| April 11, 2008 |
| October 13, 2009 |
| April 2007 |
| November 2009 (final data collection date for primary outcome measure) |
| 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 ] |
| Same as current |
| Complete list of historical versions of study NCT00660166 on ClinicalTrials.gov Archive Site |
- Duration of donow 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 ]
|
| Same as current |
| |
| Human Leukocyte Antigen (HLA) Class I Haplotype Mismatched Natural Killer Cell Infusions |
| HLA Class I Haplotype Mismatched Natural Killer Cell Infusions After Autologous Stem Cell Transplant for Hematological Malignancies |
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. |
| Phase I |
| Interventional |
| Treatment, Non-Randomized, Open Label, Dose Comparison, Single Group Assignment, Safety Study |
- Lymphoma
- Myeloma
- Leukemia
|
| Biological: NK-Cell Infusion |
| |
|
|
| |
| Recruiting |
| 12 |
| November 2009 |
| November 2009 (final data collection date for primary outcome measure) |
Inclusion Criteria:
Exclusion Criteria:
- Patients who have not recovered sufficiently from the side effects of the autologous transplant (i.e. have > grade 2 toxicity in any organ system)
- Patients who have insufficient engraftment parameters according to the following criteria: WBC < 2,500 /mm3 and platelets < 50,000/mm3
- Radiation therapy, chemotherapy, or immunotherapy beginning one week before NK-cell infusion and lasting 2 weeks after NK-cell infusion.
- Intrinsic impaired organ function (as stated above).
- Physical or psychiatric conditions that in the estimation of the PI or designee place the patient at high-risk of toxicity or non-compliance.
- Uncontrolled, life-threatening infections at the time of infusion.
- Concurrent treatment with corticosteroids and/or other immuno-suppressive drugs.
|
| Both |
| 13 Years to 70 Years |
| No |
|
|
| United States |
| |
| NCT00660166 |
| Hans Klingemann, MD, PhD, Tufts Medical Center |
| Allogeneic NKCell post ABMT |
| Tufts Medical Center |
| University of Minnesota |
| Principal Investigator: |
Hans Klingemann, MD, PhD |
Tufts Medical Center |
|
|
| Tufts Medical Center |
| October 2009 |