At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 24 enrolled
Drug / intervention
Vedolizumabdrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An Open-Label, Dose-Finding Study of Vedolizumab IV Plus Standard of Care for Graft-Versus-Host Disease (GvHD) Prophylaxis in Patients Undergoing Allogeneic Hematopoietic Stem Cell Transplantation (HSCT)
In Brief
A Phase 1 clinical trial evaluating Vedolizumab for Allogeneic Hematopoietic Stem Cell Transplantation. Completed, enrolled 24 participants across 5 sites.
Detailed 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 \[allo-HSCT\]).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--
Timeline
Phase 1CompletedFinished
20162017201820192020202120222023202420252026
First PostedApr 2016
Enrollment StartJun 2016
Primary CompletionJul 2018
TodayJul 2026
First PostedApr 5, 2016
Enrollment StartJun 15, 2016
Primary CompletionJul 10, 2018
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 10.2 years ago
Interventions
Vedolizumabdrug
Vedolizumab Injection.