{"description":"Both cytarabine-based consolidation chemo and HCT are considered standard of care for this disease population. With the exception of GVHD, an event of clinical interest, adverse events experienced by the subjects were not recorded in the dataset or included in the safety analysis. Each occurrence of GVHD, in evaluable subjects who received HCT, was graded by the investigator according to accepted institutional practice: CIBMTR grading for Acute GVHD; NIH Consensus criteria for Chronic GVHD.","eventGroups":[{"deathsNumAffected":0,"deathsNumAtRisk":1,"description":"Standard of Care Consolidation (HCT)\n\nEnrolled subjects that will contribute to the population of subjects who are evaluable for the primary and secondary objectives. This will not include any subjects who end up in either observational cohort. To be included in the evaluable cohort, the subject must meet the following requirements:\n\n1. Complete remission (CR1) from standard cytarabine or HMA-based induction therapy per standard clinical criteria (Cheson Criteria)\n2. Have confirmed presence of CD34+CD38-ALDHint population by flow cytometry at the diagnostic LSC assay (LSC0)\n3. Cytarabine-based induction subjects: Are candidates for (as determined by the investigator) and receive consolidation therapy (cytarabine-based chemotherapy or HCT); HMA-based induction subjects: Are candidates for (as determined by the investigator) and receive HCT\n\nAllogeneic HCT: Allogeneic HCT","id":"EG000","otherNumAffected":0,"otherNumAtRisk":1,"seriousNumAffected":0,"seriousNumAtRisk":1,"title":"Evaluable Cohort - Transplant Arm"},{"deathsNumAffected":1,"deathsNumAtRisk":6,"description":"Standard of Care Consolidation (cytarabine-based chemo)\n\nEnrolled subjects that will contribute to the population of subjects who are evaluable for the primary and secondary objectives. This will not include any subjects who end up in either observational cohort. To be included in the evaluable cohort, the subject must meet the following requirements:\n\n1. Complete remission (CR1) from standard cytarabine or HMA-based induction therapy per standard clinical criteria (Cheson Criteria)\n2. Have confirmed presence of CD34+CD38-ALDHint population by flow cytometry at the diagnostic LSC assay (LSC0)\n3. Cytarabine-based induction subjects: Are candidates for (as determined by the investigator) and receive consolidation therapy (cytarabine-based chemotherapy or HCT)\n\nConsolidation chemotherapy: Cytarabine-based consolidation chemotherapy","id":"EG001","otherNumAffected":0,"otherNumAtRisk":6,"seriousNumAffected":0,"seriousNumAtRisk":6,"title":"Evaluable Cohort - Consolidation Chemo Arm"},{"deathsNumAffected":0,"deathsNumAtRisk":4,"description":"Enrolled subjects who do not achieve a CR to induction therapy, regardless of diagnostic phenotype. Following completion of induction therapy and remission bone marrow aspirate, if a subject is determined to not have achieved a complete remission to induction therapy, he or she would be included in observational cohort 1.","id":"EG002","otherNumAffected":0,"otherNumAtRisk":4,"seriousNumAffected":0,"seriousNumAtRisk":4,"title":"Observational Cohort 1"},{"deathsNumAffected":4,"deathsNumAtRisk":7,"description":"Enrolled subjects who achieve a CR to induction therapy but meet one or more of the following criteria:\n\n* Lack the immunophenotype of interest,\n* Cytarabine based induction subjects: Are not candidates for \\[as determined by the investigator (e.g. unfit or refusal)\\] and do not receive consolidation therapy (cytarabine-based chemotherapy or HCT)\n* HMA-based induction subjects: Are not candidates for \\[as determined by the investigator (e.g. unfit, lack of donor, refusal)\\] and do not receive HCT\n\nFinal investigator determination of fit-ness can occur at any time until the start of consolidation therapy.\n\nHMA-based induction subjects will not receive consolidation cytarabine-based chemotherapy as part of the evaluable cohort if they do not receive HCT.","id":"EG003","otherNumAffected":0,"otherNumAtRisk":7,"seriousNumAffected":0,"seriousNumAtRisk":7,"title":"Observational Cohort 2"}],"frequencyThreshold":"0","timeFrame":"Graft Versus Host Disease (GVHD) events were collected from the time of consolidation HCT through long term follow-up (up to approximately 5 years). - Acute GVHD: Confirmed GVHD within 100 days of HCT. - Chronic GVHD: Confirmed GVHD 100 days or more after HCT."}