AzTrials
AzTrials

Hematopoietic Stem CellsPhase 3NCT03657160

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

A Phase 3 study testing Vedolizumab in people with Hematopoietic Stem Cells, run by Millennium Pharmaceuticals, Inc. at 139 sites in 27 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 12 years and older
Conditions the study is for
Hematopoietic Stem Cells
What is being tested?
Vedolizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
343 participants
Where
139 sitesin 27 countries
Study dates
6 Feb 2019to 9 May 2022
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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).

Trial locations and contacts

139 sites in 27 countries.

139 sites in 27 countries

United States27 sites

  • Children's Healthcare of Atlanta

    Atlanta, Georgia, 30322

  • Emory University - Winship Cancer Institute

    Atlanta, Georgia, 30322

  • Augusta University Georgia Cancer Center

    Augusta, Georgia, 30912

  • Marlene and Stewart Greenebaum Cancer Center

    Baltimore, Maryland, 21201

  • University of Alabama at Birmingham Comprehensive Cancer Center

    Birmingham, Alabama, 35294

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

  • Boston Children's Hospital

    Boston, Massachusetts, 02215

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02215

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263

  • Roswell Park Comprehensive Cancer Center

    Buffalo, New York, 14263

  • University of North Carolina Hospitals

    Chapel Hill, North Carolina, 27514

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

  • University of Virginia Health System

    Charlottesville, Virginia, 22908

  • Robert H. Lurie Comprehensive Cancer Center of Northwestern University

    Chicago, Illinois, 60611

  • Texas Oncology - Baylor Charles A. Sammons Cancer Center

    Dallas, Texas, 75246

  • Barbara Ann Karmanos Cancer Institute

    Detroit, Michigan, 48201

  • Indiana University Melvin and Bren Simon Cancer Center

    Indianapolis, Indiana, 46202

  • University of Kentucky Chandler Medical Center

    Lexington, Kentucky, 40536

  • David Geffen School of Medicine at University of California Los Angeles

    Los Angeles, California, 90095

  • Loyola University Medical Center

    Maywood, Illinois, 60153

  • Cohen Children's Medical Center

    New Hyde Park, New York, 11040

  • Weill Cornell Medical College

    New York, New York, 10021

  • Columbia University Medical Center - The Columbia Center for Translational Immunology

    New York, New York, 10032

  • Oregon Health and Science University

    Portland, Oregon, 97239

  • Massey Cancer Center

    Richmond, Virginia, 23298

  • Mayo Clinic - Rochester

    Rochester, Minnesota, 55905

Other trials in United States

South Korea11 sites

  • Kyungpook National University Hospital

    Daegu, Gyeongsangbuk-do, 41944

  • Keimyung University Dongsan Hospital

    Daegu, Gyeongsangbuk-do, 42601

  • Daegu Catholic University Medical Center

    Daegu, 42472

  • Chungnam National University Hospital

    Daejeon, 35015

  • Pusan National University Hospital

    Pusan, Gyeongsangnam-do, 49241

  • Seoul National University Bundang Hospital

    Seongnam-si, Gyeonggi-do, 13620

  • Seoul National University Hospital

    Seoul, Gyeonggi-do, 03080

  • Korea University Anam Hospital

    Seoul, 02841

  • Severance Hospital

    Seoul, 03722

  • Samsung Medical Center

    Seoul, 06351

  • The Catholic University of Korea - Seoul St. Mary's Hospital

    Seoul, 06591

Other trials in South Korea

Italy10 sites

  • Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona

    Ancona, 60126

  • Ospedale Mazzoni

    Ascoli Piceno, The Marches, 63100

  • Azienda Ospedaliera Policlinico di Bari

    Bari, 70124

  • Policlinico Universitario di Catania

    Catania, 95124

  • Ospedale dell'Angelo

    Mestre, Venezia, 30174

  • Istituto Clinico Humanitas Humanitas Cancer Center

    Milan, 20089'

  • Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda

    Milan, 20162

  • Presidio Ospedaliero di Pescara

    Pescara, 65125

  • Azienda Grande Ospedale Metropolitano Bianchi Melacrino Morelli

    Reggio Calabria, Calabria, 89122

  • Azienda Ospedaliera Cardinale G. Panico

    Tricase, Lecce, 73039

Other trials in Italy

Spain10 sites

  • Hospital Universitari Germans Trias i Pujol

    Badalona, Barcelona, 08916

  • Hospital Universitario de Gran Canaria Doctor Negrin

    Las Palmas de Gran Canaria, LAS Palmas, 35010

  • Hospital Universitario Ramon Y Cajal

    Madrid, 28034

  • Hospital Universitario Fundacion Jimenez Diaz

    Madrid, 28040

  • Hospital General Universitario Morales Meseguer

    Murcia, 30008

  • Hospital Universitario Virgen de la Arrixaca

    Murcia, 30120

  • Clinica Universidad de Navarra

    Pamplona, Navarre, 31008

  • Hospital Universitario de Salamanca

    Salamanca, 37007

  • Hospital Universitario Virgen del Rocio

    Seville, 41013

  • Hospital Clinico Universitario de Valencia

    Valencia, 46010

Other trials in Spain

Japan9 sites

  • Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital

    Bunkyo-Ku, Tokyo, 113-8677

  • Kyushu University Hospital

    Fukuoka, Fukuoka, 812-8582

  • Hiroshima Red Cross Hospital and Atomic-bomb Survivors Hospital

    Hiroshima, Hiroshima, 730-8619

  • Japanese Red Cross Aichi Medical Center Nagoya Daiichi Hospital

    Nagoya, Aichi-ken, 453-8511

  • Shizuoka Cancer Center

    Nakatogari, Shizuoka, 411-8777

  • Okayama University Hospital

    Okayama, Okayama-ken, 700-8558

  • Osaka City University Hospital

    Osaka, 545-8586

  • Hokkaido University Hospital

    Sapporo, Hokkaido, 060-8648

  • Jichi Medical University Hospital

    Shimotsuke, Tochigi, 329-0498

Other trials in Japan

France8 sites

  • Centre Hospitalier Universitaire Amiens-Picardie

    Amiens, Picardie, 80054 CEDEX 1

  • Centre Hospitalier Universitaire de Limoges

    Limoges, Limousin, Lorraine, 87042

  • Centre Hospitalier Universitaire Nantes - Hotel Dieu

    Nantes, Pays de la Loire Region, 44093

  • Hopital Saint-Antoine

    Paris, Île-de-France Region, 75012

  • Groupe Hospitalier Pitie-Salpetriere

    Paris, Île-de-France Region, 75013

  • Hopital Necker-Enfants Malades

    Paris, Île-de-France Region, 75473 cedex 15

  • Hopital Saint Louis

    Paris, Île-de-France Region, 75475

  • Hopital Pontchaillou

    Rennes, Brittany Region, 35033

Other trials in France

Brazil7 sites

  • Hospital de Cancer de Barretos

    Barretos, São Paulo, 14784-400

  • Instituto do Cancer e Transplante de Curitiba

    Curitiba, Paraná, 80510-130

  • Hospital Universitario Walter Cantidio - Universidade Federal do Ceara

    Fortaleza, Ceará, 60430-380

  • Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo

    São Paulo, 01246-000

  • Fundacao Antonio Prudente - A.C.Camargo Cancer Center

    São Paulo, 01509-010

  • Instituto Brasileiro de Controle do Cancer - Sao Camilo Oncolgia

    São Paulo, 03102-006

  • Hospital Santa Marcelina

    São Paulo, 08270-070

Other trials in Brazil

Germany7 sites

  • Universitatsklinikum Carl Gustav Carus Dresden

    Dresden, Saxony, 01307

  • Universitatsklinikum Frankfurt

    Frankfurt am Main, Hesse, 60590

  • Universitatsklinikum Halle

    Halle, Saxony-Anhalt, 06120

  • Universitaetsklinikum Schleswig-Holstein - Campus Kiel

    Kiel, Schleswig-Holstein, 24105

  • Universitatsmedizin der Johannes Gutenberg Universitat Mainz

    Mainz, Rhineland-Palatinate, 55131

  • Universitatsmedizin Mannheim

    Mannheim, Baden-Wurttemberg, 68167

  • Diakonie-Klinikum Stuttgart

    Stuttgart, Baden-Wurttemberg, 70176

Other trials in Germany

Taiwan7 sites

  • Buddhist Tzu Chi General Hospital

    Hualien City, Hualien, 970

  • Kaohsiung Medical University Hospital

    Kaohsiung City, 807

  • China Medical University Hospital

    Taichung, 404

  • Taichung Veterans General Hospital

    Taichung, 40705

  • National Taiwan University Hospital

    Taipei, 100

  • Koo Foundation Sun Yat-Sen Cancer Center

    Taipei, 11259

  • Chang Gung Memorial Hospital

    Taoyuan, 333

Other trials in Taiwan

Australia5 sites

  • Saint Vincent's Hospital Sydney

    Darlinghurst, New South Wales, 2010

