Principal Investigator
Enrollment Status
Clinical Trial ID
Clinical Trial 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 or older and who are planning to receive an approved immune
effector cell (IEC) therapy for hematologic malignancies.
Phase
Phase 2
Funding Agency/Sponsor
Industrial
Disease
Lymphoma
Enrollment Eligibility
Inclusion Criteria:
- 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 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.