A Study of INCB050465 in Relapsed or Refractory Mantle Ce... | NCT03235544 | Trialant
NCT03235544
Sponsor
Incyte Corporation
Status
Completed
Last Update Posted
Mar 18, 2025Actual
Enrollment
162Actual
Phase
Phase 2
Conditions
Lymphoma
Interventions
Parsaclisib
Countries
United States
Belgium
Czechia
Denmark
France
Germany
Israel
Italy
Poland
Spain
United Kingdom
Protocol Section
Identification Module
NCT ID
NCT03235544
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
INCB 50465-205 (CITADEL-205)
Secondary IDs
ID
Type
Description
Link
Parsaclisib
Other Identifier
Incyte Corporation
2017-003148-19
EudraCT Number
Brief Title
A Study of INCB050465 in Relapsed or Refractory Mantle Cell Lymphoma Previously Treated With or Without a Bruton's Tyrosine Kinase (BTK) Inhibitor
Official Title
A Phase 2, Open-Label, 2-Cohort, Multicenter Study of INCB050465, a PI3Kδ Inhibitor, in Relapsed or Refractory Mantle Cell Lymphoma Previously Treated With or Without a BTK Inhibitor (CITADEL-205)
Acronym
(CITADEL-205)
Organization
Incyte CorporationINDUSTRY
Status Module
Record Verification Date
Feb 2025
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
Nov 20, 2017Actual
Primary Completion Date
Apr 30, 2024Actual
Completion Date
Apr 30, 2024Actual
First Submitted Date
Jul 27, 2017
First Submission Date that Met QC Criteria
Jul 27, 2017
First Posted Date
Aug 1, 2017Actual
Results Waived
Not provided
Results First Submitted Date
Jan 14, 2022
Results First Submitted that Met QC Criteria
Jan 14, 2022
Results First Posted Date
Feb 10, 2022Actual
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 27, 2025
Last Update Posted Date
Mar 18, 2025Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Incyte CorporationINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
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
This is a Phase 2, open-label, 2-cohort study designed to evaluate the efficacy and safety of 2 parsaclisib treatment regimens in participants with relapsed or refractory mantle cell lymphoma (MCL) previously treated either with or without a Bruton's tyrosine kinase (BTK) inhibitor.
Detailed Description
Not provided
Conditions Module
Conditions
Lymphoma
Keywords
Mantle cell lymphoma
non-Hodgkin lymphoma
Bruton's tyrosine kinase (BTK)
phosphatidylinositol 3-kinase (PI3K)
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
162Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Cohort 1: Treatment A (Exposed to Ibrutinib)
Experimental
Participants received parsaclisib 20 mg tablets, orally, once daily (QD) for 8 weeks followed by 20 mg once weekly (QW) for up to 52 weeks.
Participants who were exposed to ibrutinib before enrollment were included in this group.
Drug: Parsaclisib
Cohort 1: Treatment B (Exposed to Ibrutinib)
Experimental
Participants received parsaclisib 20 mg tablets, orally, QD for 8 weeks followed by 2.5 mg QD for up to 116 weeks.
Participants who were exposed to ibrutinib before enrollment were included in this group.
Drug: Parsaclisib
Cohort 2: Treatment A (Bruton's Tyrosine Kinase Inhibitor Naïve)
Experimental
Participants received parsaclisib 20 mg tablets, orally, QD for 8 weeks followed by 20 mg QW for up to approximately 145 weeks.
Participants who had not received a BTK inhibitor previously were included in this group.
Drug: Parsaclisib
Cohort 2: Treatment B (Bruton's Tyrosine Kinase Inhibitor Naïve)
Experimental
Participants received parsaclisib 20 mg tablets, orally, QD for 8 weeks followed by 2.5 mg QD for up to approximately 136 weeks.
Participants who had not received a BTK inhibitor previously were included in this group.
Drug: Parsaclisib
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Parsaclisib
Drug
Parsaclisib tablets administered orally with water and without regard to food.
Cohort 1: Treatment A (Exposed to Ibrutinib)
Cohort 1: Treatment B (Exposed to Ibrutinib)
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Objective Response Rate (ORR)
ORR=percentage of participants with complete response(CR) or partial response(PR) per revised response criteria for lymphomas,determined by independent review committee(IRC).Criteria for CR:1.Target nodes/nodal masses of lymph nodes,extralymphatic sites regressed to≤1.5cm in longest dimension transverse diameter of lesion(LDi);2.Absence of non-measured lesion;3.Organ enlargement regressed to normal;4.No new lesions;5.Normal bone marrow morphology;if indeterminate,immunohistochemistry negative.Criteria for PR:1.Lymph nodes,extralymphatic sites- ≥50%decrease in sum of product of perpendicular diameters for multiple lesions(SPD)of up to 6 target measurable nodes,extranodal sites;if lesion is too small to measure on computed tomography(CT),assign5mm×5mm as default;if no longer visible,0×0mm.Node>5mm×5mm but smaller than normal,use actual measurement.2.Absent/regressed non-measured lesions,no increase.3.Organ enlargement-Spleen regressed by>50%in length beyond normal.4.No new lesions.
Up to 1016 days
Secondary Outcomes
Measure
Description
Time Frame
Duration of Response (DOR)
DOR=time from first documented evidence of CR or PR until disease progression or death from any cause among participants who achieve an objective response as determined by IRC. Criteria for CR: 1.Target nodes/nodal masses of lymph nodes and extralymphatic sites must regress to ≤ 1.5 cm in LDi; 2. Absence of non-measured lesion; 3.Organ enlargement regressed to normal; 4.No new lesions; 5.Bone marrow must be normal by morphology; if indeterminate, immunohistochemistry negative. The criteria for PR included: 1.Lymph nodes and extralymphatic sites- a. ≥50% decrease in SPD of up to 6 target measurable nodes and extranodal sites; b. when a lesion is too small to measure on CT, assign 5 mm×5 mm as the default; c.when no longer visible, 0×0 mm. For a node >5 mm×5 mm but smaller than normal, use actual measurement. 2.Non-measured lesions- Absent/regressed, but no increase. 3. Organ enlargement-Spleen must have regressed by >50% in length beyond normal. 4.No new lesions.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Men and women, aged 18 years or older.
Documented failure to achieve at least partial response (PR) with, or documented disease progression after, the most recent treatment regimen.
Radiographically measurable lymphadenopathy or extranodal lymphoid malignancy.
Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2.
Exclusion Criteria:
History of central nervous system lymphoma (either primary or metastatic).
Prior treatment with idelalisib, other selective phosphatidylinositol 3-kinase delta (PI3Kδ) inhibitors, or a pan PI3K inhibitor.
Allogeneic stem cell transplant within the last 6 months, or autologous stem cell transplant within the last 3 months before the date of first dose of study treatment.
Active graft-versus-host disease.
Liver disease: Participants positive for hepatitis B surface antigen or hepatitis B core antibody will be eligible if they are negative for hepatitis B virus-deoxyribonucleic acid (HBV-DNA). Participants positive for anti-hepatitis C virus (HCV) antibody will be eligible if they are negative for HCV-ribonucleic acid (RNA).
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
Not provided
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Fred Zheng, MD
Incyte Corporation
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
University of Alabama At Birmingham Comprehensive Cancer Center
Birmingham
Alabama
35205
United States
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
Plan to Share IPD
Yes
Description
Individual participant data (IPD) will be made available to interested researchers after the end of study, a thorough analysis, and the publication of the data in the clinical study report (CSR). As required, results of the data will be posted to ClinicalTrials.gov. Upon request, individual investigators may obtain IPD from the sponsor. The format for data delivery will be determined between sponsor and investigator.
