NCT01106950|TerminatedPhase 2ResultsDMC
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study drug (Ontak) no longer available
Adoptive Transfer of Haploidentical Natural Killer Cells to Treat Refractory or Relapsed AML MT2010-02
Sponsor study identifier
Secondary identifiers
OTHER · Blood and Marrow Transplantation Program
OTHER · IRB, University of Minnesota
interventional
15
1 country
1
Study Start
July 2010
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
October 2011
Actual (reported)Study Completion
December 2012
Actual (reported)This is a phase II therapeutic study of related donor HLA-haploidentical NK-cell based therapy after a high dose of fludarabine/cyclophosphamide with denileukin diftitox preparative regimen for the treatment of poor prognosis acute myelogenous leukemia (AML).
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2012
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 19, 2010
Actual (reported)April 20, 2010
Actual (reported)July 2010
Date type not reportedThis date has not been verified as actual or estimated.
October 2011
Actual (reported)December 2012
Actual (reported)June 26, 2013
Actual (reported)Percent of Patients With Successful Expansion of Natural Killer Cells After Infusion
The primary objective of this study was to estimate the incidence of in vivo expansion of natural killer (NK) cells 14 days after infusion of an allogeneic donor product enriched for NK progenitors. Successful in vivo donor NK cell expansion was defined by measuring an absolute circulating donor-derived NK cell count of \>100 cells/ul in the patient's peripheral blood 14 days after infusion.
Day 14
Percent of Patients With Complete Remission of Disease
At least 4 weeks after last dose (28 days)
Percent of Patients With Disease Free Survival
Month 6
Percent of Patients With Incidence of Relapse
Month 6
Number of Patients With Treatment-Related Death
Day 100
Percent of Patients With Natural Killer Cell Expansion Versus KIR Genotype Versus Treg Depletion
Day 14
Patients are treated with donor natural killer cells, fludarabine, cyclophosphamide, Denileukin diftitox, Donor lymphapheresis and IL-2.
Given by infusion on Day 0. The product is T cell-depleted (CD3-) and B cell-depleted (CD19). Target dose for infusion is \< or = 8 x 10\^7 nucleated cells/kilogram.
Administered as a 1 hour intravenous infusion once a day for 5 doses beginning on day -6.
Masonic Cancer Center, University of Minnesota
Minneapolis, Minnesota, 55455, United States
Bachanova V, Cooley S, Defor TE, Verneris MR, Zhang B, McKenna DH, Curtsinger J, Panoskaltsis-Mortari A, Lewis D, Hippen K, McGlave P, Weisdorf DJ, Blazar BR, Miller JS. Clearance of acute myeloid leukemia by haploidentical natural killer cells is improved using IL-2 diphtheria toxin fusion protein. Blood. 2014 Jun 19;123(25):3855-63. doi: 10.1182/blood-2013-10-532531. Epub 2014 Apr 9.
Jeffrey S. Miller, M.D.
Masonic Cancer Center, University of Minnesota
15 participants (actual enrollment reported by the registry).
First Submitted
April 19, 2010
First Posted
April 20, 2010
Study Start
July 2010
Date type not reportedThis date has not been verified as actual or estimated.
Administered as a 2 hour intravenous infusion with high volume fluid flush and mesna per institutional guidelines on day -5 and -4 one hour after fludarabine infusion. (Day -4 administration may be omitted if patient has had a transplant in the previous 4 months.)
12 ug/kg/day will be administered on day -1 and day -2 intravenously.
Day -1 before planned NK cell infusion, the donor will undergo lymphapheresis (Removal of lymphocytes from donated blood, with the remainder of the blood retransfused into the donor).
Administered after NK cell infusion, 10 million units every other day for a total of 6 doses. (Patients weighing less than 45 kilograms will receive a dose of 5 million units/m\^2 every other day for 6 doses).
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
October 2011
Actual (reported)Study Completion
December 2012
Actual (reported)Last Updated
December 28, 2017
Results First Posted
June 26, 2013
Record last verified: 2017-12
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Source: ClinicalTrials.gov.
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