  • Austin Health

    Heidelberg, Victoria, 3084

  • Royal Brisbane and Women's Hospital

    Herston, Queensland, 4006

  • Fiona Stanley Hospital

    Murdoch, Western Australia, 6150

  • The Royal Melbourne Hospital

    Parkville, Victoria, 3050

Other trials in Australia

Israel5 sites

  • Soroka University Medical Center

    Beersheba, Beersheba, 84101

  • Rambam Health Care Campus - Rambam Medical Center

    Haifa, 3109601

  • Hadassah Medical Center

    Jerusalem, 9112001

  • The Chaim Sheba Medical Center

    Ramat Gan, 5265601

  • Tel Aviv Sourasky Medical Center

    Tel Aviv, 6423906

Other trials in Israel

United Kingdom5 sites

  • Cardiff and Vale University Health Board

    Cardiff, Wales, CF14 4XW

  • The Clatterbridge Cancer Centre NHS Foundation Trust

    Liverpool, England, L7 8XP

  • Barts Health NHS Trust

    London, England, EC1M 6BQ

  • Imperial College Healthcare NHS Trust

    London, England, W12 0HS

  • Sheffield Teaching Hospitals NHS Foundation Trust

    Sheffield, England, S10 2JF

Other trials in United Kingdom

Argentina3 sites

  • Hospital Italiano de Buenos Aires

    Buenos Aires, C1199ABB

  • Fundacion Favaloro Hospital Universitario

    Ciudad Autonoma de Buenos Aires, Buenos Aires, C1093AAS

  • Hospital Privado Centro Medico de Cordoba

    Córdoba, X5014KEH

Other trials in Argentina

Portugal3 sites

  • Instituto Portugues de Oncologia de Lisboa Francisco Gentil

    Lisbon, 1099-023

  • Centro Hospitalar de Lisboa Norte EPE- Hospital Santa Maria

    Lisbon, 1649-035

  • Instituto Portugues de Oncologia do Porto Francisco Gentil

    Porto, 4200-072

Other trials in Portugal

Singapore3 sites

  • National University Hospital

    Singapore, 119228

  • Singapore General Hospital

    Singapore, 169608

  • Raffles Hospital

    Singapore, 188770

Other trials in Singapore

Belgium2 sites

  • Ziekenhuisnetwerk Stuivenberg

    Antwerp, 2060

  • Universitair Ziekenhuis Leuven

    Leuven, Flemish Brabant, 3000

Other trials in Belgium

Canada2 sites

  • Saskatchewan Cancer Agency

    Saskatoon, Saskatchewan, S7N 4H4

  • CancerCare Manitoba

    Winnipeg, Manitoba, R3E 0V9

Other trials in Canada

Greece2 sites

  • University General Hospital of Athens Attikon

    Athens, Attica, 12462

  • University Regional General Hospital of Patras

    Patras, Peloponnese, 26504

Other trials in Greece

Romania2 sites

  • Institutul Clinic Fundeni

    Bucharest, 022328

  • Spitalul Clinic Judetean de Urgenta Targu Mure

    Târgu Mureş, Mureș County, 540042

Other trials in Romania

Russia2 sites

  • National Research Center for Hematology

    Moscow, 125167

  • Sverdlovsk Regional Clinical Hospital #1

    Yekaterinburg, Sverdlovsk Oblast, 620102

Other trials in Russia

Sweden2 sites

  • Skanes Universitetssjukhus i Lund

    Lund, Skåne County, 221 85

  • Karolinska Universitetssjukhuset

    Stockholm, 141 86

Other trials in Sweden

Switzerland2 sites

  • Universitatsspital Basel

    Basel, 4031

  • Universitatsspital Zurich

    Zurich, 8091

Other trials in Switzerland

Austria1 site

  • Ordensklinikum Linz Elisabethinen

    Linz, Upper Austria, 4020

Other trials in Austria

Hungary1 site

  • Debreceni Egyetem Klinikai Kozpont

    Debrecen, Hajdú-Bihar, 4032

Other trials in Hungary

Mexico1 site

  • Hospital Universitario "Dr. Jose Eleuterio Gonzalez"

    Monterrey, Nuevo León, 64460

Other trials in Mexico

Norway1 site

  • Oslo University Hospital - Rikshospitalet

    Oslo, 0372

Other trials in Norway

Poland1 site

  • Uniwersyteckie Centrum Kliniczne

    Gdansk, Pomeranian Voivodeship, 80-214

Other trials in Poland

About this study

Official title: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Vedolizumab in the Prophylaxis of Intestinal Acute Graft Versus-Host Disease in Subjects Undergoing Allogeneic Hematopoietic Stem Cell Transplantation

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.

Read the detailed 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.

Being tested
Vedolizumab Placebo, Vedolizumab
Keywords
Drug Therapy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Vedolizumab PlaceboDrug

    Vedolizumab placebo-matching IV infusion.

  • VedolizumabDrug

    Also called MLN0002

    Vedolizumab IV infusion.

