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(CITADEL-205): A Study of INCB050465 in Relapsed or Refractory Mantle Cell Lymphoma Previously Treated With or Without a Bruton's Tyrosine Kinase (BTK) Inhibitor

Sponsor
Incyte Corporation (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT03235544
Collaborator
(none)
161
Enrollment
103
Locations
4
Arms
64.3
Anticipated Duration (Months)
1.6
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
161 participants
Allocation:
Non-Randomized
Intervention Model:
Sequential Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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)
Actual Study Start Date :
Nov 20, 2017
Actual Primary Completion Date :
Mar 3, 2021
Anticipated Study Completion Date :
Mar 31, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Cohort 1: Treatment A (Exposed to Ibrutinib)

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
Parsaclisib tablets administered orally with water and without regard to food.
Other Names:
  • INCB050465

    		•
    Experimental: Cohort 1: Treatment B (Exposed to Ibrutinib)

    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
    Parsaclisib tablets administered orally with water and without regard to food.
    Other Names:
  • INCB050465

    		•
    Experimental: Cohort 2: Treatment A (Bruton's Tyrosine Kinase Inhibitor Naïve)

    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
    Parsaclisib tablets administered orally with water and without regard to food.
    Other Names:
  • INCB050465

    		•
    Experimental: Cohort 2: Treatment B (Bruton's Tyrosine Kinase Inhibitor Naïve)

    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
    Parsaclisib tablets administered orally with water and without regard to food.
    Other Names:
  • INCB050465

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Objective Response Rate (ORR) [Up to approximately 165 weeks]

      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.

    Secondary Outcome Measures

    1. Duration of Response (DOR) [Up to approximately 165 weeks]

      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.

    2. Complete Response Rate (CRR) [Up to approximately 165 weeks]

      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.

    3. Progression-Free Survival (PFS) [Up to approximately 165 weeks]

      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.

    4. Overall Survival (OS) [Up to approximately 165 weeks]

      OS is defined as the time from the date of the first dose of study treatment until death from any cause.

    5. Best Percent Change From Baseline in Target Lesion Size [Up to approximately 165 weeks]

      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.

    6. Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) [From first dose of study drug up to approximately 165 weeks]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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).

