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Keep this study
Lead
St. Jude Children's Research Hospital
With
National Cancer Institute (NCI)
Assisi Foundation
Secondary objectives include the evaluation of the in vivo lifespan and phenotype of the expanded NK cells and explore the efficacy of these donor NK cells in study participants with relapsed or refractory hematologic malignancies or sarcomas.
Age
0–18
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Less than or equal to 18 years of age (may be greater than 18 years of age if currently a St. Jude patient).
You may not be if
At least two weeks since receipt of any biological therapy, systemic chemotherapy, and/or radiation therapy.
Shortening fraction greater than or equal to 25%.
Creatinine clearance or glomerular filtration rate greater than or equal to 50 cc/min/1.73 m\^2.
Pulse oximetry greater than or equal to 92% on room air.
Direct bilirubin less than or equal to 3.0 mg/dL.
Karnofsky or Lansky performance score of greater than or equal to 50.
No known allergy to murine products or HAMA testing results within normal limits.
Does not have a current pleural or pericardial effusion.
Has a suitable adult family member donor available for NK cell donation.
Is not receiving more than the equivalent of prednisone 10 mg daily.
Not pregnant (negative serum or urine pregnancy test to be conducted within 7 days prior to enrollment).
Not breast feeding.
Eligibility criteria prior to initiation of protocol therapy (preparative regimen)
Alanine aminotransferase (ALT) is no more than 2 times the upper limit of normal.
Aspartate transaminase (AST) is no more than 2 times the upper limit of normal.
Has recovered from all acute NCI Common Toxicity Criteria grade II-IV non-hematologic acute toxicities resulting from prior therapy per the judgment of the principal investigator
Eligibility criteria (NK cell DONOR):
Family member with a greater than or equal to 3 of 6 HLA match to recipient.
At least 18 years of age.
HIV negative.
Not pregnant (negative serum or urine pregnancy test to be conducted within 7 days prior to enrollment).
Not breast feeding.
Clareo Health | Pilot Study of Expanded, Donor Natural Killer Cell Infusions for Refractory Non-B Lineage Hematologic Malignancies and Solid Tumors