Phase 1
Completed N=24
Dose Finding Study of Vedolizumab for GvHD in Participants Undergoing Allogeneic HSCT
Allogeneic Hematopoietic Stem Cell Transplantation
Source: ClinicalTrials.gov NCT02728895 ↗
Enrolled (actual)
24
Serious AEs
54.2%
Results posted
Aug 2019
Primary outcomePrimary: Number of Participants With Dose-Limiting Toxicities (DLTs) — 0; 0 Participants
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]).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Dose-Limiting Toxicities (DLTs) |
0; 0 | — |
| PRIMARY Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) |
3; 21; 2; 11 | — |
| PRIMARY Mean Serum Concentrations of Vedolizumab That Helped the Likelihood of Alpha4Beta7 Target Saturation on Day 100 Following Allo-HSCT |
7.34; 18.36 | — |
| SECONDARY Time to Neutrophil Engraftment |
22; 14 | — |
| SECONDARY Percentage of Participants With Overall Grade 2 to 4 Acute Graft-Versus-Host Disease (GvHD) |
0; 19.0 | — |
| SECONDARY Percentage of Participants With Maximum Severity of Acute GvHD Based on Modified Glucksberg Criteria |
66.7; 28.6; 0; 14.3; 0; 4.8 | — |
| SECONDARY Percentage of Participants With Maximum Severity of Acute GvHD Based on Blood and Marrow Transplant Clinical Trials Network (BMT CTN) Modified International Bone Marrow Transplant Registry Database (IBMTR) Index |
0; 19.0; 66.7; 14.3; 0; 14.3 | — |
| SECONDARY Ctrough: Serum Concentration Before Dosing for Vedolizumab |
5.87; 21.34; 8.17; 29.05 | — |
Eligibility Criteria
Inclusion Criteria
- Is undergoing matched or single-antigen mismatched unrelated-donor myeloablative transplant for the treatment of acute lymphoblastic leukemia (ALL) or acute myeloid leukemia (AML); Is less than or equal to (<=) 60 years of age.
For the cohort after RP2D
- Is undergoing matched or single-antigen mismatched related or unrelated-donor transplant and receiving myeloablative conditioning or RIC for the treatment of hematologic malignancies or myeloproliferative neoplasms; Is less than or equal to (<=) 75 years of age.
Exclusion Criteria
- Has received prior allogeneic transplants or who are planned to undergo umbilical cord blood transplant, receive ex vivo T-cell-depleted hematopoietic stem cells (HSCs), received any in vivo T-cell depleting antibodies, or non-myeloablative conditioning.
- Has active cerebral/meningeal disease, active cytomegalovirus (CMV) colitis, or signs and symptoms of progressive multifocal leukoencephalopathy (PML) or any history of PML.
- Is undergoing transplant for the treatment of nonmalignant hematological disorders (for example: aplastic anemia, sickle cell anemia, thalassemias, Fanconi anemia).
Data sourced from ClinicalTrials.gov (NCT02728895). 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. Informational only — not medical advice.