Human Leukocyte Antigen (HLA) Class I Haplotype Mismatched Natural Killer Cell Infusions
June 25, 2012 updated by: Tufts Medical Center
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.
Study Overview
Status
Completed
Intervention / Treatment
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 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.
Study Type
Interventional
Enrollment (Actual)
13
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Massachusetts
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Boston, Massachusetts, United States, 02111
- Tufts Medical Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
13 years to 70 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
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 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: 1
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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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
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58 days post infusion of allogeneic NK-cells
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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Duration of donor NK cells in the recipient's blood
Time Frame: 58 days post infusion of allogeneic NK-cells
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58 days post infusion of allogeneic NK-cells
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Patient survival at 100 days and at one year post treatment (all cause mortality)
Time Frame: 100 days and one year post treatment
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100 days and one year post treatment
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Occurrence of new cancer during the first year post infusion of allogeneic NK-cells
Time Frame: One year post infusion of allogeneic NK-cells
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One year post infusion of allogeneic NK-cells
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Documented systemic infections during the first 30 days post infusion of allogeneic NK-cells.
Time Frame: 30 days post infusion of allogeneic NK-cells
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30 days post infusion of allogeneic NK-cells
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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
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58 days post infusion of allogeneic NK-cells
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Hans Klingemann, MD, PhD, Tufts Medical Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2006
Primary Completion (Actual)
June 1, 2012
Study Completion (Actual)
June 1, 2012
Study Registration Dates
First Submitted
April 11, 2008
First Submitted That Met QC Criteria
April 16, 2008
First Posted (Estimate)
April 17, 2008
Study Record Updates
Last Update Posted (Estimate)
June 27, 2012
Last Update Submitted That Met QC Criteria
June 25, 2012
Last Verified
June 1, 2012
More Information
Terms related to this study
Other Study ID Numbers
- Allogeneic NKCell post ABMT
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.