Human Leukocyte Antigen (HLA) Class I Haplotype Mismatched Natural Killer Cell Infusions
The purpose of this research study is to examine the safety of infusing escalated doses of allogeneic (from a relative of the patient), enriched natural killer (NK) cells after autologous (from the patient) stem cell transplantation. The hypothesis is that the infusion of these NK cells early after an autologous stem cell transplant will help to eliminate and eradicate any residual cancerous cells that remain in the body and may have survived the chemotherapy or radiation.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||HLA Class I Haplotype Mismatched Natural Killer Cell Infusions After Autologous Stem Cell Transplant for Hematological Malignancies|
- An evaluation of general safety will be undertaken: · Number of systemic clinical and biological adverse events occurring during the study. · Number of patients who prematurely discontinued study treatment for reasons linked to the general safety. [ Time Frame: 58 days post infusion of allogeneic NK-cells ] [ Designated as safety issue: Yes ]
- Duration of donor NK cells in the recipient's blood [ Time Frame: 58 days post infusion of allogeneic NK-cells ] [ Designated as safety issue: Yes ]
- Patient survival at 100 days and at one year post treatment (all cause mortality) [ Time Frame: 100 days and one year post treatment ] [ Designated as safety issue: Yes ]
- Occurrence of new cancer during the first year post infusion of allogeneic NK-cells [ Time Frame: One year post infusion of allogeneic NK-cells ] [ Designated as safety issue: Yes ]
- Documented systemic infections during the first 30 days post infusion of allogeneic NK-cells. [ Time Frame: 30 days post infusion of allogeneic NK-cells ] [ Designated as safety issue: Yes ]
- Occurrence of other possible NK-infusions related complications such as,fever, capillary leak syndrome and/or allergic reaction. [ Time Frame: 58 days post infusion of allogeneic NK-cells ] [ Designated as safety issue: Yes ]
|Study Start Date:||April 2006|
|Study Completion Date:||June 2012|
|Primary Completion Date:||June 2012 (Final data collection date for primary outcome measure)|
Biological: NK-Cell Infusion
The infusion of natural killer (NK) cells will be performed in the Infusion Center at New England Medical Center. The NK cells will be given to the subject intravenously (into a vein). In addition, a balanced salt solution will be infused beginning about two hours prior to and continuing for two hours after the infusion of NK cells to keep the fluid level in the body well balanced. The subject will also receive Benadryl by injection 15-30 minutes prior to infusion to counteract and prevent any unwanted allergic side effects. The subject will be observed for any side effects during this time. If the subject feels well, he/she can go home. However, there may be a requirement to keep him/her overnight.
Natural killer cells are blood cells that are responsible for eliminating cancer cells especially when there are only a few. It has been shown that NK cells coming from a "mismatched" person (a relative) have a better chance than the patient's own NK cells to recognize and kill cancer cells. These cells will be collected from the blood of a parent, child or sibling and after preparation in the laboratory, will be given to the patient early after an autologous stem cell transplantation like a blood or platelet transfusion. A person who has been diagnosed with a blood tumor and received an autologous stem cell transplant has the chance of his/her cancer coming back. This study uses NK cells obtained from a relative to prevent disease recurrence by potentially eliminating and eradicating any residual cancerous cells.
|United States, Massachusetts|
|Tufts Medical Center|
|Boston, Massachusetts, United States, 02111|
|Principal Investigator:||Hans Klingemann, MD, PhD||Tufts Medical Center|