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Venetoclax with Stem Cell and Kidney Transplant for Kidney Failure and Blood Cancer

This study is looking at adding a drug called Venetoclax to a combined stem cell and kidney transplant for people with chronic kidney failure and certain blood cancers. The goal is to see if Venetoclax, given before the transplant, is safe and helps the body accept the new stem cells from a donor. Researchers will monitor for any serious side effects from Venetoclax and check if the donor's stem cells are fully established in your body after 24 months. You might be able to join if you are 18-70 years old and have a blood cancer that your doctors believe can be cured with a stem cell transplant. The study is currently unclear on its recruitment status and plans to enroll 3 participants.

Study design
This is an interventional study with an unclear phase, planning to enroll 3 participants.
What's involved
You would receive Venetoclax daily for 8 days before the transplant, along with chemotherapy and radiation (TBI). You would then undergo a living donor kidney transplant and receive donor bone marrow or stem cells.
Compensation
Not stated in the trial record.
Follow-up
Researchers will check for full donor chimerism (when donor cells are fully established) 24 months after the transplant.

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NCT07358195

Addition of Venetoclax to Combined Hematopoietic Stem Cell and Kidney Transplantation

Not Yet Recruiting
EARLY_PHASE1Ages 18–70InterventionalTreatment
Massachusetts General Hospital
~3 participants
Updated 2026-01-22 on ClinicalTrials.gov
What's tested:VenetoclaxHematopoietic Cell Transplantation Conditioning RegimenKidney TransplantHematopoietic Cell Transplantation

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of full donor chimerism
Measured over 24 months
+2 more outcomes measured

Conditions

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

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Where it's being run

1 sites across 1 states
Massachusetts1

Who to contact

Thomas Spitzer, MD
[email protected]
617-724-1124
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Eligibility criteria

Inclusion

Patient ages 18-70
Underlying hematological malignancy which is deemed as being potentially curable with allogeneic bone marrow or PBSC transplantation by the BMT voting team.
Hematological malignancies include, but are not limited to: acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), chronic myelogenous leukemia (CML), chronic lymphocytic leukemia (CLL), non-Hodgkin lymphoma (NHL), Hodgkin lymphoma, multiple myeloma (MM), myelodysplastic syndrome (MDS. Patient should be in a partial (PR) or complete remission (CR) at the time of the transplant.
Existence of an HLA-matched or haploidentical relative who passes standard donor evaluations for bone marrow and kidney donation
LVEF \> 40% as measured by echocardiography or MUGA
FEV1, FVC, and DLCO \> 50% of predicted as measured by standard PFTs
Total bilirubin \< 2.0 (unless diagnosis of Gilbert's or hemolysis is made) and AST, ALT, alkaline phosphatase all \< 5x institutions upper limit of normal
ABO compatibility in the host vs. graft direction
Men and women of reproductive potential must agree to use a reliable method of birth control during the treatment, and women should do so for a period of 1 year following the transplant.
Participants should be on dialysis or have a CrCl ≤ 35 ml/min
Life expectancy greater than 6 months
Recipient ability to understand and provide informed consent
HLA matched or haploidentical relative as defined by 3/6, 4/6, or 5/6 HLA-matched at HLA -A, -B, or -DRB1 who is 18-70 years of age
ECOG performance status 0 or 1
Excellent health per conventional pre-donor history (medical and psychosocial evaluation)
Compatible ABO blood group
Negative donor lymphocyte cross match
No positive testing for active viral infection (Hepatitis B, Hepatitis C, HIV)
Donor ability to understand and provide informed consent
Meets standard institutional criteria for both bone marrow or peripheral blood stem cell (PBSC) and kidney donation

Exclusion

Active serious infection
Participation in other investigational drug use at the time of enrollment
Positivity for active infection with HIV, HCV, or HBV
ABO blood group incompatibility in the host-vs-graft direction

What this trial measures

  • Incidence of full donor chimerism24 months
  • Incidence of Grade IV Toxicity due to VenetoclaxDays -8 to Days -1

    NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0

  • Incidence of Grade V Toxicity due to VenetoclaxDays -8 to Days -1

    NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0