A Study of Itacitinib for the Prevention of Cytokine Rele... | NCT04071366 | Trialant
NCT04071366
Sponsor
Incyte Corporation
Status
Completed
Last Update Posted
Mar 26, 2024Actual
Enrollment
112Actual
Phase
Phase 2
Conditions
Cytokine Release Syndrome
Interventions
Itacitinib
Immune effector cell therapy
Placebo
Yescarta
Countries
United States
Protocol Section
Identification Module
NCT ID
NCT04071366
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
INCB 39110-211
Secondary IDs
Not provided
Brief Title
A Study of Itacitinib for the Prevention of Cytokine Release Syndrome Induced by Immune Effector Cell Therapy
Official Title
A Phase 2 Study of Itacitinib, for the Prevention of Cytokine Release Syndrome Induced by Immune Effector Cell Therapy
Acronym
Not provided
Organization
Incyte CorporationINDUSTRY
Status Module
Record Verification Date
Feb 2024
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Feb 7, 2020Actual
Primary Completion Date
Feb 23, 2023Actual
Completion Date
Aug 22, 2023Actual
First Submitted Date
Aug 26, 2019
First Submission Date that Met QC Criteria
Aug 26, 2019
First Posted Date
Aug 28, 2019Actual
Results Waived
Not provided
Results First Submitted Date
Jan 26, 2024
Results First Submitted that Met QC Criteria
Feb 26, 2024
Results First Posted Date
Mar 26, 2024Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Feb 26, 2024
Last Update Posted Date
Mar 26, 2024Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Incyte CorporationINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
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.
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
Drug: Immune effector cell therapy
Part 2: Double-Blind Itacitinib Twice Daily
Experimental
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
Drug: Placebo
Biological: Yescarta
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Itacitinib
Drug
Part 1: Itacitinib 200 mg once daily for 30 days. Part 2: Itacitinib 200 mg twice daily for 30 days.
Part 1: Open Label Itacitinib Once Daily
Part 2: Double-Blind Itacitinib Twice Daily
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
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
The ASBMT CRS Consensus Grading Criteria was used to assess the severity of CRS. Grade 2 CRS: temperature ≥38°C not attributable to any other cause, defined as fever; hypotension not requiring vasopressors, and/or; hypoxia requiring low-flow nasal cannula (oxygen delivered at ≤6 liters/minute) or blow-by. Grade 3 CRS: fever; hypotension requiring one vasopressor with or without vasopressin, and/or; hypoxyia requiring high-flow nasal cannula (oxygen delivered at >6 liters/minute), facemask, nonrebreather mask, or Venturi mask. Grade 4 CRS: fever; hypotension requiring multiple vasopressors (excluding vasopressin), and/or; hypoxia requiring positive pressure (e.g., continuous positive airway pressure [CPAP], bilevel intermittent positive air pressure [BiPAP], intubation, mechanical ventilation).
up to Day 14 of Parts 1 and 2
Secondary Outcomes
Measure
Description
Time Frame
Percentage of Participants With Immune Effector Cell-associated Neurotoxicity Syndrome (ICANS) by Day 28 After IEC Therapy, Assessed by Using the ICANS Consensus Grading
Participants were monitored for signs and symptoms of ICANS, if symptoms developed at any point after IEC. ICANS Consensus Grading Criteria were used to assess 5 domains of neurotoxicity: orientation (orient to year, month, city, and hospital), naming (naming 3 objects), following commands (follow commands such as: show me 2 fingers or close your eyes and stick out your tongue), writing (ability to write a standard sentence), and attention (count backwards from 100 by 10). Each domain is associated with a certain number of points, which are summed to generate a total score. Score 10: no impairment; score 7-9: Grade 1 ICANS; score 3-6: Grade 2 ICANS; score 0-2: Grade 3 ICANS.
Other Outcomes
Measure
Description
Time Frame
Number of Hospital Admissions for Participants With CRS and/or ICANS by the End of the Study
The number of hospital admissions was assessed through study completion.
up to Day 180 of Parts 1 and 2
Duration of Hospital Stay for Participants With CRS and/or ICANS by End of Study
Eligibility Module
Eligibility 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.
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
12 Years
Maximum Age
Not provided
Standard Ages
ChildAdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Peter Langmuir, MD
Incyte Corporation
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
University of Miami Sylvester Comprehensive Cancer Center
Part 1: Itacitinib 200 Milligrams (mg) QD + Kymriah
Participants being treated with Kymriah (Day 0; per prescribing information), an immune effector cell (IEC) therapy for hematologic malignancies, received itacitinib 200 mg once daily (QD) for 30 days (Day -3 to Day 26).
FG001
Part 1: Itacitinib 200 mg QD + Tecartus
Periods
Title
Milestones
Reasons Not Completed
Part 1: Open-label (29 Days)
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot
Yes
No
No
Study Protocol
Dec 8, 2022
Jan 26, 2024
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
Estimated Results First Submitted Date
Not provided
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Part 1: Singe Group Assignment Part 2: Parallel Assignment
Primary Purpose
Prevention
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Triple
Masking Description
Part 1 is not masked (open label). Part 2 is double blinded (participant, investigator)
Who Masked
ParticipantCare ProviderInvestigator
INCB039110
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.
Part 1: Open Label Itacitinib Once Daily
CAR-T cell therapy
Placebo
Drug
Participants will receive placebo twice daily.
Part 2: Double-Blind Itacitinib 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.
Part 2: Double-Blind Itacitinib Twice Daily
axicabtagene ciloleucel KTE-C19
up to Day 28 of Parts 1 and 2
Time to Onset of ICANS Using the ICANS Consensus Grading, Regardless of CRS, by Day 28 After IEC Therapy
Participants were monitored for signs and symptoms of ICANS, if symptoms developed at any point after IEC. ICANS Consensus Grading Criteria were used to assess 5 domains of neurotoxicity: orientation (orient to year, month, city, and hospital), naming (naming 3 objects), following commands (follow commands such as: show me 2 fingers or close your eyes and stick out your tongue), writing (ability to write a standard sentence), and attention (count backwards from 100 by 10). Each domain is associated with a certain number of points, which are summed to generate a total score. Score 10: no impairment; score 7-9: Grade 1 ICANS; score 3-6: Grade 2 ICANS; score 0-2: Grade 3 ICANS.
up to Day 28 of Parts 1 and 2
Duration of ICANS Occurring by Day 28 After IEC Therapy Using the ICANS Consensus Grading, Regardless of CRS
Participants were monitored for signs and symptoms of ICANS, if symptoms developed at any point after IEC. ICANS Consensus Grading Criteria were used to assess 5 domains of neurotoxicity: orientation (orient to year, month, city, and hospital), naming (naming 3 objects), following commands (follow commands such as: show me 2 fingers or close your eyes and stick out your tongue), writing (ability to write a standard sentence), and attention (count backwards from 100 by 10). Each domain is associated with a certain number of points, which are summed to generate a total score. Score 10: no impairment; score 7-9: Grade 1 ICANS; score 3-6: Grade 2 ICANS; score 0-2: Grade 3 ICANS. Duration of ICANS occurring by Day 28 corresponds to the sum of days with non-zero grade ICANS by Day 28.
up to Day 28 of Parts 1 and 2
Time to Onset of All Grades of CRS by Day 28 After IEC Therapy, Assessed by Using ASBMT CRS Consensus Grading
The ASBMT CRS Consensus Grading Criteria was used to assess the severity of CRS. Grade 1: fever; either no hypotention and/or no hypoxia. Grade 2 CRS: fever; hypotension not requiring vasopressors, and/or; hypoxia requiring low-flow nasal cannula (oxygen delivered at ≤6 liters/minute) or blow-by. Grade 3 CRS: fever; hypotension requiring one vasopressor with or without vasopressinc, and/or; hypoxyia requiring high-flow nasal cannula (oxygen delivered at >6 liters/minute), facemask, nonrebreather mask, or Venturi mask. Grade 4 CRS: fever; hypotension requiring multiple vasopressors (excluding vasopressin), and/or; hypoxia requiring positive pressure (e.g., CPAP, BiPAP, intubation, mechanical ventilation).
