A Phase 1 interventional study of NK-Cell Infusion in Lymphoma, Myeloma and Leukemia, sponsored by Tufts Medical Center. Completed at 1 site in United States. Open to participants aged 13 Years to 70 Years. Per ClinicalTrials.gov, last updated 2012-06-27.
Sponsored by Tufts Medical Center · Phase 1, Interventional, and Treatment
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.
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.
Tufts Medical Center is the lead sponsor of 194 studies on the registry; 28 are open to participants now.
Of its 30 completed or terminated interventional studies of FDA-regulated products, 16 (53%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patients who have undergone an autologous stem cell transplant for the following diseases:
Exclusion Criteria:
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.
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
Duration of donor NK cells in the recipient's blood
Time frame: 58 days post infusion of allogeneic NK-cells
Patient survival at 100 days and at one year post treatment (all cause mortality)
Time frame: 100 days and one year post treatment
Occurrence of new cancer during the first year post infusion of allogeneic NK-cells
Time frame: One year post infusion of allogeneic NK-cells
Documented systemic infections during the first 30 days post infusion of allogeneic NK-cells.
Time frame: 30 days post infusion of allogeneic NK-cells
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
This study is completed, as verified in Jun 2012. You cannot join it, but the record below documents what was studied.
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