{"denoms":[{"counts":[{"groupId":"BG000","value":"33"},{"groupId":"BG001","value":"25"},{"groupId":"BG002","value":"58"}],"units":"Participants"}],"groups":[{"description":"Phase 1 is to determine the maximum tolerated dose (MTD) and dose limiting toxicity (DLT) of the combinations of oral 5-azacitidine and romidepsin in patients with lymphoma. Patients will be administered the study drugs in a 3 + 3 dose-escalation study.","id":"BG000","title":"Phase 1"},{"description":"Patients will be treated with oral 5-azacytidine and Romidepsin at the MTD. The treatment will be administered as follows: oral 5-azacytidine 300 mg (flat dose) on Days 1-14 and Romidepsin 14 mg/m2 (flat dose) on Days 8, 15, and 22 on a 35-day cycle.","id":"BG001","title":"Phase 2"},{"description":"Total of all reporting groups","id":"BG002","title":"Total"}],"measures":[{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","lowerLimit":"23","upperLimit":"79","value":"57"},{"groupId":"BG001","lowerLimit":"42","upperLimit":"88","value":"63"},{"comment":"The median age for the entire study was not calculated at the time of data analysis. The standard deviation cannot be calculated without the raw data. The raw data cannot be accessed, as the Principal Investigator and entire study team has left the institution. In addition, the study closed with the Institutional Review Board in 2021 and further analysis cannot be conducted.","groupId":"BG002","lowerLimit":"23","upperLimit":"88","value":"NA"}]}]}],"dispersionType":"FULL_RANGE","paramType":"MEDIAN","title":"Age, Continuous","unitOfMeasure":"years"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"12"},{"groupId":"BG001","value":"10"},{"groupId":"BG002","value":"22"}]}],"title":"Female"},{"categories":[{"measurements":[{"groupId":"BG000","value":"19"},{"groupId":"BG001","value":"15"},{"groupId":"BG002","value":"34"}]}],"title":"Male"},{"categories":[{"measurements":[{"groupId":"BG000","value":"2"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"2"}]}],"title":"Unknown"}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Sex/Gender, Customized","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"10"},{"groupId":"BG001","value":"3"},{"groupId":"BG002","value":"13"}],"title":"Hispanic or Latino"},{"measurements":[{"groupId":"BG000","value":"20"},{"groupId":"BG001","value":"22"},{"groupId":"BG002","value":"42"}],"title":"Not Hispanic or Latino"},{"measurements":[{"groupId":"BG000","value":"3"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"3"}],"title":"Unknown or Not Reported"}]}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Ethnicity (NIH/OMB)","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}],"title":"American Indian or Alaska Native"},{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}],"title":"Asian"},{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}],"title":"Native Hawaiian or Other Pacific Islander"},{"measurements":[{"groupId":"BG000","value":"5"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"6"}],"title":"Black or African American"},{"measurements":[{"groupId":"BG000","value":"25"},{"groupId":"BG001","value":"22"},{"groupId":"BG002","value":"47"}],"title":"White"},{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}],"title":"More than one race"},{"measurements":[{"groupId":"BG000","value":"3"},{"groupId":"BG001","value":"2"},{"groupId":"BG002","value":"5"}],"title":"Unknown or Not Reported"}]}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Race (NIH/OMB)","unitOfMeasure":"Participants"}],"populationDescription":"Baseline characteristics and study results were only collected as the combined total from participants per study phase. Baseline characteristics were not collected per dose level and thus cannot be reported per dose level.\n\nBaseline characteristics were collected from all participants who enrolled/consented in Phase 1 (n=33) and Phase 2 (n=25). Of those 33 enrolled in Phase 1, 26 received the study interventions and only those 26 are counted in the Participant Flow."}