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NCT Number: NCT07358195

Addition of Venetoclax to Combined Hematopoietic Stem Cell and Kidney Transplantation

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Recipient Inclusion Criteria:

  • 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

Donor Inclusion Criteria:

  • 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)
  • Acceptable laboratory parameters (hematology in normal or near-normal range; liver function < 3 times the upper limit of normal and normal creatinine)
  • 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 criteria

  • 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

Treatment and study plan

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).

Primary outcomes

  1. Incidence of full donor chimerism

    Time frame: 24 months

  2. Incidence of Grade IV Toxicity due to Venetoclax

    Time frame: Days -8 to Days -1

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

  3. Incidence of Grade V Toxicity due to Venetoclax

    Time frame: Days -8 to Days -1

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

Secondary outcomes

  1. Incidence of acute renal allograft rejection

    Time frame: 24 months

  2. Incidence of delayed renal allograft rejection

    Time frame: 24 months

  3. Incidence of acute GVHD

    Time frame: 24 months

  4. Incidence of Chronic GVHD

    Time frame: 24 months

  5. Patient Survival Rate

    Time frame: 24 months

  6. Allograft Survival Rate

    Time frame: 24 months

Study contacts

Contact information is provided by the study sponsor or research team.

Thomas Spitzer, MD

CONTACT

[email protected]

617-724-1124

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Registry information

Official study title

Addition of Venetoclax to Combined Reduced Intensity Hematopoietic Stem Cell and Kidney Transplantation for Patients With Chronic Kidney Disease and Hematologic Malignancy

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
Jan 22, 2026
Registry last updated
Jan 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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