NCT07358195RecruitingEarly phase 1
Addition of Venetoclax to Combined Hematopoietic Stem Cell and Kidney Transplantation
Addition of Venetoclax to Combined Reduced Intensity Hematopoietic Stem Cell and Kidney Transplantation for Patients With Chronic Kidney Disease and Hematologic Malignancy
Source: ClinicalTrials.gov · Last updated 14 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Early phase 1
- Study type
- Interventional
- Enrollment
- 3 (estimated)
- First submitted
- 5 Jan 2026
- Start date
- 4 Feb 2026
- Primary completion date
- Dec 2030
- Lead sponsor
- Massachusetts General Hospital
- Diseases
- Chronic kidney disease
- NCT number
- NCT07358195
What you commit to
- Study type: Interventional · Early phase 1
- Planned participants: 3
- From 4 Feb 2026 to the primary completion date, Dec 2030
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Participation in other investigational drug use at the time of enrollment
Other illness
- Active serious infection
- Positivity for active infection with HIV, HCV, or HBV
Other
- ABO blood group incompatibility in the host-vs-graft direction
Criteria the registry did not label
- 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
Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Massachusetts General Hospital Coordinator of this site? Confirm its status | Boston | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.