Status:
COMPLETED
Human Leukocyte Antigen (HLA) Class I Haplotype Mismatched Natural Killer Cell Infusions
Lead Sponsor:
Tufts Medical Center
Collaborating Sponsors:
University of Minnesota
Conditions:
Lymphoma
Myeloma
Eligibility:
All Genders
13-70 years
Phase:
PHASE1
Brief Summary
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 pa...
Detailed Description
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 relati...
Eligibility Criteria
Inclusion
- Patients who have undergone an autologous stem cell transplant for the following diseases:
- Acute Myeloid Leukemia
- Non-Hodgkin's Lymphoma
- Hodgkin's Disease
- Multiple Myeloma
- Age 13 - 70 years old
- Able to give informed consent
- Hepatic and renal function: bilirubin less than or equal to 2x normal limits, AST and ALT less than or equal to 2x normal limits, serum creatinine less than or equal to 1.5x normal
- ECOG Performance Status less than or equal to 1 (at planned time of transplantation)
- Patients with no active infection
Exclusion
- 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.
Key Trial Info
Start Date :
April 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2012
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT00660166
Start Date
April 1 2006
End Date
June 1 2012
Last Update
June 27 2012
Active Locations (1)
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1
Tufts Medical Center
Boston, Massachusetts, United States, 02111