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NOT YET RECRUITING
NCT07358195
EARLY_PHASE1

Addition of Venetoclax to Combined Hematopoietic Stem Cell and Kidney Transplantation

Sponsor: Massachusetts General Hospital

View on ClinicalTrials.gov

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

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).

Locations (1)

Massachusetts General Hospital

Boston, Massachusetts, United States