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Addition of Venetoclax to Combined Hematopoietic Stem Cell and Kidney Transplantation

NCT07358195 · Status: NOT_YET_RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2026-01-22

No results posted yet for this 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.

Conditions

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

Interventions

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

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

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).

Sponsors & Collaborators

  • Massachusetts General Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-31
Primary Completion
2028-12-31
Completion
2029-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07358195 on ClinicalTrials.gov