Types
Study Protocol
Statistical Analysis Plan (SAP)
Time Frame
Data will be shared after the primary publication or 2 years after the study has ended for market authorized products and indications.
Access Criteria
Data from eligible studies will be shared with qualified researchers according to the criteria and process described in the Data Sharing section of the www.incyteclinicaltrials.com website. For approved requests, the researchers will be granted access to anonymized data under the terms of a data sharing agreement.
A total of 161 participants with relapsed or refractory mantle cell lymphoma who received 1-3 prior systemic therapies were enrolled into 2 Cohorts and treated. An additional participant was enrolled but not treated. Because this participant was not treated, he/she was not assigned to any treatment/cohort and was not included in the "Full Analysis Set" or "Safety Population" for analysis. Cohort 1 had previously received ibrutinib and Cohort 2 were Bruton's tyrosine kinase (BTK) inhibitor naive.
Recruitment Details
Participants took part in the study at 76 investigative sites in France, Spain, the United States, Italy, Poland, Czech Republic, Great Britain, Denmark, Belgium, Germany, and Israel.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Cohort 1: Treatment A (Exposed to Ibrutinib)
Participants received parsaclisib 20 milligrams (mg), orally, once daily (QD) for 8 weeks followed by 20 mg once weekly (QW) for up to 52 weeks. Participants who were exposed to ibrutinib before enrollment were included in this group.
FG001
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
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
Jan 30, 2020
Jan 12, 2022
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Non-Randomized
Intervention Model
Sequential Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
Cohort 2: Treatment A (Bruton's Tyrosine Kinase Inhibitor Naïve)
Cohort 2: Treatment B (Bruton's Tyrosine Kinase Inhibitor Naïve)
INCB050465
Up to 1016 days
Complete Response Rate (CRR)
CRR is defined as the percentage of participants with a CR as defined by response criteria for lymphomas, as determined by an IRC. The criteria for CR included: 1.Target nodes/nodal masses of lymph nodes and extralymphatic sites must regress to ≤ 1.5 cm in LDi; 2. Absence of non-measured lesion; 3.Organ enlargement regressed to normal; 4.No new lesions; 5.Bone marrow must be normal by morphology; if indeterminate, immunohistochemistry negative.
Up to 1016 days
Progression-Free Survival (PFS)
PFS is defined as the time from the date of the first dose of study treatment until the earliest date of disease progression as determined by radiographic disease assessment provided by an IRC, or death from any cause.
Up to 1016 days
Overall Survival (OS)
OS is defined as the time from the date of the first dose of study treatment until death from any cause.
Up to 2017 days
Best Percent Change From Baseline in Target Lesion Size
Target lesion size is measured by the sum of the product of diameters of all target lesion sizes and is determined by the IRC. The best percent change from Baseline is defined as the largest decrease, or smallest increase if no decrease available, from Baseline in target lesion sizes on/before new (next-line) anti-lymphoma therapy during the study. Baseline is the last nonmissing measurement obtained before the first administration of study drug. A negative percent change from Baseline indicates improvement.
Up to 1016 days
Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
An adverse event (AE) is any untoward medical occurrence associated with use of a drug in humans, whether or not considered drug related, that occurs after a participant provides informed consent. A TEAE is any AE either reported for the first time or worsening of a pre-existing event after first dose of study drug and within 30 days of the last administration of study drug regardless of starting new anti-lymphoma therapy. A SAE is any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, leads to a congenital anomaly/birth defect or is considered to be an important medical event that may not result in death, be immediately life-threatening, or require hospitalization but may be considered serious when, based on appropriate medical judgment, the event may jeopardize the participant or may require medical or surgical intervention.
Universitatsmedizin Der Johannes Gutenberg-Universitat Mainz Iii
Mainz
55131
Germany
Kliniken Maria Hilf
Mönchengladbach
41063
Germany
Rotkreuzklinikum Munich
München
80634
Germany
Universit�Tsklinikum Ulm
Ulm
89081
Germany
Rambam Medical Center
Haifa
31096
Israel
Hadassah Hebrew University Medical Center
Jerusalem
90000
Israel
Hadassah Hebrew University Medical Center Ein Karem Hadassah
Jerusalem
91120
Israel
Rabin Medical Center - Beilinson Hospital
Petah Tikva
4841492
Israel
Tel Aviv Sourasky Medical Center
Tel Aviv
64239
Israel
Fondazione Irccs Istituto Nazionale Dei Tumori
Milan
MI
20133
Italy
Centro Ricerche Cliniche
Bologna
40138
Italy
Azienda Policlinico Vittorio Emanuele
Catania
95123
Italy
Grande Ospedale Metropolitano Niguarda
Milan
20162
Italy
Ospedale Niguarda Ca Granda
Milan
22162
Italy
A.O.U. Di Modena - Policlinico
Modena
41124
Italy
A.O.U. Federico Ii
Naples
80131
Italy
Aou Maggiore Della Carita
Novara
28100
Italy
Ospedali Riuniti Villa Sofia Cervello
Palermo
90146
Italy
Sapienza University
Rome
00161
Italy
Azienda Ospedaliera Universitaria Senese Policlinico Santa Maria Alle Scotte
Siena
53100
Italy
Azienda Ospedaliero Universitaria Citta Della Salute E Della Scienza
Torino
10126
Italy
Beskidzkie Centrum Onkologii Im.Jana Pawla Ii
Bielsko-Biala
43-300
Poland
Szpital Specjalistyczny W Brzozowie, Podkarpacki Osrodek Onkologiczny Im.Ks.B.Markiewicza
Brzozów
36-200
Poland
University Clinical Center
Gdansk
80-952
Poland
Pratia McM Krakow
Krakow
30-510
Poland
Nu-Med Centrum Diagnostykii I Terapii Onkologicznej
Tomaszów Mazowiecki
97-200
Poland
Centrum Onkologii-Instytut Im. Marii Sklodowskiej-Curie
Warsaw
02-781
Poland
Hospital Del Mar
Barcelona
08003
Spain
Hospital General Universitari Vall D Hebron
Barcelona
08035
Spain
Hospital Universitari Mutua Terrassa
Barcelona
08221
Spain
Institut Catala D Oncologia
Barcelona
08916
Spain
Hospital Universitario de Burgos
Burgos
09006
Spain
Hospital General Universitario Gregorio Maranon
Madrid
28007
Spain
Md Anderson Cancer Centre Madrid
Madrid
28033
Spain
Hospital Universitario Ramon Y Cajal
Madrid
28034
Spain
Fundacion Jimenez Diaz University Hospital
Madrid
28040
Spain
Hospital Universitario 12 de Octubre
Madrid
28041
Spain
Hospital Universitario de La Paz
Madrid
28046
Spain
Hospital General Universitario Morales Meseguer
Murcia
30008
Spain
Complejo Hospitalario de Navarra
Pamplona
31008
Spain
Hospital Clinico Universitario de Salamanca
Salamanca
37007
Spain
Hospital Universitario Virgen del Rocio
Seville
41005
Spain
Hospital Arnau de Vilanova
Valencia
46015
Spain
Hospital Universitario Dr. Peset
Valencia
46017
Spain
Hospital Universitario Y Politecnic La Fe
Valencia
46026
Spain
Birmingham Heartlands Hospital
Birmingham
B9 5SS
United Kingdom
Western General Hospital
Edinburgh
EH4 2XU
United Kingdom
University College London Hospitals (Uclh)
London
NW1 2PG
United Kingdom
Derriford Hospital
Plymouth
PL6 8DH
United Kingdom
Royal Hallamshire Hospital
Sheffield
S10 2JF
United Kingdom
Cohort 1: Treatment B (Exposed to Ibrutinib)
Participants received parsaclisib 20 mg, orally, QD for 8 weeks followed by 2.5 mg QD for up to 116 weeks. Participants who were exposed to ibrutinib before enrollment were included in this group.
