NCT02728895

Brief Summary

The purpose of this study is to assess the initial tolerability, safety and recommended phase 2 dose of vedolizumab intravenous (IV) administered for GvHD prophylaxis along with standard GvHD prophylaxis therapy (in participants undergoing allogeneic hematopoietic stem cell transplantation \[allo-HSCT\]).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jun 2016

Typical duration for phase_1

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 31, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 5, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

June 15, 2016

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 10, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 10, 2018

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

August 26, 2019

Completed
Last Updated

August 26, 2019

Status Verified

July 1, 2019

Enrollment Period

2.1 years

First QC Date

March 31, 2016

Results QC Date

July 9, 2019

Last Update Submit

July 9, 2019

Conditions

Allogeneic Hematopoietic Stem Cell Transplantation

Keywords

Drug Therapy

Outcome Measures

Primary Outcomes (3)

  • Number of Participants With Dose-Limiting Toxicities (DLTs)

    DLTs was based on National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03 and was defined as any of following events: Grade 3 or higher toxicity assessed by the investigator as related to vedolizumab treatment; Grade 4 or higher regimen-related organ toxicities; and failure to engraft by Day +28. Engraftment was defined as absolute neutrophils count (ANC) greater than (\>) 500 per cubic millimeter (/mm\^3) for 3 consecutive days or \>2000/mm\^3 for 1 day.

    Baseline up to Day 28

  • Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

    Up to 18 weeks after last dose of study drug

  • Mean Serum Concentrations of Vedolizumab That Helped the Likelihood of Alpha4Beta7 Target Saturation on Day 100 Following Allo-HSCT

    Day 100

Secondary Outcomes (5)

  • Time to Neutrophil Engraftment

    Baseline up to Day 100

  • Percentage of Participants With Overall Grade 2 to 4 Acute Graft-Versus-Host Disease (GvHD)

    Baseline up to Day 100

  • Percentage of Participants With Maximum Severity of Acute GvHD Based on Modified Glucksberg Criteria

    Baseline up to Day 100

  • Percentage of Participants With Maximum Severity of Acute GvHD Based on Blood and Marrow Transplant Clinical Trials Network (BMT CTN) Modified International Bone Marrow Transplant Registry Database (IBMTR) Index

    Baseline up to Day 100

  • Ctrough: Serum Concentration Before Dosing for Vedolizumab

    Days 13 and 42 pre-dose

Study Arms (3)

Cohort 1: Vedolizumab 75 mg

EXPERIMENTAL

Vedolizumab 75 mg, injection, intravenously once on Days -1, 13 and 42.

Drug: Vedolizumab

Cohort 2: Vedolizumab 300 mg

EXPERIMENTAL

Vedolizumab 300 mg, injection, intravenously once on Days -1, 13 and 42.

Drug: Vedolizumab

Cohort 3: Vedolizumab Dose 1

EXPERIMENTAL

Vedolizumab first decided dose as determined from Cohort 1 or 2, injection, intravenously once on Days -1, 13 and 42.

Drug: Vedolizumab

Interventions

VedolizumabDRUG

Vedolizumab Injection.

Cohort 1: Vedolizumab 75 mgCohort 2: Vedolizumab 300 mgCohort 3: Vedolizumab Dose 1

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Is undergoing matched or single-antigen mismatched unrelated-donor myeloablative transplant for the treatment of acute lymphoblastic leukemia (ALL) or acute myeloid leukemia (AML); Is less than or equal to (\<=) 60 years of age.
  • For the cohort after RP2D
  • Is undergoing matched or single-antigen mismatched related or unrelated-donor transplant and receiving myeloablative conditioning or RIC for the treatment of hematologic malignancies or myeloproliferative neoplasms; Is less than or equal to (\<=) 75 years of age.

You may not qualify if:

  • Has received prior allogeneic transplants or who are planned to undergo umbilical cord blood transplant, receive ex vivo T-cell-depleted hematopoietic stem cells (HSCs), received any in vivo T-cell depleting antibodies, or non-myeloablative conditioning.
  • Has active cerebral/meningeal disease, active cytomegalovirus (CMV) colitis, or signs and symptoms of progressive multifocal leukoencephalopathy (PML) or any history of PML.
  • Is undergoing transplant for the treatment of nonmalignant hematological disorders (for example: aplastic anemia, sickle cell anemia, thalassemias, Fanconi anemia).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 2215, United States

Location

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

OSU - James Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

Location

Medical College of Wisconsin, Inc.

Milwaukee, Wisconsin, 53266, United States

Location

Related Publications (1)

  • Chen YB, Shah NN, Renteria AS, Cutler C, Jansson J, Akbari M, Chen C, Quadri S, Parfionovas A, Devine SM. Vedolizumab for prevention of graft-versus-host disease after allogeneic hematopoietic stem cell transplantation. Blood Adv. 2019 Dec 10;3(23):4136-4146. doi: 10.1182/bloodadvances.2019000893.

    PMID: 31821456DERIVED

MeSH Terms

Interventions

vedolizumab

Results Point of Contact

Title
Medical Director
Organization
Takeda
trialdisclosures@takeda.com
+1-877-825-3327

Study Officials

  • Medical Director

    Takeda

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 31, 2016

First Posted

April 5, 2016

Study Start

June 15, 2016

Primary Completion

July 10, 2018

Study Completion

July 10, 2018

Last Updated

August 26, 2019

Results First Posted

August 26, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will share

Takeda makes patient-level, de-identified data sets and associated documents available after applicable marketing approvals and commercial availability have been received, an opportunity for the primary publication of the research has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com/Approach 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.

Locations

US(5)