up to Day 28 of Parts 1 and 2
Duration of All Grades of CRS Occurring by Day 28 After IEC Therapy, Assessed by Using ASBMT CRS Consensus Grading
The ASBMT CRS Consensus Grading Criteria was used to assess the severity of CRS. Grade 1: fever; either no hypotention and/or no hypoxia. Grade 2 CRS: fever; hypotension not requiring vasopressors, and/or; hypoxia requiring low-flow nasal cannula (oxygen delivered at ≤6 liters/minute) or blow-by. Grade 3 CRS: fever; hypotension requiring one vasopressor with or without vasopressinc, and/or; hypoxyia requiring high-flow nasal cannula (oxygen delivered at >6 liters/minute), facemask, nonrebreather mask, or Venturi mask. Grade 4 CRS: fever; hypotension requiring multiple vasopressors (excluding vasopressin), and/or; hypoxia requiring positive pressure (e.g., CPAP, BiPAP, intubation, mechanical ventilation).
up to Day 56 of Parts 1 and 2
Percentage of Participants With Any Grade of CRS at 48 Hours After IEC Therapy, Assessed by Using ASBMT CRS Consensus Grading
The ASBMT CRS Consensus Grading Criteria was used to assess the severity of CRS. Grade 1: fever; either no hypotention and/or no hypoxia. Grade 2 CRS: fever; hypotension not requiring vasopressors, and/or; hypoxia requiring low-flow nasal cannula (oxygen delivered at ≤6 liters/minute) or blow-by. Grade 3 CRS: fever; hypotension requiring one vasopressor with or without vasopressinc, and/or; hypoxyia requiring high-flow nasal cannula (oxygen delivered at >6 liters/minute), facemask, nonrebreather mask, or Venturi mask. Grade 4 CRS: fever; hypotension requiring multiple vasopressors (excluding vasopressin), and/or; hypoxia requiring positive pressure (e.g., CPAP, BiPAP, intubation, mechanical ventilation).
up to Day 2 of Parts 1 and 2
Percentage of Participants With ≥Grade 2 CRS by Day 28 After First IEC Therapy, Assessed by Using ASBMT CRS Consensus Grading
The ASBMT CRS Consensus Grading Criteria was used to assess the severity of CRS. Grade 1: fever; either no hypotention and/or no hypoxia. Grade 2 CRS: fever; hypotension not requiring vasopressors, and/or; hypoxia requiring low-flow nasal cannula (oxygen delivered at ≤6 liters/minute) or blow-by. Grade 3 CRS: fever; hypotension requiring one vasopressor with or without vasopressinc, and/or; hypoxyia requiring high-flow nasal cannula (oxygen delivered at >6 liters/minute), facemask, nonrebreather mask, or Venturi mask. Grade 4 CRS: fever; hypotension requiring multiple vasopressors (excluding vasopressin), and/or; hypoxia requiring positive pressure (e.g., CPAP, BiPAP, intubation, mechanical ventilation).
up to Day 28 of Parts 1 and 2
Number of Participants With Any Treatment-emergent Adverse Event (TEAE) Except CRS and ICANS
An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. For purposes of analysis, all AEs were considered TEAEs unless the AE could unequivocally be defined as not treatment emergent.
from at Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2
Percentage of Participants With Any ≥Grade 3 Cytopenias Ongoing at Day 28
Cytopenia is characterized by low levels of white blood cells, red blood cells, or platelets. Analysis used laboratory counts at Day 28.
Day 28 of Parts 1 and 2
Percentage of Participants Who Were Treated With Tocilizumab for CRS
Tocilizumab and/or corticosteroids for CRS Grade 1 was not allowed per the protocol. However, tocilizumab may have been given as rescue medication for CRS Grade 1 if no improvement was observed within 72 hours from onset, and the participant's medical condition required intervention per investigator judgment.
up to Day 56 of Parts 1 and 2
Percentage of Participants Requiring More Than 1 Dose of Dexamethasone (or Equivalent) for ICANS
Dexamethasone use as rescue medication for ICANS was assessed.
up to Day 30 of Parts 1 and 2
The duration of hospital stays was assessed through study completion.
up to Day 180 of Parts 1 and 2
Tampa
Florida
33612
United States
Massachusetts General Hospital
Boston
Massachusetts
02114
United States
Washington University School of Medicine
St Louis
Missouri
63110
United States
Columbia University Medical Center
New York
New York
10032
United States
Memorial Sloan Kettering Cancer Center
New York
New York
10065
United States
Cincinnati Childrens Hospital Medical Center
Cincinnati
Ohio
45229
United States
Oregon Health & Science University
Portland
Oregon
97239
United States
University of Pennsylvania Hospital
Philadelphia
Pennsylvania
19104
United States
Medical College of Wisconsin
Milwaukee
Wisconsin
53226
United States
Derived
Huarte E, O'Connor RS, Peel MT, Nunez-Cruz S, Leferovich J, Juvekar A, Yang YO, Truong L, Huang T, Naim A, Milone MC, Smith PA. Itacitinib (INCB039110), a JAK1 Inhibitor, Reduces Cytokines Associated with Cytokine Release Syndrome Induced by CAR T-cell Therapy. Clin Cancer Res. 2020 Dec 1;26(23):6299-6309. doi: 10.1158/1078-0432.CCR-20-1739. Epub 2020 Sep 30.
Participants being treated with Tecartus (Day 0; per prescribing information), an IEC therapy for hematologic malignancies, received itacitinib 200 mg QD for 30 days (Day -3 to Day 26).
FG002
Part 1: Itacitinib 200 mg QD + Yescarta
Participants being treated with Yescarta (Day 0; per prescribing information), an IEC therapy for hematologic malignancies, received itacitinib 200 mg QD for 30 days (Day -3 to Day 26).
FG003
Part 2: Itacitinib 200 mg BID + Yescarta
Participants being treated with Yescarta (Day 0; per prescribing information) for relapsed or refractory large B-cell lymphoma or follicular lymphoma received itacitinib 200 mg twice daily (BID) for 30 days (Day -3 to Day 26).
FG004
Part 2: Placebo BID + Yescarta
Participants being treated with Yescarta (Day 0; per prescribing information) for relapsed or refractory large B-cell lymphoma or follicular lymphoma BID for 30 days (Day -3 to Day 26).
FG00016 subjects
FG00112 subjects
FG00235 subjects
FG0030 subjects
FG0040 subjects
COMPLETED
FG00011 subjects
FG00110 subjects
FG00222 subjects
FG0030 subjects
FG0040 subjects
NOT COMPLETED
FG0005 subjects
FG0012 subjects
FG00213 subjects
FG0030 subjects
FG0040 subjects
Type
Comment
Reasons
Death
FG0004 subjects
FG0012 subjects
FG0028 subjects
FG0030 subjects
FG0040 subjects
Progressive Disease
FG0000 subjects
FG0010 subjects
FG0024 subjects
FG0030 subjects
FG004
Withdrawal by Subject
FG0001 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG004
Part 2: Randomized (29 Days)
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG00323 subjects
FG00424 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG00317 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0036 subjects
FG004
Type
Comment
Reasons
Death
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Part 1: Itacitinib 200 Milligrams (mg) QD + Kymriah
Participants being treated with Kymriah (Day 0; per prescribing information), an immune effector cell (IEC) therapy for hematologic malignancies, received itacitinib 200 mg once daily (QD) for 30 days (Day -3 to Day 26).
