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

PHASE2WithdrawnINTERVENTIONAL
0
Timeline

Start Date

October 31, 2013

Primary Completion Date

January 31, 2017

Study Completion Date

January 31, 2017

Conditions
Acute Myelogenous Leukemia
Interventions
BIOLOGICAL

CD3-/CD19- natural killer cells

Infused on Day 0. The final CD3-/CD19- product must contain at least 20% NK cells based on previous studies using this cell product processing technique. The entire cell product will be administered except in cases where the T cell count exceeds the T cell infusion threshold. In such situations, the product volume will be adjusted to meet the lot release criteria.

BIOLOGICAL

CD3-CD56+ natural killer cells

Infused on Day 0. The final CD3-/CD56+ product must contain at least 70% NK cells based on a previous study using this cell product processing technique. The entire cell product will be administered except in cases where the T cell count exceeds the T cell infusion threshold. In such situations, the product volume will be adjusted to meet the lot release criteria.

DEVICE

CliniMACS® CD3 and CD19 Reagent System

In combination used to simultaneously deplete CD3+ cells to remove T-lymphocytes and deplete CD19+ cells to remove B-lymphocytes (CD3-/CD19-). The entire cell product will be administered except in cases where the T cell count exceeds the T cell infusion threshold. In such situations, the product volume will be adjusted to meet the lot release criteria.

DEVICE

CliniMACS® CD56 Reagent System

CliniMACS® CD3 and CD19 Reagent System will be used in addition to CliniMACS® CD56 Reagent System to enrich CD56+ NK cells. The entire cell product will be administered except in cases where the T cell count exceeds the T cell infusion threshold. In such situations, the product volume will be adjusted to meet the lot release criteria.

DRUG

Cyclophosphamide

Infused intravenously 60 mg/kg x day -5

DRUG

Fludarabine

Fludarabine 25 mg/m2 x days -6 through -2

DRUG

Aldesleukin

IL-2 subcutaneously at 6 million units every other day for 6 doses - begin evening of the NK cell infusion.

Trial Locations (2)

55455

Masonic Cancer Center, University of Minnesota, Minneapolis

63110

Washington University School of Medicine, St Louis

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Miltenyi Biomedicine GmbH

INDUSTRY

lead

Masonic Cancer Center, University of Minnesota

OTHER