Randomized, Placebo-Controlled, Phase II Trial Examining Ustekinumab for Prevention of Graft vs. Host Disease after Allogeneic Hematopoietic Cell Transplantation
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.
The primary objective of this trial is to determine the grade II-IV acute GVHD-free survival at 6 months post-HCT when ustekinumab is combined with standard of care pharmacologic GVHD prophylaxis.
1. Estimate the cumulative incidence of grade II-IV and grade III-IV acute GVHD for both ustekinumab- and placebo-treated subjects.
2. Compare acute GVHD organ involvement and severity between ustekinumab- and placebo-treated subjects.
3. Examine the cumulative incidence of NIH-defined overall chronic GVHD, and NIH moderate-severe chronic GVHD for ustekinumab- and placebo-treated subjects.
4. Estimate post-HCT relapse, non-relapse mortality, relapse-free survival, and overall survival for ustekinumab- and placebo-treated subjects.
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