FG002
Cohort 2: Treatment A (BTK Inhibitor Naïve)
Participants received parsaclisib 20 mg, orally, QD for 8 weeks followed by 20 mg QW for up to approximately 145 weeks. Participants who were not exposed to BTK inhibitor before enrollment were included in this group.
FG003
Cohort 2: Treatment B (BTK Inhibitor Naïve)
Participants received parsaclisib 20 mg, orally, QD for 8 weeks followed by 2.5 mg QD for up to approximately 136 weeks. Participants who were not exposed to BTK inhibitor before enrollment were included in this group.
FG00012 subjects
FG00141 subjects
FG00231 subjects
FG00377 subjects
COMPLETED
FG0001 subjects
FG0015 subjects
FG0028 subjects
FG00329 subjects
NOT COMPLETED
FG00011 subjects
FG00136 subjects
FG00223 subjects
FG00348 subjects
Type
Comment
Reasons
Death
FG00011 subjects
FG00131 subjects
FG00219 subjects
FG00334 subjects
Lost to Follow-up
FG0000 subjects
FG0011 subjects
FG0021 subjects
FG0031 subjects
Withdrawal by Subject
FG0000 subjects
FG0013 subjects
FG0021 subjects
FG0035 subjects
Disease Progression
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0032 subjects
Participant Transitioned to Rollover Protocol
FG0000 subjects
FG0010 subjects
FG0022 subjects
FG0035 subjects
Discomfort, Pain, and Radiographic Advancement
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
Full Analysis Set (FAS) included all participants enrolled in the study who received at least 1 dose of parsaclisib.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Cohort 1: Treatment A (Exposed to Ibrutinib)
Participants received parsaclisib 20 milligrams (mg), orally, once daily (QD) for 8 weeks followed by 20 mg once weekly (QW) for up to 52 weeks. Participants who were exposed to ibrutinib before enrollment were included in this group.
BG001
Cohort 1: Treatment B (Exposed to Ibrutinib)
Participants received parsaclisib 20 mg, orally, QD for 8 weeks followed by 2.5 mg QD for up to 116 weeks. Participants who were exposed to ibrutinib before enrollment were included in this group.
BG002
Cohort 2: Treatment A (BTK Inhibitor Naïve)
Participants received parsaclisib 20 mg, orally, QD for 8 weeks followed by 20 mg QW for up to approximately 145 weeks. Participants who were not exposed to BTK inhibitor before enrollment were included in this group.
BG003
Cohort 2: Treatment B (BTK Inhibitor Naïve)
Participants received parsaclisib 20 mg, orally, QD for 8 weeks followed by 2.5 mg QD for up to approximately 136 weeks. Participants who were not exposed to BTK inhibitor before enrollment were included in this group.
BG004
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00012
BG00141
BG00231
BG00377
BG004161
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Full Range
years
Title
Denominators
Categories
Title
Measurements
BG00070.2(53 to 82)
BG00169.8(48 to 89)
BG00272.2(43 to 89)
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0001
BG00111
BG002
Race/Ethnicity, Customized
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0003
BG0012
BG002
Race/Ethnicity, Customized
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
White
BG00011
BG00137
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
Objective Response Rate (ORR)
ORR=percentage of participants with complete response(CR) or partial response(PR) per revised response criteria for lymphomas,determined by independent review committee(IRC).Criteria for CR:1.Target nodes/nodal masses of lymph nodes,extralymphatic sites regressed to≤1.5cm in longest dimension transverse diameter of lesion(LDi);2.Absence of non-measured lesion;3.Organ enlargement regressed to normal;4.No new lesions;5.Normal bone marrow morphology;if indeterminate,immunohistochemistry negative.Criteria for PR:1.Lymph nodes,extralymphatic sites- ≥50%decrease in sum of product of perpendicular diameters for multiple lesions(SPD)of up to 6 target measurable nodes,extranodal sites;if lesion is too small to measure on computed tomography(CT),assign5mm×5mm as default;if no longer visible,0×0mm.Node>5mm×5mm but smaller than normal,use actual measurement.2.Absent/regressed non-measured lesions,no increase.3.Organ enlargement-Spleen regressed by>50%in length beyond normal.4.No new lesions.
Full Analysis Set: all participants enrolled in the study who received at least 1 dose of parsaclisib
Posted
Number
95% Confidence Interval
percentage of participants
Up to 1016 days
ID
Title
Description
OG000
Cohort 1: Treatment A (Exposed to Ibrutinib)
Participants received parsaclisib 20 milligrams (mg), orally, once daily (QD) for 8 weeks followed by 20 mg once weekly (QW) for up to 52 weeks. Participants who were exposed to ibrutinib before enrollment were included in this group.
OG001
Cohort 1: Treatment B (Exposed to Ibrutinib)
Participants received parsaclisib 20 mg, orally, QD for 8 weeks followed by 2.5 mg QD for up to 116 weeks. Participants who were exposed to ibrutinib before enrollment were included in this group.
OG002
Cohort 2: Treatment A (BTK Inhibitor Naïve)
Participants received parsaclisib 20 mg, orally, QD for 8 weeks followed by 20 mg QW for up to approximately 145 weeks. Participants who were not exposed to BTK inhibitor before enrollment were included in this group.
OG003
Cohort 2: Treatment B (BTK Inhibitor Naïve)
Participants received parsaclisib 20 mg, orally, QD for 8 weeks followed by 2.5 mg QD for up to approximately 136 weeks. Participants who were not exposed to BTK inhibitor before enrollment were included in this group.
Units
Counts
Participants
OG00012
OG00141
OG00231
OG003
Title
Denominators
Categories
Title
Measurements
OG0008.3(0.2 to 38.5)
OG00139.0(24.2 to 55.5)
OG00264.5(45.4 to 80.8)
OG003
Secondary
Duration of Response (DOR)
DOR=time from first documented evidence of CR or PR until disease progression or death from any cause among participants who achieve an objective response as determined by IRC. Criteria for CR: 1.Target nodes/nodal masses of lymph nodes and extralymphatic sites must regress to ≤ 1.5 cm in LDi; 2. Absence of non-measured lesion; 3.Organ enlargement regressed to normal; 4.No new lesions; 5.Bone marrow must be normal by morphology; if indeterminate, immunohistochemistry negative. The criteria for PR included: 1.Lymph nodes and extralymphatic sites- a. ≥50% decrease in SPD of up to 6 target measurable nodes and extranodal sites; b. when a lesion is too small to measure on CT, assign 5 mm×5 mm as the default; c.when no longer visible, 0×0 mm. For a node >5 mm×5 mm but smaller than normal, use actual measurement. 2.Non-measured lesions- Absent/regressed, but no increase. 3. Organ enlargement-Spleen must have regressed by >50% in length beyond normal. 4.No new lesions.
Full Analysis Set: all participants enrolled in the study who received at least 1 dose of parsaclisib. Only participants with objective response were analyzed.
