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

NCT01593670 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2019-05-21

Study results available
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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.

Conditions

Interventions

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

Sponsors & Collaborators

  • Mayo Clinic

    collaborator OTHER

  • Masonic Cancer Center, University of Minnesota

    lead OTHER

Principal Investigators

  • Erica Warlick, M.D. · Masonic Cancer Center, University of Minnesota

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-03-31
Primary Completion
2018-10-23
Completion
2018-10-23

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01593670 on ClinicalTrials.gov