Last updated on December 2018

GRAVITAS-119: A Single-Arm, Open-Label, Phase 1 Study of Itacitinib in Combination With Calcineurin Inhibitor-Based Interventions for the Prophylaxis of Graft-Versus-Host Disease

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Oncology | Graft-Versus-Host Disease (GVHD)
  • Age: Between 18 - 100 Years
  • Gender: Male or Female

Key Inclusion Criteria:

  • Subjects with acute leukemia, chronic myelogenous leukemia, or myelodysplasia must have no circulating blasts and < 5% blasts of the bone marrow.
  • Subjects with chronic lymphocytic leukemia/small lymphocytic lymphoma, follicular, marginal zone, diffuse large B cell, Hodgkin's lymphoma, or mantle cell lymphoma must have chemosensitive disease at time of transplant.
  • Subjects must be candidates for reduced-intensity conditioning regimens; subjects who are candidates for myeloablative conditioning regimens are excluded.
  • Subjects must be candidates for PBSC transplants; the PBSC donors must be matched related (8/8), matched unrelated (8/8), or single antigen mismatched unrelated (7/8) donors.
  • Karnofsky Performance Status score ≥ 70% or Eastern Cooperative Oncology Group Performance Status score of 0 to 2.
  • Serum creatinine ≤ 2.0 mg/dL or creatinine clearance ≥ 40 mL/min measured or calculated by Cockroft-Gault equation.
  • Be willing to avoid pregnancy or fathering children.

 Key Exclusion Criteria:

  • Has previously received an allo-HSCT.
  • Presence of an active uncontrolled infection, defined as hemodynamic instability attributable to sepsis or new symptoms, worsening physical signs, or radiographic findings attributable to infection. Persisting fever without signs or symptoms will not be interpreted as an active uncontrolled infection.
  • Known human immunodeficiency virus infection.
  • Active hepatitis B virus (HBV) or hepatitis C virus infection that requires treatment or at risk for HBV reactivation.
  • Subjects with prior malignancies, unless prior approval from the medical monitor is obtained.
  • Severe organ dysfunction, including the following:
    • Cholestatic disorders or unresolved veno-occlusive disease of the liver, defined as persistent bilirubin abnormalities not attributable to GVHD and ongoing organ dysfunction.
  • Clinically significant or uncontrolled cardiac disease, including unstable angina, acute myocardial infarction within 6 months of enrollment, New York Heart Association Class III or IV congestive heart failure, circulatory collapse requiring vasopressor or inotropic support, or arrhythmia that requires therapy.
  • Clinically significant respiratory disease that requires mechanical ventilation support or oxygen.
  • Prior treatment with a Janus kinase inhibitor or with an investigational agent, device, or procedure, within 21 days (or 5 half-lives, whichever is greater) of enrollment, unless discussed with the medical monitor.
  • Currently breastfeeding.
  • Known allergies, hypersensitivity, or intolerance to any of the study medications, excipients, or similar compounds.

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

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