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

NCT01106950 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2017-12-28

Study results available
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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).

Conditions

  • Leukemia, Myelogenous, Acute

Interventions

BIOLOGICAL

Natural Killer Cells

Given by infusion on Day 0. The product is T cell-depleted (CD3-) and B cell-depleted (CD19). Target dose for infusion is \< or = 8 x 10\^7 nucleated cells/kilogram.

DRUG

Fludarabine

Administered as a 1 hour intravenous infusion once a day for 5 doses beginning on day -6.

DRUG

Cyclophosphamide

Administered as a 2 hour intravenous infusion with high volume fluid flush and mesna per institutional guidelines on day -5 and -4 one hour after fludarabine infusion. (Day -4 administration may be omitted if patient has had a transplant in the previous 4 months.)

DRUG

Denileukin diftitox

12 ug/kg/day will be administered on day -1 and day -2 intravenously.

PROCEDURE

Donor lymphapheresis

Day -1 before planned NK cell infusion, the donor will undergo lymphapheresis (Removal of lymphocytes from donated blood, with the remainder of the blood retransfused into the donor).

DRUG

IL-2

Administered after NK cell infusion, 10 million units every other day for a total of 6 doses. (Patients weighing less than 45 kilograms will receive a dose of 5 million units/m\^2 every other day for 6 doses).

Sponsors & Collaborators

  • Masonic Cancer Center, University of Minnesota

    lead OTHER

Principal Investigators

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

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
2 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-07-31
Primary Completion
2011-10-31
Completion
2012-12-31

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 NCT01106950 on ClinicalTrials.gov