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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03657160




Registration number
NCT03657160
Ethics application status
Date submitted
30/08/2018
Date registered
4/09/2018

Titles & IDs
Public title
Vedolizumab in the Prophylaxis of Intestinal Acute Graft Versus Host Disease (aGVHD) in Participants Undergoing Allogeneic Hematopoietic Stem Cell (Allo-HSCT) Transplantation
Scientific 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
Secondary ID [1] 0 0
2018-002141-11
Secondary ID [2] 0 0
Vedolizumab-3035
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hematopoietic Stem Cells 0 0
Condition category
Condition code
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Vedolizumab Placebo
Treatment: Drugs - Vedolizumab

Placebo comparator: Placebo - Vedolizumab 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).

Experimental: Vedolizumab 300 mg - Vedolizumab 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).


Treatment: Drugs: Vedolizumab Placebo
Vedolizumab placebo-matching IV infusion.

Treatment: Drugs: Vedolizumab
Vedolizumab IV infusion.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Intestinal aGvHD-Free Survival After Allo-HSCT by +180 Days
Timepoint [1] 0 0
From the date of first dose of study drug to first documented intestinal aGvHD or death, whichever occurs first up to +180 days
Secondary outcome [1] 0 0
Intestinal aGvHD-Free and Relapse-Free Survival
Timepoint [1] 0 0
From the date of first dose of study drug to first documented intestinal aGvHD, death or relapse, whichever occurs first up to Day +180
Secondary outcome [2] 0 0
Grade C-D aGvHD-Free Survival
Timepoint [2] 0 0
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
Secondary outcome [3] 0 0
Nonrelapse Mortality (NRM)
Timepoint [3] 0 0
From the date of first dose of study drug to first documented death without relapse, up to Day +180
Secondary outcome [4] 0 0
Overall Survival (OS)
Timepoint [4] 0 0
From the date of first dose of study drug to first documented death up to Day +180
Secondary outcome [5] 0 0
Grade B-D aGvHD-Free Survival
Timepoint [5] 0 0
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

Eligibility
Key inclusion criteria
1. 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.
2. 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.
3. For whom a myeloablative conditioning or reduced intensity conditioning (RIC) is planned.
4. 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.
5. 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.
Minimum age
12 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Had prior allo- HSCT.
2. 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).
3. Planned allo-HSCT for nonmalignant hematological disorders (example, aplastic anemia, sickle cell anemia, thalassemias, Fanconi anemia or immunodeficiency).

