A Phase II Study of Selective Depletion of CD45RA+ T Cells From Allogeneic Peripheral Blood Stem Cell Grafts for the Prevention of GVHD in Children
I. Estimate the time to discontinuation of systemic immunosuppression in pediatric
recipients of cluster of differentiation 45RA positive (CD45RA+) T cell-depleted peripheral
blood stem cell transplant (PBSCT).
II. Estimate the probability of graft failure in pediatric recipients of CD45RA+
I. Estimate and compare to an appropriate historical cohort the probability of chronic
graft-versus-host disease (GVHD) (National Institutes of Health [NIH] criteria) requiring
treatment with systemic pharmacological immunosuppression in pediatric patients who receive
CD45RA+ T cell depleted PBSC.
II. Estimate the probability of acute GVHD grade II-IV.
III. Estimate the probability of steroid refractory acute GVHD.
IV. Evaluate immune reconstitution.
V. Estimate the probability of transplant-related mortality by day 100.
VI. Estimate the probability of relapse.
CONDITIONING REGIMEN: Patients undergo total body irradiation (TBI) twice daily (BID) on
days -10 to -7, receive thiotepa intravenously (IV) over 4 hours on days -6 and -5 and
fludarabine phosphate IV over 30 minutes on days -6 to -2.
TRANSPLANT: Patients undergo CD34+ enriched, CD45RA+ T cell-depleted allogeneic PBSCT on day
POST-TRANSPLANT IMMUNOSUPPRESSION: Patients receive tacrolimus IV hours or orally (PO) every
12 hours beginning on day -1 and continuing through day 50 with taper. Patients also receive
methotrexate IV on days 1, 3, 6, and 11.
After completion of study treatment, patients are followed up for up to 5 years.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Time to discontinuation of systemic immunosuppression
Time from transplant to the final discontinuation of all systemic immune suppression assessed up to 5 years
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
United States: Food and Drug Administration
|Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium||Seattle, Washington 98109|