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  • Cancer Type: Malignant Hematology
  • Study Type: Treatment
  • NCT#: NCT04572815
  • Phase: Phase II
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  • Overview

    Study Title:

    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. Secondary: 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.

  • Treatments


    Therapy (NOS)


    FK506 (Tacrolimus); Tacrolimus (); Ustekinumab/placebo ()

  • Inclusion Criteria

      Inclusion Criteria:
    • Age 18 - 70
    • Signed informed consent
    • Hematologic malignancy or disorder requiring allogeneic hematopoietic cell transplantation
    • Left ventricular ejection fraction (LVEF) >= 50%
    • 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]) > Creatinine clearance >= 50 cc/min
    • Karnofsky performance status score >= 70%
    • 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. If melphalan is part of the condition regimen, dose must be at least 75mg/m2.
    • Other criteria may apply
  • Exclusion Criteria

      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
    • Patients of childbearing age unwilling to use an effective birth control method or refrain from sexual intercourse until 15 weeks after last dose of study drug
    • Non-myeloablative conditioning regimens or conditioning regimens that use less than 75mg/m2 of melphalan
    • Prior allogeneic transplant
    • Non-malignant blood disorders (e.g. sickle cell disease, aplastic anemia)
    • Positive screening test for tuberculosis
    • Other criteria may apply

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