This phase I trial studies the side effects of CD45RA depleted T cell infusion given after an alpha/beta depleted stem cell transplant, and to see how well it works in reducing complications in patients at risk for viral or fungal infections. There is a higher rate of complications using cells from an unrelated or partially matched related donor. Some donor cells may cause a complication called graft versus host disease (GVHD) and an infection with the Epstein-Barr virus (EBV). In this study, the CliniMACs device is used before the transplant to remove alpha/beta T cells that may cause GVHD and B cells that carry EBV. The device is also used to remove CD45RA T cells. Giving CD45RA depleted T cells after the transplant may reduce some of the complications of the transplant and decrease the time it takes for the new stem cells to grow in the body.
Additional locations may be listed on ClinicalTrials.gov for NCT03810196.
Locations matching your search criteria
United States
Pennsylvania
Philadelphia
Children's Hospital of PhiladelphiaStatus: Active
Contact: Timothy Steven Olson
Phone: 267-426-5516
PRIMARY OBJECTIVES:
I. Safety evaluation assessment by cumulative incidence of acute/chronic GVHD, of CD45RA depleted donor peripheral stem cell (PSC) addback with T-cell receptor (TCR)alphabeta depleted hematopoietic stem cell transplant.
II. Evaluate tempo of immune reconstitution and compare to patients who did not receive CD45RA depleted T cells.
III. Evaluate incidence of viral (cytomegalovirus [CMV], adenovirus, Epstein Barr virus [EBV], Brook's Kidney [BK]) reactivation following TCRalphabeta depleted hematopoietic stem cell transplant (HSCT) and CD45RA depleted T cells and compare to previous studies using TCRalphabeta depleted HSCT alone.
OUTLINE:
Patients receive thiotepa intravenously (IV) over 2 hours on days -7 and -6 or days -5 and -4, cyclophosphamide IV over 2 hours on days -5 and -4 or days -3 and -2, and undergo total body irradiation (TBI) on days -3 to -1. Patients then undergo alpha/beta depleted stem cell transplant IV over 1 hour on day 0. Patients less than 2 years of age, have received radiation in the past, or are at increased risk of organ toxicities with TBI may receive busulfan instead of TBI IV on days -9 to -6. Once cells have engrafted, patients with no signs of GVHD receive CD45RA-depleted donor T-lymphocytes IV.
After completion of study treatment, patients are followed up weekly for 2-3 months, monthly for 12 months, at 1.5 and 2 years, and then annually for up to 5 years.
Lead OrganizationChildren's Hospital of Philadelphia
Principal InvestigatorTimothy Steven Olson
