TLI, TBI, ATG & Hematopoietic Stem Cell Transplantation and Recipient T Regs Therapy in Living Do… (NCT03943238) | Clinical Trial Compass
UnknownPhase 1
TLI, TBI, ATG & Hematopoietic Stem Cell Transplantation and Recipient T Regs Therapy in Living Donor Kidney Transplantation
United States22 participantsStarted 2020-02-01
Plain-language summary
This study will determine whether a preparatory regimen including total lymphoid irradiation (TLI), total body irradiation (TBI), anti-thymocyte globulin (ATG) and infusion of the donor hematopoietic stem cells when given along with recipient regulatory T cells (Tregs) will allow for eventual discontinuation of anti-rejection drugs after living donor kidney transplantation.
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion criteria
✓. All consenting adults who are 18 to 65 years, living donor renal transplant recipients at Stanford University Medical Center or Northwestern Medicine who have a haplotype matched (minimum single Human Leukocyte Antigen - DR locus (HLA-DR) and HLA-A or B match) living related or unrelated donor.
✓. Patients who agree to participate in the study and sign an Informed Consent.
✓. Patients who have no known contraindication to administration of rabbit ATG or radiation.
✓. Males and females of reproductive potential who agree to practice a reliable form of contraception for at least 1 year posttransplant
Exclusion criteria
✕. Previous treatment with rabbit ATG or a known allergy to rabbit proteins.
✕. History of malignancy with the exception of non-melanoma skin malignancies.
✕. Pregnant women or nursing mothers.
✕. Serological evidence of HIV, Hepatitis B surface antigen positive (HBsAg+), or Hepatitis C infection. Epstein Barr Virus (EBV) positive to EBV negative.
✕. Leukopenia (with a white blood cell count \< 3000/mm3) or thrombocytopenia (with a platelet count \< 100,000/mm3).
✕. Panel Reactive Antibody (PRA) greater than 80% or demonstration of historic and/or current donor specific antibody (DSA)
✕. Prior organ transplantation
What they're measuring
1
Count of participants with sustained mixed chimerism of >25% at 18 months
Timeframe: Month 18
2
Count of participants able to withdraw from immunosuppressive drugs without evidence of rejection at 18 months