This is a single arm pilot study for patients with hematologic malignancies receiving unrelated or haploidentical related mobilized peripheral stem cells (PSCs) using the CliniMACS system for alpha/beta T cell depletion plus CD19+ B cell depletion with individualized ALC-based dosing of ATG to study impact on engraftment, GVHD, and disease free survival
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
Participants in this study will receive a blood stem cell transplant, which will use an investigational device called the CliniMACs device to remove alpha/beta T cells and B cells from the blood cells collected from the donor. This is called T cell depletion and B cell depletion.
Children's Wisconsin
Milwaukee, Wisconsin, United States
RECRUITINGEvaluate incidence and extent of aGVHD and engraftment in patients receiving alpha/beta T cell depleted and CD19+ B cell depleted stem cell transplant with individualized ALC-based dosing of ATG
Time frame: 1 year
Evaluate incidence of chronic GVHD
Time frame: 5 years
Evaluate time to platelet engraftment
Time frame: 1 years
Assess incidence of viral infections
Time frame: 2 years
Evaluate incidence of relapse/progressive disease
Time frame: 2 years
Evaluate incidence of treatment-related mortality (TRM).
Time frame: 2 years
Evaluate overall and relapse free survival (RFS) at 1 year
Time frame: 1 years
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