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
6/02/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
9/05/2022
Sample size
Target
Accrual to date
Final
343
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
Recruitment hospital [1] 0 0
Saint Vincent's Hospital Sydney - Darlinghurst
Recruitment hospital [2] 0 0
Royal Brisbane and Women's Hospital - Herston
Recruitment hospital [3] 0 0
Austin Health - Heidelberg
Recruitment hospital [4] 0 0
The Royal Melbourne Hospital - Parkville
Recruitment hospital [5] 0 0
Fiona Stanley Hospital - Murdoch
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 0 0
4006 - Herston
Recruitment postcode(s) [3] 0 0
3084 - Heidelberg
Recruitment postcode(s) [4] 0 0
3050 - Parkville
Recruitment postcode(s) [5] 0 0
6150 - Murdoch
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Georgia
Country [4] 0 0
United States of America
State/province [4] 0 0
Illinois
Country [5] 0 0
United States of America
State/province [5] 0 0
Indiana
Country [6] 0 0
United States of America
State/province [6] 0 0
Kentucky
Country [7] 0 0
United States of America
State/province [7] 0 0
Maryland
Country [8] 0 0
United States of America
State/province [8] 0 0
Massachusetts
Country [9] 0 0
United States of America
State/province [9] 0 0
Michigan
Country [10] 0 0
United States of America
State/province [10] 0 0
Minnesota
Country [11] 0 0
United States of America
State/province [11] 0 0
New York
Country [12] 0 0
United States of America
State/province [12] 0 0
North Carolina
Country [13] 0 0
United States of America
State/province [13] 0 0
Oregon
Country [14] 0 0
United States of America
State/province [14] 0 0
South Carolina
Country [15] 0 0
United States of America
State/province [15] 0 0
Texas
Country [16] 0 0
United States of America
State/province [16] 0 0
Virginia
Country [17] 0 0
Argentina
State/province [17] 0 0
Buenos Aires
Country [18] 0 0
Argentina
State/province [18] 0 0
Ciudad Autonoma de Buenos Aires
Country [19] 0 0
Argentina
State/province [19] 0 0
Cordoba
Country [20] 0 0
Austria
State/province [20] 0 0
Upper Austria
Country [21] 0 0
Belgium
State/province [21] 0 0
Flemish Brabant
Country [22] 0 0
Belgium
State/province [22] 0 0
Antwerpen
Country [23] 0 0
Brazil
State/province [23] 0 0
Ceara
Country [24] 0 0
Brazil
State/province [24] 0 0
Parana
Country [25] 0 0
Brazil
State/province [25] 0 0
SAO Paulo
Country [26] 0 0
Brazil
State/province [26] 0 0
Sao Paulo
Country [27] 0 0
Canada
State/province [27] 0 0
Manitoba
Country [28] 0 0
Canada
State/province [28] 0 0
Saskatchewan
Country [29] 0 0
France
State/province [29] 0 0
Bretagne
Country [30] 0 0
France
State/province [30] 0 0
Ile-de-france
Country [31] 0 0
France
State/province [31] 0 0
Limousin, Lorraine
Country [32] 0 0
France
State/province [32] 0 0
PAYS DE LA Loire
Country [33] 0 0
France
State/province [33] 0 0
Picardie
Country [34] 0 0
Germany
State/province [34] 0 0
Baden-wuerttemberg
Country [35] 0 0
Germany
State/province [35] 0 0
Hessen
Country [36] 0 0
Germany
State/province [36] 0 0
Rheinland-pfalz
Country [37] 0 0
Germany
State/province [37] 0 0
Sachsen-anhalt
Country [38] 0 0
Germany
State/province [38] 0 0
Sachsen
Country [39] 0 0
Germany
State/province [39] 0 0
Schleswig-holstein
Country [40] 0 0
Greece
State/province [40] 0 0
Attica
Country [41] 0 0
Greece
State/province [41] 0 0
Peloponnese
Country [42] 0 0
Hungary
State/province [42] 0 0
Hajdu-bihar
Country [43] 0 0
Israel
State/province [43] 0 0
Beersheba
Country [44] 0 0
Israel
State/province [44] 0 0
Haifa
Country [45] 0 0
Israel
State/province [45] 0 0
Jerusalem
Country [46] 0 0
Israel
State/province [46] 0 0
Ramat Gan
Country [47] 0 0
Israel
State/province [47] 0 0
Tel Aviv
Country [48] 0 0
Italy
State/province [48] 0 0
Calabria
Country [49] 0 0
Italy
State/province [49] 0 0
Lecce
Country [50] 0 0
Italy
State/province [50] 0 0
Marche
Country [51] 0 0
Italy
State/province [51] 0 0
Venezia
Country [52] 0 0
Italy
State/province [52] 0 0
Ancona
Country [53] 0 0
Italy
State/province [53] 0 0
Bari
Country [54] 0 0
Italy
State/province [54] 0 0
Catania
Country [55] 0 0
Italy
State/province [55] 0 0
Milano
Country [56] 0 0
Italy
State/province [56] 0 0
Pescara
Country [57] 0 0
Japan
State/province [57] 0 0
Aichi
Country [58] 0 0
Japan
State/province [58] 0 0
Fukuoka
Country [59] 0 0
Japan
State/province [59] 0 0
Hiroshima
Country [60] 0 0
Japan
State/province [60] 0 0
Hokkaido
Country [61] 0 0
Japan
State/province [61] 0 0
Okayama
Country [62] 0 0
Japan
State/province [62] 0 0
Shizuoka
Country [63] 0 0
Japan
State/province [63] 0 0
Tochigi
Country [64] 0 0
Japan
State/province [64] 0 0
Tokyo
Country [65] 0 0
Japan
State/province [65] 0 0
Osaka
Country [66] 0 0
Korea, Republic of
State/province [66] 0 0
Gyeonggi-do
Country [67] 0 0
Korea, Republic of
State/province [67] 0 0
Gyeongsangbuk-do
Country [68] 0 0
Korea, Republic of
State/province [68] 0 0
Gyeongsangnam-do
Country [69] 0 0
Korea, Republic of
State/province [69] 0 0
Daegu
Country [70] 0 0
Korea, Republic of
State/province [70] 0 0
Daejeon
Country [71] 0 0
Korea, Republic of
State/province [71] 0 0
Seoul
Country [72] 0 0
Mexico
State/province [72] 0 0
Nuevo LEON
Country [73] 0 0
Norway
State/province [73] 0 0
Oslo
Country [74] 0 0
Poland
State/province [74] 0 0
Pomorskie
Country [75] 0 0
Portugal
State/province [75] 0 0
Lisboa
Country [76] 0 0
Portugal
State/province [76] 0 0
Porto
Country [77] 0 0
Romania
State/province [77] 0 0
Mures
Country [78] 0 0
Romania
State/province [78] 0 0
Bucuresti
Country [79] 0 0
Russian Federation
State/province [79] 0 0
Sverdlovsk
Country [80] 0 0
Russian Federation
State/province [80] 0 0
Moscow
Country [81] 0 0
Singapore
State/province [81] 0 0
Singapore
Country [82] 0 0
Spain
State/province [82] 0 0
Barcelona
Country [83] 0 0
Spain
State/province [83] 0 0
LAS Palmas
Country [84] 0 0
Spain
State/province [84] 0 0
Navarra
Country [85] 0 0
Spain
State/province [85] 0 0
Madrid
Country [86] 0 0
Spain
State/province [86] 0 0
Murcia
Country [87] 0 0
Spain
State/province [87] 0 0
Salamanca
Country [88] 0 0
Spain
State/province [88] 0 0
Sevilla
Country [89] 0 0
Spain
State/province [89] 0 0
Valencia
Country [90] 0 0
Sweden
State/province [90] 0 0
Skane
Country [91] 0 0
Sweden
State/province [91] 0 0
Stockholm
Country [92] 0 0
Switzerland
State/province [92] 0 0
Basel
Country [93] 0 0
Switzerland
State/province [93] 0 0
Zurich
Country [94] 0 0
Taiwan
State/province [94] 0 0
Hualien
Country [95] 0 0
Taiwan
State/province [95] 0 0
Kaohsiung
Country [96] 0 0
Taiwan
State/province [96] 0 0
Taichung
Country [97] 0 0
Taiwan
State/province [97] 0 0
Taipei
Country [98] 0 0
Taiwan
State/province [98] 0 0
Taoyuan
Country [99] 0 0
United Kingdom
State/province [99] 0 0
England
Country [100] 0 0
United Kingdom
State/province [100] 0 0
Wales

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Millennium Pharmaceuticals, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Medical Director
Address 0 0
Takeda
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
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.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Informed consent form (ICF), Clinical study report (CSR)
When will data be available (start and end dates)?
Available to whom?
IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://vivli.org/ourmember/takeda/


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT03657160