NCT07358195 · Massachusetts General Hospital
Addition of Venetoclax to Combined Hematopoietic Stem Cell and Kidney Transplantation
What this study is about
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.
View original scientific 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.
Interventions
DRUG
Venetoclax
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.
PROCEDURE
Hematopoietic Cell Transplantation Conditioning Regimen
Cytoxan Day -6 \& -5 Fludarabine Day -4, -3, -2 TBI Day -1
PROCEDURE
Kidney Transplant
Living donor kidney transplant
PROCEDURE
Hematopoietic Cell Transplantation
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 outcome measures
Incidence of full donor chimerism
Time frame: 24 months
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
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
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Boston, Massachusetts
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Oct 14, 2026 · Source of record for eligibility and locations