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Alabama At Birmingham Comprehensive Cancer Center Birmingham Alabama United States 35205
    2 St. Joseph Heritage Healthcare Santa Rosa California United States 95403
    3 Rocky Mountain Cancer Center-Aurora Aurora Colorado United States 80012
    4 Asclepes Research Centers Brooksville Florida United States 34613
    5 Moffitt Cancer Center Tampa Florida United States 33647
    6 Bond & Steele Clinic, P.A. Winter Haven Florida United States 33880
    7 Rush University Medical Center Chicago Illinois United States 60612
    8 Loyola University Medical Center Maywood Illinois United States 60153
    9 Illinois Cancer Specialists Niles Illinois United States 60714
    10 Hattiesburg Clinic Hematology Hattiesburg Mississippi United States 39401
    11 Clinical Research Alliance, Inc. New Hyde Park New York United States 11042
    12 Duke University Medical Center Durham North Carolina United States 27705
    13 Oncology Hematology Care, Inc. Cincinnati Ohio United States 45230
    14 Willamette Valley Cancer Institute Eugene Oregon United States 97401
    15 Kaiser Permanente - Northwest Portland Oregon United States 97227
    16 Gettysburg Cancer Center Gettysburg Pennsylvania United States 17325
    17 Texas Oncology Austin Texas United States 78705
    18 Texas Oncology San Antonio San Antonio Texas United States 78240
    19 Renovatio Clinical The Woodlands Texas United States 77380
    20 Texas Oncology - Tyler Tyler Texas United States 75702
    21 Yakima Valley Memorial Hospital/North Star Yakima Washington United States 98902
    22 Universitair Ziekenhuis Gent Gent Oost-Vlaanderen Belgium 9000
    23 Institut Jules Bordet Brussels Belgium
    24 Hopital de Jolimont La Louviere Belgium 07100
    25 Universitaire Ziekenhuis Leuven - Gasthuisberg Leuven Belgium 03000
    26 Fakultni Nemocnice Hradec Kralove Hradec Kralove Czechia 500 05
    27 Fakultni Nemocnice Kralovske Vinohrady Prague 10 Czechia 500 05
    28 Charles University General Hospital Prague 2 Czechia 128 08
    29 Fakultni Nemocnice Kralovske Vinohadry, Interni Hematologicka Klinika Prague Czechia 10034
    30 Aalborg University Hospital Aalborg Denmark 09000
    31 Aarhus Universitets Hospital Aarhus Denmark DK-8000
    32 Odense Universitetshospital (Ouh) (Odense University Hospital) Odense C Denmark 05000
    33 Zealand University Hospital Roskilde Denmark 04000
    34 Avicenne Hospital Bobigny France 93000
    35 Chu de Clermont - Ferrand- Hospital Estaing Clermont-ferrand France 63230
    36 Centre Hospitalier Universitaire Henri Mondor Creteil France 94010
    37 University Hospital Grenoble Grenoble France 38043
    38 Centre Hospitalier Departemental - La-Roche-Sur-Yon - Les Oudairies La Roche Sur Yon France 85925
    39 Centre Hospitalier Universitaire de Grenoble La Tronche France 38700
    40 Centre Hospitalier de Versailles Le Chesnay France 78157
    41 Hospices Civils de Lyon Centre Hospitalier Lyon Sud Lyon France 69008
    42 Centre Antoine Lacassagne Nice France 06189
    43 Hopital Saint-Louis Paris France 75010
    44 H�Pital Universitaire Piti�-Salp�Tri�Re Paris France 75013
    45 Centre Hospitalier Lyon-Sud Pierre-Bénite Cedex France 69310
    46 Centre Hospitalier Universitaire de Poitiers Poitiers France 86021
    47 Centre Henri Becquerel Rouen France 76038
    48 Chru Hopitaux de Tours, Hospital Bretonneau Tours France 37044
    49 Institute Gustave Roussy (Igr) Villejuif Cedex France 94805
    50 Praxis Brudler, Heinrich, Bangerter Augsburg Germany 86150
    51 Universitaetsklinikum Essen Essen Germany 45122
    52 Universit�Tsklinikum Essen Essen Germany 45147
    53 Justus-Liebig University Giessen Germany 35392
    54 Universitatsmedizin Der Johannes Gutenberg-Universitat Mainz Iii Mainz Germany 55131
    55 Kliniken Maria Hilf Moenchengladbach Germany 41063
    56 Rotkreuzklinikum Munich Munchen Germany 80634
    57 Universit�Tsklinikum Ulm ULM Germany 89081
    58 Rambam Medical Center Haifa Israel 31096
    59 Hadassah Hebrew University Medical Center Jerusalem Israel 90000
    60 Hadassah Hebrew University Medical Center Ein Karem Hadassah Jerusalem Israel 91120
    61 Rabin Medical Center - Beilinson Hospital Petach Tikva Israel 4841492
    62 Tel Aviv Sourasky Medical Center Tel Aviv Israel 64239
    63 Fondazione Irccs Istituto Nazionale Dei Tumori Milano MI Italy 20133
    64 Centro Ricerche Cliniche Bologna Italy 40138
    65 Azienda Policlinico Vittorio Emanuele Catania Italy 95123
    66 Grande Ospedale Metropolitano Niguarda Milano Italy 20162
    67 Ospedale Niguarda Ca Granda Milano Italy 22162
    68 A.O.U. Di Modena - Policlinico Modena Italy 41124
    69 A.O.U. Federico Ii Napoli Italy 80131
    70 Aou Maggiore Della Carita Novara Italy 28100
    71 Ospedali Riuniti Villa Sofia Cervello Palermo Italy 90146
    72 Sapienza University Rome Italy 00161
    73 Azienda Ospedaliera Universitaria Senese Policlinico Santa Maria Alle Scotte Siena Italy 53100
    74 Azienda Ospedaliero Universitaria Citta Della Salute E Della Scienza Torino Italy 10126
    75 Beskidzkie Centrum Onkologii Im.Jana Pawla Ii Bielsko-biala Poland 43-300
    76 Szpital Specjalistyczny W Brzozowie, Podkarpacki Osrodek Onkologiczny Im.Ks.B.Markiewicza Brzozow Poland 36-200
    77 University Clinical Center Gdansk Poland 80-952
    78 Pratia McM Krakow Krakow Poland 30-510
    79 Nu-Med Centrum Diagnostykii I Terapii Onkologicznej Tomaszow Mazowiecki Poland 97-200
    80 Centrum Onkologii-Instytut Im. Marii Sklodowskiej-Curie Warszawa Poland 02-781
    81 Hospital Del Mar Barcelona Spain 08003
    82 Hospital General Universitari Vall D Hebron Barcelona Spain 08035
    83 Hospital Universitari Mutua Terrassa Barcelona Spain 08221
    84 Institut Catala D Oncologia Barcelona Spain 08916
    85 Hospital Universitario de Burgos Burgos Spain 09006
    86 Hospital General Universitario Gregorio Maranon Madrid Spain 28007
    87 Md Anderson Cancer Centre Madrid Madrid Spain 28033
    88 Hospital Universitario Ramon Y Cajal Madrid Spain 28034
    89 Fundacion Jimenez Diaz University Hospital Madrid Spain 28040
    90 Hospital Universitario 12 de Octubre Madrid Spain 28041
    91 Hospital Universitario de La Paz Madrid Spain 28046
    92 Hospital General Universitario Morales Meseguer Murcia Spain 30008
    93 Complejo Hospitalario de Navarra Pamplona Spain 31008
    94 Hospital Clinico Universitario de Salamanca Salamanca Spain 37007
    95 Hospital Universitario Virgen del Rocio Sevilla Spain 41005
    96 Hospital Arnau de Vilanova Valencia Spain 46015
    97 Hospital Universitario Dr. Peset Valencia Spain 46017
    98 Hospital Universitario Y Politecnic La Fe Valencia Spain 46026
    99 Birmingham Heartlands Hospital Birmingham United Kingdom B9 5SS
    100 Western General Hospital Edinburgh United Kingdom EH4 2XU
    101 University College London Hospitals (Uclh) London United Kingdom NW1 2PG
    102 Derriford Hospital Plymouth United Kingdom PL6 8DH
    103 Royal Hallamshire Hospital Sheffield United Kingdom S10 2JF