BG001
Part 1: Itacitinib 200 mg QD + Tecartus
Participants being treated with Tecartus (Day 0; per prescribing information), an IEC therapy for hematologic malignancies, received itacitinib 200 mg QD for 30 days (Day -3 to Day 26).
BG002
Part 1: Itacitinib 200 mg QD + Yescarta
Participants being treated with Yescarta (Day 0; per prescribing information), an IEC therapy for hematologic malignancies, received itacitinib 200 mg QD for 30 days (Day -3 to Day 26).
BG003
Part 2: Itacitinib 200 mg BID + Yescarta
Participants being treated with Yescarta (Day 0; per prescribing information) for relapsed or refractory large B-cell lymphoma or follicular lymphoma received itacitinib 200 mg twice daily (BID) for 30 days (Day -3 to Day 26).
BG004
Part 2: Placebo BID + Yescarta
Participants being treated with Yescarta (Day 0; per prescribing information) for relapsed or refractory large B-cell lymphoma or follicular lymphoma BID for 30 days (Day -3 to Day 26).
BG005
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00016
BG00112
BG00235
BG00323
BG00424
BG005110
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00068.8± 15.22
BG00166.2± 12.08
BG00263.5± 10.21
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0004
BG0011
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0000
BG0011
BG002
Race/Ethnicity, Customized
Count of Participants
Participants
Title
Denominators
Categories
White/Caucasian
Title
Measurements
BG00013
BG00112
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
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
The ASBMT CRS Consensus Grading Criteria was used to assess the severity of CRS. Grade 2 CRS: temperature ≥38°C not attributable to any other cause, defined as fever; hypotension not requiring vasopressors, and/or; hypoxia requiring low-flow nasal cannula (oxygen delivered at ≤6 liters/minute) or blow-by. Grade 3 CRS: fever; hypotension requiring one vasopressor with or without vasopressin, and/or; hypoxyia requiring high-flow nasal cannula (oxygen delivered at >6 liters/minute), facemask, nonrebreather mask, or Venturi mask. Grade 4 CRS: fever; hypotension requiring multiple vasopressors (excluding vasopressin), and/or; hypoxia requiring positive pressure (e.g., continuous positive airway pressure [CPAP], bilevel intermittent positive air pressure [BiPAP], intubation, mechanical ventilation).
Efficacy Evaluable Analysis Set (EAS): all participants who received at least 1 dose of study drug and received IEC therapy. The exact 95% confidence interval (2-sided) was calculated using the Clopper-Pearson method.
Posted
Number
95% Confidence Interval
percentage of participants
up to Day 14 of Parts 1 and 2
ID
Title
Description
OG000
Part 1: Itacitinib 200 Milligrams (mg) QD + Kymriah
Participants being treated with Kymriah (Day 0; per prescribing information), an immune effector cell (IEC) therapy for hematologic malignancies, received itacitinib 200 mg once daily (QD) for 30 days (Day -3 to Day 26).
OG001
Part 1: Itacitinib 200 mg QD + Tecartus
Participants being treated with Tecartus (Day 0; per prescribing information), an IEC therapy for hematologic malignancies, received itacitinib 200 mg QD for 30 days (Day -3 to Day 26).
OG002
Part 1: Itacitinib 200 mg QD + Yescarta
Participants being treated with Yescarta (Day 0; per prescribing information), an IEC therapy for hematologic malignancies, received itacitinib 200 mg QD for 30 days (Day -3 to Day 26).
OG003
Part 2: Itacitinib 200 mg BID + Yescarta
Participants being treated with Yescarta (Day 0; per prescribing information) for relapsed or refractory large B-cell lymphoma or follicular lymphoma received itacitinib 200 mg twice daily (BID) for 30 days (Day -3 to Day 26).
OG004
Part 2: Placebo BID + Yescarta
Participants being treated with Yescarta (Day 0; per prescribing information) for relapsed or refractory large B-cell lymphoma or follicular lymphoma BID for 30 days (Day -3 to Day 26).
Units
Counts
Participants
OG00016
OG00112
OG00235
OG003
Title
Denominators
Categories
Title
Measurements
OG00012.5(1.6 to 38.3)
OG00141.7(15.2 to 72.3)
OG00220.0(8.4 to 36.9)
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG003
OG004
One-sided Z-test
0.0030
Difference in CRS rate
-0.39
2-Sided
95
-0.6463
-0.1363
Superiority
OG002
OG004
Secondary
Percentage of Participants With Immune Effector Cell-associated Neurotoxicity Syndrome (ICANS) by Day 28 After IEC Therapy, Assessed by Using the ICANS Consensus Grading
Participants were monitored for signs and symptoms of ICANS, if symptoms developed at any point after IEC. ICANS Consensus Grading Criteria were used to assess 5 domains of neurotoxicity: orientation (orient to year, month, city, and hospital), naming (naming 3 objects), following commands (follow commands such as: show me 2 fingers or close your eyes and stick out your tongue), writing (ability to write a standard sentence), and attention (count backwards from 100 by 10). Each domain is associated with a certain number of points, which are summed to generate a total score. Score 10: no impairment; score 7-9: Grade 1 ICANS; score 3-6: Grade 2 ICANS; score 0-2: Grade 3 ICANS.
EAS. The exact 95% confidence interval (2-sided) was calculated using the Clopper-Pearson method.
Posted
Number
95% Confidence Interval
percentage of participants
up to Day 28 of Parts 1 and 2
ID
Title
Description
OG000
Part 1: Itacitinib 200 Milligrams (mg) QD + Kymriah
Participants being treated with Kymriah (Day 0; per prescribing information), an immune effector cell (IEC) therapy for hematologic malignancies, received itacitinib 200 mg once daily (QD) for 30 days (Day -3 to Day 26).
OG001
Part 1: Itacitinib 200 mg QD + Tecartus
Participants being treated with Tecartus (Day 0; per prescribing information), an IEC therapy for hematologic malignancies, received itacitinib 200 mg QD for 30 days (Day -3 to Day 26).
Secondary
Time to Onset of ICANS Using the ICANS Consensus Grading, Regardless of CRS, by Day 28 After IEC Therapy
Participants were monitored for signs and symptoms of ICANS, if symptoms developed at any point after IEC. ICANS Consensus Grading Criteria were used to assess 5 domains of neurotoxicity: orientation (orient to year, month, city, and hospital), naming (naming 3 objects), following commands (follow commands such as: show me 2 fingers or close your eyes and stick out your tongue), writing (ability to write a standard sentence), and attention (count backwards from 100 by 10). Each domain is associated with a certain number of points, which are summed to generate a total score. Score 10: no impairment; score 7-9: Grade 1 ICANS; score 3-6: Grade 2 ICANS; score 0-2: Grade 3 ICANS.
EAS. Only participants with ICANS onset by Day 28 were analyzed.
Posted
Median
Full Range
days
up to Day 28 of Parts 1 and 2
ID
Title
Description
OG000
Part 1: Itacitinib 200 Milligrams (mg) QD + Kymriah
Participants being treated with Kymriah (Day 0; per prescribing information), an immune effector cell (IEC) therapy for hematologic malignancies, received itacitinib 200 mg once daily (QD) for 30 days (Day -3 to Day 26).
OG001
Part 1: Itacitinib 200 mg QD + Tecartus
Participants being treated with Tecartus (Day 0; per prescribing information), an IEC therapy for hematologic malignancies, received itacitinib 200 mg QD for 30 days (Day -3 to Day 26).
Secondary
Duration of ICANS Occurring by Day 28 After IEC Therapy Using the ICANS Consensus Grading, Regardless of CRS
Participants were monitored for signs and symptoms of ICANS, if symptoms developed at any point after IEC. ICANS Consensus Grading Criteria were used to assess 5 domains of neurotoxicity: orientation (orient to year, month, city, and hospital), naming (naming 3 objects), following commands (follow commands such as: show me 2 fingers or close your eyes and stick out your tongue), writing (ability to write a standard sentence), and attention (count backwards from 100 by 10). Each domain is associated with a certain number of points, which are summed to generate a total score. Score 10: no impairment; score 7-9: Grade 1 ICANS; score 3-6: Grade 2 ICANS; score 0-2: Grade 3 ICANS. Duration of ICANS occurring by Day 28 corresponds to the sum of days with non-zero grade ICANS by Day 28.
