170
Participants
Start Date
July 14, 2016
Primary Completion Date
July 1, 2025
Study Completion Date
July 1, 2026
Anti-thymocyte globulin (rabbit)
Given intravenous (IV) prior to transplant on Days -14, -13, -12.
Blinatumomab
Given by continuous IV infusion at least 2 weeks post-engraftment. Blinatumomab will be given only to patients with CD19+ malignancies.
Cyclophosphamide
Given by IV infusion prior to transplant on Day -9.
Fludarabine
Given IV prior to transplant on Days -8, -7, -6, -5, and -4.
G-CSF
Given IV or subcutaneous (SQ) following transplant on Days 6 and 7.
Melphalan
Given IV prior to transplant on Days -2 and -1.
Mesna
Given IV prior to cyclophosphamide administration and at approximately 3, 6, and 9 hours after cyclophosphamide infusion.
Rituximab
Given IV prior to transplant on Day -1.
Tacrolimus
Given oral (PO) or IV beginning prior to transplant on Day -2. The dose will begin to taper at approximately day +60 after transplant in the absence of GVHD. Tacrolimus was used for the first 5 participants enrolled on study. Subsequent participants receive sirolimus.
Thiotepa
Given IV prior to transplant on Day -3.
HPC,A Infusion
Hematopoietic Progenitor Cell, Apheresis (HPC,A) infusion of TCRɑβ+ depleted cells on day of transplant (Day 0) and HPC,A infusion of CD45RA+ depleted cells on Day +1 following transplant.
CliniMACS
The mechanism of action of the CliniMACS Cell Selection System is based on magnetic-activated cell sorting (MACS). The CliniMACS device is a powerful tool for the isolation of many cell types from heterogeneous cell mixtures, (e.g. apheresis products). These can then be separated in a magnetic field using an immunomagnetic label specific for the cell type of interest, such as CD3+ human T cells.
Sirolimus
Given orally (PO) starting Day 0. The dose will be tapered off over two weeks starting on Day +42 in the absence of GVHD.
St. Jude Children's Research Hospital, Memphis
St. Jude Children's Research Hospital
OTHER