A Phase 2 Study of Itacitinib, for the Prevention of Cytokine Release Syndrome Induced by Immune Effector Cell Therapy
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 who are planning to receive tisagenlecleucel or axicabtagene ciloleucel immune effector cell (IEC) therapy for any approved hematologic indication.
Objective
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
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
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.
If you are interested in learning more about clinical trials, our clinical trial navigators can discuss your options and recommend opportunities that may be suitable for you. Call 813-745-6100 or 1-800-679-0775 (toll-free) or submit a clinical trials inquiry form.
Please call 1-888-663-3488 for support from a Moffitt representative. New Patients and Healthcare Professionals can submit an online form by selecting the appropriate button below. Existing patients can call 1-888-663-3488. Click here for a current list of insurances accepted at Moffitt.
NEW PATIENTS To request a new patient appointment, please fill out the online form or call 1-888-663-3488.
REFERRING PHYSICIANS Providers and medical staff can refer patients by submitting our online referral form.
Moffit now offers Virtual Visits for patients. If you are eligible for a virtual appointment, our scheduling team will discuss this option further with you.
Moffitt Cancer Center is committed to the health and safety of our patients and their families. For more information on how we’re protecting our new and existing patients, visit our COVID-19 Info Hub