140
Participants
Start Date
January 31, 2019
Primary Completion Date
August 7, 2024
Study Completion Date
August 7, 2025
Cyclophosphamide
"Cyclophosphamide is a nitrogen mustard derivative. It acts as an alkylating agent that causes cross-linking of DNA strands by binding with nucleic acids and other intracellular structures, thus interfering with the normal function of DNA.~intravenously (IV) once daily (QD) on day -9"
Fludarabine
"Fludarabine phosphate is a synthetic purine nucleoside analog. It acts by inhibiting DNA polymerase, ribonucleotide reductase and DNA primase by competing with the physiologic substrate, deoxyadenosine triphosphate, resulting in inhibition of DNA synthesis.~fludarabine phosphate IV QD on days -8 to -4"
Thiotepa
Thiotepa is a cell-cycle nonspecific polyfunctional alkylating agent.
Melphalan
"Melphalan, a derivative of nitrogen mustard, is a bifunctional alkylating agent. Melphalan is active against tumor cells that are actively dividing or at rest.~melphalan IV QD on days -2 to -1"
G-csf
G-csf (granulocytic colony stimulating factor), is a biosynthetic hematopoietic agent that is made using recombinant DNA technology in cultures of Escherichia coli. G-CSF stimulates production, maturation and activation of neutrophils. In addition, endogenous G-CSF enhances certain functions of mature neutrophils, including phagocytosis, chemotaxis and antibody--dependent cellular cytotoxicity.
Mesna
Mesna is a synthetic sulfhydryl (thiol) compound. Mesna contains free sulfhydryl groups that interact chemically with urotoxic metabolites of oxaza-phosphorine derivatives such as cyclophosphamide and ifosfamide. Following glomerular filtration, mesna disulfide is rapidly reduced in the renal tubules back to mesna, the active form of the drug.
CliniMACS
Cells for infusion are prepared using the CliniMACS
ATG (rabbit)
"Anti-thymocyte globulin is a purified, pasteurized, gamma immune globulin, obtained by immunization of rabbits with human thymocytes.~rabbit anti-thymocyte globulin IV daily over 6 hours on days -5 to -3,"
Blinatumomab
"Blinatumomab is a bispecific CD19-directed CD3 T-cell engager that mediates formation of a synapse between T cells and the CD19+ target cell, resulting in lysis of that CD19+ cell.Blinatumomab will be given to patients with a history of CD19+ malignancy as determined by St. Jude hematopathologist review of current and historical specimens and reports.~blinatumomab IV for 28 days beginning at least 1 week post-DLI"
TCRα/β+
IV on day 0 and may receive an additional dose on day 1
CD19+
IV on day 0 and may receive an additional dose on day 1
CD45RA-depleted DLI
infusion IV
St. Jude Children's Research Hospital, Memphis
St. Jude Children's Research Hospital
OTHER