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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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ClinicalTrials.gov Identifier: NCT03657160
Recruitment Status : Recruiting
First Posted : September 4, 2018
Last Update Posted : October 22, 2020
Sponsor:
Information provided by (Responsible Party):
Takeda ( Millennium Pharmaceuticals, Inc. )

Study Description
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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.

Condition or disease Intervention/treatment Phase
Hematopoietic Stem Cells Drug: Vedolizumab Drug: Vedolizumab Placebo Phase 3

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 558 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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
Actual Study Start Date : February 6, 2019
Estimated Primary Completion Date : December 27, 2021
Estimated Study Completion Date : June 26, 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Vedolizumab

Arms and Interventions
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Arm Intervention/treatment
Experimental: Vedolizumab 300 mg
Vedolizumab 300 milligram (mg), intravenous infusion, once on Days -1 (baseline), +13, +41, +69, +97, +125, and +153. Participants will receive background graft-versus-host disease (GvHD) prophylaxis regimen.
 Drug: Vedolizumab
Vedolizumab intravenous infusion.
Other Name: MLN0002
Placebo Comparator: Placebo
Vedolizumab placebo-matching, intravenous infusion, once on Days -1 (baseline), +13, +41, +69, +97, +125, and +153. Participants will receive background GvHD prophylaxis regimen.
 Drug: Vedolizumab Placebo
Vedolizumab placebo-matching intravenous infusion.


Outcome Measures
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Primary Outcome Measures :
  1. Intestinal aGvHD-Free Survival by Day +180 After Allo-HSCT [ Time Frame: From the date of first dose of study drug to first documented intestinal aGvHD or death, whichever occurs first (up to Day +180) ]
    Intestinal aGvHD-free survival is defined as the time from the date of first dose of study drug to first documented intestinal aGvHD per aGVHD Clinical Stage criteria or death due to any cause, whichever occurs first.


Secondary Outcome Measures :
  1. Intestinal aGvHD-Free and Relapse-Free Survival by Day +180 [ Time Frame: From the date of first dose of study drug to first documented intestinal aGvHD criteria, relapse or death, whichever occurs first (up to Day +180) ]
    Intestinal aGvHD-free and relapse-free survival is defined as the time from the date of first dose of study drug to first documented intestinal aGvHD per aGVHD Clinical Stage criteria, relapse or death due to any cause, whichever occurs first.

  2. Grade C-D aGvHD-Free Survival by Day +180 [ Time Frame: 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) ]
    Grade C-D aGvHD-free survival is defined as the time from the date of first dose of study drug to first documented Grade C-D aGvHD per international bone marrow transplant registry database (IBMTR) severity index or death due to any cause, whichever occurs first.

  3. Nonrelapse Mortality (NRM) by Day +180 [ Time Frame: From the date of first dose of study drug to the date of death without occurrence of a relapse (up to Day +180) ]
    NRM is defined as death not attributable to disease recurrence and will be assessed from the date of first dose of study drug to the date of death without occurrence of a relapse.

  4. Overall Survival (OS) by Day +180 [ Time Frame: From the date of the date of first dose of study drug to the date of death (up to Day +180) ]
    OS is defined as the time from the date of the date of first dose of study drug to the date of death, due to any cause.

  5. Grade B-D aGvHD-Free Survival by Day +180 [ Time Frame: From the date of first dose of study drug to first documented Grade B-D or death, whichever occurs first (up to Day +180) ]
    Grade B-D aGvHD-free survival is defined as the time from the date of first dose of study drug to first documented Grade B-D aGvHD per IBMTR severity index or death due to any cause, whichever occurs first.


Eligibility Criteria
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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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.
  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 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:

  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).
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03657160


Contacts
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Contact: Takeda Study Registration Call Center +1-877-825-3327 medinfoUS@takeda.com

Locations
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Sponsors and Collaborators
Millennium Pharmaceuticals, Inc.
Investigators
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Study Director: Medical Director Clinical Science Takeda
More Information
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Responsible Party: Millennium Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT03657160    
Other Study ID Numbers: Vedolizumab-3035
2018-002141-11 ( EudraCT Number )
JapicCTI-184221 ( Registry Identifier: JapicCTI )
U1111-1216-2319 ( Registry Identifier: WHO )
First Posted: September 4, 2018    Key Record Dates
Last Update Posted: October 22, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Takeda makes patient-level, de-identified data sets and associated documents available for all interventional studies after applicable marketing approvals and commercial availability have been received (or program is completely terminated), an opportunity for the primary publication of the research and final report development has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com for details). To obtain access, researchers must submit a legitimate academic research proposal for adjudication by an independent review panel, who will review the scientific merit of the research and the requestor's qualifications and conflict of interest that can result in potential bias. Once approved, qualified researchers who sign a data sharing agreement are provided access to these data in a secure research environment.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Takeda ( Millennium Pharmaceuticals, Inc. ):
Drug Therapy
Additional relevant MeSH terms:
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Graft vs Host Disease
Immune System Diseases
Vedolizumab
Gastrointestinal Agents