Phase 2
N=63
A Study of Itacitinib for the Prevention of Cytokine Release Syndrome Induced by Immune Effector Cell Therapy
Cytokine Release Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT04071366 ↗Enrolled (actual)
63
Serious AEs
19.1%
Results posted
Mar 2024
Primary outcome: Primary: Percentage of Participants Who Developed ≥Grade 2 Cytokine Release Syndrome (CRS) by Day 14 After Immune Effector Cell (IEC) Therapy, Assessed by Using American Society for Blood and Marrow Transplantation (ASBMT) CRS Consensus Grading — 12.5; 41.7; 20.0; 17.4 percentage of participants — p=0.0030
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Itacitinib (Drug); Immune effector cell therapy (Drug); Placebo (Drug); Yescarta (Biological)
- Age
- Pediatric, Adult, Older Adult · 12+ yrs
- Sex
- All
- Sponsor
- Incyte Corporation
- Primary completion
- Feb 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Who Developed ≥Grade 2 Cytokine Release Syndrome (CRS) by Day 14 After Immune Effector Cell (IEC) Therapy, Assessed by Using American Society for Blood and Marrow Transplantation (ASBMT) CRS Consensus Grading |
12.5; 41.7; 20.0; 17.4; 56.5 | 0.0030 sig |
| SECONDARY Percentage of Participants With Immune Effector Cell-associated Neurotoxicity Syndrome (ICANS) by Day 28 After IEC Therapy, Assessed by Using the ICANS Consensus Grading |
31.3; 41.7; 45.7; 13.0; 34.8 | — |
| SECONDARY Time to Onset of ICANS Using the ICANS Consensus Grading, Regardless of CRS, by Day 28 After IEC Therapy |
4.0; 4.0; 5.0; 5.0; 6.5 | — |
| SECONDARY Duration of ICANS Occurring by Day 28 After IEC Therapy Using the ICANS Consensus Grading, Regardless of CRS |
3.0; 5.0; 1.5; 2.0; 3.5 | — |
| SECONDARY Time to Onset of All Grades of CRS by Day 28 After IEC Therapy, Assessed by Using ASBMT CRS Consensus Grading |
2.0; 2.5; 1.0; 2.0; 3.0 | — |
| SECONDARY Duration of All Grades of CRS Occurring by Day 28 After IEC Therapy, Assessed by Using ASBMT CRS Consensus Grading |
5.0; 4.0; 5.0; 5.0; 4.0 | — |
| SECONDARY Percentage of Participants With Any Grade of CRS at 48 Hours After IEC Therapy, Assessed by Using ASBMT CRS Consensus Grading |
37.5; 33.3; 48.6; 26.1; 30.4 | — |
| SECONDARY Percentage of Participants With ≥Grade 2 CRS by Day 28 After First IEC Therapy, Assessed by Using ASBMT CRS Consensus Grading |
12.5; 41.7; 20.0; 21.7; 56.5 | — |
| SECONDARY Number of Participants With Any Treatment-emergent Adverse Event (TEAE) Except CRS and ICANS |
16; 12; 35; 22; 24 | — |
| SECONDARY Percentage of Participants With Any ≥Grade 3 Cytopenias Ongoing at Day 28 |
8.3; 22.2; 26.6; 31.8; 13.6; 0.0 | — |
| SECONDARY Percentage of Participants Who Were Treated With Tocilizumab for CRS |
18.8; 41.7; 20.0; 17.4; 65.2 | — |
| SECONDARY Percentage of Participants Requiring More Than 1 Dose of Dexamethasone (or Equivalent) for ICANS |
12.5; 25.0; 22.9; 4.3; 30.4 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT04071366). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.