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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 : April 13, 2021
Sponsor:
Information provided by (Responsible Party):
Incyte Corporation

Brief 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 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 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 62 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Phase 2, Single-Arm, Open-Label 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 : March 15, 2022
Estimated Study Completion Date : March 15, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Itacitinib Drug: Itacitinib
Itacitinib 200 mg once 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.




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.

  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 hospital admissions for participants with CRS and/or ICANS [ Time Frame: Through end of study, up to 180 days. ]
  8. Duration of hospital stay for participants with CRS and/or ICANS [ Time Frame: Through end of study, up to 180 days. ]


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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:

  • 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

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.

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, Kansas
The University of Kansas Cancer Center Not yet recruiting
Westwood, Kansas, United States, 66205
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
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: April 13, 2021
Last Verified: April 2021
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
Disease
Pathologic Processes