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

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.

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.

Sponsors & Collaborators

• Miltenyi Biomedicine GmbH

  collaborator INDUSTRY

• Masonic Cancer Center, University of Minnesota

  lead OTHER

Principal Investigators

• Jeffrey S. Miller, M.D. · Masonic Cancer Center, University of Minnesota

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2013-10-31

Primary Completion

2017-01-31

Completion

2017-01-31

Countries

• United States

Study Locations