drugset / Trial / NCT01639456

CD3/CD19 Depleted or CD3 Depleted/CD56 Selected Haploid Donor Natural Killer Cell Treatment in Older AML in First Complete Remission

NCT01639456

RandomizedSingle-groupOpen-labelTreatment

Summary

This is a phase II trial designed to test the safety and efficacy (disease free survival \[DFS\]) of related donor HLA-haploidentical NK-cell based therapy for the treatment of acute myelogenous leukemia (AML). The natural killer (NK) cell product will be given to patients 60 years and older who are in a first complete remission after 1 or 2 courses of standard AML induction. After a preparative regimen of cyclophosphamide and fludarabine, patients will receive a single infusion of either CD3-/CD19- NK cells or CD3-/CD56+ NK cells followed by a short course of Interleukin-2 (IL-2) to facilitate NK cell survival and expansion.

Timeline

Start
2013-10
Primary completion
2017-01
Completion
2017-01

Drugs

EvaluationDrugModalityDoseRoute
Subject CD3-/CD19- natural killer cells Cell therapy
Subject TROCULEUCEL Cell therapy
Background Cyclophosphamide Other / unclassified 60 mg/kg Intravenous
Background Fludarabine Small molecule 25 mg/m2
Background aldesleukin Protein / enzyme biologic 6e+06 iu Subcutaneous