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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
3
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.
Cytoxan Day -6 \& -5 Fludarabine Day -4, -3, -2 TBI Day -1
Living donor kidney transplant
Massachusetts General Hospital
Boston, Massachusetts, United States
Incidence of full donor chimerism
Time frame: 24 months
Incidence of Grade IV Toxicity due to Venetoclax
NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
Time frame: Days -8 to Days -1
Incidence of Grade V Toxicity due to Venetoclax
NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
Time frame: Days -8 to Days -1
Incidence of acute renal allograft rejection
Time frame: 24 months
Incidence of delayed renal allograft rejection
Time frame: 24 months
Incidence of acute GVHD
Time frame: 24 months
Incidence of Chronic GVHD
Time frame: 24 months
Patient Survival Rate
Time frame: 24 months
Allograft Survival Rate
Time frame: 24 months
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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).