A Dose-Finding Study of Vedolizumab for Treatment of Steroid-Refractory Acute Intestinal Graft-Versus-Host Disease (GvHD) in Participants Who Have Undergone Allogeneic Hematopoietic Stem Cell Transplantation (Allo-HSCT)

Description

The purpose of this study is to assess the initial activity, tolerability, safety and to identify a recommended dose and regimen of vedolizumab intravenous (IV) administered for treatment of steroid-refractory acute intestinal GvHD in participants who have undergone allo-HSCT.

Study Start Date

March, 31 2017

Estimated Completion Date

June 2019

Interventions

  • Drug: Vedolizumab

Study ID

Takeda -- Vedolizumab-2004

Status

Recruiting

Trial ID

NCT02993783

Study Type

Interventional

Trial Phase

Phase 2

Enrollment Quota

38

Sponsor

Takeda

Inclusion Criteria

    1. Recipient of 1 allogeneic hematopoietic stem cell transplantation (allo-HSCT) but not more than 1 (allo-HSCT). 2. Has primary steroid-refractory intestinal graft-versus-host disease (GvHD). Steroid-refractory disease is defined as worsening or no improvement in 5 to 7 days of treatment with methylprednisolone 2 mg/kg or equivalent or lack of a complete response (CR) after 14 days of primary treatment with methylprednisolone 2 mg/kg or equivalent. Note that participants who develop intestinal GvHD while receiving systemic therapy for other GvHD are still eligible after 5 to 7 days, even if the intestinal GvHD has not been present for the entire duration. Participants who may have received an increase in their steroid dose treatment (e.g., increased methylprednisolone from 1 mg/kg to 2 mg/kg) before enrollment will be eligible, provided the participant has met the definition of steroid refractory above. 3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 3. 4. Evidence of myeloid engraftment defined by absolute neutrophil count ?0.5*109/L on 3 consecutive days.

Exclusion Criteria

    1. Presence of chronic GvHD at Screening (including acute-chronic overlap syndrome). 2. Relapse of underlying malignantdisease after allo-HSCT. 3. Hyperacute GvHD defined as onset of GvHD within the first 15 days following hematopoietic stem cell infusion. 4. Received systemic agents other than corticosteroids for treatment of acute GvHD. GvHD prophylaxis agents (e.g., calcineurin inhibitors) may be continued. 5. Acute steroid-resistant GvHD beyond 28 days from primary treatment. 6. Life expectancy of <3 weeks.

Gender

All

Ages

18 Years and older

Accepts Healthy Volunteers

No

Study Locations and Contact Information (16)

Study Location Distance Name Phone Email
Massachusetts General Hospital - Boston, Massachusetts 2.8 miles None None None
Mount Sinai PRIME - Lake Success, New York 175.2 miles None None None
Mount Sinai PRIME - Lake Success, New York 175.2 miles None None None
Mount Sinai PRIME - Lake Success, New York 175.2 miles None None None
Mount Sinai PRIME - Lake Success, New York 175.2 miles None None None
Mount Sinai PRIME - Lake Success, New York 175.2 miles None None None
OSU James Comprehensive Cancer Center - Columbus, Ohio 641.8 miles None None None
OSU James Comprehensive Cancer Center - Columbus, Ohio 641.8 miles None None None
OSU James Comprehensive Cancer Center - Columbus, Ohio 641.8 miles None None None
OSU James Comprehensive Cancer Center - Columbus, Ohio 641.8 miles None None None
OSU James Comprehensive Cancer Center - Columbus, Ohio 641.8 miles None None None
Washington University - Saint Louis, Missouri 1,039.5 miles None None None
Baylor University Medical Center - Dallas, Texas 1,549.8 miles None None None
Seattle Cancer Care Alliance - Seattle, Washington 2,490.2 miles None None None
Seattle Cancer Care Alliance - Seattle, Washington 2,490.2 miles None None None
Seattle Cancer Care Alliance - Seattle, Washington 2,490.2 miles None None None

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