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ACTIVE NOT RECRUITING
NCT04572815
PHASE2

Ustekinumab for the Prevention of Acute Graft-versus-Host Disease After Unrelated Donor Hematopoietic Cell Transplant

Sponsor: Fred Hutchinson Cancer Center

View on ClinicalTrials.gov

Summary

This phase II trial studies how well ustekinumab works in preventing acute graft-versus-host disease after unrelated donor hematopoietic cell transplant. Sometimes the transplanted cells from a donor can attack the body's normal tissues (called graft-versus-host disease). Giving ustekinumab after the transplant may help prevent acute graft-versus-host disease by controlling the body's immune response. Funding Source- FDA OOPD.

Official title: Randomized, Placebo-Controlled, Phase II Trial Examining Ustekinumab for Prevention of Graft Vs. Host Disease After Allogeneic Hematopoietic Cell Transplantation

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

116

Start Date

2021-05-14

Completion Date

2027-06-30

Last Updated

2026-01-02

Healthy Volunteers

No

Interventions

DRUG

Placebo Administration

Given IV and SC

OTHER

Quality-of-Life Assessment

Ancillary studies

OTHER

Questionnaire Administration

Ancillary studies

BIOLOGICAL

Ustekinumab

Given IV and SC

Locations (4)

City of Hope Comprehensive Cancer Center,

Duarte, California, United States

H. Lee Moffitt Cancer Center & Research Institute

Tampa, Florida, United States

Roswell Park Cancer Institute

Buffalo, New York, United States

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, United States