Haploidentical Natural Killer Cells to Treat Refractory or Relapsed Acute Myelogenous Leukemia (AML)

Phase 2 Terminated 15 enrolled Masonic Cancer Center, University of Minnesota

NaSingle-groupOpen-labelTreatment

Summary

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).

Timeline

Start: 2010-07
Primary completion: 2011-10
Completion: 2012-12

Outcome

Outcome not reported

Stopped: “study drug (Ontak) no longer available”

Publications

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.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Natural Killer Cells	Cell therapy	8e+07 cells/kg	—
Background	Cyclophosphamide	Other / unclassified	—	Intravenous
Background	Fludarabine	Small molecule	—	Intravenous
Background	IL-2	Protein / enzyme biologic	5e+06 iu	—
Background	IL-2	Protein / enzyme biologic	1e+07 iu	—
Background	denileukin diftitox	Protein / enzyme biologic	12 ug/kg	Intravenous