Vedolizumab in the Prophylaxis of Intestinal Acute Graft Versus Host Disease (aGVHD) in Participants Undergoing Allogeneic Hematopoietic Stem Cell (Allo-HSCT) Transplantation
Condition: Hematopoietic Stem Cells
MeSH terms: Graft vs Host Disease
Intervention: Vedolizumab Placebo; Vedolizumab
Intervention description: Vedolizumab placebo-matching IV infusion.; Vedolizumab IV infusion.
Intervention MeSH terms: Vedolizumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 343.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No
Keywords: Drug Therapy

Summary:

      The purpose of this study is to evaluate the efficacy of vedolizumab when added to background
      aGvHD prophylaxis regimen compared to placebo and background aGvHD prophylaxis regimen on
      intestinal aGvHD-free survival by Day +180 in participants who receive allo-HSCT as treatment
      for a hematologic malignancy or myeloproliferative disorder.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Must be >= 18 years of age and, in selected countries, adolescents aged 12 years and
             greater and weighing >=30 kilogram (kg) at time of randomization.

          2. Must undergo deoxyribose nucleic acid (DNA)-based human leukocyte antigen (HLA)
             matching and be 8 of 8 or 7 of 8 HLA-matched (singe allele or antigen mismatch at
             HLA-A, -B, and -C, and HLA-DRB1 is allowable) unrelated hematopoietic stem cell
             transplantation (HSCT) from either peripheral blood or bone marrow stem cells for a
             hematologic malignancy or myeloproliferative disorder.

          3. For whom a myeloablative conditioning or reduced intensity conditioning (RIC) is
             planned.

          4. Allo-HSCT eligible (meeting institutional criteria)-participants planned medical care
             should include aGvHD prophylaxis with a combination of calcineurin inhibitor (CNI)
             (cyclosporine [CYS] or tacrolimus [TAC]) and methotrexate (MTX) or CNI and
             mycophenolate mofetil (MMF). With the exception of antithymocyte globulin (ATG)
             (antithymocyte globulin-Fresenius [ATG-F] or thymoglobulin), all other therapies,
             approved or investigational, for GvHD prophylaxis are excluded.

          5. Eastern Cooperative Oncology Group (ECOG) performance status of <= 2 for participants
             aged >=18 years at randomization or >=60 % using the Karnofsky performance status for
             adolescent participants aged >=16 years at randomization or the Lansky performance
             status for adolescent participants aged 12 to < 16 years at randomization.

        Exclusion Criteria:

          1. Had prior allo- HSCT.

          2. 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).

          3. Planned allo-HSCT for nonmalignant hematological disorders (example, aplastic anemia,
             sickle cell anemia, thalassemias, Fanconi anemia or immunodeficiency).