    Sponsors and Collaborators

    • Incyte Corporation

    Investigators

    • Study Director: Fred Zheng, MD, Incyte Corporation

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    Incyte Corporation
    ClinicalTrials.gov Identifier:
    NCT03235544
    Other Study ID Numbers:
    • INCB 50465-205 (CITADEL-205)
    • Parsaclisib
    • 2017-003148-19
    First Posted:
    Aug 1, 2017
    Last Update Posted:
    Jul 13, 2022
    Last Verified:
    Jul 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Incyte Corporation
    Mantle cell lymphoma
    non-Hodgkin lymphoma
    Bruton's tyrosine kinase (BTK)
    phosphatidylinositol 3-kinase (PI3K)
    Additional relevant MeSH terms:
    Lymphoma
    Lymphoma, Mantle-Cell

    Study Results

    Participant Flow

    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 from 20 November 2017 and are planned to continue in the study up to 31 March 2023. Data is reported up to primary completion date, 15 January 2021. This study is ongoing.
    Pre-assignment Detail A total of 161 participants with relapsed or refractory mantle cell lymphoma who received 1-3 prior systemic therapies were enrolled into 2 Cohorts: Cohort 1 had previously received ibrutinib and Cohort 2 were Bruton's tyrosine kinase (BTK) inhibitor naive. Participants were further allocated to Treatments A and B in each cohort to receive parsaclisib.
    Arm/Group Title Cohort 1: Treatment A (Exposed to Ibrutinib) Cohort 1: Treatment B (Exposed to Ibrutinib) Cohort 2: Treatment A (BTK Inhibitor Naïve) Cohort 2: Treatment B (BTK Inhibitor Naïve)
    Arm/Group Description 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. 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. Participants received parsaclisib 20 mg tablets, 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. 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 were not exposed to BTK inhibitor before enrollment were included in this group.
    Period Title: Overall Study
    STARTED 12 41 31 77
    COMPLETED 0 0 0 0
    NOT COMPLETED 12 41 31 77

    Baseline Characteristics

    Arm/Group Title Cohort 1: Treatment A (Exposed to Ibrutinib) Cohort 1: Treatment B (Exposed to Ibrutinib) Cohort 2: Treatment A (BTK Inhibitor Naïve) Cohort 2: Treatment B (BTK Inhibitor Naïve) Total
    Arm/Group Description Participants received parsaclisib 20 mg tablets, orally, QD for 8 weeks followed by 20 mg QW for up to 52 weeks. Participants who were exposed to ibrutinib before enrollment were included in this group. 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. Participants received parsaclisib 20 mg tablets, 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. 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 were not exposed to BTK inhibitor before enrollment were included in this group. Total of all reporting groups
    Overall Participants 12 41 31 77 161
    Age (years) [Mean (Full Range) ]
    Mean (Full Range) [years]
    70.2
    69.8
    72.2
    71.5
    70.9
    Sex: Female, Male (Count of Participants)
    Female
    1
    8.3%
    11
    26.8%
    5
    16.1%
    17
    22.1%
    34
    21.1%
    Male
    11
    91.7%
    30
    73.2%
    26
    83.9%
    60
    77.9%
    127
    78.9%
    Race/Ethnicity, Customized (Count of Participants)
    Hispanic or Latino
    3
    25%
    2
    4.9%
    4
    12.9%
    5
    6.5%
    14
    8.7%
    Not Hispanic or Latino
    6
    50%
    28
    68.3%
    21
    67.7%
    57
    74%
    112
    69.6%
    Not Reported
    1
    8.3%
    5
    12.2%
    6
    19.4%
    8
    10.4%
    20
    12.4%
    Unknown
    2
    16.7%
    4
    9.8%
    0
    0%
    1
    1.3%
    7
    4.3%
    Other
    0
    0%
    0
    0%
    0
    0%
    2
    2.6%
    2
    1.2%
    Missing
    0
    0%
    2
    4.9%
    0
    0%
    4
    5.2%
    6
    3.7%
    Race/Ethnicity, Customized (Count of Participants)
    White
    11
    91.7%
    37
    90.2%
    24
    77.4%
    64
    83.1%
    136
    84.5%
    Black or African American
    0
    0%
    0
    0%
    0
    0%
    2
    2.6%
    2
    1.2%
    Asian
    0
    0%
    0
    0%
    0
    0%
    1
    1.3%
    1
    0.6%
    American-Indian/Alaska Native
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Native Hawaiian/Pacific Islander
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Other
    1
    8.3%
    1
    2.4%
    5
    16.1%
    3
    3.9%
    10
    6.2%
    Missing
    0
    0%
    3
    7.3%
    2
    6.5%
    7
    9.1%
    12
    7.5%

