Status:
COMPLETED
Genetically Modified Haploidentical Natural Killer Cell Infusions for B-Lineage Acute Lymphoblastic Leukemia
Lead Sponsor:
St. Jude Children's Research Hospital
Collaborating Sponsors:
National Cancer Institute (NCI)
Assisi Foundation
Conditions:
Lymphoblastic Leukemia, Acute
Eligibility:
All Genders
Up to 18 years
Phase:
PHASE1
Brief Summary
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)...
Detailed Description
NK cell cytotoxicity is most powerful against acute myeloid leukemia (AML) cells, whereas their capacity to lyse ALL cells is generally low and difficult to predict. A novel method has been developed ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- Pregnant (negative serum or urine pregnancy test to be conducted within 7 days prior to enrollment)
- Breastfeeding
Key Trial Info
Start Date :
October 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2014
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT00995137
Start Date
October 1 2009
End Date
May 1 2014
Last Update
April 26 2017
Active Locations (1)
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1
St Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105-3678