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Addition of Venetoclax to Combined Hematopoietic Stem Cell and Kidney Transplantation

RecruitingEarly phase 1

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

Who can join

Ages 18 to 70 · All sexes

Full eligibility criteria
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

About the study

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.

What is being tested

Sponsor: Massachusetts General Hospital · Participants: 3 · Started: Feb 4, 2026

Contact the study team

Official record on ClinicalTrials.gov — NCT07358195

Locations in the U.S.

MassachusettsMassachusetts General Hospital, Boston

Conditions

From ClinicalTrials.gov, data retrieved Nov 15, 2026. Each study sets its own eligibility; the study team decides who can join.