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.

View Full Description

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.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Must be greater than or equal to (>=) 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 less than (<) 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).

Study is for people with:

Myeloproliferative Neoplasms

Phase:

Phase 3

Estimated Enrollment:

343

Study ID:

NCT03657160

Recruitment Status:

Completed

Sponsor:

Millennium Pharmaceuticals, Inc.

Check Your Eligibility

Let’s see if you might be eligible for this study.

What is your age and gender ?

Submit

There are 135 Locations for this study

See Locations Near You

University of Alabama at Birmingham Comprehensive Cancer Center
Birmingham Alabama, 35294, United States
David Geffen School of Medicine at University of California Los Angeles
Los Angeles California, 90095, United States
Children's Healthcare of Atlanta
Atlanta Georgia, 30322, United States
Emory University - Winship Cancer Institute
Atlanta Georgia, 30322, United States
Augusta University Georgia Cancer Center
Augusta Georgia, 30912, United States
Robert H. Lurie Comprehensive Cancer Center of Northwestern University
Chicago Illinois, 60611, United States
Loyola University Medical Center
Maywood Illinois, 60153, United States
Indiana University Melvin and Bren Simon Cancer Center
Indianapolis Indiana, 46202, United States
University of Kentucky Chandler Medical Center
Lexington Kentucky, 40536, United States
Marlene and Stewart Greenebaum Cancer Center
Baltimore Maryland, 21201, United States
Massachusetts General Hospital
Boston Massachusetts, 02114, United States
Beth Israel Deaconess Medical Center
Boston Massachusetts, 02215, United States
Boston Children's Hospital
Boston Massachusetts, 02215, United States
Dana Farber Cancer Institute
Boston Massachusetts, 02215, United States
Barbara Ann Karmanos Cancer Institute
Detroit Michigan, 48201, United States
Mayo Clinic - Rochester
Rochester Minnesota, 55905, United States
Roswell Park Cancer Institute
Buffalo New York, 14263, United States
Roswell Park Comprehensive Cancer Center
Buffalo New York, 14263, United States
Cohen Children's Medical Center
New Hyde Park New York, 11040, United States
Weill Cornell Medical College
New York New York, 10021, United States
Columbia University Medical Center - The Columbia Center for Translational Immunology
New York New York, 10032, United States
University of North Carolina Hospitals
Chapel Hill North Carolina, 27514, United States
Oregon Health and Science University
Portland Oregon, 97239, United States
Medical University of South Carolina
Charleston South Carolina, 29425, United States
Texas Oncology - Baylor Charles A. Sammons Cancer Center
Dallas Texas, 75246, United States
University of Virginia Health System
Charlottesville Virginia, 22908, United States
Massey Cancer Center
Richmond Virginia, 23298, United States
Fundacion Favaloro Hospital Universitario
Ciudad Autonoma de Buenos Aires Buenos Aires, C1093, Argentina
Hospital Italiano de Buenos Aires
Ciudad Autonoma de Buenos Aires , C1199, Argentina
Hospital Privado Centro Medico de Cordoba
Cordoba , X5014, Argentina
Saint Vincent's Hospital Sydney
Darlinghurst New South Wales, 2010, Australia
Royal Brisbane and Women's Hospital
Herston Queensland, 4006, Australia
Austin Health
Heidelberg Victoria, 3084, Australia
The Royal Melbourne Hospital
Parkville Victoria, 3050, Australia
Fiona Stanley Hospital
Murdoch Western Australia, 6150, Australia
Ordensklinikum Linz Elisabethinen
Linz Upper Austria, 4020, Austria
Universitair Ziekenhuis Leuven
Leuven Flemish Brabant, 3000, Belgium
Ziekenhuisnetwerk Stuivenberg
Antwerpen , 2060, Belgium