Posted
Median
95% Confidence Interval
months
Up to 1016 days
ID
Title
Description
OG000
Cohort 1: Treatment A (Exposed to Ibrutinib)
Participants received parsaclisib 20 milligrams (mg), orally, once daily (QD) for 8 weeks followed by 20 mg once weekly (QW) for up to 52 weeks. Participants who were exposed to ibrutinib before enrollment were included in this group.
OG001
Cohort 1: Treatment B (Exposed to Ibrutinib)
Secondary
Complete Response Rate (CRR)
CRR is defined as the percentage of participants with a CR as defined by response criteria for lymphomas, as determined by an IRC. The criteria for CR included: 1.Target nodes/nodal masses of lymph nodes and extralymphatic sites must regress to ≤ 1.5 cm in LDi; 2. Absence of non-measured lesion; 3.Organ enlargement regressed to normal; 4.No new lesions; 5.Bone marrow must be normal by morphology; if indeterminate, immunohistochemistry negative.
Full Analysis Set: all participants enrolled in the study who received at least 1 dose of parsaclisib
Posted
Number
95% Confidence Interval
percentage of participants
Up to 1016 days
ID
Title
Description
OG000
Cohort 1: Treatment A (Exposed to Ibrutinib)
Participants received parsaclisib 20 milligrams (mg), orally, once daily (QD) for 8 weeks followed by 20 mg once weekly (QW) for up to 52 weeks. Participants who were exposed to ibrutinib before enrollment were included in this group.
OG001
Cohort 1: Treatment B (Exposed to Ibrutinib)
Participants received parsaclisib 20 mg, orally, QD for 8 weeks followed by 2.5 mg QD for up to 116 weeks. Participants who were exposed to ibrutinib before enrollment were included in this group.
OG002
Cohort 2: Treatment A (BTK Inhibitor Naïve)
Secondary
Progression-Free Survival (PFS)
PFS is defined as the time from the date of the first dose of study treatment until the earliest date of disease progression as determined by radiographic disease assessment provided by an IRC, or death from any cause.
Full Analysis Set: all participants enrolled in the study who received at least 1 dose of parsaclisib
Posted
Median
95% Confidence Interval
months
Up to 1016 days
ID
Title
Description
OG000
Cohort 1: Treatment A (Exposed to Ibrutinib)
Participants received parsaclisib 20 milligrams (mg), orally, once daily (QD) for 8 weeks followed by 20 mg once weekly (QW) for up to 52 weeks. Participants who were exposed to ibrutinib before enrollment were included in this group.
OG001
Cohort 1: Treatment B (Exposed to Ibrutinib)
Participants received parsaclisib 20 mg, orally, QD for 8 weeks followed by 2.5 mg QD for up to 116 weeks. Participants who were exposed to ibrutinib before enrollment were included in this group.
OG002
Cohort 2: Treatment A (BTK Inhibitor Naïve)
Participants received parsaclisib 20 mg, orally, QD for 8 weeks followed by 20 mg QW for up to approximately 145 weeks. Participants who were not exposed to BTK inhibitor before enrollment were included in this group.
Secondary
Overall Survival (OS)
OS is defined as the time from the date of the first dose of study treatment until death from any cause.
Full Analysis Set
Posted
Median
95% Confidence Interval
months
Up to 2017 days
ID
Title
Description
OG000
Cohort 1: Treatment A (Exposed to Ibrutinib)
Participants received parsaclisib 20 milligrams (mg), orally, once daily (QD) for 8 weeks followed by 20 mg once weekly (QW) for up to 52 weeks. Participants who were exposed to ibrutinib before enrollment were included in this group.
OG001
Cohort 1: Treatment B (Exposed to Ibrutinib)
Participants received parsaclisib 20 mg, orally, QD for 8 weeks followed by 2.5 mg QD for up to 116 weeks. Participants who were exposed to ibrutinib before enrollment were included in this group.
OG002
Cohort 2: Treatment A (BTK Inhibitor Naïve)
Participants received parsaclisib 20 mg, orally, QD for 8 weeks followed by 20 mg QW for up to approximately 145 weeks. Participants who were not exposed to BTK inhibitor before enrollment were included in this group.
OG003
Cohort 2: Treatment B (BTK Inhibitor Naïve)
Secondary
Best Percent Change From Baseline in Target Lesion Size
Target lesion size is measured by the sum of the product of diameters of all target lesion sizes and is determined by the IRC. The best percent change from Baseline is defined as the largest decrease, or smallest increase if no decrease available, from Baseline in target lesion sizes on/before new (next-line) anti-lymphoma therapy during the study. Baseline is the last nonmissing measurement obtained before the first administration of study drug. A negative percent change from Baseline indicates improvement.
Full Analysis Set: all participants enrolled in the study who received at least 1 dose of parsaclisib. The overall number of participants analyzed is the number of participants with data available for analysis.
Posted
Mean
Standard Deviation
percent change in lesion size
Up to 1016 days
ID
Title
Description
OG000
Cohort 1: Treatment A (Exposed to Ibrutinib)
Participants received parsaclisib 20 milligrams (mg), orally, once daily (QD) for 8 weeks followed by 20 mg once weekly (QW) for up to 52 weeks. Participants who were exposed to ibrutinib before enrollment were included in this group.
OG001
Cohort 1: Treatment B (Exposed to Ibrutinib)
Participants received parsaclisib 20 mg, orally, QD for 8 weeks followed by 2.5 mg QD for up to 116 weeks. Participants who were exposed to ibrutinib before enrollment were included in this group.
Secondary
Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
An adverse event (AE) is any untoward medical occurrence associated with use of a drug in humans, whether or not considered drug related, that occurs after a participant provides informed consent. A TEAE is any AE either reported for the first time or worsening of a pre-existing event after first dose of study drug and within 30 days of the last administration of study drug regardless of starting new anti-lymphoma therapy. A SAE is any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, leads to a congenital anomaly/birth defect or is considered to be an important medical event that may not result in death, be immediately life-threatening, or require hospitalization but may be considered serious when, based on appropriate medical judgment, the event may jeopardize the participant or may require medical or surgical intervention.
Safety Population: all enrolled participants who received at least 1 dose of parsaclisib
Posted
Number
percentage of participants
From first dose of study drug up to 2045 days
ID
Title
Description
OG000
Cohort 1: Treatment A (Exposed to Ibrutinib)
Participants received parsaclisib 20 milligrams (mg), orally, once daily (QD) for 8 weeks followed by 20 mg once weekly (QW) for up to 52 weeks. Participants who were exposed to ibrutinib before enrollment were included in this group.
OG001
Time Frame
From first dose of study drug up to 2045 days
Description
Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
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
Cohort 1: Treatment A (Exposed to Ibrutinib)
Participants received parsaclisib 20 milligrams (mg), orally, once daily (QD) for 8 weeks followed by 20 mg once weekly (QW) for up to 52 weeks. Participants who were exposed to ibrutinib before enrollment were included in this group.
11
12
5
12
9
12
EG001
Cohort 1: Treatment B (Exposed to Ibrutinib)
Participants received parsaclisib 20 mg, orally, QD for 8 weeks followed by 2.5 mg QD for up to 116 weeks. Participants who were exposed to ibrutinib before enrollment were included in this group.
31
41
20
41
28
41
EG002
Cohort 2: Treatment A (BTK Inhibitor Naïve)
Participants received parsaclisib 20 mg, orally, QD for 8 weeks followed by 20 mg QW for up to approximately 145 weeks. Participants who were not exposed to BTK inhibitor before enrollment were included in this group.
