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CD3/CD19 Depleted or CD3 Depleted/CD56 Selected Haploidentical Donor Natural Killer (NK) Cell Based Therapy for AML Patients Not in CR

NCT03152526 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2020-07-09

Study results available
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Summary

This is a phase II trial designed to test the safety and efficacy (complete response \[CR\]) of related donor HLA-haploidentical NK-cell based therapy for the treatment of acute myelogenous leukemia (AML).

Patients with newly diagnosed AML who failed to achieve a complete remission (CR) after one or two standard induction attempts receive after a preparative regimen of cyclophosphamide and fludarabine a single infusion of 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

DEVICE

Interventions

CliniMACS® CD3 and CD19 Reagent System

Sponsors & Collaborators

  • Masonic Cancer Center, University of Minnesota

    collaborator OTHER

  • University of Chicago

    collaborator OTHER

  • Ohio State University

    collaborator OTHER

  • Miltenyi Biotec B.V. & Co. KG

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-10-18
Primary Completion
2018-03-21
Completion
2018-03-21
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03152526 on ClinicalTrials.gov