Hospital Universitario Walter Cantidio - Universidade Federal do Ceara
Fortaleza Ceara, 60430, Brazil
Instituto do Cancer e Transplante de Curitiba
Curitiba Parana, 80510, Brazil
Hospital de Cancer de Barretos
Barretos SAO Paulo, 14784, Brazil
Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo
Sao Paulo , 01246, Brazil
Fundacao Antonio Prudente - A.C.Camargo Cancer Center
Sao Paulo , 01509, Brazil
Instituto Brasileiro de Controle do Cancer - Sao Camilo Oncolgia
Sao Paulo , 03102, Brazil
Hospital Santa Marcelina
Sao Paulo , 08270, Brazil
CancerCare Manitoba
Winnipeg Manitoba, R3E 0, Canada
Saskatchewan Cancer Agency
Saskatoon Saskatchewan, S7N 4, Canada
Hopital Pontchaillou
Rennes Cedex 9 Bretagne, 35033, France
Hopital Saint Louis
Paris Cedex 10 Ile-de-france, 75475, France
Hopital Saint-Antoine
Paris Ile-de-france, 75012, France
Groupe Hospitalier Pitie-Salpetriere
Paris Ile-de-france, 75013, France
Hopital Necker-Enfants Malades
Paris Ile-de-france, 75473, France
Centre Hospitalier Universitaire de Limoges
Limoges Cedex Limousin, Lorraine, 87042, France
Centre Hospitalier Universitaire Nantes - Hotel Dieu
Nantes Cedex 1 PAYS DE LA Loire, 44093, France
Centre Hospitalier Universitaire Amiens-Picardie
Amiens Picardie, 80054, France
Universitatsmedizin Mannheim
Mannheim Baden-wuerttemberg, 68167, Germany
Diakonie-Klinikum Stuttgart
Stuttgart Baden-wuerttemberg, 70176, Germany
Universitatsklinikum Frankfurt
Frankfurt am Main Hessen, 60590, Germany
Universitatsmedizin der Johannes Gutenberg Universitat Mainz
Mainz Rheinland-pfalz, 55131, Germany
Universitatsklinikum Halle
Halle Sachsen-anhalt, 06120, Germany
Universitatsklinikum Carl Gustav Carus Dresden
Dresden Sachsen, 01307, Germany
Universitaetsklinikum Schleswig-Holstein - Campus Kiel
Kiel Schleswig-holstein, 24105, Germany
University General Hospital of Athens Attikon
Athens Attica, 12462, Greece
University Regional General Hospital of Patras
Patras Peloponnese, 26504, Greece
Debreceni Egyetem Klinikai Kozpont
Debrecen Hajdu-bihar, 4032, Hungary
Soroka University Medical Center
Beer Sheva Beersheba, 84101, Israel
Rambam Health Care Campus - Rambam Medical Center
Haifa , 31096, Israel
Hadassah Medical Center
Jerusalem , 91120, Israel
The Chaim Sheba Medical Center
Ramat Gan , 52656, Israel
Tel Aviv Sourasky Medical Center
Tel Aviv , 64239, Israel
Azienda Grande Ospedale Metropolitano Bianchi Melacrino Morelli
Reggio Calabria Calabria, 89122, Italy
Azienda Ospedaliera Cardinale G. Panico
Tricase Lecce, 73039, Italy
Ospedale Mazzoni
Ascoli Piceno Marche, 63100, Italy
Ospedale dell'Angelo
Mestre Venezia, 30174, Italy
Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona
Ancona , 60126, Italy
Azienda Ospedaliera Policlinico di Bari
Bari , 70124, Italy
Policlinico Universitario di Catania
Catania , 95124, Italy
Istituto Clinico Humanitas Humanitas Cancer Center
Milano , 20089, Italy
Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda
Milano , 20162, Italy
Presidio Ospedaliero di Pescara
Pescara , 65125, Italy
Japanese Red Cross Aichi Medical Center Nagoya Daiichi Hospital
Nagoya Aichi, 453-8, Japan
Kyushu University Hospital
Fukuoka-shi Fukuoka, 812-8, Japan
Hiroshima Red Cross Hospital and Atomic-bomb Survivors Hospital
Hiroshima-shi Hiroshima, 730-8, Japan
Hokkaido University Hospital
Sapporo-shi Hokkaido, 060-8, Japan
Okayama University Hospital
Okayama-city Okayama, 700-8, Japan
Shizuoka Cancer Center
Nagaizumi Shizuoka, 411-8, Japan
Jichi Medical University Hospital
Shimotsuke-city Tochigi, 329-0, Japan
Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital
Bunkyo-Ku Tokyo, 113-8, Japan
Osaka City University Hospital
Osaka , 545-8, Japan
Seoul National University Bundang Hospital
Seongnam-si Gyeonggi-do, 13620, Korea, Republic of
Seoul National University Hospital
