drugset / Trial / NCT01593670
Decitabine and Vorinostat Conditioning Followed by CD3-/CD19- NK Cells Infusion for High Risk Myelodysplastic Syndromes
NaSingle-groupOpen-labelTreatment
Summary
This is a Phase II therapeutic trial combining Decitabine days 1-5 with oral Vorinostat twice daily days 6-15 followed by a single infusion of CD3-/CD19- enriched donor natural killer (NK) cells on day 17 and a short course of Interleukin-2 (IL-2) to facilitate NK cell survival and expansion. Two courses of treatment will be given separated by 6-8 weeks. The intent is to administer all treatment in the outpatient setting.
Timeline
- Start
- 2013-03
- Primary completion
- 2018-10-23
- Completion
- 2018-10-23
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Decitabine | Small molecule | 10 mg/m2 | Intravenous |
| Subject | Vorinostat | Small molecule | 200 mg | Oral |
| Background | aldesleukin | Protein / enzyme biologic | 6e+06 iu | Subcutaneous |