Vedolizumab-3035

A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Vedolizumab in the Prophylaxis of Intestinal Acute Graft Versus-Host Disease in Subjects Undergoing Allogeneic Hematopoietic Stem Cell Transplantation

Study treatment

• Experimental arm: Vedolizumab 300mg intranvenous infusion
• Placebo arm: Vedolizumab placebo matching intravenous infusion

Inclusion criteria

• Participants must undergo 8 of 8 or 7 of 8 human leukocyte antigen (HLA)-matched (antigen at HLA-A, -B, and -C, and allelic at HLA-DRB1) unrelated hematopoietic stem cell transplantation (HSCT) from either peripheral blood or bone marrow stem cells for a hematologic malignancy or myeloproliferative disorder
• Participants for whom a myeloablative conditioning or reduced intensity conditioning (RIC) is planned
• Allogeneic hematopoietic stem cell transplantation (Allo-HSCT) eligible (meeting institutional criteria)-participants planned medical care should include acute graft-versus-host disease (aGvHD) prophylaxis with a combination of calcineurin inhibitor (CNI) (cyclosporine [CYS] or tacrolimus [TAC]) and methotrexate (MTX) or CNI and mycophenolate mofetil (MMF).
• ECOG 0-2

Exclusion criteria

• Had prior allo- or autologous HSCT
• Planned umbilical cord blood transplant or planned to receive posttransplant cyclophosphamide, in vivo or ex vivo T cell-depleted hematopoietic stem cells (HSCs) with the exception of ATG (ATG-F or thymoglobulin)
• Planned allo-HSCT for nonmalignant hematological disorders

Participating sites

• University hospital Leuven Gasthuisberg
• ZNA