Purpose of study: This phase I/II trial is to evaluate the safety and feasibility of TCRαβ-depleted graft from haploidentical family donors in treating children and adolescents with malignant or non-malignant diseases.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
40mg/M2 once daily IV on days -7 to -2
50 mg/kg IV on day -3 and -2
Asan Medical Center
Seoul, South Korea
RECRUITINGTo evaluate tralsplant-related mortality after haploidentical hematopoietic stem cell transplantation using TCRαβ-depleted graft
Time frame: 1 year posttransplant
To assess engraftment and graft failure
Time frame: 28 days posttransplant
To estimate the risk of acute GVHD
Time frame: 100 days posttransplant
To estimate the incidence of relapse
Time frame: 100 days and 1 year post-transplant
To estimate the incidence and severity of chronic GVHD
Time frame: 1 year posttransplant
To estimate the overall survival
Time frame: 1 year posttransplant
To estimate the incidence of bacterial, fungal and viral infection
Time frame: 100 days and 1 year posttransplant
To estimate the reactivation rate of CMV, EBV
Time frame: 100 days and 1 year posttransplant
To evaluate the immune reconstitution of T, B, and NK cells
Time frame: days 7, 14, 21, 28, 60, 90, 180, 270, and 365 days post-transplant
To evaluate the lineage-specific chimerism using flow cytomery of CD3+, CD19, CD56, TCR αβ, and TCRγδ at pre-transplant
Time frame: days 7, 10, 14, 21, 28, 60, 90, 180, 270 and 365 post-transplant
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Beginning on day 4 and continuing until blood counts recover
200 cGy per day on D-6 to -4 (eligible disease except aplastic anemia) 200 cGy per day on D-5 \& -4 (severe aplastic anemia)
Immunogenetic depletion of TCRαβ cells
To assess event free survival
Time frame: 1 year posttransplant