This phase II trial studies how well vedolizumab plus post-transplant cyclophosphamide (PTCy) and short course tacrolimus work for the prevention of graft versus host disease (GVHD) in patients undergoing allogeneic hematopoietic cell transplantation (HCT) after reduced intensity conditioning. Allogeneic HCT is a procedure in which a person receives blood-forming stem cells (cells from which all blood cells develop) from a donor. Giving reduced conditioning chemotherapy before an allogeneic HCT helps kill cancer cells in the body and helps make room in the patient's bone marrow for new stem cells to grow using less than standard doses of chemotherapy. Sometimes, the transplanted cells from a donor can attack the body's normal cells (called graft-versus-host disease). Vedolizumab is a monoclonal antibody, which is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). It may reduce inflammation. Cyclophosphamide is in a class of medications called alkylating agents. It works by damaging the cell's deoxyribonucleic acid and may kill cancer cells. It may also lower the body's immune response. Tacrolimus suppresses the immune system by preventing the activation of certain types of immune cells. Giving vedolizumab plus PTCy and short course tacrolimus may be effective at preventing GVHD after allogeneic HCT.
Age range
18 Years – 80 Years
Sex
ALL
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Incidence of primary engraftment failure (Safety lead-in segment)
Timeframe: From starting the first dose of vedolizumab to the first observation of event, day +30, whichever comes first
Incidence of severe infusion reaction (Safety lead-in segment)
Timeframe: From starting the first dose of vedolizumab to the first observation of event, day +30, whichever comes first
Incidence of grade 4-5 adverse events (Safety lead-in segment)
Timeframe: From starting the first dose of vedolizumab to the first observation of event, day +30, whichever comes first
Non-relapse mortality (NRM) (Safety lead-in segment)
Timeframe: From date of stem cell infusion until non-disease related death, assessed up to 1 year post-hematopoietic cell transplant (HCT)
Incidence of grade 2-4 acute graft versus host disease (GVHD)-free survival
Timeframe: From start of HCT to first occurrence of grade 2-4 acute GVHD followed until day +180 or death from any cause, whichever occurs first, assessed up to 1 year post-HCT