EAS. Only participants with ICANS onset by Day 28 were analyzed.
Posted
Median
Full Range
days
up to Day 28 of Parts 1 and 2
ID
Title
Description
OG000
Part 1: Itacitinib 200 Milligrams (mg) QD + Kymriah
Participants being treated with Kymriah (Day 0; per prescribing information), an immune effector cell (IEC) therapy for hematologic malignancies, received itacitinib 200 mg once daily (QD) for 30 days (Day -3 to Day 26).
OG001
Part 1: Itacitinib 200 mg QD + Tecartus
Participants being treated with Tecartus (Day 0; per prescribing information), an IEC therapy for hematologic malignancies, received itacitinib 200 mg QD for 30 days (Day -3 to Day 26).
Secondary
Time to Onset of All Grades of CRS by Day 28 After IEC Therapy, Assessed by Using ASBMT CRS Consensus Grading
The ASBMT CRS Consensus Grading Criteria was used to assess the severity of CRS. Grade 1: fever; either no hypotention and/or no hypoxia. Grade 2 CRS: fever; hypotension not requiring vasopressors, and/or; hypoxia requiring low-flow nasal cannula (oxygen delivered at ≤6 liters/minute) or blow-by. Grade 3 CRS: fever; hypotension requiring one vasopressor with or without vasopressinc, and/or; hypoxyia requiring high-flow nasal cannula (oxygen delivered at >6 liters/minute), facemask, nonrebreather mask, or Venturi mask. Grade 4 CRS: fever; hypotension requiring multiple vasopressors (excluding vasopressin), and/or; hypoxia requiring positive pressure (e.g., CPAP, BiPAP, intubation, mechanical ventilation).
EAS. Only participants with CRS onset by Day 28 were analyzed.
Posted
Median
Full Range
days
up to Day 28 of Parts 1 and 2
ID
Title
Description
OG000
Part 1: Itacitinib 200 Milligrams (mg) QD + Kymriah
Participants being treated with Kymriah (Day 0; per prescribing information), an immune effector cell (IEC) therapy for hematologic malignancies, received itacitinib 200 mg once daily (QD) for 30 days (Day -3 to Day 26).
OG001
Part 1: Itacitinib 200 mg QD + Tecartus
Participants being treated with Tecartus (Day 0; per prescribing information), an IEC therapy for hematologic malignancies, received itacitinib 200 mg QD for 30 days (Day -3 to Day 26).
Secondary
Duration of All Grades of CRS Occurring by Day 28 After IEC Therapy, Assessed by Using ASBMT CRS Consensus Grading
The ASBMT CRS Consensus Grading Criteria was used to assess the severity of CRS. Grade 1: fever; either no hypotention and/or no hypoxia. Grade 2 CRS: fever; hypotension not requiring vasopressors, and/or; hypoxia requiring low-flow nasal cannula (oxygen delivered at ≤6 liters/minute) or blow-by. Grade 3 CRS: fever; hypotension requiring one vasopressor with or without vasopressinc, and/or; hypoxyia requiring high-flow nasal cannula (oxygen delivered at >6 liters/minute), facemask, nonrebreather mask, or Venturi mask. Grade 4 CRS: fever; hypotension requiring multiple vasopressors (excluding vasopressin), and/or; hypoxia requiring positive pressure (e.g., CPAP, BiPAP, intubation, mechanical ventilation).
EAS. Only participants with CRS onset by Day 28 were analyzed.
Posted
Median
Full Range
days
up to Day 56 of Parts 1 and 2
ID
Title
Description
OG000
Part 1: Itacitinib 200 Milligrams (mg) QD + Kymriah
Participants being treated with Kymriah (Day 0; per prescribing information), an immune effector cell (IEC) therapy for hematologic malignancies, received itacitinib 200 mg once daily (QD) for 30 days (Day -3 to Day 26).
OG001
Part 1: Itacitinib 200 mg QD + Tecartus
Participants being treated with Tecartus (Day 0; per prescribing information), an IEC therapy for hematologic malignancies, received itacitinib 200 mg QD for 30 days (Day -3 to Day 26).
Secondary
Percentage of Participants With Any Grade of CRS at 48 Hours After IEC Therapy, Assessed by Using ASBMT CRS Consensus Grading
The ASBMT CRS Consensus Grading Criteria was used to assess the severity of CRS. Grade 1: fever; either no hypotention and/or no hypoxia. Grade 2 CRS: fever; hypotension not requiring vasopressors, and/or; hypoxia requiring low-flow nasal cannula (oxygen delivered at ≤6 liters/minute) or blow-by. Grade 3 CRS: fever; hypotension requiring one vasopressor with or without vasopressinc, and/or; hypoxyia requiring high-flow nasal cannula (oxygen delivered at >6 liters/minute), facemask, nonrebreather mask, or Venturi mask. Grade 4 CRS: fever; hypotension requiring multiple vasopressors (excluding vasopressin), and/or; hypoxia requiring positive pressure (e.g., CPAP, BiPAP, intubation, mechanical ventilation).
EAS. The exact 95% confidence interval (2-sided) was calculated using the Clopper-Pearson method.
Posted
Number
95% Confidence Interval
percentage of participants
up to Day 2 of Parts 1 and 2
ID
Title
Description
OG000
Part 1: Itacitinib 200 Milligrams (mg) QD + Kymriah
Participants being treated with Kymriah (Day 0; per prescribing information), an immune effector cell (IEC) therapy for hematologic malignancies, received itacitinib 200 mg once daily (QD) for 30 days (Day -3 to Day 26).
OG001
Part 1: Itacitinib 200 mg QD + Tecartus
Participants being treated with Tecartus (Day 0; per prescribing information), an IEC therapy for hematologic malignancies, received itacitinib 200 mg QD for 30 days (Day -3 to Day 26).
Secondary
Percentage of Participants With ≥Grade 2 CRS by Day 28 After First IEC Therapy, Assessed by Using ASBMT CRS Consensus Grading
The ASBMT CRS Consensus Grading Criteria was used to assess the severity of CRS. Grade 1: fever; either no hypotention and/or no hypoxia. Grade 2 CRS: fever; hypotension not requiring vasopressors, and/or; hypoxia requiring low-flow nasal cannula (oxygen delivered at ≤6 liters/minute) or blow-by. Grade 3 CRS: fever; hypotension requiring one vasopressor with or without vasopressinc, and/or; hypoxyia requiring high-flow nasal cannula (oxygen delivered at >6 liters/minute), facemask, nonrebreather mask, or Venturi mask. Grade 4 CRS: fever; hypotension requiring multiple vasopressors (excluding vasopressin), and/or; hypoxia requiring positive pressure (e.g., CPAP, BiPAP, intubation, mechanical ventilation).
EAS. The exact 95% confidence interval (2-sided) was calculated using the Clopper-Pearson method.
Posted
Number
95% Confidence Interval
percentage of participants
up to Day 28 of Parts 1 and 2
ID
Title
Description
OG000
Part 1: Itacitinib 200 Milligrams (mg) QD + Kymriah
Participants being treated with Kymriah (Day 0; per prescribing information), an immune effector cell (IEC) therapy for hematologic malignancies, received itacitinib 200 mg once daily (QD) for 30 days (Day -3 to Day 26).
OG001
Part 1: Itacitinib 200 mg QD + Tecartus
Participants being treated with Tecartus (Day 0; per prescribing information), an IEC therapy for hematologic malignancies, received itacitinib 200 mg QD for 30 days (Day -3 to Day 26).
