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Clinical Trial 20397

Cancer Type: Immunotherapy
Study Type: Supportive Care
NCT#: NCT04071366

Phase: Phase II
Principal Investigator: Lazaryan, Aleksandr

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Study Title

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


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 who are planning to receive tisagenlecleucel or axicabtagene ciloleucel immune effector cell (IEC) therapy for any approved hematologic indication.


Primary: To evaluate the efficacy of itacitinib as a preventative treatment for CRS associated with IEC therapy Secondary: -To evaluate the proportion of participants with ICANS regardless of CRS, after IEC therapy -To evaluate the onset and episode of ICANS using the ICANS Consensus Grading, regardless of CRS, by Day 18 -To evaluate the duration of all grades of CRS, by Day 28 -To evaluate the proportion of participants who develop any grade of CRS within 48 hours after IEC therapy -To evaluate the proportion of participants who develop greater than/equal to Grade 2 CRS by Day 28 of administration after first IEC therapy -To characterize the safety of icacitinib, before and after IEC therapy, excluding CRS and ICANS -To evaluate the number of and length of hospital admissions for CRS and ICANS Exploratory -To evaluate ORR and MRD with IEC therapy in combination with itacitinib -To evaluate tocilizumab treatment necessity for participants on itacitinib against historical data -To evaluate ferritin, CRP, IL-6, IFN-γ, IL-1 and NO levels after IEC therapy -to evaluate cytokine and biomarker profiles associated with and/or predictive of CRS and/or ICANS after IEC therapy -To evaluate PK of itacitinib in participants received IEC therapy



Therapy (NOS)


Itacitinib ()

Inclusion Criteria

  • Eligible to receive an IEC therapy that is approved by the health authority in the country where the study is being conducted for 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.

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