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

Part of paid clinical trials in Duarte, California.

Sponsor
Fred Hutchinson Cancer Center
Study ID
NCT04572815
Phase
PHASE2
Status
Active Not Recruiting

Conditions

  • Hematologic and Lymphocytic Disorder
  • Hematopoietic and Lymphoid System Neoplasm

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Placebo Administration — DRUG
    Given IV and SC
  • Quality-of-Life Assessment — OTHER
    Ancillary studies
  • Questionnaire Administration — OTHER
    Ancillary studies
  • Ustekinumab — BIOLOGICAL
    Given IV and SC

Study Details

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.

Key Dates

Start date
May 14, 2021
Status verified
Dec 2025
Primary completion
Oct 27, 2025
Completion
Jun 30, 2027

Study Design

Enrollment
116 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Arm I (ustekinumab)
    Between 4 and 72 hours prior to start of HCT conditioning therapy, patients receive ustekinumab IV. Beginning 8 weeks after receiving IV ustekinumab, patients receive ustekinumab SC on days 50 (+/- 5 days), 100 (+/- 7 days), and 160 (+/- 7 days) post-HCT in the absence of grade III-IV acute GVHD, disease relapse or unacceptable toxicity. NOTE: HCT infusion takes place on day 0.
  • Placebo Comparator: Arm II (placebo)
    Between 4 and 72 hours prior to start of HCT conditioning therapy, patients receive a placebo IV. Beginning 8 weeks after IV placebo, patients receive a placebo SC on days 50 (+/- 5 days), 100 (+/- 7 days), and 160 (+/- 7 days) post-HCT in the absence of grade III-IV acute GVHD, disease relapse, or unacceptable toxicity. NOTE: HCT infusion takes place on day 0.

Primary Outcome Measure

Grade II-IV acute graft versus host disease (GVHD) survival [ Time Frame: At 6 months post-hematopoietic cell transplantation (HCT) ]

Locations (4)

FacilityCityStateZIPSite coordinators
City of Hope Comprehensive Cancer Center,DuarteCalifornia91010-
H. Lee Moffitt Cancer Center & Research InstituteTampaFlorida33612-
Roswell Park Cancer InstituteBuffaloNew York14263-
Fred Hutch/University of Washington Cancer ConsortiumSeattleWashington98109-

Find similar trials in Duarte, CA

By research site
City of Hope Comprehensive Cancer Center· Duarte, CAH. Lee Moffitt Cancer Center & Research Institute· Tampa, FLRoswell Park Cancer Institute· Buffalo, NYFred Hutch/University of Washington Cancer Consortium· Seattle, WA

Related Studies