    Outcome Measures

    1. Primary Outcome
    Title Objective Response Rate (ORR)
    Description 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.
    Time Frame Up to approximately 165 weeks

    Outcome Measure Data

    Analysis Population Description
    FAS included all participants enrolled in the study who received at least 1 dose of parsaclisib.
    Arm/Group Title Cohort 1: Treatment A (Exposed to Ibrutinib) Cohort 1: Treatment B (Exposed to Ibrutinib) Cohort 2: Treatment A (BTK Inhibitor Naïve) Cohort 2: Treatment B (BTK Inhibitor Naïve)
    Arm/Group Description Participants received parsaclisib 20 mg tablets, orally, QD for 8 weeks followed by 20 mg QW for up to 52 weeks. Participants who were exposed to ibrutinib before enrollment were included in this group. 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. Participants received parsaclisib 20 mg tablets, 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. 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 were not exposed to BTK inhibitor before enrollment were included in this group.
    Measure Participants 12 41 31 77
    Number (95% Confidence Interval) [percentage of participants]
    8.3
    69.2%
    36.6
    89.3%
    64.5
    208.1%
    70.1
    91%
    2. Secondary Outcome
    Title Duration of Response (DOR)
    Description 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.
    Time Frame Up to approximately 165 weeks

    Outcome Measure Data

    Analysis Population Description
    FAS included all participants enrolled in the study who received at least 1 dose of parsaclisib. Only participants with objective response were analyzed for this outcome measure.
    Arm/Group Title Cohort 1: Treatment A (Exposed to Ibrutinib) Cohort 1: Treatment B (Exposed to Ibrutinib) Cohort 2: Treatment A (BTK Inhibitor Naïve) Cohort 2: Treatment B (BTK Inhibitor Naïve)
    Arm/Group Description Participants received parsaclisib 20 mg tablets, orally, QD for 8 weeks followed by 20 mg QW for up to 52 weeks. Participants who were exposed to ibrutinib before enrollment were included in this group. 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. Participants received parsaclisib 20 mg tablets, 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. 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 were not exposed to BTK inhibitor before enrollment were included in this group.
    Measure Participants 1 15 20 54
    Median (95% Confidence Interval) [months]
    NA
    3.71
    17.45
    12.09
    3. Secondary Outcome
    Title Complete Response Rate (CRR)
    Description 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.
    Time Frame Up to approximately 165 weeks

    Outcome Measure Data

    Analysis Population Description
    FAS included all participants enrolled in the study who received at least 1 dose of parsaclisib.
    Arm/Group Title Cohort 1: Treatment A (Exposed to Ibrutinib) Cohort 1: Treatment B (Exposed to Ibrutinib) Cohort 2: Treatment A (BTK Inhibitor Naïve) Cohort 2: Treatment B (BTK Inhibitor Naïve)
    Arm/Group Description Participants received parsaclisib 20 mg tablets, orally, QD for 8 weeks followed by 20 mg QW for up to 52 weeks. Participants who were exposed to ibrutinib before enrollment were included in this group. 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. Participants received parsaclisib 20 mg tablets, 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. 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 were not exposed to BTK inhibitor before enrollment were included in this group.
    Measure Participants 12 41 31 77
    Number (95% Confidence Interval) [percentage of participants]
    0.0
    0%
    2.4
    5.9%
    22.6
    72.9%
    15.6
    20.3%
    4. Secondary Outcome
    Title Progression-Free Survival (PFS)
    Description 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.
    Time Frame Up to approximately 165 weeks