Seoul Gyeonggi-do, 03080, Korea, Republic of
Kyungpook National University Hospital
Daegu Gyeongsangbuk-do, 41944, Korea, Republic of
Keimyung University Dongsan Hospital
Daegu Gyeongsangbuk-do, 42601, Korea, Republic of
Pusan National University Hospital
Busan Gyeongsangnam-do, 49241, Korea, Republic of
Daegu Catholic University Medical Center
Daegu , 42472, Korea, Republic of
Chungnam National University Hospital
Daejeon , 35015, Korea, Republic of
Korea University Anam Hospital
Seoul , 02841, Korea, Republic of
Severance Hospital
Seoul , 03722, Korea, Republic of
Samsung Medical Center
Seoul , 06351, Korea, Republic of
The Catholic University of Korea - Seoul St. Mary's Hospital
Seoul , 06591, Korea, Republic of
Hospital Universitario "Dr. Jose Eleuterio Gonzalez"
Monterrey Nuevo LEON, 64460, Mexico
Oslo University Hospital - Rikshospitalet
Oslo , 0372, Norway
Uniwersyteckie Centrum Kliniczne
Gdansk Pomorskie, 80-21, Poland
Instituto Portugues de Oncologia de Lisboa Francisco Gentil
Lisboa , 1099-, Portugal
Centro Hospitalar de Lisboa Norte EPE- Hospital Santa Maria
Lisboa , 1649-, Portugal
Instituto Portugues de Oncologia do Porto Francisco Gentil
Porto , 4200-, Portugal
Spitalul Clinic Judetean de Urgenta Targu Mure
Târgu-Mureş Mures, 54004, Romania
Institutul Clinic Fundeni
Bucuresti , 02232, Romania
Sverdlovsk Regional Clinical Hospital #1
Ekaterinburg Sverdlovsk, 62010, Russian Federation
National Research Center for Hematology
Moscow , 12516, Russian Federation
National University Hospital
Singapore , 11922, Singapore
Singapore General Hospital
Singapore , 16960, Singapore
Raffles Hospital
Singapore , 18877, Singapore
Hospital Universitari Germans Trias i Pujol
Badalona Barcelona, 08916, Spain
Hospital Universitario de Gran Canaria Doctor Negrin
Las Palmas De Gran Canaria LAS Palmas, 35010, Spain
Clinica Universidad de Navarra
Pamplona Navarra, 31008, Spain
Hospital Universitario Ramon Y Cajal
Madrid , 28034, Spain
Hospital Universitario Fundacion Jimenez Diaz
Madrid , 28040, Spain
Hospital General Universitario Morales Meseguer
Murcia , 30008, Spain
Hospital Universitario Virgen de la Arrixaca
Murcia , 30120, Spain
Hospital Universitario de Salamanca
Salamanca , 37007, Spain
Hospital Universitario Virgen del Rocio
Sevilla , 41013, Spain
Hospital Clinico Universitario de Valencia
Valencia , 46010, Spain
Skanes Universitetssjukhus i Lund
Lund Skane, 221 8, Sweden
Karolinska Universitetssjukhuset
Stockholm , 141 8, Sweden
Universitatsspital Basel
Basel , 4031, Switzerland
Universitatsspital Zurich
Zurich , 8091, Switzerland
Buddhist Tzu Chi General Hospital
Hualien City Hualien, 970, Taiwan
Kaohsiung Medical University Hospital
Kaohsiung , 807, Taiwan
China Medical University Hospital
Taichung , 404, Taiwan
Taichung Veterans General Hospital
Taichung , 40705, Taiwan
National Taiwan University Hospital
Taipei , 100, Taiwan
Koo Foundation Sun Yat-Sen Cancer Center
Taipei , 11259, Taiwan
Chang Gung Memorial Hospital
Taoyuan , 333, Taiwan
The Clatterbridge Cancer Centre NHS Foundation Trust
Liverpool England, L7 8X, United Kingdom
Barts Health NHS Trust
London England, EC1M , United Kingdom
Imperial College Healthcare NHS Trust
London England, W12 0, United Kingdom
Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield England, S10 2, United Kingdom
Cardiff and Vale University Health Board
Cardiff Wales, CF14 , United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Myeloproliferative Neoplasms

Phase:

Phase 3

Estimated Enrollment:

343

Study ID:

NCT03657160

Recruitment Status:

Completed

Sponsor:


Millennium Pharmaceuticals, Inc.

How clear is this clinincal trial information?

×

Introducing, the Journey Bar

Use this bar to access information about the steps in your cancer journey.