-1594b: Given DS-1594b PO\n\nAzacitidine: Given IV or SC\n\nVenetoclax: Given PO","id":"OG006","title":"Phase 2 Cohort C (DS-1594b, Venetoclax, Azacitidine)"},{"description":"Patients receive DS-1594b PO BID on days 1-28. For additional information, see trial description.\n\nDS-1594b: Given DS-1594b PO\n\nCyclophosphamide: Given IV\n\nCytarabine: Given IT\n\nDexamethasone: Given PO or IV\n\nFilgrastim: Given SC\n\nLeucovorin: Given IV or PO\n\nMesna: Given IV\n\nMethotrexate: Given IT\n\nPrednisone: Given PO\n\nRituximab: Given IV\n\nVincristine: Given IV","id":"OG007","title":"Phase 2 Cohort D (DS-1594b, Mini-HCVD)"}],"paramType":"NUMBER","populationDescription":"Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.","reportingStatus":"POSTED","timeFrame":"Day 28","title":"Recommended Phase 2 Dose (RP2D) (Phase I)","type":"PRIMARY","unitOfMeasure":"Milligrams"}