Secondary
Number of Participants With Any Treatment-emergent Adverse Event (TEAE) Except CRS and ICANS
An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. For purposes of analysis, all AEs were considered TEAEs unless the AE could unequivocally be defined as not treatment emergent.
Safety Evaluable Set: all enrolled participants who received at least 1 dose of study drug
Posted
Number
participants
from at Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2
ID
Title
Description
OG000
Part 1: Itacitinib 200 Milligrams (mg) QD + Kymriah
Participants being treated with Kymriah (Day 0; per prescribing information), an immune effector cell (IEC) therapy for hematologic malignancies, received itacitinib 200 mg once daily (QD) for 30 days (Day -3 to Day 26).
OG001
Part 1: Itacitinib 200 mg QD + Tecartus
Participants being treated with Tecartus (Day 0; per prescribing information), an IEC therapy for hematologic malignancies, received itacitinib 200 mg QD for 30 days (Day -3 to Day 26).
OG002
Secondary
Percentage of Participants With Any ≥Grade 3 Cytopenias Ongoing at Day 28
Cytopenia is characterized by low levels of white blood cells, red blood cells, or platelets. Analysis used laboratory counts at Day 28.
EAS. Only participants with available data were analyzed.
Posted
Number
percentage of participants
Day 28 of Parts 1 and 2
ID
Title
Description
OG000
Part 1: Itacitinib 200 Milligrams (mg) QD + Kymriah
Participants being treated with Kymriah (Day 0; per prescribing information), an immune effector cell (IEC) therapy for hematologic malignancies, received itacitinib 200 mg once daily (QD) for 30 days (Day -3 to Day 26).
OG001
Part 1: Itacitinib 200 mg QD + Tecartus
Participants being treated with Tecartus (Day 0; per prescribing information), an IEC therapy for hematologic malignancies, received itacitinib 200 mg QD for 30 days (Day -3 to Day 26).
OG002
Part 1: Itacitinib 200 mg QD + Yescarta
Participants being treated with Yescarta (Day 0; per prescribing information), an IEC therapy for hematologic malignancies, received itacitinib 200 mg QD for 30 days (Day -3 to Day 26).
Other Pre-specified
Number of Hospital Admissions for Participants With CRS and/or ICANS by the End of the Study
The number of hospital admissions was assessed through study completion.
Data have not been reported, as the outcome measure is exploratory.
Posted
up to Day 180 of Parts 1 and 2
ID
Title
Description
OG000
Part 1: Itacitinib 200 Milligrams (mg) QD + Kymriah
Participants being treated with Kymriah (Day 0; per prescribing information), an immune effector cell (IEC) therapy for hematologic malignancies, received itacitinib 200 mg once daily (QD) for 30 days (Day -3 to Day 26).
OG001
Part 1: Itacitinib 200 mg QD + Tecartus
Participants being treated with Tecartus (Day 0; per prescribing information), an IEC therapy for hematologic malignancies, received itacitinib 200 mg QD for 30 days (Day -3 to Day 26).
OG002
Part 1: Itacitinib 200 mg QD + Yescarta
Participants being treated with Yescarta (Day 0; per prescribing information), an IEC therapy for hematologic malignancies, received itacitinib 200 mg QD for 30 days (Day -3 to Day 26).
OG003
Part 2: Itacitinib 200 mg BID + Yescarta
Other Pre-specified
Duration of Hospital Stay for Participants With CRS and/or ICANS by End of Study
The duration of hospital stays was assessed through study completion.
Data have not been reported as the outcome measure is exploratory.
Posted
up to Day 180 of Parts 1 and 2
ID
Title
Description
OG000
Part 1: Itacitinib 200 Milligrams (mg) QD + Kymriah
Participants being treated with Kymriah (Day 0; per prescribing information), an immune effector cell (IEC) therapy for hematologic malignancies, received itacitinib 200 mg once daily (QD) for 30 days (Day -3 to Day 26).
OG001
Part 1: Itacitinib 200 mg QD + Tecartus
Participants being treated with Tecartus (Day 0; per prescribing information), an IEC therapy for hematologic malignancies, received itacitinib 200 mg QD for 30 days (Day -3 to Day 26).
OG002
Part 1: Itacitinib 200 mg QD + Yescarta
Participants being treated with Yescarta (Day 0; per prescribing information), an IEC therapy for hematologic malignancies, received itacitinib 200 mg QD for 30 days (Day -3 to Day 26).
OG003
Part 2: Itacitinib 200 mg BID + Yescarta
Secondary
Percentage of Participants Who Were Treated With Tocilizumab for CRS
Tocilizumab and/or corticosteroids for CRS Grade 1 was not allowed per the protocol. However, tocilizumab may have been given as rescue medication for CRS Grade 1 if no improvement was observed within 72 hours from onset, and the participant's medical condition required intervention per investigator judgment.
EAS
Posted
Number
percentage of participants
up to Day 56 of Parts 1 and 2
ID
Title
Description
OG000
Part 1: Itacitinib 200 Milligrams (mg) QD + Kymriah
Participants being treated with Kymriah (Day 0; per prescribing information), an immune effector cell (IEC) therapy for hematologic malignancies, received itacitinib 200 mg once daily (QD) for 30 days (Day -3 to Day 26).
OG001
Part 1: Itacitinib 200 mg QD + Tecartus
Participants being treated with Tecartus (Day 0; per prescribing information), an IEC therapy for hematologic malignancies, received itacitinib 200 mg QD for 30 days (Day -3 to Day 26).
OG002
Part 1: Itacitinib 200 mg QD + Yescarta
Participants being treated with Yescarta (Day 0; per prescribing information), an IEC therapy for hematologic malignancies, received itacitinib 200 mg QD for 30 days (Day -3 to Day 26).
Secondary
Percentage of Participants Requiring More Than 1 Dose of Dexamethasone (or Equivalent) for ICANS
Dexamethasone use as rescue medication for ICANS was assessed.
EAS
Posted
Number
percentage of participants
up to Day 30 of Parts 1 and 2
ID
Title
Description
OG000
Part 1: Itacitinib 200 Milligrams (mg) QD + Kymriah
Participants being treated with Kymriah (Day 0; per prescribing information), an immune effector cell (IEC) therapy for hematologic malignancies, received itacitinib 200 mg once daily (QD) for 30 days (Day -3 to Day 26).
OG001
Part 1: Itacitinib 200 mg QD + Tecartus
Participants being treated with Tecartus (Day 0; per prescribing information), an IEC therapy for hematologic malignancies, received itacitinib 200 mg QD for 30 days (Day -3 to Day 26).
OG002
Part 1: Itacitinib 200 mg QD + Yescarta
Participants being treated with Yescarta (Day 0; per prescribing information), an IEC therapy for hematologic malignancies, received itacitinib 200 mg QD for 30 days (Day -3 to Day 26).
OG003
Part 2: Itacitinib 200 mg BID + Yescarta
Time Frame
TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.
Description
Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Part 1: Itacitinib 200 Milligrams (mg) QD + Kymriah
Participants being treated with Kymriah (Day 0; per prescribing information), an immune effector cell (IEC) therapy for hematologic malignancies, received itacitinib 200 mg once daily (QD) for 30 days (Day -3 to Day 26).
4
16
2
16
16
16
EG001
Part 1: Itacitinib 200 mg QD + Tecartus
Participants being treated with Tecartus (Day 0; per prescribing information), an IEC therapy for hematologic malignancies, received itacitinib 200 mg QD for 30 days (Day -3 to Day 26).
2
12
1
12
12
12
EG002
Part 1: Itacitinib 200 mg QD + Yescarta
Participants being treated with Yescarta (Day 0; per prescribing information), an IEC therapy for hematologic malignancies, received itacitinib 200 mg QD for 30 days (Day -3 to Day 26).