    Outcome Measure Data

    Analysis Population Description
    FAS included all participants enrolled in the study who received at least 1 dose of parsaclisib.
    Arm/Group Title Cohort 1: Treatment A (Exposed to Ibrutinib) Cohort 1: Treatment B (Exposed to Ibrutinib) Cohort 2: Treatment A (BTK Inhibitor Naïve) Cohort 2: Treatment B (BTK Inhibitor Naïve)
    Arm/Group Description Participants received parsaclisib 20 mg tablets, orally, QD for 8 weeks followed by 20 mg QW for up to 52 weeks. Participants who were exposed to ibrutinib before enrollment were included in this group. 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. Participants received parsaclisib 20 mg tablets, 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. 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 were not exposed to BTK inhibitor before enrollment were included in this group.
    Measure Participants 12 41 31 77
    Median (95% Confidence Interval) [months]
    3.94
    3.68
    8.11
    13.60
    5. Secondary Outcome
    Title Overall Survival (OS)
    Description OS is defined as the time from the date of the first dose of study treatment until death from any cause.
    Time Frame Up to approximately 165 weeks

    Outcome Measure Data

    Analysis Population Description
    FAS included all participants enrolled in the study who received at least 1 dose of parsaclisib.
    Arm/Group Title Cohort 1: Treatment A (Exposed to Ibrutinib) Cohort 1: Treatment B (Exposed to Ibrutinib) Cohort 2: Treatment A (BTK Inhibitor Naïve) Cohort 2: Treatment B (BTK Inhibitor Naïve)
    Arm/Group Description Participants received parsaclisib 20 mg tablets, orally, QD for 8 weeks followed by 20 mg QW for up to 52 weeks. Participants who were exposed to ibrutinib before enrollment were included in this group. 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. Participants received parsaclisib 20 mg tablets, 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. 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 were not exposed to BTK inhibitor before enrollment were included in this group.
    Measure Participants 12 41 31 77
    Median (95% Confidence Interval) [months]
    10.91
    11.01
    NA
    NA
    6. Secondary Outcome
    Title Best Percent Change From Baseline in Target Lesion Size
    Description 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.
    Time Frame Up to approximately 165 weeks

    Outcome Measure Data

    Analysis Population Description
    FAS included all participants enrolled in the study who received at least 1 dose of parsaclisib. Overall number analyzed are the number of participants with data available for analyses.
    Arm/Group Title Cohort 1: Treatment A (Exposed to Ibrutinib) Cohort 1: Treatment B (Exposed to Ibrutinib) Cohort 2: Treatment A (BTK Inhibitor Naïve) Cohort 2: Treatment B (BTK Inhibitor Naïve)
    Arm/Group Description Participants received parsaclisib 20 mg tablets, orally, QD for 8 weeks followed by 20 mg QW for up to 52 weeks. Participants who were exposed to ibrutinib before enrollment were included in this group. 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. Participants received parsaclisib 20 mg tablets, 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. 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 were not exposed to BTK inhibitor before enrollment were included in this group.
    Measure Participants 6 31 25 69
    Mean (Standard Deviation) [percent change in lesion size]
    -19.82
    (35.926)
    -7.41
    (135.103)
    -64.49
    (53.354)
    -67.61
    (32.222)
    7. Secondary Outcome
    Title Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
    Description 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.
    Time Frame From first dose of study drug up to approximately 165 weeks

    Outcome Measure Data

    Analysis Population Description
    Safety Population included all enrolled participants who received at least 1 dose of parsaclisib.
    Arm/Group Title Cohort 1: Treatment A (Exposed to Ibrutinib) Cohort 1: Treatment B (Exposed to Ibrutinib) Cohort 2: Treatment A (BTK Inhibitor Naïve) Cohort 2: Treatment B (BTK Inhibitor Naïve)
    Arm/Group Description Participants received parsaclisib 20 mg tablets, orally, QD for 8 weeks followed by 20 mg QW for up to 52 weeks. Participants who were exposed to ibrutinib before enrollment were included in this group. 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. Participants received parsaclisib 20 mg tablets, 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. 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 were not exposed to BTK inhibitor before enrollment were included in this group.
    Measure Participants 12 41 31 77
    TEAEs
    83.3
    694.2%
    87.8
    214.1%
    93.5
    301.6%
    89.6
    116.4%
    SAEs
    41.7
    347.5%
    41.5
    101.2%
    35.5
    114.5%
    45.5
    59.1%

