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

Completed · Phase 3 · Has a placebo group

Conditions studied: Hematopoietic Stem Cells

In brief

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.

Key facts

Study ID

NCT03657160

Run by

Millennium Pharmaceuticals, Inc.

People needed

343

Starts

2019-02-06

Expected to finish

2022-05-09

Last updated by the study team

2023-06-06

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 <= 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.

You may not qualify if…

• 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).

Where it is running

• David Geffen School of Medicine at University of California Los Angeles — Los Angeles, California, United States
• Children's Healthcare of Atlanta — Atlanta, Georgia, United States
• Emory University - Winship Cancer Institute — Atlanta, Georgia, United States
• Augusta University Georgia Cancer Center — Augusta, Georgia, United States
• Robert H. Lurie Comprehensive Cancer Center of Northwestern University — Chicago, Illinois, United States
• Loyola University Medical Center — Maywood, Illinois, United States
• Indiana University Melvin and Bren Simon Cancer Center — Indianapolis, Indiana, United States
• University of Kentucky Chandler Medical Center — Lexington, Kentucky, United States
• Marlene and Stewart Greenebaum Cancer Center — Baltimore, Maryland, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• Boston Children's Hospital — Boston, Massachusetts, United States
• Dana Farber Cancer Institute — Boston, Massachusetts, United States
• Barbara Ann Karmanos Cancer Institute — Detroit, Michigan, United States
• Mayo Clinic - Rochester — Rochester, Minnesota, United States
• Roswell Park Cancer Institute — Buffalo, New York, United States
• Roswell Park Comprehensive Cancer Center — Buffalo, New York, United States
• Cohen Children's Medical Center — New Hyde Park, New York, United States
• Weill Cornell Medical College — New York, New York, United States
• Columbia University Medical Center - The Columbia Center for Translational Immunology — New York, New York, United States
• University of North Carolina Hospitals — Chapel Hill, North Carolina, United States
• Oregon Health and Science University — Portland, Oregon, United States
• Medical University of South Carolina — Charleston, South Carolina, United States
• Texas Oncology - Baylor Charles A. Sammons Cancer Center — Dallas, Texas, United States
• University of Alabama at Birmingham Comprehensive Cancer Center — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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