Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
NCT Number: NCT07358195
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.
Trial opening soon.
Get Notified18 year–70 year
All sexes
Interventional
Early Phase 1
Boston, Massachusetts, 02114, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Recipient Inclusion Criteria:
Donor Inclusion Criteria:
Exclusion criteria
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
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).
Time frame: 24 months
Time frame: Days -8 to Days -1
NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
Time frame: Days -8 to Days -1
NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
Time frame: 24 months
Time frame: 24 months
Time frame: 24 months
Time frame: 24 months
Time frame: 24 months
Time frame: 24 months
Contact information is provided by the study sponsor or research team.
Massachusetts General Hospital
Other
Addition of Venetoclax to Combined Reduced Intensity Hematopoietic Stem Cell and Kidney Transplantation for Patients With Chronic Kidney Disease and Hematologic Malignancy
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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