Phase 1b/2a Trial of Allogeneic Hematopoietic Stem Cell Transplantation (HSCT) From an HLA-partially Matched Related or Unrelated Donor After TCRαβ+ T-cell/CD19+ B-cell Depletion for Patients Who Will Receive a Kidney Transplant (KT) From the Same HSCT/KT Donor

Summary

This is a single center, non-randomized, non-controlled open-label phase 1b/2a trial of performing sequential αβdepleted-HSCT and KT in patients requiring KT to prevent kidney rejection post-KT, in the absence of any post-KT immunosuppression, to abrogate the need for lifelong immunosuppression, the risk of chronic rejection and, ultimately, the need for repeated transplantation.

Eligibility

Age range

1–30 years

Sex

All

Healthy volunteers

No

Interventions

• Drug
  Cyclophosphamide 1200 mg/Kg

  Cyclophosphamide 1200 mg/Kg will be administered as part of the conditioning regimen A prior to HSCT

• Drug
  Fludarabine

  Fludarabine (starting dose 0.5 mg/Kg and then PK guided to reach an AUC of 18-20) will be administered as part of the conditioning regimen prior to HSCT

• Drug
  Cyclophosphamide 100 mg/Kg

  Cyclophosphamide 100 mg/Kg will be administered as part of the conditioning regimen B prior to HSCT

• Radiation
  Total Body Irradiation

  Total Body Irradiation 200 cGy will be administered as part of the conditioning regimen prior to HSCT

• Drug
  ATG

  ATG 7.5 mg/Kg will be administered as part of the conditioning regimen prior to HSCT

• Drug
  Rituximab

  Rituximab 200 mg/m2 will be administered within 24 hours of the HSCT

Location