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

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ClinicalTrials.gov Identifier: NCT04071366
Recruitment Status : Recruiting
First Posted : August 28, 2019
Last Update Posted : October 26, 2022
Sponsor:
Information provided by (Responsible Party):
Incyte Corporation

Study Description
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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 or older and who are planning to receive an approved immune effector cell (IEC) therapy for hematologic malignancies.

Condition or disease Intervention/treatment Phase
Cytokine Release Syndrome Drug: Itacitinib Drug: Immune effector cell therapy Drug: Placebo Biological: Yescarta Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 108 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Part 1: Singe Group Assignment Part 2: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description: Part 1 is not masked (open label). Part 2 is double blinded (participant, investigator)
Primary Purpose: Prevention
Official Title: A Phase 2 Study of Itacitinib, for the Prevention of Cytokine Release Syndrome Induced by Immune Effector Cell Therapy
Actual Study Start Date : February 7, 2020
Estimated Primary Completion Date : June 15, 2023
Estimated Study Completion Date : November 15, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Part 1: Open Label Itacitinib Once Daily
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.
 Drug: Itacitinib
Part 1: Itacitinib 200 mg once daily for 30 days. Part 2: Itacitinib 200 mg twice daily for 30 days.
Other Name: INCB039110

Drug: Immune effector cell therapy
Participants will receive IEC therapy that is approved by the health authority in the country where the study is being conducted for any approved hematologic indication.
Other Name: CAR-T cell therapy
Experimental: Part 2: Double-Blind Itacitinib Twice Daily
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.
 Drug: Itacitinib
Part 1: Itacitinib 200 mg once daily for 30 days. Part 2: Itacitinib 200 mg twice daily for 30 days.
Other Name: INCB039110

Drug: Placebo
Participants will receive placebo twice daily.

Biological: Yescarta
Eligible participants are receiving Yescarta (An infusion of chimeric antigen receptor (CAR)-transduced autologous T cells) for relapsed or refractory larbe B-cell lymphoma or follicular lymphoma intravenously.
Other Name: axicabtagene ciloleucel KTE-C19


Outcome Measures
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Primary Outcome Measures :
  1. Proportion of participants who develop ≥ Grade 2 CRS [ Time Frame: Day 14 ]
    Assessed using American Society for Blood and Marrow Transplantation (ASBMT) CRS Consensus Grading.


Secondary Outcome Measures :
  1. Proportion of participants with immune effector cell-associated neurotoxicity syndrome (ICANS) after IEC therapy [ Time Frame: Day 28 ]
    Assessed using the ICANS Consensus Grading. Complete response or partial response for ICANS is defined as either complete disappearance or decrease in the grade of severity as measured by ASTCT Consensus Grading for ICANS. The ASTCT grade is from 1 to 5 for ICANS with 1 being mild symptoms and 5 being severe symptoms.

  2. Duration of ICANS regardless of CRS [ Time Frame: Day 28 ]
    Assessed using the ICANS Consensus Grading.

  3. Duration of all grades of CRS [ Time Frame: Day 28 ]
    Assessed using ASBMT CRS Consensus Grading.

  4. Proportion of participants with any grade of CRS after IEC therapy [ Time Frame: 48 hours ]
    Assessed using ASBMT CRS Consensus Grading.

  5. Proportion of participants with ≥ Grade 2 CRS after first IEC therapy [ Time Frame: Day 28 ]
    Assessed using ASBMT CRS Consensus Grading.

  6. Number of treatment-emergent adverse events [ Time Frame: Day -3 through safety follow-up, up to approximately 60 days. ]
    Defined as adverse events reported for the first time or worsening of a pre-existing event after first dose of itacitinib.

  7. Number of Particpants with ≥ Grade 3 Cytopenias [ Time Frame: Through end of study, up to 90 days. ]
    Cytopenia is diagnosed with a blood test called a complete blood count (CBC). A CBC shows white blood cell, red blood cell, and platelet counts.

  8. Number of hospital admissions for participants with CRS and/or ICANS [ Time Frame: Through end of study, up to 180 days. ]
    Assessed using ASBMT CRS Consensus Grading.

  9. Duration of hospital stay for participants with CRS and/or ICANS [ Time Frame: Through end of study, up to 180 days. ]
    Assessed using ASBMT CRS Consensus Grading.

  10. Percentage of participants who were treated with tocilizumab for CRS [ Time Frame: 30 days ]
    Assessed using ASBMT CRS Consensus Grading.

  11. Percentage of participants requiring >1 dose of dexamethasone (or equivalent) for ICANS. [ Time Frame: 30 days ]
    Assessed using the ICANS Consensus Grading.


Eligibility Criteria
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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04071366


Contacts
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Contact: Incyte Corporation Call Center (US) 1.855.463.3463 medinfo@incyte.com

Locations
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United States, Florida
University of Miami Sylvester Comprehensive Cancer Center Recruiting
Miami, Florida, United States, 33136
Moffitt Cancer Center Recruiting
Tampa, Florida, United States, 33612
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
United States, Missouri
Washington University School of Medicine Recruiting
Saint Louis, Missouri, United States, 63110
United States, New York
Columbia University Medical Center Recruiting
New York, New York, United States, 10032
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
United States, Ohio
Cincinnati Childrens Hospital Medical Center Recruiting
Cincinnati, Ohio, United States, 45229
United States, Oregon
Oregon Health & Science University Recruiting
Portland, Oregon, United States, 97239
United States, Pennsylvania
University of Pennsylvania Hospital Recruiting
Philadelphia, Pennsylvania, United States, 19104
United States, Wisconsin
Medical College of Wisconsin Recruiting
Milwaukee, Wisconsin, United States, 53226
Sponsors and Collaborators
Incyte Corporation
Investigators
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Study Director: Peter Langmuir, MD Incyte Corporation
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Incyte Corporation
ClinicalTrials.gov Identifier: NCT04071366    
Other Study ID Numbers: INCB 39110-211
First Posted: August 28, 2019    Key Record Dates
Last Update Posted: October 26, 2022
Last Verified: October 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Incyte Corporation:
Cytokine release syndrome
immune effector cell-associated neurotoxicity syndrome
Janus kinase inhibitor
immune effector cell therapy
Additional relevant MeSH terms:
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Syndrome
Cytokine Release Syndrome
Disease
Pathologic Processes
 Systemic Inflammatory Response Syndrome
Inflammation
Shock