19
31
12
31
27
31
EG003
Cohort 2: Treatment B (BTK Inhibitor Naïve)
Participants received parsaclisib 20 mg, orally, QD for 8 weeks followed by 2.5 mg QD for up to approximately 136 weeks. Participants who were not exposed to BTK inhibitor before enrollment were included in this group.
34
77
45
77
66
77
EG004
Total
Total
95
161
82
161
130
161
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Abdominal pain
Gastrointestinal disorders
MedDRA 27
Systematic Assessment
EG0001 events1 affected12 at risk
EG0010 events0 affected41 at risk
EG0020 events0 affected31 at risk
EG0030 events0 affected77 at risk
EG0041 events1 affected161 at risk
Abdominal pain upper
Gastrointestinal disorders
MedDRA 27
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected41 at risk
EG0021 events1 affected31 at risk
EG003
Accidental overdose
Injury, poisoning and procedural complications
MedDRA 27
Systematic Assessment
EG0000 events0 affected12 at risk
EG0011 events1 affected41 at risk
EG0020 events0 affected31 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA 27
Systematic Assessment
EG0000 events0 affected12 at risk
EG0012 events2 affected41 at risk
EG0020 events0 affected31 at risk
EG003
Acute myelomonocytic leukaemia
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 27
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected41 at risk
EG0020 events0 affected31 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA 27
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected41 at risk
EG0020 events0 affected31 at risk
EG003
Arrhythmia supraventricular
Cardiac disorders
MedDRA 27
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected41 at risk
EG0021 events1 affected31 at risk
EG003
Ascites
Gastrointestinal disorders
MedDRA 27
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected41 at risk
EG0021 events1 affected31 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA 27
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected41 at risk
EG0020 events0 affected31 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA 27
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected41 at risk
EG0020 events0 affected31 at risk
EG003
Atypical pneumonia
Infections and infestations
MedDRA 27
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected41 at risk
EG0020 events0 affected31 at risk
EG003
Autoimmune colitis
Gastrointestinal disorders
MedDRA 27
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected41 at risk
EG0020 events0 affected31 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 27
Systematic Assessment
EG0000 events0 affected12 at risk
EG0012 events2 affected41 at risk
EG0020 events0 affected31 at risk
EG003
Bacteraemia
Infections and infestations
MedDRA 27
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected41 at risk
EG0020 events0 affected31 at risk
EG003
Basal cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 27
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected41 at risk
EG0021 events1 affected31 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 27
Systematic Assessment
EG0000 events0 affected12 at risk
EG0011 events1 affected41 at risk
EG0020 events0 affected31 at risk
EG003
COVID-19
Infections and infestations
MedDRA 27
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected41 at risk
EG0020 events0 affected31 at risk
EG003
COVID-19 pneumonia
Infections and infestations
MedDRA 27
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected41 at risk
EG0020 events0 affected31 at risk
EG003
Cardiac arrest
Cardiac disorders
MedDRA 27
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected41 at risk
EG0020 events0 affected31 at risk
EG003
Cardiac failure
Cardiac disorders
MedDRA 27
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected41 at risk
EG0021 events1 affected31 at risk
EG003
Chronic obstructive pulmonary disease
Respiratory, thoracic and mediastinal disorders
MedDRA 27
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected41 at risk
EG0021 events1 affected31 at risk
EG003
Clostridium difficile colitis
Infections and infestations
MedDRA 27
Systematic Assessment
EG0000 events0 affected12 at risk
EG0011 events1 affected41 at risk
EG0020 events0 affected31 at risk
EG003
Colitis
Gastrointestinal disorders
MedDRA 27
Systematic Assessment
EG0000 events0 affected12 at risk
EG0012 events2 affected41 at risk
EG0020 events0 affected31 at risk
EG003
Cytomegalovirus colitis
Infections and infestations
MedDRA 27
Systematic Assessment
EG0000 events0 affected12 at risk
EG0011 events1 affected41 at risk
EG0020 events0 affected31 at risk
EG003
Cytomegalovirus infection
Infections and infestations
MedDRA 27
Systematic Assessment
EG0000 events0 affected12 at risk
EG0011 events1 affected41 at risk
EG0020 events0 affected31 at risk
EG003
Cytomegalovirus infection reactivation
Infections and infestations
MedDRA 27
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected41 at risk
EG0020 events0 affected31 at risk
EG003
Deep vein thrombosis
Vascular disorders
MedDRA 27
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected41 at risk
EG0021 events1 affected31 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 27
Systematic Assessment
EG0000 events0 affected12 at risk
EG0012 events2 affected41 at risk
EG0020 events0 affected31 at risk
EG003
Dermatitis exfoliative
Skin and subcutaneous tissue disorders
MedDRA 27
Systematic Assessment
EG0000 events0 affected12 at risk
EG0011 events1 affected41 at risk
EG0020 events0 affected31 at risk
EG003
Dermatitis psoriasiform
Skin and subcutaneous tissue disorders
MedDRA 27
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected41 at risk
EG0020 events0 affected31 at risk
EG003
Diabetic metabolic decompensation
Metabolism and nutrition disorders
MedDRA 27
Systematic Assessment
EG0000 events0 affected12 at risk
EG0011 events1 affected41 at risk
EG0020 events0 affected31 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 27
Systematic Assessment
EG0001 events1 affected12 at risk
EG0016 events3 affected41 at risk
EG0020 events0 affected31 at risk
EG003
Drug reaction with eosinophilia and systemic symptoms
Skin and subcutaneous tissue disorders
MedDRA 27
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected41 at risk
EG0020 events0 affected31 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 27
Systematic Assessment
EG0000 events0 affected12 at risk
EG0012 events2 affected41 at risk
EG0020 events0 affected31 at risk
EG003
Dyspnoea exertional
Respiratory, thoracic and mediastinal disorders
MedDRA 27
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected41 at risk
EG0020 events0 affected31 at risk
EG003
Eastern Cooperative Oncology Group performance status worsened
Investigations
MedDRA 27
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected41 at risk
EG0020 events0 affected31 at risk
EG003
Eczema
Skin and subcutaneous tissue disorders
MedDRA 27
Systematic Assessment
EG0000 events0 affected12 at risk
EG0012 events1 affected41 at risk
EG0020 events0 affected31 at risk
EG003
Endocarditis staphylococcal
Infections and infestations
MedDRA 27
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected41 at risk
EG0020 events0 affected31 at risk
EG003
Epilepsy
Nervous system disorders
MedDRA 27
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected41 at risk
EG0021 events1 affected31 at risk
EG003
Fatigue
General disorders
MedDRA 27
Systematic Assessment
EG0000 events0 affected12 at risk
EG0012 events2 affected41 at risk
EG0020 events0 affected31 at risk
EG003
Febrile neutropenia
Blood and lymphatic system disorders
MedDRA 27
Systematic Assessment
EG0000 events0 affected12 at risk
EG0011 events1 affected41 at risk
EG0020 events0 affected31 at risk
EG003
Gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA 27
