NCT07358195

Addition of Venetoclax to Combined Hematopoietic Stem Cell and Kidney Transplantation

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

• Status: Not Yet Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 3 (estimated)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Kidney Failure Chronic
• Stem Cell Transplant
• Stem Cell Transplant Complications
• Tolerance
• Hematologic Cancer

Interventions

Type	Name	Description
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).

Timeline

• Start date: 2026-07-01
• Primary completion: 2028-12-01
• Completion: 2029-12-01
• First posted: 2026-01-22
• Last updated: 2026-01-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study