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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT03657160
Registration number
NCT03657160
Ethics application status
Date submitted
30/08/2018
Date registered
4/09/2018
Date last updated
6/06/2023
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
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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
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Secondary ID [1]
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2018-002141-11
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Secondary ID [2]
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Vedolizumab-3035
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Hematopoietic Stem Cells
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Condition category
Condition code
Inflammatory and Immune System
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Other inflammatory or immune system disorders
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Intestinal aGvHD-Free Survival After Allo-HSCT by +180 Days
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Assessment method [1]
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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.
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Timepoint [1]
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From the date of first dose of study drug to first documented intestinal aGvHD or death, whichever occurs first up to +180 days
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Secondary outcome [1]
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Intestinal aGvHD-Free and Relapse-Free Survival
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Assessment method [1]
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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.
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Timepoint [1]
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From the date of first dose of study drug to first documented intestinal aGvHD, death or relapse, whichever occurs first up to Day +180
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Secondary outcome [2]
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Grade C-D aGvHD-Free Survival
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Assessment method [2]
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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.
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Timepoint [2]
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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
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Secondary outcome [3]
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Nonrelapse Mortality (NRM)
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Assessment method [3]
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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.
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Timepoint [3]
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From the date of first dose of study drug to first documented death without relapse, up to Day +180
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Secondary outcome [4]
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Overall Survival (OS)
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Assessment method [4]
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Overall Survival by Days +180 is the time from the date of first study drug administration (Day-1) to death from any cause.
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Timepoint [4]
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From the date of first dose of study drug to first documented death up to Day +180
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Secondary outcome [5]
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Grade B-D aGvHD-Free Survival
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Assessment method [5]
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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.
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Timepoint [5]
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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
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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.
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Minimum age
12
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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).
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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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
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
6/02/2019
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
9/05/2022
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Sample size
Target
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Accrual to date
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Final
343
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
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Recruitment hospital [1]
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Saint Vincent's Hospital Sydney - Darlinghurst
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Royal Brisbane and Women's Hospital - Herston
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Austin Health - Heidelberg
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The Royal Melbourne Hospital - Parkville
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Fiona Stanley Hospital - Murdoch
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2010 - Darlinghurst
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4006 - Herston
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3084 - Heidelberg
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3050 - Parkville
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6150 - Murdoch
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Recruitment outside Australia
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Millennium Pharmaceuticals, Inc.
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Address
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Ethics approval
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Summary
Brief 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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT03657160
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Public notes
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Contacts
Principal investigator
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Medical Director
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Takeda
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT03657160
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