Addition of Venetoclax to Combined Hematopoietic Stem Cell and Kidney Transplantation

Trial statusNot yet recruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-70
SponsorMassachusetts General Hospital

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Venetoclax
  • Hematopoietic Cell Transplantation Conditioning Regimen
  • Kidney Transplant
  • Hematopoietic Cell Transplantation

Treatment groups

3 Participants
are divided into 1 treatment group

Sponsors and collaborators