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Clinical Trial 21135

Cancer Type: Malignant Hematology
Study Type: Treatment
NCT#: NCT04572815

Phase: Phase II
Prinicipal Investigator: Pidala, Joseph

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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

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:

  • 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]) > 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
  • 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 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
  • Other criteria may apply

  • If you are interested in learning more about clinical trials, our clinical trial navigators can discuss your options and recommend opportunities that may be suitable for you. Call 813-745-6100 or 1-800-679-0775 (toll-free) or submit a clinical trials inquiry form.