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NCT01593670 · ClinicalTrials.gov registry record · Phase 2
Decitabine and Vorinostat Conditioning Followed by CD3-/CD19- NK Cells Infusion for High Risk Myelodysplastic Syndromes
A Phase 2 study, sponsored by Masonic Cancer Center, University of Minnesota.
- Completed
- Registry status
- Phase 2
- Development phase
- 9
- Enrollment target
NCT01593670 is a Phase 2 study that has completed, run by Masonic Cancer Center, University of Minnesota. The registered enrollment target is 9 participants.
The verdict
NCT01593670, a Phase 2 study, has completed, sponsored by Masonic Cancer Center, University of Minnesota.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 9 participants
- Enrollment target
Study 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.
Interventions
- DRUG Decitabine
- BIOLOGICAL Interleukin-2
- DRUG Vorinostat
- OTHER Natural killer (NK) cells
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 9 participants |
| Start Date | 2013-03 |
| Est. Completion | 2018-10-23 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01593670
The ClinicalTrials.gov registry entry for NCT01593670 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 9 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Masonic Cancer Center, University of Minnesota, which has 249 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Decitabine is the first listed.
NCT01593670 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01593670 about?
NCT01593670 is a clinical study titled "Decitabine and Vorinostat Conditioning Followed by CD3-/CD19- NK Cells Infusion for High Risk Myelodysplastic Syndromes". 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 co...
What is the current status of trial NCT01593670?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 9 participants. The study started on 2013-03. Estimated completion is 2018-10-23.
What interventions are being tested in trial NCT01593670?
The interventions under investigation include: Decitabine (DRUG), Interleukin-2 (BIOLOGICAL), Vorinostat (DRUG), Natural killer (NK) cells (OTHER).
Who is sponsoring clinical trial NCT01593670?
This trial is sponsored by Masonic Cancer Center, University of Minnesota, which has 249 total clinical trials registered on ClinicalTrials.gov.
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