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Not yet recruitingNCT07358195Updated Jan 22, 2026

Addition of Venetoclax to Combined Hematopoietic Stem Cell and Kidney Transplantation

An Early Phase 1 interventional study of Venetoclax and Hematopoietic Cell Transplantation Conditioning Regimen in Kidney Failure Chronic, Stem Cell Transplant and Stem Cell Transplant Complications, sponsored by Massachusetts General Hospital. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-01-22.

Sponsored by Massachusetts General Hospital · Early Phase 1, Interventional, and Treatment

Phase
Early Phase 1
Study type
Interventional
Enrollment
3
Allocation
Not applicable
Ages
18 Years to 70 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Kidney Failure Chronic
  • Stem Cell Transplant
  • Stem Cell Transplant Complications
  • Tolerance
  • Hematologic Cancer
03

In context

Renal Insufficiency, Chronic

3,144 studies on the registry are indexed under Renal Insufficiency, Chronic; 704 are open to participants now.

This study's planned enrollment of 3 is below the median of 74 across 2,176 interventional studies indexed under Renal Insufficiency, Chronic.

Browse Renal Insufficiency, Chronic studies →

Lead sponsor

Massachusetts General Hospital is the lead sponsor of 2,536 studies on the registry; 446 are open to participants now.

Of its 214 completed or terminated interventional studies of FDA-regulated products, 161 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

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
05

Study design

Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
3 participants (estimated)

Study arms

  • Experimental
    Recipient

    Stem Cell and Kidney Transplant

    Drug: Venetoclax · Procedure: Hematopoietic Cell Transplantation Conditioning Regimen · Procedure: Kidney Transplant · Procedure: Hematopoietic Cell Transplantation

Interventions

  • DrugVenetoclax

    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.

  • ProcedureHematopoietic Cell Transplantation Conditioning Regimen

    Cytoxan Day -6 \& -5 Fludarabine Day -4, -3, -2 TBI Day -1

  • ProcedureKidney Transplant

    Living donor kidney transplant

  • ProcedureHematopoietic 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).

06

What researchers measure

Primary outcomes

  1. Incidence of full donor chimerism

    Time frame: 24 months

  2. Incidence of Grade IV Toxicity due to Venetoclax

    NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0

    Time frame: Days -8 to Days -1

  3. Incidence of Grade V Toxicity due to Venetoclax

    NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0

    Time frame: Days -8 to Days -1

Secondary outcomes

  1. Incidence of acute renal allograft rejection

    Time frame: 24 months

  2. Incidence of delayed renal allograft rejection

    Time frame: 24 months

  3. Incidence of acute GVHD

    Time frame: 24 months

  4. Incidence of Chronic GVHD

    Time frame: 24 months

  5. Patient Survival Rate

    Time frame: 24 months

  6. Allograft Survival Rate

    Time frame: 24 months

07

Study locations

1 site
  • Massachusetts General Hospital
    Boston, Massachusetts 02114, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 22, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07358195
Lead sponsor
Massachusetts General Hospital
Responsible party
Thomas Spitzer (Professor of Medicine, Harvard Medical School Director Emeritus, Bone Marrow Transplant Program, Massachusetts General Hospital) — Principal investigator
First posted
Jan 22, 2026
Start date
Jul 2026 (estimated)
Primary completion
Dec 2028 (estimated)
Completion
Dec 2029 (estimated)
Last update
Jan 22, 2026

Study contacts

Thomas Spitzer, MD
Contact
tspitzer@mgh.harvard.edu
617-724-1124

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.

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