Study groups in NCT03657160
Study groupRoleWhat they receive
PlaceboPlacebo comparatorVedolizumab placebo-matching, intravenous (IV) infusion, once on Day -1 along with background graft-versus-host disease (GvHD) prophylaxis regimen prior to Allo-HSCT and once on Days +13, +41, +69, +97, +125, and +153 post Allo-HSCT up to the end of study treatment (up to 182 days).
Receives: Drug: Vedolizumab Placebo
Vedolizumab 300 mgExperimentalVedolizumab 300 mg, IV infusion, once on Day -1 along with background GvHD prophylaxis regimen prior to Allo-HSCT and once on Days +13, +41, +69, +97, +125, and +153 post Allo-HSCT up to the end of study treatment (up to 182 days).
Receives: Drug: Vedolizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Intestinal aGvHD-Free Survival After Allo-HSCT by +180 Days

    Intestinal aGvHD Free Survival is the time from the date of first study drug administration (Day-1) to intestinal aGvHD event/death, where an event is defined as death due to any cause or Stage 1-4 intestinal involvement per Acute Graft versus-Host Disease Clinical Stage criteria. Data was censored for participants who have not had the intestinal aGvHD event or died or have had the event after pre-specified timing, e.g., last contact or Day +180 after allo HSCT whichever occurs first.

    Measured: From the date of first dose of study drug to first documented intestinal aGvHD or death, whichever occurs first up to +180 days

Secondary outcomes (5)

  1. Intestinal aGvHD-Free and Relapse-Free Survival

    Intestinal aGvHD and Relapse Free Survival is the time from the date of first study drug administration (Day-1) to intestinal aGvHD event/death/relapse, where an event is defined as death or Stage 1-4 intestinal involvement per Acute Graft versus-Host Disease Clinical Stage criteria, or relapse. It will be censored for participants who have not had the event or have had the event after pre-specified timing, e.g., last contact or Day +180 after allo-HSCT whichever occurs first.

    Measured: From the date of first dose of study drug to first documented intestinal aGvHD, death or relapse, whichever occurs first up to Day +180

  2. Grade C-D aGvHD-Free Survival

    Grade C-D aGvHD Free Survival is the time from the date of first study drug administration (Day-1) to GvHD event/death, where an event is defined as Grade C-D aGvHD any organ involvement per International Bone Marrow Transplant Registry Database (IBMTR) Severity Index for aGvHD or death. It will be censored for participants who have not had the event or have had the event after pre-specified timing, eg, last contact or Day +180 after allo-HSCT whichever occurs first.

    Measured: From the date of first dose of study drug to first documented Grade C-D aGvHD or death, whichever occurs first up to Day +180

  3. Nonrelapse Mortality (NRM)

    Non-relapse mortality is the time from the date of first study drug administration (Day-1) to death without occurrence of a relapse. Data was censored for participants who have not had the event or have had the event after pre-specified timing, e.g., last contact or Day +180 after allo HSCT whichever occurs first.

    Measured: From the date of first dose of study drug to first documented death without relapse, up to Day +180

  4. Overall Survival (OS)

    Overall Survival by Days +180 is the time from the date of first study drug administration (Day-1) to death from any cause.

    Measured: From the date of first dose of study drug to first documented death up to Day +180

  5. Grade B-D aGvHD-Free Survival

    Grade B-D aGvHD Free Survival is the time from the date of first study drug administration (Day-1) to aGvHD event or death, where an event is defined as death or grade B-D any organ involvement per IBMTR Severity Index for aGvHD.

    Measured: From the date of first dose of study drug to first documented grade B-D aGvHD or death, whichever occurs first up to Day +180

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Sep 2018
  2. Study start6 Feb 2019
  3. Primary completion7 Feb 2022
  4. Study completion9 May 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
343 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03657160
Sponsor's protocol ID
Vedolizumab-3035
Other IDs
2018-002141-11, JapicCTI-184221, U1111-1216-2319, 2018
Status last verified
May 2023
First submitted
30 Aug 2018
Last updated
6 Jun 2023
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.

Publications

  • Chen YB, Mohty M, Zeiser R, Teshima T, Jamy O, Maertens J, Purtill D, Chen J, Cao H, Rossiter G, Jansson J, Floisand Y. Vedolizumab for the prevention of intestinal acute GVHD after allogeneic hematopoietic stem cell transplantation: a randomized phase 3 trial. Nat Med. 2024 Aug;30(8):2277-2287. doi: 10.1038/s41591-024-03016-4. Epub 2024 Jun 6.

    PubMed 38844797

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Vedolizumab in people with Hematopoietic Stem Cells, run by Millennium Pharmaceuticals, Inc. at 139 sites in 27 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 139 sites in United States, South Korea, Italy, Spain, Japan and 22 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 Apr 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Intestinal aGvHD-Free Survival After Allo-HSCT by +180 Days (time frame: From the date of first dose of study drug to first documented intestinal aGvHD or death, whichever occurs first up to +180 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03657160, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2023.

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