Vedolizumab in the Prophylaxis of Intestinal Acute Graft Versus Host Disease (aGVHD) in Participants Undergoing Allogeneic Hematopoietic Stem Cell (Allo-HSCT) Transplantation

Overview

About this study

The purpose of this study is to evaluate the effectiveness 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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • 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.
  • 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.
  • For whom a myeloablative conditioning or reduced intensity conditioning (RIC) is planned.
  • 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.
  • Eastern Cooperative Oncology Group (ECOG) performance status of less than or equal to (<=) 2 for participants aged ≥ 18 years at randomization or ≥ 60 percent (%) using the Karnofsky performance status for adolescent subjects aged ≥ 16 years at randomization or the Lansky performance status for adolescent participants aged 12 to ≤ 16 years at randomization.

Exclusion Criteria:

  • Had prior allo- 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 (example; aplastic anemia, sickle cell anemia, thalassemias, Fanconi anemia or immunodeficiency).

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Hassan Alkhateeb, M.D.

Open for enrollment

Contact information:

Anton Mett CCRP

(507) 538-9812

Mett.Anton@mayo.edu

More information

Publications

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Study Results Summary

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Supplemental Study Information

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Additional contact information

Cancer-related trials contact form

Phone: 855-776-0015 (toll-free)

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