Adding Venetoclax to Combined Stem Cell and Kidney Transplant in Blood Cancer
Tests venetoclax added to combined stem cell and kidney transplant in adults with kidney failure.
Plain-language title generated from the registry record
Registry title: Addition of Venetoclax to Combined Hematopoietic Stem Cell and Kidney Transplantation
Key facts
- Where
- Boston, United StatesSee the site
- Phase
- Early phase 1
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 70 years old?
Source: NCT07358195, who can take part
Where in United States
- Massachusetts General HospitalBoston, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Massachusetts General Hospital
- Trial code
- NCT07358195
- Record updated
- 14 October 2026
- Original description
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.Read full original descriptionShow less
Addition of Venetoclax to Combined Reduced Intensity Hematopoietic Stem Cell and Kidney Transplantation for Patients With Chronic Kidney Disease and Hematologic Malignancy
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.
Exclusion: Participation in other investigational drug use at the time of enrollment; Active serious infection; Positivity for active infection with HIV, HCV, or HBV; ABO blood group incompatibility in the host-vs-graft direction.
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.