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Protocol No. 2011LS124 Principal Investigator Warlick, Erica
Phase Phase II
Age Group Adult Scope National
Secondary Protocol No. MNPrtnrshpBiotech+Med Gen; Mayo IRB 12-004104
Title MT2012-04 Decitabine and Vorinostat with CD3/CD19 Depleted Haploidentical Donor Natural Killer (NK) Cells for the Treatment of High Risk Myelodysplastic Syndromes (MDS)
Objective Evaluate the objective response rate (CR + PR+ Hematologic Improvement (HI)) after 2 courses of Decitabine and Vorinostat with haploidentical NK cells in high risk myelodysplastic syndrome (MDS).
Treatment Patients will be treated with Decitabine, Vorinostat, Interleukin-2 activated donor natural killer cell infusion and Interleukin-2 over a 22 day cycle. A second cycle, 6-8 weeks after the start of cycle 1, will be offered if treatment was tolerated and no progression to AML.
Description 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 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.
Key Eligibility Patient must have a diagnosis of high risk MDS requiring treatment.
Applicable Disease Sites Myelodysplastic syndromes (MDS)
Drugs Involved Dacogen (decitabine)
NK cell infusion
Vorinostat (SAHA)
Status Open
Participating Institutions Masonic Cancer Center
Mayo Clinic Cancer Center
Detailed Eligibility Must be between 18 and 75 years of age and have acceptable organ function. Must also have the ability to be off prednisone and other immunosuppressive drugs for at least 3 days prior to NK cell infusion. Women of childbearing potential must agree to use effective methods of contraception. Women who are pregnant or nursing are not eligible. Anyone with an uncontrolled bacterial or viral infection, inability to swallow capsules, or with active HIV are not eligible. A signed informed consent and HIPAA authorization are required.
Treatment Type Treatment
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