Addition of Venetoclax to Combined Hematopoietic Stem Cell and Kidney Transplantation (NCT07358195) | Clinical Trial Compass
Not Yet RecruitingEarly Phase 1
Addition of Venetoclax to Combined Hematopoietic Stem Cell and Kidney Transplantation
United States3 participantsStarted 2026-07
Plain-language summary
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.
Who can participate
Age range18 Years – 70 Years
SexALL
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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 d…