9
35
9
35
35
35
EG003
Part 1: Itacitinib 200 mg + Any IEC
Participants being treated with Kymriah, Yescarta, and Tecartus (Day 0; per prescribing information), IEC therapies for hematologic malignancies, received itacitinib 200 mg once daily for 30 days (Day -3 to Day 26).
15
63
12
63
63
63
EG004
Part 2: Itacitinib 200 mg BID + Yescarta
Participants being treated with Yescarta (Day 0; per prescribing information) for relapsed or refractory large B-cell lymphoma or follicular lymphoma received itacitinib 200 mg twice daily (BID) for 30 days (Day -3 to Day 26).
2
23
3
23
22
23
EG005
Part 2: Placebo BID + Yescarta
Participants being treated with Yescarta (Day 0; per prescribing information) for relapsed or refractory large B-cell lymphoma or follicular lymphoma BID for 30 days (Day -3 to Day 26).
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 26
Systematic Assessment
EG0001 events1 affected16 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected35 at risk
EG003
Memory impairment
Nervous system disorders
MedDRA 26
Systematic Assessment
EG0001 events1 affected16 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected35 at risk
EG003
Mental impairment
Nervous system disorders
MedDRA 26
Systematic Assessment
EG0001 events1 affected16 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected35 at risk
EG003
Mental status changes
Psychiatric disorders
MedDRA 26
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected12 at risk
EG0023 events3 affected35 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA 26
Systematic Assessment
EG0001 events1 affected16 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected35 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA 26
Systematic Assessment
EG0002 events2 affected16 at risk
EG0011 events1 affected12 at risk
EG0021 events1 affected35 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA 26
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected35 at risk
EG003
Musculoskeletal stiffness
Musculoskeletal and connective tissue disorders
MedDRA 26
Systematic Assessment
EG0001 events1 affected16 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected35 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 26
Systematic Assessment
EG0002 events2 affected16 at risk
EG0012 events2 affected12 at risk
EG0024 events4 affected35 at risk
EG003
Myoclonus
Nervous system disorders
MedDRA 26
Systematic Assessment
EG0002 events2 affected16 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected35 at risk
EG003
Nasal congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 26
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected35 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 26
Systematic Assessment
EG0005 events5 affected16 at risk
EG0017 events5 affected12 at risk
EG00221 events15 affected35 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA 26
Systematic Assessment
EG0001 events1 affected16 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected35 at risk
EG003
Neurotoxicity
Nervous system disorders
MedDRA 26
Systematic Assessment
EG0001 events1 affected16 at risk
EG0011 events1 affected12 at risk
EG0024 events2 affected35 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA 26
Systematic Assessment
EG0006 events3 affected16 at risk
EG0015 events3 affected12 at risk
EG0023 events3 affected35 at risk
EG003
Neutrophil count decreased
Investigations
MedDRA 26
Systematic Assessment
EG0003 events2 affected16 at risk
EG0012 events2 affected12 at risk
EG00214 events8 affected35 at risk
EG003
Night sweats
Skin and subcutaneous tissue disorders
MedDRA 26
Systematic Assessment
EG0001 events1 affected16 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected35 at risk
EG003
Nocturia
Renal and urinary disorders
MedDRA 26
Systematic Assessment
EG0001 events1 affected16 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected35 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA 26
Systematic Assessment
EG0001 events1 affected16 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected35 at risk
EG003
Oedema
General disorders
MedDRA 26
Systematic Assessment
EG0001 events1 affected16 at risk
EG0011 events1 affected12 at risk
EG0020 events0 affected35 at risk
EG003
Oedema peripheral
General disorders
MedDRA 26
Systematic Assessment
EG0005 events5 affected16 at risk
EG0010 events0 affected12 at risk
EG0023 events3 affected35 at risk
EG003
Onychomycosis
Infections and infestations
MedDRA 26
Systematic Assessment
EG0001 events1 affected16 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected35 at risk
EG003
Oral candidiasis
Infections and infestations
MedDRA 26
Systematic Assessment
EG0000 events0 affected16 at risk
EG0012 events2 affected12 at risk
EG0022 events2 affected35 at risk
EG003
Oral pain
Gastrointestinal disorders
MedDRA 26
Systematic Assessment
EG0001 events1 affected16 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected35 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA 26
Systematic Assessment
EG0000 events0 affected16 at risk
EG0012 events2 affected12 at risk
EG0020 events0 affected35 at risk
EG003
Orthostatic hypotension
Vascular disorders
MedDRA 26
Systematic Assessment
EG0001 events1 affected16 at risk
EG0012 events1 affected12 at risk
EG0023 events3 affected35 at risk
EG003
Pain
General disorders
MedDRA 26
Systematic Assessment
EG0003 events3 affected16 at risk
EG0010 events0 affected12 at risk
EG0022 events2 affected35 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 26
Systematic Assessment
EG0001 events1 affected16 at risk
EG0011 events1 affected12 at risk
EG0020 events0 affected35 at risk
EG003
Pancytopenia
Blood and lymphatic system disorders
MedDRA 26
Systematic Assessment
EG0000 events0 affected16 at risk
EG0011 events1 affected12 at risk
EG0023 events3 affected35 at risk
EG003
Penile ulceration
Skin and subcutaneous tissue disorders
MedDRA 26
Systematic Assessment
EG0001 events1 affected16 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected35 at risk
EG003
Platelet count decreased
Investigations
MedDRA 26
Systematic Assessment
EG0006 events4 affected16 at risk
EG0013 events2 affected12 at risk
EG00210 events6 affected35 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA 26
Systematic Assessment
EG0001 events1 affected16 at risk
EG0011 events1 affected12 at risk
EG0020 events0 affected35 at risk
EG003
Pollakiuria
Renal and urinary disorders
MedDRA 26
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected35 at risk
EG003
Polyomavirus viraemia
Infections and infestations
MedDRA 26
Systematic Assessment
EG0001 events1 affected16 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected35 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA 26
Systematic Assessment
EG0001 events1 affected16 at risk
EG0011 events1 affected12 at risk
EG0020 events0 affected35 at risk
EG003
Purpura
Skin and subcutaneous tissue disorders
MedDRA 26
Systematic Assessment
EG0001 events1 affected16 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected35 at risk
EG003
Pyrexia
General disorders
MedDRA 26
Systematic Assessment
EG00013 events8 affected16 at risk
EG00112 events8 affected12 at risk
EG00225 events22 affected35 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA 26
Systematic Assessment
EG0001 events1 affected16 at risk
EG0011 events1 affected12 at risk
EG0021 events1 affected35 at risk
EG003
Rash erythematous
Skin and subcutaneous tissue disorders
MedDRA 26
Systematic Assessment
EG0001 events1 affected16 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected35 at risk
EG003
Rash maculo-papular
Skin and subcutaneous tissue disorders
MedDRA 26
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected12 at risk
EG0021 events1 affected35 at risk
EG003
Rash papular
Skin and subcutaneous tissue disorders
MedDRA 26
Systematic Assessment
EG0000 events0 affected16 at risk
EG0012 events2 affected12 at risk
EG0020 events0 affected35 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MedDRA 26
Systematic Assessment
EG0002 events2 affected16 at risk
EG0011 events1 affected12 at risk
EG0021 events1 affected35 at risk
EG003
