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Human Leukocyte Antigen (HLA) Class I Haplotype Mismatched Natural Killer Cell Infusions | Clinical Trials | Clareo Health

COMPLETEDPHASE1

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

NCT00660166•Tufts Medical Center

View on ClinicalTrials.gov

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 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.

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.

Eligibility

Age

13 - 70 years

Sex

ALL

Healthy Volunteers

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.

Locations (1)

Tufts Medical Center

Boston, Massachusetts, United States

Key Dates

Start Date

April 1, 2006

Primary Completion Date

June 1, 2012

Completion Date

June 1, 2012

Last Updated

June 27, 2012

Enrollment

ACTUAL participants

Conditions

LymphomaMyelomaLeukemia

Interventions

NK-Cell Infusion

BIOLOGICAL

Long-term Evaluation and Follow-up Care of Patients Treated With Stem Cell Transplants

NCT00106925

Graft-versus-leukemiaGraft vs Host Disease+1 more

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RECRUITINGPHASE3

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NCT06152575

Multiple Myeloma

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 27, 2012Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Human Leukocyte Antigen (HLA) Class I Haplotype Mismatched Natural Killer Cell Infusions

Inclusion Criteria

Exclusion Criteria

Long-term Evaluation and Follow-up Care of Patients Treated With Stem Cell Transplants

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