Cytokine Release Syndrome

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

Incyte Study ID:
INCB 39110-211
CT.gov ID:
NCT04071366
Eudra ID:
N/A
Sponsor:
Incyte Corporation
Collaborator:
N/A
Study Contact Information:
1.855.463.3463 or [email protected]
Study Complete
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Results Available

Protocol
Available Languages: English
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Statistical Analysis Plan (SAP)
Available Languages: English
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Clinical Study Purpose

"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.

Clinical Study Summary

MEDICAL CONDITION(S)
  • Cytokine Release Syndrome
    • PRODUCT
  • Drug: Itacitinib
  • Drug: Immune effector cell therapy
  • Drug: Placebo
    • COLLABORATORS
    N/A
    DATE
    Feb 2020 - Feb 2023
    TYPE
    Interventional
    PHASE
    Phase 2
    SEX
    Female & Male
    AGE
    12+ years
    ACCEPTS HEALTHY VOLUNTEERS
    No

    Clinical Study Locations

    Location
    Status
    Location
    UNIVERSITY OF PENNSYLVANIA HOSPITAL
    PHILADELPHIA, PA, US, 19104
    Status
    Recruiting
    Location
    OREGON HEALTH & SCIENCE UNIVERSITY
    PORTLAND, OR, US, 97239
    Status
    Recruiting
    Location
    WASHINGTON UNIVERSITY SCHOOL OF MEDICINE
    SAINT LOUIS, MO, US, 63110
    Status
    Recruiting
    Location
    MOFFITT CANCER CENTER
    TAMPA, FL, US, 33612
    Status
    Recruiting
    Location
    MASSACHUSETTS GENERAL HOSPITAL
    BOSTON, MA, US, 02114
    Status
    Recruiting
    Location
    COLUMBIA UNIVERSITY MEDICAL CENTER
    NEW YORK, NY, US, 10032
    Status
    Recruiting

    Key Inclusion and Exclusion 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.

    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.

    Protocol Summary

    Incyte Study ID:
    INCB 39110-211
    Primary Purpose:
    Prevention
    Allocation:
    Randomized
    Study Design:
    Parallel Assignment
    Masking:
    Triple (Participant, Care Provider, Investigator)
    Interventions:
    Drug
    Enrollment:
    112
    Primary Outcome
    Open

    Proportion of participants who develop ≥ Grade 2 CRS

    Timeframe: Day 14

    Secondary Outcome
    Open

    Proportion of participants with immune effector cell-associated neurotoxicity syndrome (ICANS) after IEC therapy

    Timeframe: Day 28

    Duration of ICANS regardless of CRS

    Timeframe: Day 28

    Duration of all grades of CRS

    Timeframe: Day 28

    Proportion of participants with any grade of CRS after IEC therapy

    Timeframe: 48 hours

    Proportion of participants with ≥ Grade 2 CRS after first IEC therapy

    Timeframe: Day 28

    Number of treatment-emergent adverse events

    Timeframe: Day -3 through safety follow-up, up to approximately 60 days.

    Number of Particpants with ≥ Grade 3 Cytopenias

    Timeframe: Through end of study, up to 90 days.

    Number of hospital admissions for participants with CRS and/or ICANS

    Timeframe: Through end of study, up to 180 days.

    Duration of hospital stay for participants with CRS and/or ICANS

    Timeframe: Through end of study, up to 180 days.

    Percentage of participants who were treated with tocilizumab for CRS

    Timeframe: 30 days

    Percentage of participants requiring >1 dose of dexamethasone (or equivalent) for ICANS.

    Timeframe: 30 days