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

Sponsor
Incyte Corporation (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04071366
Collaborator
(none)
108
Enrollment
10
Locations
2
Arms
43.9
Anticipated Duration (Months)
10.8
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

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
  • Drug: Itacitinib
  • Drug: Immune effector cell therapy
  • Drug: Placebo
  • Biological: Yescarta
 Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
108 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Part 1: Singe Group Assignment Part 2: Parallel AssignmentPart 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 :
Feb 7, 2020
Anticipated Primary Completion Date :
Oct 4, 2023
Anticipated Study Completion Date :
Oct 4, 2023

Arms and Interventions

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 Names:
  • 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 Names:
  • 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 Names:
  • 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 Names:
  • axicabtagene ciloleucel KTE-C19

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Proportion of participants who develop ≥ Grade 2 CRS [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 [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 [Day 28]

      Assessed using the ICANS Consensus Grading.

    3. Duration of all grades of CRS [Day 28]

      Assessed using ASBMT CRS Consensus Grading.

    4. Proportion of participants with any grade of CRS after IEC therapy [48 hours]

      Assessed using ASBMT CRS Consensus Grading.

    5. Proportion of participants with ≥ Grade 2 CRS after first IEC therapy [Day 28]

      Assessed using ASBMT CRS Consensus Grading.

    6. Number of treatment-emergent adverse events [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 [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 [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 [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 [30 days]

      Assessed using ASBMT CRS Consensus Grading.

    11. Percentage of participants requiring >1 dose of dexamethasone (or equivalent) for ICANS. [30 days]

      Assessed using the ICANS Consensus Grading.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    12 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 University of Miami Sylvester Comprehensive Cancer Center Miami Florida United States 33136
    2 Moffitt Cancer Center Tampa Florida United States 33612
    3 Massachusetts General Hospital Boston Massachusetts United States 02114
    4 Washington University School of Medicine Saint Louis Missouri United States 63110
    5 Columbia University Medical Center New York New York United States 10032
    6 Memorial Sloan Kettering Cancer Center New York New York United States 10065
    7 Cincinnati Childrens Hospital Medical Center Cincinnati Ohio United States 45229
    8 Oregon Health & Science University Portland Oregon United States 97239
    9 University of Pennsylvania Hospital Philadelphia Pennsylvania United States 19104
    10 Medical College of Wisconsin Milwaukee Wisconsin United States 53226

    Sponsors and Collaborators

    • Incyte Corporation

    Investigators

    • Study Director: Peter Langmuir, MD, Incyte Corporation

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Incyte Corporation
    ClinicalTrials.gov Identifier:
    NCT04071366
    Other Study ID Numbers:
    • INCB 39110-211
    First Posted:
    Aug 28, 2019
    Last Update Posted:
    May 27, 2022
    Last Verified:
    May 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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:
    Syndrome
    Cytokine Release Syndrome

    Study Results

    No Results Posted as of May 27, 2022