RECRUITING

TLI, TBI, ATG & Hematopoietic Stem Cell Transplantation and Recipient T Regs Therapy in Living Donor Kidney Transplantation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Phase 1 Study of Total Lymphoid Irradiation, Total Body Irradiation, Anti-Thymocyte Globulin and Purified Donor CD34+, T-cell and Recipient T Regulatory Cell Transfusion in Human Leukocyte Antigen Mismatched Living Donor Kidney Transplantation

Quick Facts

Study Start:2020-02-01
Study Completion:2024-10-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03943238

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. 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.
  2. 2. Patients who agree to participate in the study and sign an Informed Consent.
  3. 3. Patients who have no known contraindication to administration of rabbit ATG or radiation.
  4. 4. Males and females of reproductive potential who agree to practice a reliable form of contraception for at least 1 year posttransplant
  1. 1. Previous treatment with rabbit ATG or a known allergy to rabbit proteins.
  2. 2. History of malignancy with the exception of non-melanoma skin malignancies.
  3. 3. Pregnant women or nursing mothers.
  4. 4. Serological evidence of HIV, Hepatitis B surface antigen positive (HBsAg+), or Hepatitis C infection. Epstein Barr Virus (EBV) positive to EBV negative.
  5. 5. Leukopenia (with a white blood cell count \< 3000/mm3) or thrombocytopenia (with a platelet count \< 100,000/mm3).
  6. 6. Panel Reactive Antibody (PRA) greater than 80% or demonstration of historic and/or current donor specific antibody (DSA)
  7. 7. Prior organ transplantation
  8. 8. High risk of primary kidney disease recurrence
  9. 9. Advanced coronary or vascular disease.

Contacts and Locations

Study Contact

Kevin Ly, BS
CONTACT
650-497-6057
kevinly@stanford.edu
Stephan Busque, MD
CONTACT
650-498-6189
sbusque@stanford.edu

Principal Investigator

Everett Meyer, MD
STUDY_DIRECTOR
Stanford University

Study Locations (Sites)

Stanford University
Palo Alto, California, 94305
United States
Nothwestern University
Chicago, Illinois, 60611
United States

Collaborators and Investigators

Sponsor: Stanford University

  • Everett Meyer, MD, STUDY_DIRECTOR, Stanford University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-02-01
Study Completion Date2024-10-01

Study Record Updates

Study Start Date2020-02-01
Study Completion Date2024-10-01

Terms related to this study

Keywords Provided by Researchers

  • kidney transplant
  • Immunological Tolerance
  • Tregs
  • Stem cells

Additional Relevant MeSH Terms

  • Living Donor Kidney Transplantation