Systematic Assessment
EG0000 events0 affected12 at risk
EG0011 events1 affected41 at risk
EG0020 events0 affected31 at risk
EG003
General physical health deterioration
General disorders
MedDRA 27
Systematic Assessment
EG0001 events1 affected12 at risk
EG0010 events0 affected41 at risk
EG0020 events0 affected31 at risk
EG003
Hepatic cytolysis
Hepatobiliary disorders
MedDRA 27
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected41 at risk
EG0021 events1 affected31 at risk
EG003
Hypersensitivity
Immune system disorders
MedDRA 27
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected41 at risk
EG0020 events0 affected31 at risk
EG003
Hyperthermia
General disorders
MedDRA 27
Systematic Assessment
EG0000 events0 affected12 at risk
EG0011 events1 affected41 at risk
EG0020 events0 affected31 at risk
EG003
Hyperuricaemia
Metabolism and nutrition disorders
MedDRA 27
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected41 at risk
EG0021 events1 affected31 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA 27
Systematic Assessment
EG0000 events0 affected12 at risk
EG0011 events1 affected41 at risk
EG0021 events1 affected31 at risk
EG003
Hypotension
Vascular disorders
MedDRA 27
Systematic Assessment
EG0000 events0 affected12 at risk
EG0011 events1 affected41 at risk
EG0020 events0 affected31 at risk
EG003
Incarcerated inguinal hernia
Gastrointestinal disorders
MedDRA 27
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected41 at risk
EG0020 events0 affected31 at risk
EG003
Infection
Infections and infestations
MedDRA 27
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected41 at risk
EG0020 events0 affected31 at risk
EG003
Intestinal perforation
Gastrointestinal disorders
MedDRA 27
Systematic Assessment
EG0000 events0 affected12 at risk
EG0011 events1 affected41 at risk
EG0020 events0 affected31 at risk
EG003
Ischaemic stroke
Nervous system disorders
MedDRA 27
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected41 at risk
EG0020 events0 affected31 at risk
EG003
Leukocytosis
Blood and lymphatic system disorders
MedDRA 27
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected41 at risk
EG0020 events0 affected31 at risk
EG003
Lung disorder
Respiratory, thoracic and mediastinal disorders
MedDRA 27
Systematic Assessment
EG0000 events0 affected12 at risk
EG0012 events1 affected41 at risk
EG0020 events0 affected31 at risk
EG003
Mantle cell lymphoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 27
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected41 at risk
EG0020 events0 affected31 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 27
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected41 at risk
EG0020 events0 affected31 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA 27
Systematic Assessment
EG0000 events0 affected12 at risk
EG0012 events2 affected41 at risk
EG0020 events0 affected31 at risk
EG003
Neutrophil count decreased
Investigations
MedDRA 27
Systematic Assessment
EG0000 events0 affected12 at risk
EG0011 events1 affected41 at risk
EG0020 events0 affected31 at risk
EG003
Nodule
General disorders
MedDRA 27
Systematic Assessment
EG0000 events0 affected12 at risk
EG0011 events1 affected41 at risk
EG0020 events0 affected31 at risk
EG003
Oedema peripheral
General disorders
MedDRA 27
Systematic Assessment
EG0000 events0 affected12 at risk
EG0011 events1 affected41 at risk
EG0020 events0 affected31 at risk
EG003
Oesophagitis ulcerative
Gastrointestinal disorders
MedDRA 27
Systematic Assessment
EG0000 events0 affected12 at risk
EG0011 events1 affected41 at risk
EG0020 events0 affected31 at risk
EG003
Oligoarthritis
Musculoskeletal and connective tissue disorders
MedDRA 27
Systematic Assessment
EG0000 events0 affected12 at risk
EG0011 events1 affected41 at risk
EG0020 events0 affected31 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 27
Systematic Assessment
EG0000 events0 affected12 at risk
EG0012 events2 affected41 at risk
EG0020 events0 affected31 at risk
EG003
Parainfluenzae virus infection
Infections and infestations
MedDRA 27
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected41 at risk
EG0021 events1 affected31 at risk
EG003
Peripheral swelling
General disorders
MedDRA 27
Systematic Assessment
EG0000 events0 affected12 at risk
EG0012 events2 affected41 at risk
EG0020 events0 affected31 at risk
EG003
Pneumocystis jirovecii pneumonia
Infections and infestations
MedDRA 27
Systematic Assessment
EG0001 events1 affected12 at risk
EG0010 events0 affected41 at risk
EG0020 events0 affected31 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 27
Systematic Assessment
EG0000 events0 affected12 at risk
EG0012 events2 affected41 at risk
EG0020 events0 affected31 at risk
EG003
Pneumonia pneumococcal
Infections and infestations
MedDRA 27
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected41 at risk
EG0020 events0 affected31 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA 27
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected41 at risk
EG0021 events1 affected31 at risk
EG003
Pyrexia
General disorders
MedDRA 27
Systematic Assessment
EG0000 events0 affected12 at risk
EG0011 events1 affected41 at risk
EG0021 events1 affected31 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA 27
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected41 at risk
EG0020 events0 affected31 at risk
EG003
Renal failure
Renal and urinary disorders
MedDRA 27
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected41 at risk
EG0020 events0 affected31 at risk
EG003
Respiratory syncytial virus infection
Infections and infestations
MedDRA 27
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected41 at risk
EG0020 events0 affected31 at risk
EG003
Respiratory tract infection
Infections and infestations
MedDRA 27
Systematic Assessment
EG0001 events1 affected12 at risk
EG0010 events0 affected41 at risk
EG0020 events0 affected31 at risk
EG003
Septic shock
Infections and infestations
MedDRA 27
Systematic Assessment
EG0000 events0 affected12 at risk
EG0011 events1 affected41 at risk
EG0020 events0 affected31 at risk
EG003
Spinal fracture
Injury, poisoning and procedural complications
MedDRA 27
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected41 at risk
EG0021 events1 affected31 at risk
EG003
Spondylitis
Musculoskeletal and connective tissue disorders
MedDRA 27
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected41 at risk
EG0021 events1 affected31 at risk
EG003
Sudden death
General disorders
MedDRA 27
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected41 at risk
EG0020 events0 affected31 at risk
EG003
Swelling
General disorders
MedDRA 27
Systematic Assessment
EG0000 events0 affected12 at risk
EG0011 events1 affected41 at risk
EG0020 events0 affected31 at risk
EG003
Transient ischaemic attack
Nervous system disorders
MedDRA 27
Systematic Assessment
EG0001 events1 affected12 at risk
EG0010 events0 affected41 at risk
EG0020 events0 affected31 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 27
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected41 at risk
EG0021 events1 affected31 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 27
Systematic Assessment
EG0000 events0 affected12 at risk
EG0011 events1 affected41 at risk
EG0020 events0 affected31 at risk
EG003
Urosepsis
Infections and infestations
MedDRA 27
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected41 at risk
EG0020 events0 affected31 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 27
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected41 at risk
EG0020 events0 affected31 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Abdominal distension
Gastrointestinal disorders
MedDRA 27
Systematic Assessment
EG0001 events1 affected12 at risk
EG0011 events1 affected41 at risk
