Clinical Trials / Research Studies

Clinical Trials / Research Studies

A Study of Itacitinib for the Prevention of Cytokine Release Syndrome Induced by Immune Effector Cell Therapy

Why are we doing this research?

The purpose of this study is to assess the safety and efficacy of oral administration of itacitinib once daily for the prevention of cytokine release syndrome (CRS) in male or female participants aged 12 years or older and who are planning to receive tisagenlecleucel or axicabtagene ciloleucel immune effector cell (IEC) therapy for any approved hematologic indication.

INCB 39110-211: A Phase 2, Single-Arm, Open-Label Study of Itacitinib for the Prevention of Cytokine Release Syndrome Induced by Immune Effector Cell Therapy

Who can participate?

Inclusion Criteria:

  • Eligible to receive either tisagenlecleucel or axicabtagene ciloleucel for approved hematologic indications.
  • Eastern Cooperative Oncology Group performance status 0 to 1.
  • Willingness to avoid pregnancy or fathering children

Exclusion Criteria:

  • Evidence of active uncontrolled/untreated infection (viral, bacterial, fungal, opportunistic) of any origin.
  • Evidence of active hepatitis B virus or hepatitis C virus infection.
  • Known human immunodeficiency virus.
  • Active acute or chronic graft-versus-host disease requiring systemic therapy.
  • Concurrent use of chronic systemic steroids or immunosuppressant medications.
  • Any unresolved toxicity ≥ Grade 2 (except stable Grade 2 peripheral neuropathy or alopecia) from previous anticancer therapy.
  • Known history or prior diagnosis of immunologic or inflammatory/autoimmune disease affecting the central nervous system (CNS) and unrelated to their disease under study or previous treatment.
  • Clinically significant or uncontrolled cardiac disease.
  • Acute lymphoblastic leukemia participants with protocol-defined CNS status are eligible only in the absence of neurologic symptoms suggestive of CNS leukemia.
  • Diffuse large B-cell lymphoma participants must have no signs or symptoms of CNS disease or detectable evidence of CNS disease; participants who have been previously treated for CNS disease but have no evidence of disease at screening are eligible.
  • Laboratory values at screening outside the protocol-defined ranges.

Ages

  • 12 years and older

Conditions

  • Leukemia ALL Relapse - Refractory
  • Adult - Leukemia ALL Relapse - Refractory
  • Lymphoma Non-Hodgkin Relapse - Refractory
  • Adult - Lymphoma Non-Hodgkin Relapse - Refractory

Contact

Cincinnati Children’s Hospital Medical Center
Division of Hematology/Oncology
3333 Burnet Ave., Cincinnati, OH 45229-3039
Phone: 513-636-2799
cancer@cchmc.org