{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"6"}]}],"title":"Complete Response (CR)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"9"}]}],"title":"Partial Response (PR)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"2"}]}],"title":"Stable Disease (SD)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"6"}]}],"title":"Progressive Disease (PD)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"15"}]}],"title":"CR + PR"}],"denoms":[{"counts":[{"groupId":"OG000","value":"23"}],"units":"Participants"}],"description":"The endpoint for this objective will be objective response rate (ORR), defined per Cheson criteria. Response will be assessed by imaging after cycles 3 and 6, and then every 6 months thereafter. Response at 3 months (after cycle 3) will be used for purposes of the interim efficacy analysis.","groups":[{"description":"Patients receive romidepsin IV over 4 hours on days 1, 8, and 15 and lenalidomide PO QD on days 1-21. Treatment repeats every 28 days for up to 1 year in the absence of disease progression or unacceptable toxicity.\n\nromidepsin: Given IV\n\nlenalidomide: Given PO\n\nlaboratory biomarker analysis: Correlative studies","id":"OG000","title":"Treatment (Romidepsin, Lenalidomide)"}],"paramType":"NUMBER","reportingStatus":"POSTED","timeFrame":"Assessed after cycles 3 and 6, then every 6 months up to 3 years","title":"Objective Response Rate (ORR), as Defined Per Cheson Criteria","type":"PRIMARY","unitOfMeasure":"participants"}