Not yet recruiting NCT07358195
Addition of Venetoclax to Combined Hematopoietic Stem Cell and Kidney Transplantation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Venetoclax, Hematopoietic Cell Transplantation Conditioning Regimen, Kidney Transplant, Hematopoietic Cell Transplantation.
- Who it may be relevant to
- Registry conditions: Kidney Failure Chronic, Stem Cell Transplant, Stem Cell Transplant Complications, Tolerance. Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Addition of Venetoclax to Combined Reduced Intensity Hematopoietic Stem Cell and Kidney Transplantation for Patients With Chronic Kidney Disease and Hematologic Malignancy
Overview
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]
- Incidence of Grade V Toxicity due to Venetoclax [Time frame: Days -8 to Days -1]
Secondary outcome measures (6)
- Incidence of acute renal allograft rejection [Time frame: 24 months]
- Incidence of delayed renal allograft rejection [Time frame: 24 months]
- Incidence of acute GVHD [Time frame: 24 months]
- Incidence of Chronic GVHD [Time frame: 24 months]
- Patient Survival Rate [Time frame: 24 months]
- Allograft Survival Rate [Time frame: 24 months]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Massachusetts General Hospital — Boston
Identifiers
NCT: NCT07358195 · DFCC 25-668