Dose Finding Study of Vedolizumab for GvHD in Participants Undergoing Allogeneic HSCT

Completed · Phase 1

Conditions studied: Allogeneic Hematopoietic Stem Cell Transplantation

In brief

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 \[allo-HSCT\]).

Key facts

Study ID

NCT02728895

Run by

Takeda

People needed

24

Starts

2016-06-15

Expected to finish

2018-07-10

Last updated by the study team

2019-08-26

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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).

Where it is running

• Massachusetts General Hospital — Boston, Massachusetts, United States
• Dana-Farber Cancer Institute — Boston, Massachusetts, United States
• Icahn School of Medicine at Mount Sinai — New York, New York, United States
• OSU - James Comprehensive Cancer Center — Columbus, Ohio, United States
• Medical College of Wisconsin, Inc. — Milwaukee, Wisconsin, United States

Full record on ClinicalTrials.gov

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