Venetoclax added to reduced-intensity conditioning for combined stem cell and kidney transplant

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This early-phase trial aims to evaluate the safety of adding venetoclax to a reduced-intensity conditioning protocol before a combined hematopoietic stem cell and kidney transplant. Participants are adults with a potentially curable hematologic malignancy and an available matched or haploidentical donor. The primary endpoint is stable donor hematopoiesis without severe venetoclax-related toxicity (CTCAE grade IV or V). The study uses a venetoclax-containing conditioning regimen along with kidney transplantation and donor stem cell transplantation. Enrollment is limited to patients at Massachusetts General Hospital with specific physiologic and organ function criteria.

Why it matters

Who can join: the full rules

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

Where it's running

• Massachusetts General Hospital
  Boston, Massachusetts, United States Recruiting

Study contacts

• Study coordinator: Thomas Spitzer, MD
• Email: tspitzer@mgh.harvard.edu
• Phone: 617-724-1124

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.