Clinical Trials Logo

Clinical Trial Summary

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.


Clinical Trial Description

The drug being tested in this study is called vedolizumab. This study will look at the tolerability and effectiveness of vedolizumab IV in participants with acute intestinal GvHD who have received no systemic therapy for the treatment of acute GvHD (prophylaxis acceptable) other than corticosteroids.

The study enrolled 17 participants. Participants will be randomly assigned (by chance, like flipping a coin) to one of the two treatment groups:

- Vedolizumab 300 mg

- Vedolizumab 600 mg

All participants will be infused intravenously at the same time each day throughout the study. Vedolizumab IV will be administered on Days 1, 15, 43, 71, and 99. After approximately 10 participants are enrolled at each dose level and have data available from the Day 28 evaluation, safety, tolerability, efficacy, and pharmacokinetic (PK), results will be assessed for each dose level, and the appropriate dose for subsequent participants in the study will be determined.

This multi-center trial will be conducted in multiple countries. The overall time to participate in this study is 32 weeks. Participants will make multiple visits to the clinic after last dose of study drug for a follow-up assessment. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02993783
Study type Interventional
Source Takeda
Contact
Status Terminated
Phase Phase 2
Start date April 28, 2017
Completion date May 9, 2018

See also
  Status Clinical Trial Phase
Recruiting NCT03294824 - Non Randomized Comparative Study With Control
Recruiting NCT04098653 - Decitabine + BUCY vs BUCY Conditioning Regimen for Myeloid Tumors Undergoing Allo-HSCT Phase 2/Phase 3
Recruiting NCT03256071 - Low Dose Decitabine + Modified BUCY Conditioning Regimen for High Risk Acute Myeloid Leukemia Undergoing Allo-HSCT Phase 2/Phase 3
Terminated NCT02653196 - A Multi-Institutional Pilot Study of Allogeneic Hematopoietic Stem Cell Transplantation for Patients With Malignant Neuro-Epithelial and Other Solid Tumors Early Phase 1
Terminated NCT00429039 - A Study to Accelerate Immune System Recovery Following Stem Cell Transplantation Phase 2
Recruiting NCT04123392 - Decitabine + BUCY vs BUCY Conditioning Regimen for TP53+ Myeloid Tumors Undergoing Allo-HSCT Phase 2/Phase 3
Recruiting NCT03357172 - Determination of Factors Involved in the Regulation of Immune Responses After Allogeneic Hematopoietic Stem Cell Transplantation N/A
Completed NCT02250300 - MLN9708 for the Prophylaxis of Chronic Graft-versus-host Disease in Patient Undergoing Allogeneic Transplantation Phase 1/Phase 2
Recruiting NCT04372524 - Biomarker Verification in Pediatric Chronic GvHD: ABLE 2.0 / PBMTC 1901 Study
Recruiting NCT03593161 - Humor Therapy and Distress After Allogeneic Stem Cell Transplantation N/A
Not yet recruiting NCT03902041 - The Prospective Randomized Controlled Study of Eltrombopag on Hematopoietic Reconstruction After Allogeneic HSCT
Completed NCT02270346 - Inspiratory Muscle Training in Allogeneic Hematopoietic Stem Cell Transplantation Recipients N/A
Recruiting NCT03297528 - Chemotherapy and DLI for Prevention of Second Relapse in Patients With Relapsed Acute Leukemia After Allotransplant Phase 2
Completed NCT01879072 - Prospective Cohort for the Evaluation of Biomarkers Following HCT (BMT CTN 1202)
Recruiting NCT01379391 - Efficacy and Safety of rHuTPO on Platelet Engraftment After Allo-HSCT Phase 4
Active, not recruiting NCT04822532 - Precision Dosing of Busulfan in Children Undergoing HSCT N/A
Recruiting NCT03530085 - Dec+Flu+Bu Conditioning Regimen for Elderly AML in CR Undergoing Allo-HSCT Phase 2/Phase 3
Completed NCT02728895 - Dose Finding Study of Vedolizumab for GvHD in Participants Undergoing Allogeneic HSCT Phase 1
Recruiting NCT03596892 - Decitabine+BUCY vs BUCY Conditioning Regimen for MLL+ Acute Leukemia Undergoing Allo-HSCT Phase 2/Phase 3
Recruiting NCT03148197 - Changes in the Gut Microbiota of Patients Undergoing Allogeneic Stem Cell Transplantation (COLLECT) N/A