EG0020 events0 affected31 at risk
EG0031 events1 affected77 at risk
EG0043 events3 affected161 at risk
Abdominal pain
Gastrointestinal disorders
MedDRA 27
Systematic Assessment
EG0000 events0 affected12 at risk
EG0013 events3 affected41 at risk
EG0021 events1 affected31 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA 27
Systematic Assessment
EG0000 events0 affected12 at risk
EG0011 events1 affected41 at risk
EG0021 events1 affected31 at risk
EG003
Anaemia
Blood and lymphatic system disorders
MedDRA 27
Systematic Assessment
EG0004 events3 affected12 at risk
EG00110 events8 affected41 at risk
EG0024 events4 affected31 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA 27
Systematic Assessment
EG0001 events1 affected12 at risk
EG0012 events2 affected41 at risk
EG0020 events0 affected31 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 27
Systematic Assessment
EG0000 events0 affected12 at risk
EG0014 events4 affected41 at risk
EG0022 events2 affected31 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA 27
Systematic Assessment
EG0000 events0 affected12 at risk
EG0011 events1 affected41 at risk
EG0020 events0 affected31 at risk
EG003
Asthenia
General disorders
MedDRA 27
Systematic Assessment
EG0000 events0 affected12 at risk
EG0017 events7 affected41 at risk
EG0023 events3 affected31 at risk
EG003
Atrial flutter
Cardiac disorders
MedDRA 27
Systematic Assessment
EG0001 events1 affected12 at risk
EG0010 events0 affected41 at risk
EG0020 events0 affected31 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 27
Systematic Assessment
EG0000 events0 affected12 at risk
EG0012 events2 affected41 at risk
EG0024 events4 affected31 at risk
EG003
Blood creatinine increased
Investigations
MedDRA 27
Systematic Assessment
EG0000 events0 affected12 at risk
EG0013 events2 affected41 at risk
EG0023 events2 affected31 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 27
Systematic Assessment
EG0000 events0 affected12 at risk
EG0011 events1 affected41 at risk
EG0022 events2 affected31 at risk
EG003
COVID-19
Infections and infestations
MedDRA 27
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected41 at risk
EG0022 events2 affected31 at risk
EG003
Colitis
Gastrointestinal disorders
MedDRA 27
Systematic Assessment
EG0001 events1 affected12 at risk
EG0010 events0 affected41 at risk
EG0020 events0 affected31 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 27
Systematic Assessment
EG0000 events0 affected12 at risk
EG0015 events4 affected41 at risk
EG0023 events3 affected31 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 27
Systematic Assessment
EG0001 events1 affected12 at risk
EG0015 events5 affected41 at risk
EG0022 events2 affected31 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 27
Systematic Assessment
EG0002 events2 affected12 at risk
EG0014 events4 affected41 at risk
EG0021 events1 affected31 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 27
Systematic Assessment
EG0003 events2 affected12 at risk
EG00118 events9 affected41 at risk
EG00211 events8 affected31 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA 27
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected41 at risk
EG0022 events2 affected31 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA 27
Systematic Assessment
EG0000 events0 affected12 at risk
EG0012 events2 affected41 at risk
EG0022 events2 affected31 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 27
Systematic Assessment
EG0001 events1 affected12 at risk
EG0013 events3 affected41 at risk
EG0023 events3 affected31 at risk
EG003
Ear discomfort
Ear and labyrinth disorders
MedDRA 27
Systematic Assessment
EG0001 events1 affected12 at risk
EG0010 events0 affected41 at risk
EG0020 events0 affected31 at risk
EG003
Eosinophilia
Blood and lymphatic system disorders
MedDRA 27
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected41 at risk
EG0022 events2 affected31 at risk
EG003
Eructation
Gastrointestinal disorders
MedDRA 27
Systematic Assessment
EG0001 events1 affected12 at risk
EG0010 events0 affected41 at risk
EG0020 events0 affected31 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
MedDRA 27
Systematic Assessment
EG0000 events0 affected12 at risk
EG0011 events1 affected41 at risk
EG0020 events0 affected31 at risk
EG003
Fatigue
General disorders
MedDRA 27
Systematic Assessment
EG0002 events2 affected12 at risk
EG0012 events2 affected41 at risk
EG0022 events2 affected31 at risk
EG003
Headache
Nervous system disorders
MedDRA 27
Systematic Assessment
EG0002 events2 affected12 at risk
EG0012 events2 affected41 at risk
EG0024 events3 affected31 at risk
EG003
Hyperhidrosis
Skin and subcutaneous tissue disorders
MedDRA 27
Systematic Assessment
EG0001 events1 affected12 at risk
EG0010 events0 affected41 at risk
EG0021 events1 affected31 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA 27
Systematic Assessment
EG0001 events1 affected12 at risk
EG0011 events1 affected41 at risk
EG0020 events0 affected31 at risk
EG003
Hypernatraemia
Metabolism and nutrition disorders
MedDRA 27
Systematic Assessment
EG0001 events1 affected12 at risk
EG0010 events0 affected41 at risk
EG0020 events0 affected31 at risk
EG003
Hypertension
Vascular disorders
MedDRA 27
Systematic Assessment
EG0001 events1 affected12 at risk
EG0011 events1 affected41 at risk
EG0021 events1 affected31 at risk
EG003
Hyperuricaemia
Metabolism and nutrition disorders
MedDRA 27
Systematic Assessment
EG0001 events1 affected12 at risk
EG0014 events2 affected41 at risk
EG0022 events2 affected31 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA 27
Systematic Assessment
EG0000 events0 affected12 at risk
EG0011 events1 affected41 at risk
EG0020 events0 affected31 at risk
EG003
Hypophosphataemia
Metabolism and nutrition disorders
MedDRA 27
Systematic Assessment
EG0000 events0 affected12 at risk
EG0011 events1 affected41 at risk
EG0022 events2 affected31 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA 27
Systematic Assessment
EG0002 events2 affected12 at risk
EG0010 events0 affected41 at risk
EG0020 events0 affected31 at risk
EG003
Malnutrition
Metabolism and nutrition disorders
MedDRA 27
Systematic Assessment
EG0001 events1 affected12 at risk
EG0010 events0 affected41 at risk
EG0020 events0 affected31 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA 27
Systematic Assessment
EG0000 events0 affected12 at risk
EG0012 events2 affected41 at risk
EG0022 events2 affected31 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 27
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected41 at risk
EG0022 events1 affected31 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 27
Systematic Assessment
EG0003 events2 affected12 at risk
EG0012 events1 affected41 at risk
EG0022 events2 affected31 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 27
Systematic Assessment
EG0002 events2 affected12 at risk
EG0013 events2 affected41 at risk
EG0024 events4 affected31 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA 27
Systematic Assessment
EG0002 events2 affected12 at risk
EG0019 events6 affected41 at risk
EG0024 events3 affected31 at risk
EG003
Neutrophil count decreased
Investigations
MedDRA 27
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected41 at risk
EG0022 events2 affected31 at risk
EG003
Oedema peripheral
General disorders
MedDRA 27
Systematic Assessment
EG0003 events2 affected12 at risk
EG0014 events3 affected41 at risk
EG0022 events2 affected31 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 27
Systematic Assessment
EG0000 events0 affected12 at risk
EG0012 events2 affected41 at risk
EG0022 events2 affected31 at risk
EG003
Platelet count decreased
Investigations
MedDRA 27
Systematic Assessment
EG0001 events1 affected12 at risk
EG0010 events0 affected41 at risk
