17
Participants
Start Date
July 14, 2017
Primary Completion Date
February 13, 2021
Study Completion Date
March 16, 2022
Decitabine
"* After 2 cycles, patients with progressive disease or relapse (a clear progression with at least \>20% bone marrow blasts and an increase of at least 50% from prior biopsy) should be removed from protocol and proceed to salvage treatment according to center preference~* Transplant eligible patients who achieve CR, CRc, or CRi, after 3 cycles with a suitable donor will proceed to conditioning regimen and transplant~* Transplant eligible patients with PR after 3 cycles may be removed from protocol and proceed to salvage treatment according to center preference~* Transplant eligible patients with a suitable donor who achieve mLFS, CR, CRc, or CRi, may proceed to transplant after at 3 cycles~* Transplant ineligible patients with (CR, CRc or CRi, PR) will continue on maintenance doses~* Transplant ineligible patient with SD after cycle 4 may be removed from protocol and proceed to alternative treatment or continue on protocol according to treating physician's preference."
Bone marrow biopsy/aspirate
"* Baseline, Cycle 1 Day 10, Cycle 1 Day 28, Cycle 2 Day 28, Cycle 3 Day 28, and Progression or relapse~* Biopsy/aspirate on Cycle 1 Day 10 is for participants enrolled at Washington University only~* Biopsy/aspirate on Cycle 2 Day 28 is at the discretion of the treating physician"
Peripheral blood draw
-Baseline, Cycle 1 Day 10, Cycle 1 Day 28, Cycle 2 Day 28, Cycle 3 Day 28, and Progression/Relapse
Skin biopsy
"* Optional but if refuse skin biopsy then participant can provided buccal swab~* There is no required time frame for this sample - it may have been collected months or even years prior to the first dose of decitabine~* If WBC at time of enrollment is \>30,000/µl, skin biopsy should be collected at the time of C1D28 bone marrow biopsy or thereafter"
Buccal swab
-Baseline (if skin biopsy declined) and Cycle 2 Day 28
Washington University School of Medicine, St Louis
Collaborators (1)
Janssen Pharmaceuticals
INDUSTRY
National Institutes of Health (NIH)
NIH
National Cancer Institute (NCI)
NIH
Washington University School of Medicine
OTHER