    Adverse Events

    Time Frame From first dose of study drug up to approximately 182 weeks (up to data cut-off: 14 May 2021)
    Adverse Event Reporting Description Safety Population included all enrolled participants who received at least 1 dose of parsaclisib.
    Arm/Group Title Cohort 1: Treatment A (Exposed to Ibrutinib) Cohort 1: Treatment B (Exposed to Ibrutinib)E Cohort 2: Treatment A (Bruton's Tyrosine Kinase Inhibitor Naïve) Cohort 2: Treatment B (Bruton's Tyrosine Kinase Inhibitor Naïve) Total
    Arm/Group Description 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. 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. 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. 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 were not exposed to BTK inhibitor before enrollment were included in this group. Total
    All Cause Mortality
    Cohort 1: Treatment A (Exposed to Ibrutinib) Cohort 1: Treatment B (Exposed to Ibrutinib)E Cohort 2: Treatment A (Bruton's Tyrosine Kinase Inhibitor Naïve) Cohort 2: Treatment B (Bruton's Tyrosine Kinase Inhibitor Naïve) Total
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 11/12 (91.7%) 23/41 (56.1%) 11/31 (35.5%) 20/77 (26%) 65/161 (40.4%)
    Serious Adverse Events
    Cohort 1: Treatment A (Exposed to Ibrutinib) Cohort 1: Treatment B (Exposed to Ibrutinib)E Cohort 2: Treatment A (Bruton's Tyrosine Kinase Inhibitor Naïve) Cohort 2: Treatment B (Bruton's Tyrosine Kinase Inhibitor Naïve) Total
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 5/12 (41.7%) 17/41 (41.5%) 11/31 (35.5%) 35/77 (45.5%) 68/161 (42.2%)
    Blood and lymphatic system disorders
    Febrile neutropenia 0/12 (0%) 0 1/41 (2.4%) 1 0/31 (0%) 0 0/77 (0%) 0 1/161 (0.6%) 1
    Leukocytosis 0/12 (0%) 0 0/41 (0%) 0 0/31 (0%) 0 1/77 (1.3%) 1 1/161 (0.6%) 1
    Neutropenia 0/12 (0%) 0 2/41 (4.9%) 2 0/31 (0%) 0 0/77 (0%) 0 2/161 (1.2%) 2
    Cardiac disorders
    Arrhythmia supraventricular 0/12 (0%) 0 0/41 (0%) 0 1/31 (3.2%) 1 0/77 (0%) 0 1/161 (0.6%) 1
    Atrial fibrillation 0/12 (0%) 0 0/41 (0%) 0 0/31 (0%) 0 1/77 (1.3%) 1 1/161 (0.6%) 1
    Cardiac failure 0/12 (0%) 0 0/41 (0%) 0 1/31 (3.2%) 1 0/77 (0%) 0 1/161 (0.6%) 1
    Gastrointestinal disorders
    Abdominal pain 1/12 (8.3%) 1 0/41 (0%) 0 0/31 (0%) 0 0/77 (0%) 0 1/161 (0.6%) 1
    Abdominal pain upper 0/12 (0%) 0 0/41 (0%) 0 1/31 (3.2%) 1 0/77 (0%) 0 1/161 (0.6%) 1
    Ascites 0/12 (0%) 0 0/41 (0%) 0 1/31 (3.2%) 1 0/77 (0%) 0 1/161 (0.6%) 1
    Autoimmune colitis 0/12 (0%) 0 0/41 (0%) 0 0/31 (0%) 0 1/77 (1.3%) 1 1/161 (0.6%) 1
    Colitis 0/12 (0%) 0 2/41 (4.9%) 2 0/31 (0%) 0 5/77 (6.5%) 5 7/161 (4.3%) 7
    Diarrhoea 1/12 (8.3%) 1 3/41 (7.3%) 6 0/31 (0%) 0 10/77 (13%) 10 14/161 (8.7%) 17
    Gastrointestinal haemorrhage 0/12 (0%) 0 1/41 (2.4%) 1 0/31 (0%) 0 0/77 (0%) 0 1/161 (0.6%) 1
    Incarcerated inguinal hernia 0/12 (0%) 0 0/41 (0%) 0 0/31 (0%) 0 1/77 (1.3%) 1 1/161 (0.6%) 1