Seasonal allergy
Immune system disorders
MedDRA 26
Systematic Assessment
EG0001 events1 affected16 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected35 at risk
EG003
Sensitive skin
Skin and subcutaneous tissue disorders
MedDRA 26
Systematic Assessment
EG0001 events1 affected16 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected35 at risk
EG003
Sepsis
Infections and infestations
MedDRA 26
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected35 at risk
EG003
Serum ferritin increased
Investigations
MedDRA 26
Systematic Assessment
EG0000 events0 affected16 at risk
EG0011 events1 affected12 at risk
EG0021 events1 affected35 at risk
EG003
Sinus bradycardia
Cardiac disorders
MedDRA 26
Systematic Assessment
EG0001 events1 affected16 at risk
EG0010 events0 affected12 at risk
EG0022 events2 affected35 at risk
EG003
Sinus tachycardia
Cardiac disorders
MedDRA 26
Systematic Assessment
EG0000 events0 affected16 at risk
EG0012 events2 affected12 at risk
EG0026 events5 affected35 at risk
EG003
Skin ulcer
Skin and subcutaneous tissue disorders
MedDRA 26
Systematic Assessment
EG0001 events1 affected16 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected35 at risk
EG003
Staphylococcal infection
Infections and infestations
MedDRA 26
Systematic Assessment
EG0001 events1 affected16 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected35 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA 26
Systematic Assessment
EG0001 events1 affected16 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected35 at risk
EG003
Supraventricular tachycardia
Cardiac disorders
MedDRA 26
Systematic Assessment
EG0000 events0 affected16 at risk
EG0011 events1 affected12 at risk
EG0020 events0 affected35 at risk
EG003
Syncope
Nervous system disorders
MedDRA 26
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected12 at risk
EG0023 events2 affected35 at risk
EG003
Tachycardia
Cardiac disorders
MedDRA 26
Systematic Assessment
EG0002 events2 affected16 at risk
EG0012 events1 affected12 at risk
EG0025 events5 affected35 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA 26
Systematic Assessment
EG0003 events2 affected16 at risk
EG0013 events3 affected12 at risk
EG0023 events2 affected35 at risk
EG003
Tremor
Nervous system disorders
MedDRA 26
Systematic Assessment
EG0002 events2 affected16 at risk
EG0010 events0 affected12 at risk
EG0025 events5 affected35 at risk
EG003
Urinary incontinence
Renal and urinary disorders
MedDRA 26
Systematic Assessment
EG0002 events2 affected16 at risk
EG0010 events0 affected12 at risk
EG0022 events2 affected35 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 26
Systematic Assessment
EG0001 events1 affected16 at risk
EG0010 events0 affected12 at risk
EG0021 events1 affected35 at risk
EG003
Vision blurred
Eye disorders
MedDRA 26
Systematic Assessment
EG0002 events2 affected16 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected35 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 26
Systematic Assessment
EG0005 events2 affected16 at risk
EG0012 events2 affected12 at risk
EG0024 events3 affected35 at risk
EG003
Weight decreased
Investigations
MedDRA 26
Systematic Assessment
EG0005 events3 affected16 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected35 at risk
EG003
Wheezing
Respiratory, thoracic and mediastinal disorders
MedDRA 26
Systematic Assessment
EG0000 events0 affected16 at risk
EG0011 events1 affected12 at risk
EG0020 events0 affected35 at risk
EG003
White blood cell count decreased
Investigations
MedDRA 26
Systematic Assessment
EG0000 events0 affected16 at risk
EG0013 events2 affected12 at risk
EG00210 events6 affected35 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
Following the first publication, the Institution and/or Principal Investigator may publish data or results from the Study, provided, however, that the Institution and/or Principal Investigator submits the proposed publication to the Sponsor for review at least sixty (60) days prior to the date of the proposed publication. Sponsor may remove from the proposed publication any information that is considered confidential and/or proprietary other than Study data and results.
Participants being treated with Yescarta (Day 0; per prescribing information), an IEC therapy for hematologic malignancies, received itacitinib 200 mg QD for 30 days (Day -3 to Day 26).
OG003
Part 2: Itacitinib 200 mg BID + Yescarta
Participants being treated with Yescarta (Day 0; per prescribing information) for relapsed or refractory large B-cell lymphoma or follicular lymphoma received itacitinib 200 mg twice daily (BID) for 30 days (Day -3 to Day 26).
OG004
Part 2: Placebo BID + Yescarta
Participants being treated with Yescarta (Day 0; per prescribing information) for relapsed or refractory large B-cell lymphoma or follicular lymphoma BID for 30 days (Day -3 to Day 26).
Units
Counts
Participants
OG00016
OG00112
OG00235
OG00323
OG00423
Title
Denominators
Categories
Title
Measurements
OG00031.3(11.0 to 58.7)
OG00141.7(15.2 to 72.3)
OG00245.7(28.8 to 63.4)
OG00313.0(2.8 to 33.6)
OG00434.8(16.4 to 57.3)
OG002
Part 1: Itacitinib 200 mg QD + Yescarta
Participants being treated with Yescarta (Day 0; per prescribing information), an IEC therapy for hematologic malignancies, received itacitinib 200 mg QD for 30 days (Day -3 to Day 26).
OG003
Part 2: Itacitinib 200 mg BID + Yescarta
Participants being treated with Yescarta (Day 0; per prescribing information) for relapsed or refractory large B-cell lymphoma or follicular lymphoma received itacitinib 200 mg twice daily (BID) for 30 days (Day -3 to Day 26).
OG004
Part 2: Placebo BID + Yescarta
Participants being treated with Yescarta (Day 0; per prescribing information) for relapsed or refractory large B-cell lymphoma or follicular lymphoma BID for 30 days (Day -3 to Day 26).
Units
Counts
Participants
OG0005
OG0015
OG00216
OG0033
OG0048
Title
Denominators
Categories
Title
Measurements
OG0004.0(0 to 11)
OG0014.0(0 to 6)
OG0025.0(1 to 9)
OG0035.0(4 to 9)
OG0046.5(2 to 11)
OG002
Part 1: Itacitinib 200 mg QD + Yescarta
Participants being treated with Yescarta (Day 0; per prescribing information), an IEC therapy for hematologic malignancies, received itacitinib 200 mg QD for 30 days (Day -3 to Day 26).
OG003
Part 2: Itacitinib 200 mg BID + Yescarta
Participants being treated with Yescarta (Day 0; per prescribing information) for relapsed or refractory large B-cell lymphoma or follicular lymphoma received itacitinib 200 mg twice daily (BID) for 30 days (Day -3 to Day 26).
OG004
Part 2: Placebo BID + Yescarta
Participants being treated with Yescarta (Day 0; per prescribing information) for relapsed or refractory large B-cell lymphoma or follicular lymphoma BID for 30 days (Day -3 to Day 26).
Units
Counts
Participants
OG0005
OG0015
OG00216
OG0033
OG0048
Title
Denominators
Categories
Title
Measurements
OG0003.0(1 to 4)
OG0015.0(1 to 17)
OG0021.5(1 to 16)
OG0032.0(2 to 11)
OG0043.5(2 to 13)
OG002
Part 1: Itacitinib 200 mg QD + Yescarta
Participants being treated with Yescarta (Day 0; per prescribing information), an IEC therapy for hematologic malignancies, received itacitinib 200 mg QD for 30 days (Day -3 to Day 26).
OG003
Part 2: Itacitinib 200 mg BID + Yescarta
Participants being treated with Yescarta (Day 0; per prescribing information) for relapsed or refractory large B-cell lymphoma or follicular lymphoma received itacitinib 200 mg twice daily (BID) for 30 days (Day -3 to Day 26).
OG004
Part 2: Placebo BID + Yescarta
Participants being treated with Yescarta (Day 0; per prescribing information) for relapsed or refractory large B-cell lymphoma or follicular lymphoma BID for 30 days (Day -3 to Day 26).
Units
Counts
Participants
OG00014
OG00110
OG00230
OG00315
OG00420
Title
Denominators
Categories
Title
Measurements
OG0002.0(1 to 6)
OG0012.5(0 to 7)
OG0021.0(1 to 8)
OG0032.0(0 to 8)
OG0043.0(0 to 9)
OG002
Part 1: Itacitinib 200 mg QD + Yescarta
Participants being treated with Yescarta (Day 0; per prescribing information), an IEC therapy for hematologic malignancies, received itacitinib 200 mg QD for 30 days (Day -3 to Day 26).
