This is a study utilizing the Magnetic-activated cell sorting (CliniMACS®) Alpha-Beta T-cell (αβT)/Cluster of Differentiation 19 (CD19), also called B lymphocyte antigen CD19 depletion device for Children and Young Adults with Hematologic Malignancies undergoing alternative Donor Allogeneic Hematopoietic Cell Transplantation (HSCT). Patients will receive an allogenic HSCT from a matched unrelated donor (MUD), mismatch unrelated donor (MMUD) or a mismatched related (haploidentical) donor. Patients will receive a granulocyte-colony stimulating factor (G-CSF) ± Plerixafor donor mobilized peripheral stem cell donor transplant following CliniMACS® αβT cell/CD19+B cell depletion. Cluster of Differentiation 34 (CD34) and αβT cell content of the graft is determined based on the transplant indication.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
CliniMACS® αβT cell/CD19+B cell depletion device for Children and Young Adults with Hematologic Malignancies undergoing alternative Donor Allogeneic Hematopoietic Cell Transplantation (HSCT)
Nationwide Children's Hospital
Columbus, Ohio, United States
RECRUITINGOne-year overall survival of patients undergoing allogeneic HSCT using the T-Cell Receptor (TCR) αβ/CD19+ depleted platform and grafts from alternative donors (MUD, MMUD and haploidentical)
One-year overall survival of patients undergoing allogeneic HSCT
Time frame: 1 year
Neutrophil and platelet engraftment following TCR αβ/CD19+ depleted alternative donor (MUD, MMUD and haploidentical) HSCT
Neutrophil and platelet engraftment by day 100
Time frame: 100 days
Incidence of final status graft failure
Incidence of final status graft failure by 1 year
Time frame: 1 year
Incidence grade III-IV acute graft versus host disease (GVHD)
Incidence grade III-IV acute graft versus host disease (GVHD) by 1 year
Time frame: 1 year
Incidence of chronic GVHD
Incidence of chronic GVHD by 1 year
Time frame: 1 year
100 day and 1 year Transplant related mortality
100 day and 1 year Transplant related mortality by 1 year
Time frame: 1 year
1 year Event free survival
1 year Event free survival
Time frame: 1 year
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.