Clinical Trial 21135

• Overview

  Study Title:

  Randomized, Placebo-Controlled, Phase II Trial Examining Ustekinumab for Prevention of Graft vs. Host Disease after Allogeneic Hematopoietic Cell Transplantation

  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.

  Objective:

  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

  Therapies:

  Therapy (NOS)

  Medications:

  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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