MedDataX Logo

Donor Natural Killer Cells and Aldesleukin in Treating Patients w/High Risk AML Undergoing Donor Stem Cell Transplant

NCT00303667 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2017-12-28

Study results available
· View outcomes & findings →

Summary

RATIONALE: Giving chemotherapy, such as fludarabine phosphate and cyclophosphamide, and total body irradiation, before peripheral blood stem cell transplant helps stop the growth of cancer cells. It may also stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells and natural killer (NK) cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Giving IL-2 (aldesleukin) after NK cell infusion may stimulate them to kill any remaining cancer cells.

PURPOSE: This phase I/II (currently enrolling in phase II) trial is studying how well a donor natural killer cell infusion works in treating patients who are undergoing donor stem cell transplant for acute myeloid leukemia.

Conditions

  • Acute Myelogenous Leukemia

Interventions

BIOLOGICAL

aldesleukin

Administered subcutaneously (SQ) 9 million units every other day beginning Day -12 through -2 (evening of natural killer cell infusion) for a total of 6 doses.

BIOLOGICAL

natural killer cells

Infusion given on Day -12; The targeted infused cell dose of CD3- CD19- selected NK product is within the range of 2-3 x 10\^7 cells/kg.

DRUG

cyclophosphamide

Administered intravenously (IV) 50 mg/kg on Day -15

DRUG

fludarabine phosphate

Administered intravenously (IV) 40 mg/m\^2 on Days -18 through -14

PROCEDURE

allogeneic hematopoietic stem cell transplantation

On day 0, patients will receive an allogeneic transplant using pool cells from the day -1 and day 0 PBSC which will be CD34+ selected as the donor graft. The graft will be infused over 15-60 minutes.

RADIATION

total body irradiation

Administered on Day -13, 200 cGy two times.

BIOLOGICAL

Thymoglobulin

intravenous (IV) 3 mg/kg on Day 0 (day of donor CD34 cell infusion)

DRUG

Cyclosporin A

1.5 mg/kg by mouth or intravenously for target dose range of 150-250; day -15 through day -8.

DRUG

cyclophosphamide

Administered intravenously (IV) 50 mg/kg on Days -16 and -15

DRUG

fludarabine phosphate

Administered intravenously (IV) 35 mg/m\^2 on Days -18 through -14

Sponsors & Collaborators

  • Masonic Cancer Center, University of Minnesota

    lead OTHER

Principal Investigators

  • Sarah Cooley, MD · Masonic Cancer Center, University of Minnesota

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2005-01-31
Primary Completion
2011-03-31
Completion
2011-03-31

Countries

  • United States

Study Locations

Related Clinical Trials

More Related Trials

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 NCT00303667 on ClinicalTrials.gov