CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 9 enrolled
Drug / intervention
Decitabine +3 moredrug
Likely dose
Decitabine 10 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01593670
NCT01593670Phase 2Completed
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Decitabine and Vorinostat With CD3/CD19 Depleted Haploidentical Donor Natural Killer (NK) Cells for the Treatment of High Risk Myelodysplastic Syndromes (MDS)

Masonic Cancer Center, University of Minnesota·interventional·Posted May 8, 2012·Updated May 21, 2019

In Brief

A Phase 2 clinical trial evaluating Decitabine, Vorinostat, and 2 other interventions for Myelodysplastic Syndrome. Completed, enrolled 9 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMyelodysplastic Syndrome
CountriesUnited States
CollaboratorsMayo Clinic

Timeline

Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedMay 8, 2012
Enrollment StartMar 1, 2013
Primary CompletionOct 23, 2018
TodayJul 2, 2026
Enrollment to primary: 5.6 yearsPosted 14.2 years ago

Interventions

Decitabinedrug

administered intravenous (IV), 10 mg/m\^2/day over 1 hour on days 1-5.

Vorinostatdrug

200 mg by mouth (PO) twice a day on days 6-15

Interleukin-2biological

6 million Units subcutaneous (SQ) 3 times a week for 3 doses beginning day 17

Natural killer (NK) cellsother

infusion intravenously (IV) over 15 to 60 minutes day 17