{"denoms":[{"counts":[{"groupId":"OG000","value":"0"}],"units":"Participants"}],"description":"OR, defined as complete or partial metabolic response recorded from first day of treatment until disease progression/recurrence or initiation of new antineoplastic therapy, as per the Lugano response criteria.","groups":[{"description":"The phase II study will include treatment with ixazomib and romidepsin at the MTD established in the Phase I study. Each cycle is 28 days and patients will receive treatment until progressive disease, unacceptable toxicity, or if any other withdrawal criteria are met.\n\nRomidepsin: Romidepsin is a histone deacetylase (HDAC) inhibitor. HDACs catalyze the removal of acetyl groups from acetylated lysine residues in histones, resulting in the modulation of gene expression.\n\nIxazomib: Ixazomib is a reversible proteasome inhibitor. Ixazomib preferentially binds and inhibits the chymotrypsin-like activity of the beta 5 subunit of the 20S proteasome.","id":"OG000","title":"Romidepsin Plus Ixazomib"}],"populationDescription":"Data for this secondary outcome was not collected or analyzed due to the early termination of the study by the funder prior to the start of any Phase II activity.","reportingStatus":"POSTED","timeFrame":"36 months","title":"Phase II: Overall Response Rate (ORR)","type":"SECONDARY"}