Vedolizumab in the Prophylaxis of Intestinal Acute Graft Versus Host Disease (aGVHD) in Participants Undergoing Allogeneic Hematopoietic Stem Cell (Allo-HSCT) Transplantation
CompletedPhase 3Results postedLast updated 6 June 2023
What this trial tests
Phase 3 trial testing Vedolizumab Placebo in Hematopoietic Stem Cells in 343 participants. Completed in 9 May 2022.
12 and older, any sex, with Hematopoietic Stem Cells. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Intestinal aGvHD-Free Survival After Allo-HSCT by +180 DaysPrimary· From the date of first dose of study drug to first documented intestinal aGvHD or death, whichever occurs first up to +180 days
Intestinal aGvHD Free Survival is the time from the date of first study drug administration (Day-1) to intestinal aGvHD event/death, where an event is defined as death due to any cause or Stage 1-4 intestinal involvement per Acute Graft versus-Host Disease Clinical Stage criteria. Data was censored for participants who have not had the intestinal aGvHD event or died or have had the event after pre-specified timing, e.g., last contact or Day +180 after allo HSCT whichever occurs first.
Group
Value
95% CI
Placebo
NA
14 – 182
Vedolizumab 300 mg
NA
2 – 182
Intestinal aGvHD-Free and Relapse-Free SurvivalSecondary· From the date of first dose of study drug to first documented intestinal aGvHD, death or relapse, whichever occurs first up to Day +180
Intestinal aGvHD and Relapse Free Survival is the time from the date of first study drug administration (Day-1) to intestinal aGvHD event/death/relapse, where an event is defined as death or Stage 1-4 intestinal involvement per Acute Graft versus-Host Disease Clinical Stage criteria, or relapse. It will be censored for participants who have not had the event or have had the event after pre-specified timing, e.g., last contact or Day +180 after allo-HSCT whichever occurs first.
Group
Value
95% CI
Placebo
NA
14 – 182
Vedolizumab 300 mg
NA
2 – 182
Grade C-D aGvHD-Free SurvivalSecondary· 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 the time from the date of first study drug administration (Day-1) to GvHD event/death, where an event is defined as Grade C-D aGvHD any organ involvement per International Bone Marrow Transplant Registry Database (IBMTR) Severity Index for aGvHD or death. It will be censored for participants who have not had the event or have had the event after pre-specified timing, eg, last contact or Day +180 after allo-HSCT whichever occurs first.
Group
Value
95% CI
Placebo
NA
12 – 182
Vedolizumab 300 mg
NA
12 – 182
Nonrelapse Mortality (NRM)Secondary· From the date of first dose of study drug to first documented death without relapse, up to Day +180
Non-relapse mortality is the time from the date of first study drug administration (Day-1) to death without occurrence of a relapse. Data was censored for participants who have not had the event or have had the event after pre-specified timing, e.g., last contact or Day +180 after allo HSCT whichever occurs first.
Group
Value
95% CI
Placebo
NA
14 – 182
Vedolizumab 300 mg
NA
19 – 182
Overall Survival (OS)Secondary· From the date of first dose of study drug to first documented death up to Day +180
Overall Survival by Days +180 is the time from the date of first study drug administration (Day-1) to death from any cause.
Group
Value
95% CI
Placebo
NA
14 – 182
Vedolizumab 300 mg
NA
19 – 182
Grade B-D aGvHD-Free SurvivalSecondary· From the date of first dose of study drug to first documented grade B-D aGvHD or death, whichever occurs first up to Day +180
Grade B-D aGvHD Free Survival is the time from the date of first study drug administration (Day-1) to aGvHD event or death, where an event is defined as death or grade B-D any organ involvement per IBMTR Severity Index for aGvHD.
Group
Value
95% CI
Placebo
NA
12 – 182
Vedolizumab 300 mg
NA
12 – 182
Adverse events — posted to ClinicalTrials.gov
Time frame: From the first dose of study drug up to end of study (up to 39 months).
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Placebo
Serious: 114/165 (69%)
Deaths: 34/169
Vedolizumab 300 mg
Serious: 120/169 (71%)
Deaths: 26/174
Serious adverse events (209 terms)
Reaction
System
Placebo
Vedolizumab 300 mg
Acute graft versus host disease in intestine
Immune system disorders
—
—
Pyrexia
General disorders
—
—
Sepsis
Infections and infestations
—
—
Alanine aminotransferase increased
Investigations
—
—
Acute myeloid leukaemia recurrent
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
—
—
Febrile neutropenia
Blood and lymphatic system disorders
—
—
Pneumonia
Infections and infestations
—
—
Acute kidney injury
Renal and urinary disorders
—
—
Diarrhoea
Gastrointestinal disorders
—
—
Cytomegalovirus infection reactivation
Infections and infestations
—
—
Pancytopenia
Blood and lymphatic system disorders
—
—
Stomatitis
Gastrointestinal disorders
—
—
Multiple organ dysfunction syndrome
General disorders
—
—
Acute graft versus host disease
Immune system disorders
—
—
Acute graft versus host disease in liver
Immune system disorders
—
—
Bacteraemia
Infections and infestations
—
—
Myelodysplastic syndrome
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
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.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT06815003 — Vedolizumab Plus Post-transplant Cyclophosphamide and Short Course Tacrolimus for the Prevention of Graft Versus Host Di
· Phase 2
· recruiting
NCT06227910 — A Study of Vedolizumab With and Without Upadacitinib in Adults With Crohn's Disease
· Phase 3
· recruiting
NCT06443502 — A Study to Learn About the Safety of Vedolizumab and How Well it Works in Children and Teenagers With Active Chronic Pou
· Phase 3
· recruiting
NCT06570772 — Study to Investigate Comparative Efficacy, Safety and Immunogenicity Between AVT16 and Entyvio
· Phase 3
· terminated
Other Millennium Pharmaceuticals, Inc. trials
Trials by the same sponsor.
NCT03888534 — Intravenous Ixazomib in Pediatric Participants With Relapsed or Refractory Acute Lymphoblastic Leukemia (ALL) or Lymphob
· Phase 1
· withdrawn
NCT04056468 — A Study to Evaluate Pharmacokinetics (PK) and Safety of Oral Mobocertinib in Participants With Moderate or Severe Hepati
· Phase 1
· completed
NCT04454918 — Study to Assess Absolute Bioavailability (ABA) of TAK-906 and to Characterize Mass Balance, Pharmacokinetics (PK), Metab
· Phase 1
· completed
NCT04056455 — A Study of Mobocertinib Capsules in People With Severe Kidney Problems and People With Healthy Kidneys
· Phase 1
· completed
NCT04091438 — A Study of a Single Intravenous Infusion Dose of TAK-925 in Participants With Idiopathic Hypersomnia
· Phase 1
· completed
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Millennium Pharmaceuticals, Inc.
Last refreshed: 6 June 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03657160.