EG0022 events2 affected31 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA 27
Systematic Assessment
EG0001 events1 affected12 at risk
EG0012 events1 affected41 at risk
EG0021 events1 affected31 at risk
EG003
Pseudomonas test positive
Investigations
MedDRA 27
Systematic Assessment
EG0001 events1 affected12 at risk
EG0010 events0 affected41 at risk
EG0020 events0 affected31 at risk
EG003
Pyrexia
General disorders
MedDRA 27
Systematic Assessment
EG0001 events1 affected12 at risk
EG0016 events6 affected41 at risk
EG0025 events5 affected31 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA 27
Systematic Assessment
EG0001 events1 affected12 at risk
EG0014 events4 affected41 at risk
EG0022 events2 affected31 at risk
EG003
Rash maculo-papular
Skin and subcutaneous tissue disorders
MedDRA 27
Systematic Assessment
EG0000 events0 affected12 at risk
EG0012 events2 affected41 at risk
EG0022 events2 affected31 at risk
EG003
Renal failure
Renal and urinary disorders
MedDRA 27
Systematic Assessment
EG0002 events2 affected12 at risk
EG0012 events1 affected41 at risk
EG0020 events0 affected31 at risk
EG003
Respiratory rate increased
Investigations
MedDRA 27
Systematic Assessment
EG0001 events1 affected12 at risk
EG0010 events0 affected41 at risk
EG0020 events0 affected31 at risk
EG003
Rhinitis
Infections and infestations
MedDRA 27
Systematic Assessment
EG0000 events0 affected12 at risk
EG0011 events1 affected41 at risk
EG0022 events2 affected31 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA 27
Systematic Assessment
EG0001 events1 affected12 at risk
EG0011 events1 affected41 at risk
EG0021 events1 affected31 at risk
EG003
Tachycardia
Cardiac disorders
MedDRA 27
Systematic Assessment
EG0001 events1 affected12 at risk
EG0012 events2 affected41 at risk
EG0020 events0 affected31 at risk
EG003
Testicular oedema
Reproductive system and breast disorders
MedDRA 27
Systematic Assessment
EG0001 events1 affected12 at risk
EG0010 events0 affected41 at risk
EG0020 events0 affected31 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA 27
Systematic Assessment
EG0001 events1 affected12 at risk
EG0015 events3 affected41 at risk
EG0022 events2 affected31 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 27
Systematic Assessment
EG0000 events0 affected12 at risk
EG0011 events1 affected41 at risk
EG0022 events2 affected31 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 27
Systematic Assessment
EG0001 events1 affected12 at risk
EG0012 events1 affected41 at risk
EG0024 events3 affected31 at risk
EG003
Vertigo
Ear and labyrinth disorders
MedDRA 27
Systematic Assessment
EG0001 events1 affected12 at risk
EG0010 events0 affected41 at risk
EG0020 events0 affected31 at risk
EG003
Viral infection
Infections and infestations
MedDRA 27
Systematic Assessment
EG0001 events1 affected12 at risk
EG0010 events0 affected41 at risk
EG0020 events0 affected31 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 27
Systematic Assessment
EG0001 events1 affected12 at risk
EG0012 events2 affected41 at risk
EG0022 events2 affected31 at risk
EG003
Weight decreased
Investigations
MedDRA 27
Systematic Assessment
EG0002 events2 affected12 at risk
EG0013 events3 affected41 at risk
EG0020 events0 affected31 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 received parsaclisib 20 mg, orally, QD for 8 weeks followed by 2.5 mg QD for up to 116 weeks. Participants who were exposed to ibrutinib before enrollment were included in this group.
OG002
Cohort 2: Treatment A (BTK Inhibitor Naïve)
Participants received parsaclisib 20 mg, orally, QD for 8 weeks followed by 20 mg QW for up to approximately 145 weeks. Participants who were not exposed to BTK inhibitor before enrollment were included in this group.
OG003
Cohort 2: Treatment B (BTK Inhibitor Naïve)
Participants received parsaclisib 20 mg, orally, QD for 8 weeks followed by 2.5 mg QD for up to approximately 136 weeks. Participants who were not exposed to BTK inhibitor before enrollment were included in this group.
Units
Counts
Participants
OG0001
OG00116
OG00220
OG00355
Title
Denominators
Categories
Title
Measurements
OG000NA(NA to NA)The median and the lower and upper limits of the 95% confidence interval (CI) were not estimable due to the low number of participants with events of response.
OG0013.20(1.87 to 7.95)
OG00217.45(3.81 to NA)The upper limit of the 95% CI was not estimable due to the low number of participants with events of response.
OG00313.01(9.03 to 16.59)
Participants received parsaclisib 20 mg, orally, QD for 8 weeks followed by 20 mg QW for up to approximately 145 weeks. Participants who were not exposed to BTK inhibitor before enrollment were included in this group.
OG003
Cohort 2: Treatment B (BTK Inhibitor Naïve)
Participants received parsaclisib 20 mg, orally, QD for 8 weeks followed by 2.5 mg QD for up to approximately 136 weeks. Participants who were not exposed to BTK inhibitor before enrollment were included in this group.
Units
Counts
Participants
OG00012
OG00141
OG00231
OG00377
Title
Denominators
Categories
Title
Measurements
OG0000.0(0.0 to 26.5)
OG0012.4(0.1 to 12.9)
OG00222.6(9.6 to 41.1)
OG00315.6(8.3 to 25.6)
OG003
Cohort 2: Treatment B (BTK Inhibitor Naïve)
Participants received parsaclisib 20 mg, orally, QD for 8 weeks followed by 2.5 mg QD for up to approximately 136 weeks. Participants who were not exposed to BTK inhibitor before enrollment were included in this group.
Units
Counts
Participants
OG00012
OG00141
OG00231
OG00377
Title
Denominators
Categories
Title
Measurements
OG0003.94(1.35 to NA)The upper limit of the 95% CI was not estimable due to the low number of participants with events.
OG0013.68(1.87 to 5.49)
OG0028.11(5.29 to 21.62)
OG00313.83(10.02 to 16.89)
Participants received parsaclisib 20 mg, orally, QD for 8 weeks followed by 2.5 mg QD for up to approximately 136 weeks. Participants who were not exposed to BTK inhibitor before enrollment were included in this group.
Units
Counts
Participants
OG00012
OG00141
OG00231
OG00377
Title
Denominators
Categories
Title
Measurements
OG00010.91(1.35 to 17.64)
OG00111.01(7.23 to 17.12)
OG00233.48(21.62 to 54.67)
OG00345.86(34.20 to NA)The upper limit of the confidence interval was not estimable because too few participants died.
OG002
Cohort 2: Treatment A (BTK Inhibitor Naïve)
Participants received parsaclisib 20 mg, orally, QD for 8 weeks followed by 20 mg QW for up to approximately 145 weeks. Participants who were not exposed to BTK inhibitor before enrollment were included in this group.
OG003
Cohort 2: Treatment B (BTK Inhibitor Naïve)
Participants received parsaclisib 20 mg, orally, QD for 8 weeks followed by 2.5 mg QD for up to approximately 136 weeks. Participants who were not exposed to BTK inhibitor before enrollment were included in this group.
Units
Counts
Participants
OG0006
OG00132
OG00225
OG00368
Title
Denominators
Categories
Title
Measurements
OG000-19.82± 35.926
OG001-9.51± 133.438
OG002-64.65± 53.360
OG003-67.54± 32.918
Cohort 1: Treatment B (Exposed to Ibrutinib)
Participants received parsaclisib 20 mg, orally, QD for 8 weeks followed by 2.5 mg QD for up to 116 weeks. Participants who were exposed to ibrutinib before enrollment were included in this group.
OG002
Cohort 2: Treatment A (BTK Inhibitor Naïve)
Participants received parsaclisib 20 mg, orally, QD for 8 weeks followed by 20 mg QW for up to approximately 145 weeks. Participants who were not exposed to BTK inhibitor before enrollment were included in this group.
OG003
Cohort 2: Treatment B (BTK Inhibitor Naïve)
Participants received parsaclisib 20 mg, orally, QD for 8 weeks followed by 2.5 mg QD for up to approximately 136 weeks. Participants who were not exposed to BTK inhibitor before enrollment were included in this group.