    Intestinal perforation 0/12 (0%) 0 1/41 (2.4%) 1 0/31 (0%) 0 0/77 (0%) 0 1/161 (0.6%) 1
    Nausea 0/12 (0%) 0 0/41 (0%) 0 0/31 (0%) 0 1/77 (1.3%) 1 1/161 (0.6%) 1
    Oesophagitis ulcerative 0/12 (0%) 0 1/41 (2.4%) 1 0/31 (0%) 0 0/77 (0%) 0 1/161 (0.6%) 1
    Vomiting 0/12 (0%) 0 0/41 (0%) 0 0/31 (0%) 0 1/77 (1.3%) 1 1/161 (0.6%) 1
    General disorders
    Fatigue 0/12 (0%) 0 1/41 (2.4%) 1 0/31 (0%) 0 0/77 (0%) 0 1/161 (0.6%) 1
    General physical health deterioration 1/12 (8.3%) 1 0/41 (0%) 0 0/31 (0%) 0 0/77 (0%) 0 1/161 (0.6%) 1
    Hyperthermia 0/12 (0%) 0 1/41 (2.4%) 1 0/31 (0%) 0 0/77 (0%) 0 1/161 (0.6%) 1
    Nodule 0/12 (0%) 0 1/41 (2.4%) 1 0/31 (0%) 0 0/77 (0%) 0 1/161 (0.6%) 1
    Peripheral swelling 0/12 (0%) 0 2/41 (4.9%) 2 0/31 (0%) 0 0/77 (0%) 0 2/161 (1.2%) 2
    Pyrexia 0/12 (0%) 0 1/41 (2.4%) 1 1/31 (3.2%) 1 2/77 (2.6%) 2 4/161 (2.5%) 4
    Sudden death 0/12 (0%) 0 0/41 (0%) 0 0/31 (0%) 0 1/77 (1.3%) 1 1/161 (0.6%) 1
    Swelling 0/12 (0%) 0 1/41 (2.4%) 1 0/31 (0%) 0 0/77 (0%) 0 1/161 (0.6%) 1
    Hepatobiliary disorders
    Hepatocellular injury 0/12 (0%) 0 0/41 (0%) 0 1/31 (3.2%) 1 0/77 (0%) 0 1/161 (0.6%) 1
    Infections and infestations
    Atypical pneumonia 0/12 (0%) 0 0/41 (0%) 0 0/31 (0%) 0 1/77 (1.3%) 1 1/161 (0.6%) 1
    Bacteraemia 0/12 (0%) 0 0/41 (0%) 0 0/31 (0%) 0 1/77 (1.3%) 1 1/161 (0.6%) 1
    Bronchitis 0/12 (0%) 0 0/41 (0%) 0 0/31 (0%) 0 1/77 (1.3%) 1 1/161 (0.6%) 1
    Clostridium difficile colitis 0/12 (0%) 0 1/41 (2.4%) 1 0/31 (0%) 0 0/77 (0%) 0 1/161 (0.6%) 1
    Cytomegalovirus colitis 0/12 (0%) 0 1/41 (2.4%) 1 0/31 (0%) 0 0/77 (0%) 0 1/161 (0.6%) 1
    Cytomegalovirus infection 0/12 (0%) 0 1/41 (2.4%) 1 0/31 (0%) 0 0/77 (0%) 0 1/161 (0.6%) 1
    Cytomegalovirus infection reactivation 0/12 (0%) 0 0/41 (0%) 0 0/31 (0%) 0 1/77 (1.3%) 1 1/161 (0.6%) 1
    Endocarditis staphylococcal 0/12 (0%) 0 0/41 (0%) 0 0/31 (0%) 0 1/77 (1.3%) 1 1/161 (0.6%) 1
    Infection 0/12 (0%) 0 0/41 (0%) 0 0/31 (0%) 0 1/77 (1.3%) 1 1/161 (0.6%) 1
    Parainfluenzae virus infection 0/12 (0%) 0 0/41 (0%) 0 1/31 (3.2%) 1 0/77 (0%) 0 1/161 (0.6%) 1
    Pneumocystis jirovecii pneumonia 1/12 (8.3%) 1 0/41 (0%) 0 0/31 (0%) 0 1/77 (1.3%) 1 2/161 (1.2%) 2
    Pneumonia 0/12 (0%) 0 2/41 (4.9%) 2 0/31 (0%) 0 1/77 (1.3%) 1 3/161 (1.9%) 3
    Pneumonia pneumococcal 0/12 (0%) 0 0/41 (0%) 0 0/31 (0%) 0 1/77 (1.3%) 2 1/161 (0.6%) 2
    Respiratory tract infection 1/12 (8.3%) 1 0/41 (0%) 0 0/31 (0%) 0 0/77 (0%) 0 1/161 (0.6%) 1
    Septic shock 0/12 (0%) 0 1/41 (2.4%) 1 0/31 (0%) 0 1/77 (1.3%) 1 2/161 (1.2%) 2
    Upper respiratory tract infection 0/12 (0%) 0 0/41 (0%) 0 1/31 (3.2%) 1 0/77 (0%) 0 1/161 (0.6%) 1
    Urinary tract infection 0/12 (0%) 0 1/41 (2.4%) 1 0/31 (0%) 0 0/77 (0%) 0 1/161 (0.6%) 1
    Urosepsis 0/12 (0%) 0 0/41 (0%) 0 0/31 (0%) 0 1/77 (1.3%) 1 1/161 (0.6%) 1
    Injury, poisoning and procedural complications
