Phase 3
N=343
Vedolizumab in the Prophylaxis of Intestinal Acute Graft Versus Host Disease (aGVHD) in Participants Undergoing Allogeneic Hematopoietic Stem Cell (Allo-HSCT) Transplantation
Hematopoietic Stem Cells
Bottom Line
View on ClinicalTrials.gov: NCT03657160 ↗Enrolled (actual)
343
Serious AEs
70.1%
Results posted
Apr 2023
Primary outcome: Primary: Intestinal aGvHD-Free Survival After Allo-HSCT by +180 Days — NA; NA days — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Vedolizumab Placebo (Drug); Vedolizumab (Drug)
- Age
- Pediatric, Adult, Older Adult · 12+ yrs
- Sex
- All
- Sponsor
- Millennium Pharmaceuticals, Inc.
- Primary completion
- Feb 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Intestinal aGvHD-Free Survival After Allo-HSCT by +180 Days |
NA; NA | <0.001 sig |
| SECONDARY Intestinal aGvHD-Free and Relapse-Free Survival |
NA; NA | 0.0043 sig |
| SECONDARY Grade C-D aGvHD-Free Survival |
NA; NA | 0.0204 sig |
| SECONDARY Nonrelapse Mortality (NRM) |
NA; NA | 0.0668 |
| SECONDARY Overall Survival (OS) |
NA; NA | 0.1458 |
| SECONDARY Grade B-D aGvHD-Free Survival |
NA; NA | 0.0105 sig |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- Must be >= 18 years of age and, in selected countries, adolescents aged 12 years and greater and weighing >=30 kilogram (kg) at time of randomization.
- 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.
- For whom a myeloablative conditioning or reduced intensity conditioning (RIC) is planned.
- 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.
- Eastern Cooperative Oncology Group (ECOG) performance status of =18 years at randomization or >=60 % using the Karnofsky performance status for adolescent participants aged >=16 years at randomization or the Lansky performance status for adolescent participants aged 12 to < 16 years at randomization.
Exclusion Criteria
- Had prior allo- HSCT.
- 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).
- Planned allo-HSCT for nonmalignant hematological disorders (example, aplastic anemia, sickle cell anemia, thalassemias, Fanconi anemia or immunodeficiency).
Data sourced from ClinicalTrials.gov (NCT03657160). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.