Addition of Venetoclax to Combined Reduced Intensity Hematopoietic Stem Cell and Kidney Transplantation for Patients With Chronic Kidney Disease and Hematologic Malignancy

Summary

The primary objective is to assess the safety of the addition of venetoclax to reduced intensity conditioning for HLA-matched and haploidentical combined HSC and kidney transplantation as measured by stable full donor hematopoiesis and absence of CTCAE grade IV or V toxicity attributable to venetoclax.

Eligibility

Age range

18–70 years

Sex

All

Healthy volunteers

No

Interventions

• Drug
  Venetoclax

  Venetoclax 400mg orally once daily on days -8 through -1 with daily monitoring for tumor lysis syndrome. Venetoclax tablets will be swallowed (not crushed). Venetoclax dosing will not be repeated in the event of vomiting.

• Procedure
  Hematopoietic Cell Transplantation Conditioning Regimen

  Cytoxan Day -6 \& -5 Fludarabine Day -4, -3, -2 TBI Day -1

• Procedure
  Kidney Transplant

  Living donor kidney transplant

• Procedure
  Hematopoietic Cell Transplantation

  Donor bone marrow (target of 4 x 108 nucleated cells/kg of recipient ideal body weight) PBSC A goal dose of 5 x 106 CD34+ cells / kg of recipient actual body weight will be infused (minimum acceptable is 2 x 106 CD34+ cells / kg).

Location