Status:
COMPLETED
A Study of Itacitinib for the Prevention of Cytokine Release Syndrome Induced by Immune Effector Cell Therapy
Lead Sponsor:
Incyte Corporation
Conditions:
Cytokine Release Syndrome
Eligibility:
All Genders
12+ years
Phase:
PHASE2
Brief Summary
"The purpose of this study is to assess the safety and efficacy of oral administration of itacitinib for the prevention of cytokine release syndrome (CRS) in male or female participants aged 12 years ...
Eligibility Criteria
Inclusion
- Part 1: Eligible to receive any IEC therapy for any approved indication.
- Part 2: Eligible to receive Yescarta for relapsed or refractory large B-cell lymphoma or follicular lymphoma.
- Eastern Cooperative Oncology Group performance status 0 to 1.
- Willingness to avoid pregnancy or fathering children
Exclusion
- 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.
Key Trial Info
Start Date :
February 7 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 22 2023
Estimated Enrollment :
112 Patients enrolled
Trial Details
Trial ID
NCT04071366
Start Date
February 7 2020
End Date
August 22 2023
Last Update
March 26 2024
Active Locations (10)
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1
University of Miami Sylvester Comprehensive Cancer Center
Miami, Florida, United States, 33136
2
Moffitt Cancer Center
Tampa, Florida, United States, 33612
3
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
4
Washington University School of Medicine
St Louis, Missouri, United States, 63110