Myeloproliferative Neoplasms Clinical Trial
Vedolizumab in the Prophylaxis of Intestinal Acute Graft Versus Host Disease (aGVHD) in Participants Undergoing Allogeneic Hematopoietic Stem Cell (Allo-HSCT) Transplantation
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.
Full Description
The drug being tested in this study is called vedolizumab. Vedolizumab is being tested to treat people who are undergoing allo-HSCT transplantation. This study will look at the efficacy and safety of vedolizumab in the prophylaxis of intestinal aGvHD in participants undergoing allo-HSCT transplantation.
The study will enroll approximately 558 participants. Participants will be randomly assigned (by chance, like flipping a coin) in 1:1 ratio to one of the two treatment groups-which will remain undisclosed to the participant and study doctor during the study (unless there is an urgent medical need) along with background GvHD prophylaxis regimen:
Vedolizumab 300 mg
Placebo (dummy inactive intravenous infusion)
This multi-center trial will be conducted Worldwide. The overall time to participate in this study is 12 months.
Eligibility Criteria
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 <= 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:
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).
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There are 135 Locations for this study
Birmingham Alabama, 35294, United States
Los Angeles California, 90095, United States
Atlanta Georgia, 30322, United States
Atlanta Georgia, 30322, United States
Augusta Georgia, 30912, United States
Chicago Illinois, 60611, United States
Maywood Illinois, 60153, United States
Indianapolis Indiana, 46202, United States
Lexington Kentucky, 40536, United States
Baltimore Maryland, 21201, United States
Boston Massachusetts, 02114, United States
Boston Massachusetts, 02215, United States
Boston Massachusetts, 02215, United States
Boston Massachusetts, 02215, United States
Detroit Michigan, 48201, United States
Rochester Minnesota, 55905, United States
Buffalo New York, 14263, United States
Buffalo New York, 14263, United States
New Hyde Park New York, 11040, United States
New York New York, 10021, United States
New York New York, 10032, United States
Chapel Hill North Carolina, 27514, United States
Portland Oregon, 97239, United States
Charleston South Carolina, 29425, United States
Dallas Texas, 75246, United States
Charlottesville Virginia, 22908, United States
Richmond Virginia, 23298, United States
Ciudad Autonoma de Buenos Aires Buenos Aires, C1093, Argentina
Ciudad Autonoma de Buenos Aires , C1199, Argentina
Cordoba , X5014, Argentina
Darlinghurst New South Wales, 2010, Australia
Herston Queensland, 4006, Australia
Heidelberg Victoria, 3084, Australia
Parkville Victoria, 3050, Australia
Murdoch Western Australia, 6150, Australia
Linz Upper Austria, 4020, Austria
Leuven Flemish Brabant, 3000, Belgium
Antwerpen , 2060, Belgium
Fortaleza Ceara, 60430, Brazil
Curitiba Parana, 80510, Brazil
Barretos SAO Paulo, 14784, Brazil
Sao Paulo , 01246, Brazil
Sao Paulo , 01509, Brazil
Sao Paulo , 03102, Brazil
Sao Paulo , 08270, Brazil
Winnipeg Manitoba, R3E 0, Canada
Saskatoon Saskatchewan, S7N 4, Canada
Rennes Cedex 9 Bretagne, 35033, France
Paris Cedex 10 Ile-de-france, 75475, France
Paris Ile-de-france, 75012, France
Paris Ile-de-france, 75013, France
Paris Ile-de-france, 75473, France
Limoges Cedex Limousin, Lorraine, 87042, France
Nantes Cedex 1 PAYS DE LA Loire, 44093, France
Amiens Picardie, 80054, France
Mannheim Baden-wuerttemberg, 68167, Germany
Stuttgart Baden-wuerttemberg, 70176, Germany
Frankfurt am Main Hessen, 60590, Germany
Mainz Rheinland-pfalz, 55131, Germany
Halle Sachsen-anhalt, 06120, Germany
Dresden Sachsen, 01307, Germany
Kiel Schleswig-holstein, 24105, Germany
Athens Attica, 12462, Greece
Patras Peloponnese, 26504, Greece
Debrecen Hajdu-bihar, 4032, Hungary
Beer Sheva Beersheba, 84101, Israel
Haifa , 31096, Israel
Jerusalem , 91120, Israel
Ramat Gan , 52656, Israel
Tel Aviv , 64239, Israel
Reggio Calabria Calabria, 89122, Italy
Tricase Lecce, 73039, Italy
Ascoli Piceno Marche, 63100, Italy
Mestre Venezia, 30174, Italy
Ancona , 60126, Italy
Bari , 70124, Italy
Catania , 95124, Italy
Milano , 20089, Italy
Milano , 20162, Italy
Pescara , 65125, Italy
Nagoya Aichi, 453-8, Japan
Fukuoka-shi Fukuoka, 812-8, Japan
Hiroshima-shi Hiroshima, 730-8, Japan
Sapporo-shi Hokkaido, 060-8, Japan
Okayama-city Okayama, 700-8, Japan
Nagaizumi Shizuoka, 411-8, Japan
Shimotsuke-city Tochigi, 329-0, Japan
Bunkyo-Ku Tokyo, 113-8, Japan
Osaka , 545-8, Japan
Seongnam-si Gyeonggi-do, 13620, Korea, Republic of
Seoul Gyeonggi-do, 03080, Korea, Republic of
Daegu Gyeongsangbuk-do, 41944, Korea, Republic of
Daegu Gyeongsangbuk-do, 42601, Korea, Republic of
Busan Gyeongsangnam-do, 49241, Korea, Republic of
Daegu , 42472, Korea, Republic of
Daejeon , 35015, Korea, Republic of
Seoul , 02841, Korea, Republic of
Seoul , 03722, Korea, Republic of
Seoul , 06351, Korea, Republic of
Seoul , 06591, Korea, Republic of
Monterrey Nuevo LEON, 64460, Mexico
Oslo , 0372, Norway
Gdansk Pomorskie, 80-21, Poland
Lisboa , 1099-, Portugal
Lisboa , 1649-, Portugal
Porto , 4200-, Portugal
Târgu-Mureş Mures, 54004, Romania
Bucuresti , 02232, Romania
Ekaterinburg Sverdlovsk, 62010, Russian Federation
Moscow , 12516, Russian Federation
Singapore , 11922, Singapore
Singapore , 16960, Singapore
Singapore , 18877, Singapore
Badalona Barcelona, 08916, Spain
Las Palmas De Gran Canaria LAS Palmas, 35010, Spain
Pamplona Navarra, 31008, Spain
Madrid , 28034, Spain
Madrid , 28040, Spain
Murcia , 30008, Spain
Murcia , 30120, Spain
Salamanca , 37007, Spain
Sevilla , 41013, Spain
Valencia , 46010, Spain
Lund Skane, 221 8, Sweden
Stockholm , 141 8, Sweden
Basel , 4031, Switzerland
Zurich , 8091, Switzerland
Hualien City Hualien, 970, Taiwan
Kaohsiung , 807, Taiwan
Taichung , 404, Taiwan
Taichung , 40705, Taiwan
Taipei , 100, Taiwan
Taipei , 11259, Taiwan
Taoyuan , 333, Taiwan
Liverpool England, L7 8X, United Kingdom
London England, EC1M , United Kingdom
London England, W12 0, United Kingdom
Sheffield England, S10 2, United Kingdom
Cardiff Wales, CF14 , United Kingdom
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