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

Incyte

Status and phase: Completed; Phase 2

Conditions: Cytokine Release Syndrome

Treatments: Biological: Yescarta; Drug: Placebo; Drug: Itacitinib; Drug: Immune effector cell therapy

Study type: Interventional

Funder types: Industry

Identifiers

NCT04071366

INCB 39110-211

Details and patient eligibility

About

"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.

Enrollment: 112 patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

112 participants in 2 patient groups

Part 1: Open Label Itacitinib Once Daily

Experimental group

Description:

During Part 1, all participants receive itacitinib 200mg once daily (open label) for 30 days. The study population will include participants receiving any approved IEC for an approved indication.

Treatment:

Drug: Immune effector cell therapy

Drug: Itacitinib

Part 2: Double-Blind Itacitinib Twice Daily

Experimental group

Description:

During Part 2, participants will be randomized to receive itacitinib 200mg or placebo twice daily for 30 days. The study population also includes participants who are receiving Yescarta for relapsed or refractory large B-cell lymphoma or follicular lymphoma.

Treatment:

Drug: Itacitinib

Biological: Yescarta

Drug: Placebo