Safety Trial of NK DLI From 6/6 HLA Matched Family Member Following Nonmyeloablative ASCT

PHASE1CompletedINTERVENTIONAL
Enrollment

47

Participants

Timeline

Start Date

May 31, 2005

Primary Completion Date

May 31, 2013

Study Completion Date

November 30, 2013

Conditions
Lymphoma
Interventions
DEVICE

NK Cell infusion using CD56 monoclonal antibody

The cells from leukapheresis will be natural killer (NK) cell selected using a CD56 antibody and a cell column system provided by Miltenyi Biotec. The target cell dose for each NK cell infusion will be up to 1 X 10(7) CD56+ cells/kg patient weight with less than 0.5 X 10(6) CD3+ cells/kg patient weight. The first NK cell infusion will be administered 6 weeks post transplant in patients who have ≤ grade II acute graft versus host disease (aGVHD) at the time of infusion. Patients will be evaluated for toxicity and response until 20 weeks after the last NK Infusion.

PROCEDURE

Donor Apheresis

Apheresis repeated daily up to 3 days until target dose of cells reached (preferably without donor receiving growth factors). Cells were transfused immediately after collection and processing. If collections occurred during initial mobilization at the time of stem cell transplant, the donor was off growth factor for \>24 hours. These extra cell collections from the donor were sufficient for the natural killer cells used in the trial. The cells were NK selected using a CD56 antibody (CliniMACS CD56 Reagent), CliniMACSplus instrument and CliniMACS tubing set provided by Miltenyi Biotec using the company protocol (Miltenyi Biotec Inc, Auburn, California). Pre and post processing cell count, viability, Hematopoietic Progenitor Cell Assay (HPCA) and flow analysis were done.

Trial Locations (1)

27710

Duke University Health System, Durham

All Listed Sponsors
lead

David Rizzieri, MD

OTHER

NCT00586690 - Safety Trial of NK DLI From 6/6 HLA Matched Family Member Following Nonmyeloablative ASCT | Biotech Hunter | Biotech Hunter