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

• Status: Recruiting
• Trial end date: 2026-03-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fred Hutchinson Cancer Research Center
• Collaborator: Food and Drug Administration (FDA)
• Treatments: Immunoglobulin G; Immunoglobulins; Interleukin-12; Ustekinumab

Criteria

Inclusion Criteria:

• Signed informed consent

• Hematologic malignancy or disorder requiring allogeneic hematopoietic cell transplantation

• Left ventricular ejection fraction (LVEF) >= 45%

• Forced expiratory volume in 1 second (FEV1), forced vital capacity (FVC), and diffusion capacity of the lung for carbon monoxide (DLCO) >= 50% of predicted values on pulmonary function tests

• Transaminases (aspartate aminotransferase [AST], aspartate aminotransferase [ALT]) < 3 times upper limit of normal values

• Creatinine clearance >= 50 cc/min

• Karnofsky performance status score >= 60%

• HCT donor is at least 8/8 (matched at human leukocyte antigen [HLA]-A, -B, -C, -DRB1) matched with the recipient

• PBSC (peripheral blood mobilized stem cells) as graft source

• Fully myeloablative, reduced-toxicity ablative, or reduced-intensity conditioning regimens

Exclusion Criteria:

• Active infection not controlled with appropriate antimicrobial therapy

• Human immunodeficiency virus (HIV), hepatitis B, or hepatitis C infection

• Anti-thymocyte globulin (ATG) as part of the conditioning regimen or GVHD prophylaxis

• Pregnant or nursing women

• Subjects of childbearing age unwilling to use an effective birth control method or refrain from sexual intercourse until 3 months after last dose of study drug

• Non-myeloablative conditioning regimens

• Prior allogeneic transplant

• Non-malignant blood disorders (e.g. sickle cell disease, aplastic anemia)

• Positive screening test for tuberculosis