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

Part of paid clinical trials in Minneapolis, Minnesota.

Sponsor
Masonic Cancer Center, University of Minnesota
Study ID
NCT01593670
Phase
PHASE2
Status
Completed

Conditions

  • Myelodysplastic Syndrome

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Mar 31, 2013
Status verified
May 2019
Primary completion
Oct 23, 2018
Completion
Oct 23, 2018

Study Design

Enrollment
9 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Patients With High Risk MDS
    Patients who received treatment for high risk myelodysplastic syndromes (MDS). Treatment Received: Decitabine 10 mg/m\^2/day intravenous (IV) over 1 hour days 1-5; Vorinostat 200 mg by mouth (PO) twice a day days 6-15; Il-2 activated donor natural killer cells (NK) infusion IV over 15 to 60 minutes day 17; Interleukin-2 6 million units subcutaneous (SQ) 3 times a week for 3 doses beginning day 17. Repeat treatment course 6 to 8 weeks after cycle 1 start date.

Primary Outcome Measure

The Number of Patients Who Achieved a Clinical Response [ Time Frame: After 2 Courses of Treatment (Approx. 3 months) ]

Locations (2)

FacilityCityStateZIPSite coordinators
Masonic Cancer Center, University of MinnesotaMinneapolisMinnesota55455-
Mayo ClinicRochesterMinnesota55901-

Find similar trials in Minneapolis, MN

By research site
Masonic Cancer Center, University of Minnesota· Minneapolis, MNMayo Clinic· Rochester, MN

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