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

Part of paid clinical trials in Miami, Florida.

Sponsor
Incyte Corporation
Study ID
NCT04071366
Phase
PHASE2
Status
Completed

Conditions

  • Cytokine Release Syndrome

Eligibility Criteria

Sex
ALL
Age
12 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Itacitinib — DRUG
    Part 1: Itacitinib 200 mg once daily for 30 days. Part 2: Itacitinib 200 mg twice daily for 30 days.
  • Immune effector cell therapy — DRUG
    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.
  • Placebo — DRUG
    Participants will receive placebo twice daily.
  • Yescarta — BIOLOGICAL
    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.

Study Details

"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.

Key Dates

Start date
Feb 7, 2020
Status verified
Feb 2024
Primary completion
Feb 23, 2023
Completion
Aug 22, 2023

Study Design

Enrollment
112 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • 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.
  • 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.

Primary Outcome Measure

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 [ Time Frame: up to Day 14 of Parts 1 and 2 ]

Locations (10)

FacilityCityStateZIPSite coordinators
University of Miami Sylvester Comprehensive Cancer CenterMiamiFlorida33136-
Moffitt Cancer CenterTampaFlorida33612-
Massachusetts General HospitalBostonMassachusetts02114-
Washington University School of MedicineSt LouisMissouri63110-
Columbia University Medical CenterNew YorkNew York10032-
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065-
Cincinnati Childrens Hospital Medical CenterCincinnatiOhio45229-
Oregon Health & Science UniversityPortlandOregon97239-
University of Pennsylvania HospitalPhiladelphiaPennsylvania19104-
Medical College of WisconsinMilwaukeeWisconsin53226-

Find similar trials in Miami, FL

By research site
University of Miami Sylvester Comprehensive Cancer Center· Miami, FLMoffitt Cancer Center· Tampa, FLMassachusetts General Hospital· Boston, MAWashington University School of Medicine· St Louis, MOColumbia University Medical Center· New York, NYMemorial Sloan Kettering Cancer Center· New York, NY

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