OG003
Part 2: Itacitinib 200 mg BID + Yescarta
Participants being treated with Yescarta (Day 0; per prescribing information) for relapsed or refractory large B-cell lymphoma or follicular lymphoma received itacitinib 200 mg twice daily (BID) for 30 days (Day -3 to Day 26).
OG004
Part 2: Placebo BID + Yescarta
Participants being treated with Yescarta (Day 0; per prescribing information) for relapsed or refractory large B-cell lymphoma or follicular lymphoma BID for 30 days (Day -3 to Day 26).
Units
Counts
Participants
OG00014
OG00110
OG00230
OG00315
OG00420
Title
Denominators
Categories
Title
Measurements
OG0005.0(2 to 11)
OG0014.0(2 to 11)
OG0025.0(1 to 11)
OG0035.0(3 to 12)
OG0044.0(1 to 8)
OG002
Part 1: Itacitinib 200 mg QD + Yescarta
Participants being treated with Yescarta (Day 0; per prescribing information), an IEC therapy for hematologic malignancies, received itacitinib 200 mg QD for 30 days (Day -3 to Day 26).
OG003
Part 2: Itacitinib 200 mg BID + Yescarta
Participants being treated with Yescarta (Day 0; per prescribing information) for relapsed or refractory large B-cell lymphoma or follicular lymphoma received itacitinib 200 mg twice daily (BID) for 30 days (Day -3 to Day 26).
OG004
Part 2: Placebo BID + Yescarta
Participants being treated with Yescarta (Day 0; per prescribing information) for relapsed or refractory large B-cell lymphoma or follicular lymphoma BID for 30 days (Day -3 to Day 26).
Units
Counts
Participants
OG00016
OG00112
OG00235
OG00323
OG00423
Title
Denominators
Categories
Title
Measurements
OG00037.5(15.2 to 64.6)
OG00133.3(9.9 to 65.1)
OG00248.6(31.4 to 66.0)
OG00326.1(10.2 to 48.4)
OG00430.4(13.2 to 52.9)
OG002
Part 1: Itacitinib 200 mg QD + Yescarta
Participants being treated with Yescarta (Day 0; per prescribing information), an IEC therapy for hematologic malignancies, received itacitinib 200 mg QD for 30 days (Day -3 to Day 26).
OG003
Part 2: Itacitinib 200 mg BID + Yescarta
Participants being treated with Yescarta (Day 0; per prescribing information) for relapsed or refractory large B-cell lymphoma or follicular lymphoma received itacitinib 200 mg twice daily (BID) for 30 days (Day -3 to Day 26).
OG004
Part 2: Placebo BID + Yescarta
Participants being treated with Yescarta (Day 0; per prescribing information) for relapsed or refractory large B-cell lymphoma or follicular lymphoma BID for 30 days (Day -3 to Day 26).
Units
Counts
Participants
OG00016
OG00112
OG00235
OG00323
OG00423
Title
Denominators
Categories
Title
Measurements
OG00012.5(1.6 to 38.3)
OG00141.7(15.2 to 72.3)
OG00220.0(8.4 to 36.9)
OG00321.7(7.5 to 43.7)
OG00456.5(34.5 to 76.8)
Part 1: Itacitinib 200 mg QD + Yescarta
Participants being treated with Yescarta (Day 0; per prescribing information), an IEC therapy for hematologic malignancies, received itacitinib 200 mg QD for 30 days (Day -3 to Day 26).
OG003
Part 2: Itacitinib 200 mg BID + Yescarta
Participants being treated with Yescarta (Day 0; per prescribing information) for relapsed or refractory large B-cell lymphoma or follicular lymphoma received itacitinib 200 mg twice daily (BID) for 30 days (Day -3 to Day 26).
OG004
Part 2: Placebo BID + Yescarta
Participants being treated with Yescarta (Day 0; per prescribing information) for relapsed or refractory large B-cell lymphoma or follicular lymphoma BID for 30 days (Day -3 to Day 26).
Units
Counts
Participants
OG00016
OG00112
OG00235
OG00323
OG00424
Title
Denominators
Categories
Title
Measurements
OG00016
OG00112
OG00235
OG00322
OG00424
OG003
Part 2: Itacitinib 200 mg BID + Yescarta
Participants being treated with Yescarta (Day 0; per prescribing information) for relapsed or refractory large B-cell lymphoma or follicular lymphoma received itacitinib 200 mg twice daily (BID) for 30 days (Day -3 to Day 26).
OG004
Part 2: Placebo BID + Yescarta
Participants being treated with Yescarta (Day 0; per prescribing information) for relapsed or refractory large B-cell lymphoma or follicular lymphoma BID for 30 days (Day -3 to Day 26).
Units
Counts
Participants
OG00016
OG00112
OG00235
OG00323
OG00423
Title
Denominators
Categories
Neutrophils
ParticipantsOG00016
ParticipantsOG00112
ParticipantsOG00235
ParticipantsOG00322
ParticipantsOG00423
Title
Measurements
OG0008.3
OG00122.2
OG00226.6
OG003
Hemoglobin
ParticipantsOG00016
ParticipantsOG00112
ParticipantsOG00235
ParticipantsOG00322
Platelets
ParticipantsOG00016
ParticipantsOG00112
ParticipantsOG00235
ParticipantsOG00322
Participants being treated with Yescarta (Day 0; per prescribing information) for relapsed or refractory large B-cell lymphoma or follicular lymphoma received itacitinib 200 mg twice daily (BID) for 30 days (Day -3 to Day 26).
OG004
Part 2: Placebo BID + Yescarta
Participants being treated with Yescarta (Day 0; per prescribing information) for relapsed or refractory large B-cell lymphoma or follicular lymphoma BID for 30 days (Day -3 to Day 26).
Units
Counts
Participants
OG0000
OG0010
OG0020
OG0030
OG0040
Participants being treated with Yescarta (Day 0; per prescribing information) for relapsed or refractory large B-cell lymphoma or follicular lymphoma received itacitinib 200 mg twice daily (BID) for 30 days (Day -3 to Day 26).
OG004
Part 2: Placebo BID + Yescarta
Participants being treated with Yescarta (Day 0; per prescribing information) for relapsed or refractory large B-cell lymphoma or follicular lymphoma BID for 30 days (Day -3 to Day 26).
Units
Counts
Participants
OG0000
OG0010
OG0020
OG0030
OG0040
OG003
Part 2: Itacitinib 200 mg BID + Yescarta
Participants being treated with Yescarta (Day 0; per prescribing information) for relapsed or refractory large B-cell lymphoma or follicular lymphoma received itacitinib 200 mg twice daily (BID) for 30 days (Day -3 to Day 26).
OG004
Part 2: Placebo BID + Yescarta
Participants being treated with Yescarta (Day 0; per prescribing information) for relapsed or refractory large B-cell lymphoma or follicular lymphoma BID for 30 days (Day -3 to Day 26).
Units
Counts
Participants
OG00016
OG00112
OG00235
OG00323
OG00423
Title
Denominators
Categories
Title
Measurements
OG00018.8
OG00141.7
OG00220.0
OG00317.4
OG00465.2
Participants being treated with Yescarta (Day 0; per prescribing information) for relapsed or refractory large B-cell lymphoma or follicular lymphoma received itacitinib 200 mg twice daily (BID) for 30 days (Day -3 to Day 26).
OG004
Part 2: Placebo BID + Yescarta
Participants being treated with Yescarta (Day 0; per prescribing information) for relapsed or refractory large B-cell lymphoma or follicular lymphoma BID for 30 days (Day -3 to Day 26).