26
Participants
Start Date
December 17, 2020
Primary Completion Date
July 1, 2024
Study Completion Date
May 15, 2026
Romidepsin
Romidepsin (12mg/ m\^2) will be administered on days 1 and 10 of each cycle through a peripheral or central intravenous catheter for 6 cycles.
Lenalidomide
Lenalidomide will be administered by oral intake in a dose-escalation with a starting dose of 5mg daily, a second dose level of 10mg daily, a third dose level at 15mg daily, and a fourth dose level at 20mg daily on days -7 to day 10 of first cycle. After the second cycle, lenalidomide will be given from day 1 to day 10 in each cycle for up to 6 cycles.
CC-486 (5-azacitidine)
CC-486 (5-azacitidine) with a dose of 300mg oral intake daily will be given on day 1 to day 10 for 6 cycles.
Dexamethasone
Dexamethasone, 40mg, by mouth (PO), will be given on days 1 and 10 of each cycle.
EKG
Screening
Bone Marrow Aspiration/Biopsy
Baseline, end of treatment and disease progression, and Day 30 (+7).
MRI
Baseline, every 2 cycles, end of treatment and disease progression, and follow-up.
Lumbar Puncture
Baseline, every 2 cycles, end of treatment and disease progression, and follow-up.
TTE
Screening
National Institutes of Health Clinical Center, Bethesda
National Cancer Institute (NCI)
NIH