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Addition of Venetoclax to Combined Hematopoietic Stem Cell and Kidney Transplantation
Sponsor: Massachusetts General Hospital
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.
Official title: Addition of Venetoclax to Combined Reduced Intensity Hematopoietic Stem Cell and Kidney Transplantation for Patients With Chronic Kidney Disease and Hematologic Malignancy
Key Details
Gender
All
Age Range
18 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
3
Start Date
2026-07
Completion Date
2029-12
Last Updated
2026-01-22
Healthy Volunteers
No
Conditions
Interventions
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.
Hematopoietic Cell Transplantation Conditioning Regimen
Cytoxan Day -6 \& -5 Fludarabine Day -4, -3, -2 TBI Day -1
Kidney Transplant
Living donor kidney transplant
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).
Locations (1)
Massachusetts General Hospital
Boston, Massachusetts, United States