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Vedolizumab Plus Post-transplant Cyclophosphamide and Short Course Tacrolimus for the Prevention of Graft Versus Host Disease in Patients Undergoing Allogeneic Hematopoietic Cell Transplantation After Reduced Intensity Conditioning
Sponsor: City of Hope Medical Center
Summary
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.
Official title: Phase-2 Study of Vedolizumab Plus Post-Transplant Cyclophosphamide and Short Course Tacrolimus for Graft-versus-Host Disease Prevention After Reduced Intensity Conditioning Peripheral Blood Stem Cell Allogeneic Hematopoietic Cell Transplantation
Key Details
Gender
All
Age Range
18 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
35
Start Date
2025-04-18
Completion Date
2028-10-15
Last Updated
2025-06-27
Healthy Volunteers
No
Conditions
Interventions
Allogeneic Hematopoietic Stem Cell Transplantation
Undergo allogeneic HCT
Biospecimen Collection
Undergo blood sample collection
Bone Marrow Biopsy
Undergo bone marrow biopsy
Computed Tomography
Undergo CT
Cyclophosphamide
Given IV
Echocardiography
Undergo ECHO
Fludarabine
Given IV
Melphalan
Given IV
Multigated Acquisition Scan
Undergo MUGA
Questionnaire Administration
Ancillary studies
Tacrolimus
Given IV or PO
Vedolizumab
Given IV
Locations (1)
City of Hope Medical Center
Duarte, California, United States