NCT01593670

Decitabine and Vorinostat Conditioning Followed by CD3-/CD19- NK Cells Infusion for High Risk Myelodysplastic Syndromes

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: Masonic Cancer Center, University of Minnesota · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

A single donor apheresis will be collected on day 15 of cycle 1, enriched for NK cells with the large scale CliniMacs device (Miltenyi) and activated by overnight incubation with IL-2. After washing, the final NK cell product will be divided in two, with half given fresh on day 17 of course #1 and half stored frozen until day 17 of course #2. Clinical response will be formally assessed 4-6 weeks after the start of 2nd course based on International Working Group (IWG) criteria; however, bone marrow evaluations will be completed to assess for any sign of significant disease progression between cycle 1 and 2.

Conditions

• Myelodysplastic Syndrome

Interventions

Type	Name	Description
DRUG	Decitabine	administered intravenous (IV), 10 mg/m\^2/day over 1 hour on days 1-5.
DRUG	Vorinostat	200 mg by mouth (PO) twice a day on days 6-15
BIOLOGICAL	Interleukin-2	6 million Units subcutaneous (SQ) 3 times a week for 3 doses beginning day 17
OTHER	Natural killer (NK) cells	infusion intravenously (IV) over 15 to 60 minutes day 17

Timeline

• Start date: 2013-03-01
• Primary completion: 2018-10-23
• Completion: 2018-10-23
• First posted: 2012-05-08
• Last updated: 2019-05-21
• Results posted: 2017-06-14

Locations

2 sites across 1 country: United States