Study Summary
The purpose of this study is to learn more about newer methods of transplanting blood cells donated by a partially matched family member to children with high-risk CD19 positive leukemia ALL. Primary Objective: \- To assess the safety and feasibility of combining CD19-CAR(Mem) T cells after TCRαβ+/CD19 depleted haploidentical donor transplantation for pediatric patients with relapsed/refractory CD19+ B-cell malignancies. Secondary Objectives: * To estimate 1-year post-transplant overall survival, event-free survival, and GVHD-free relapse-free survival (GRFS). * To estimate cumulative incidence of engraftment, acute and chronic GVHD, and immune-related adverse events, including CRS and ICANS.
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Request More InfoInterventions
Anti-Thymocyte Globulin (Rabbit)DRUG
Days -10, -11, -12.
CyclophosphamideDRUG
60 mg/kg intravenous once daily on day -9.
FludarabineDRUG
30 mg/m2 intravenous once daily for \>10 kg, 1 mg/kg intravenous once daily for ≤10 kg on days -4, -5, -6, -7, -8.
ThiotepaDRUG
5 mg/kg intravenous twice daily on day -3.
MesnaDRUG
Mesna is planned to be administered at 15 mg/kg/dose prior to cyclophosphamide and at approximately 3, 6, and 9 hours after the cyclophosphamide infusion, to give a 1:1 ratio of mesna:cyclophosphamide.
MelphalanDRUG
70 mg/m2 intravenous once daily for \>10 kg, 2.3 mg/kg intravenous once daily for ≤10 kg on days -1, and -2.
FilgrastimDRUG
G-CSF\* 10 mcg/kg/day SC days 0, -1, -2, -3, -4, -5.
CliniMACS SystemDEVICE
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.
Study Locations
| Facility | City | State | Country |
|---|---|---|---|
| St. Jude Children's Research Hospital | Memphis | Tennessee | United States |