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

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Updated on 19 December 2022
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cancer
hematologic cancer

Summary

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.

Description

For more information, please contact Incyte Corporation at 1.855.463.3463

Details
Condition Hematologic Cancer, Hematologic Indications
Clinical Study IdentifierTX246587
Last Modified on19 December 2022

Eligibility

 Yes No Not Sure

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

Healthy Volunteers
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
Clear my responses
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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