Vedolizumab in the Prophylaxis of Intestinal Acute Graft versus Host Disease (aGVHD) in Participants Undergoing Allogeneic Hematopoietic Stem Cell (Allo-HSCT) Transplantation

A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Vedolizumab in the Prophylaxis of Intestinal Acute Graft Versus-Host Disease in Subjects Undergoing Allogeneic Hematopoietic Stem Cell Transplantation

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080224160

Enrollment

343

Registered

2018-11-26

Start date

2019-02-06

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hematopoietic Stem Cells

Interventions

investigational material(s) Generic name etc : Vedolizumab 300 mg INN of investigational material : Vedolizumab Therapeutic category code : 239 Other agents affecting digestive organs Dosage and Admin

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Must be >= 18 years of age and, in selected countries, adolescents aged 12 years and greater and weighing >=30 kg at time of randomization. 2. Must undergo deoxyribose nucleic acid (DNA)-based human leukocyte antigen (HLA) matching and be 8 of 8 or 7 of 8 HLA-matched (singe allele or antigen mismatch at HLA-A, -B, and -C, and HLA-DRB1 is allowable) unrelated hematopoietic stem cell transplantation (HSCT) from either peripheral blood or bone marrow stem cells for a hematologic malignancy or myeloproliferative disorder. 3. For whom a myeloablative conditioning or reduced intensity conditioning (RIC) is planned. 4. Allo-HSCT eligible (meeting institutional criteria)-participants planned medical care should include aGvHD prophylaxis with a combination of calcineurin inhibitor (CNI) (cyclosporine [CYS] or tacrolimus [TAC]) and methotrexate (MTX) or CNI and mycophenolate mofetil (MMF). With the exception of antithymocyte globulin (ATG) (antithymocyte globulin-Fresenius [ATG-F] or thymoglobulin), all other therapies, approved or investigational, for GvHD prophylaxis are excluded. 5. Eastern Cooperative Oncology Group (ECOG) performance status of =18 years at randomization or >=60 percent (%) using the Karnofsky performance status for adolescent subjects aged >=16 years at randomization or the Lansky performance status for adolescent participants aged 12 to < 16 years at randomization..

Exclusion criteria

Exclusion criteria: 1. Had prior allo- HSCT. 2. Planned umbilical cord blood transplant or planned to receive posttransplant cyclophosphamide, in vivo or ex vivo T cell-depleted hematopoietic stem cells (HSCs) with the exception of ATG (ATG-F or thymoglobulin). 3. Planned allo-HSCT for nonmalignant hematological disorders (example, aplastic anemia, sickle cell anemia, thalassemias, Fanconi anemia or immunodeficiency).

Design outcomes

Primary

Measure	Time frame
1.efficacy: Intestinal aGvHD-Free Survival After Allo-HSCT by Day +180 Timeframe; From the date of first dose of study drug to first documented intestinal aGvHD or death, whichever occurs first up to Day +180 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.	—

Measure

Time frame

1.efficacy: Intestinal aGvHD-Free Survival After Allo-HSCT by Day +180 Timeframe; From the date of first dose of study drug to first documented intestinal aGvHD or death, whichever occurs first up to Day +180 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.

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Secondary

Measure	Time frame
1.Efficacy: Intestinal aGvHD-Free and Relapse-Free Survival Timeframe; From the date of first dose of study drug to first documented intestinal aGvHD criteria, relapse or death, whichever occurs first up to Day +180 GvHD and Relapse Free Survival is the time from the date of first study drug administration (Day-1) to GvHD event/death/relapse, where an event is defined as death or aGvHD Grade 3-4 by modified Glucksberg criteria or chronic GvHD requiring system immunosuppression or 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. 2.Efficacy: Grade C-D aGvHD-Free Survival Timeframe; 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 GvHD and Relapse Free Survival is the time from the date of first study drug administration (Day-1) to GvHD event/death/relapse, where an event is defined as death or aGvHD Grade 3-4 by modified Glucksberg criteria or chronic GvHD requiring system immunosuppression or 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. 3.Efficacy: Nonrelapse Mortality (NRM) Timeframe; From the date of first dose of study drug to first documented intestinal aGvHD or death, whichever occurs first 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. 4.Efficacy: Overall Survival (OS) Timeframe; From the date of first dose of study drug to first documented intestinal aGvHD or death, whichever occurs first up to Day +180 Overall Surviva	—

Measure

Time frame

1.Efficacy: Intestinal aGvHD-Free and Relapse-Free Survival Timeframe; From the date of first dose of study drug to first documented intestinal aGvHD criteria, relapse or death, whichever occurs first up to Day +180 GvHD and Relapse Free Survival is the time from the date of first study drug administration (Day-1) to GvHD event/death/relapse, where an event is defined as death or aGvHD Grade 3-4 by modified Glucksberg criteria or chronic GvHD requiring system immunosuppression or 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. 2.Efficacy: Grade C-D aGvHD-Free Survival Timeframe; 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 GvHD and Relapse Free Survival is the time from the date of first study drug administration (Day-1) to GvHD event/death/relapse, where an event is defined as death or aGvHD Grade 3-4 by modified Glucksberg criteria or chronic GvHD requiring system immunosuppression or 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. 3.Efficacy: Nonrelapse Mortality (NRM) Timeframe; From the date of first dose of study drug to first documented intestinal aGvHD or death, whichever occurs first 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. 4.Efficacy: Overall Survival (OS) Timeframe; From the date of first dose of study drug to first documented intestinal aGvHD or death, whichever occurs first up to Day +180 Overall Surviva

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Countries

Japan, Other (Refer to the section, "Other")

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026