Addition of Venetoclax to Combined Hematopoietic Stem Cell and Kidney Transplantation

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Massachusetts General Hospital
Study ID
NCT07358195
Phase
EARLY_PHASE1
Status
Not Yet Recruiting

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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Venetoclax — DRUG
    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 — PROCEDURE
    Cytoxan Day -6 \& -5 Fludarabine Day -4, -3, -2 TBI Day -1
  • Kidney Transplant — PROCEDURE
    Living donor kidney transplant
  • Hematopoietic Cell Transplantation — PROCEDURE
    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).

Study Details

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.

Key Dates

Start date
Jul 31, 2026
Status verified
Dec 2025
Primary completion
Dec 31, 2028
Completion
Dec 31, 2029

Study Design

Enrollment
3 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Recipient
    Stem Cell and Kidney Transplant

Primary Outcome Measure

Incidence of full donor chimerism [ Time Frame: 24 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Massachusetts General HospitalBostonMassachusetts02114
Thomas Spitzer, MD
[email protected]
617-724-1124

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By research site
Massachusetts General Hospital· Boston, MA

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