Genetically Modified Haploidentical Natural Killer Cell Infusions for B-Lineage Acute Lymphoblastic Leukemia

Completed · Phase 1

Conditions studied: Lymphoblastic Leukemia, Acute

In brief

This study will determine the maximum tolerated dose of genetically modified natural killer (NK) cells in research participants with relapsed or refractory B-lineage acute lymphoblastic leukemia (ALL).

Key facts

Study ID

NCT00995137

Run by

St. Jude Children's Research Hospital

People needed

14

Starts

2009-10-01

Expected to finish

2014-05-01

Last updated by the study team

2017-04-26

Who can join

Age: any, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age: less than or equal to 18 years of age. May be greater than 18 years of age if currently a St. Jude patient.
• Patients with relapsed or refractory B-lineage ALL who are not eligible for hematopoietic stem cell transplantation (HSCT) because their leukemia is not in remission (>5% blasts in bone marrow as evidenced either by morphology or by flow cytometry).
• Shortening fraction greater than or equal to 25%.
• Glomerular filtration rate greater than or equal to 50 cc/min/1.73 m2.
• Pulse oximetry greater than or equal to 92% on room air.
• Direct bilirubin less than or equal to 3.0 mg/dL.
• Alanine aminotransferase (ALT) is no more than 2 times the upper limit of normal.
• Aspartate transaminases (AST) is no more than 2 times the upper limit of normal.
• 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.
• No prior receipt of a gene-transfer agent (e.g. retroviral, adenoviral, lentiviral vector).
• Does not have a current pleural or pericardial effusion.
• Has a suitable adult family member donor available for NK cell donation.
• Has recovered from all acute NCI Common Toxicity Criteria grade II-IV non-hematologic acute toxicities resulting from previous therapy as per the judgment of the principal investigator.
• At least two weeks since receipt of any biological therapy, systemic chemotherapy, and/or radiation therapy.
• Is not receiving more than the equivalent of prednisone 10 mg daily.

You may not qualify if…

• Pregnant (negative serum or urine pregnancy test to be conducted within 7 days prior to enrollment)
• Breastfeeding

Where it is running

• St Jude Children's Research Hospital — Memphis, Tennessee, United States

Full record on ClinicalTrials.gov

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