    Accidental overdose 0/12 (0%) 0 1/41 (2.4%) 1 0/31 (0%) 0 0/77 (0%) 0 1/161 (0.6%) 1
    Spinal fracture 0/12 (0%) 0 0/41 (0%) 0 1/31 (3.2%) 1 0/77 (0%) 0 1/161 (0.6%) 1
    Investigations
    Alanine aminotransferase increased 0/12 (0%) 0 0/41 (0%) 0 0/31 (0%) 0 1/77 (1.3%) 1 1/161 (0.6%) 1
    Aspartate aminotransferase increased 0/12 (0%) 0 0/41 (0%) 0 0/31 (0%) 0 1/77 (1.3%) 1 1/161 (0.6%) 1
    Eastern Cooperative Oncology Group performance status worsened 0/12 (0%) 0 0/41 (0%) 0 0/31 (0%) 0 1/77 (1.3%) 1 1/161 (0.6%) 1
    Metabolism and nutrition disorders
    Dehydration 0/12 (0%) 0 2/41 (4.9%) 2 0/31 (0%) 0 0/77 (0%) 0 2/161 (1.2%) 2
    Diabetic metabolic decompensation 0/12 (0%) 0 1/41 (2.4%) 1 0/31 (0%) 0 0/77 (0%) 0 1/161 (0.6%) 1
    Hyperuricaemia 0/12 (0%) 0 0/41 (0%) 0 1/31 (3.2%) 1 0/77 (0%) 0 1/161 (0.6%) 1
    Hypokalaemia 0/12 (0%) 0 1/41 (2.4%) 1 1/31 (3.2%) 1 2/77 (2.6%) 2 4/161 (2.5%) 4
    Musculoskeletal and connective tissue disorders
    Back pain 0/12 (0%) 0 1/41 (2.4%) 1 0/31 (0%) 0 0/77 (0%) 0 1/161 (0.6%) 1
    Pain in extremity 0/12 (0%) 0 1/41 (2.4%) 1 0/31 (0%) 0 0/77 (0%) 0 1/161 (0.6%) 1
    Spondylitis 0/12 (0%) 0 0/41 (0%) 0 1/31 (3.2%) 1 0/77 (0%) 0 1/161 (0.6%) 1
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Acute myelomonocytic leukaemia 0/12 (0%) 0 0/41 (0%) 0 0/31 (0%) 0 1/77 (1.3%) 1 1/161 (0.6%) 1
    Mantle cell lymphoma 0/12 (0%) 0 0/41 (0%) 0 0/31 (0%) 0 1/77 (1.3%) 1 1/161 (0.6%) 1
    Nervous system disorders
    Epilepsy 0/12 (0%) 0 0/41 (0%) 0 1/31 (3.2%) 1 0/77 (0%) 0 1/161 (0.6%) 1
    Ischaemic stroke 0/12 (0%) 0 0/41 (0%) 0 0/31 (0%) 0 1/77 (1.3%) 1 1/161 (0.6%) 1
    Transient ischaemic attack 1/12 (8.3%) 1 0/41 (0%) 0 0/31 (0%) 0 0/77 (0%) 0 1/161 (0.6%) 1
    Renal and urinary disorders
    Acute kidney injury 0/12 (0%) 0 1/41 (2.4%) 1 0/31 (0%) 0 1/77 (1.3%) 1 2/161 (1.2%) 2
    Renal failure 0/12 (0%) 0 0/41 (0%) 0 0/31 (0%) 0 1/77 (1.3%) 1 1/161 (0.6%) 1
    Respiratory, thoracic and mediastinal disorders
    Chronic obstructive pulmonary disease 0/12 (0%) 0 0/41 (0%) 0 1/31 (3.2%) 1 0/77 (0%) 0 1/161 (0.6%) 1
    Dyspnoea 0/12 (0%) 0 2/41 (4.9%) 2 0/31 (0%) 0 0/77 (0%) 0 2/161 (1.2%) 2
    Dyspnoea exertional 0/12 (0%) 0 0/41 (0%) 0 0/31 (0%) 0 1/77 (1.3%) 1 1/161 (0.6%) 1
    Lung disorder 0/12 (0%) 0 1/41 (2.4%) 2 0/31 (0%) 0 0/77 (0%) 0 1/161 (0.6%) 2
    Pulmonary embolism 0/12 (0%) 0 0/41 (0%) 0 1/31 (3.2%) 1 1/77 (1.3%) 1 2/161 (1.2%) 2
    Skin and subcutaneous tissue disorders
    Dermatitis exfoliative 0/12 (0%) 0 1/41 (2.4%) 1 0/31 (0%) 0 0/77 (0%) 0 1/161 (0.6%) 1
    Dermatitis psoriasiform 0/12 (0%) 0 0/41 (0%) 0 0/31 (0%) 0 1/77 (1.3%) 1 1/161 (0.6%) 1
    Drug reaction with eosinophilia and systemic symptoms 0/12 (0%) 0 0/41 (0%) 0 0/31 (0%) 0 1/77 (1.3%) 1 1/161 (0.6%) 1
    Eczema 0/12 (0%) 0 1/41 (2.4%) 2 0/31 (0%) 0 0/77 (0%) 0 1/161 (0.6%) 2
    Rash 0/12 (0%) 0 0/41 (0%) 0 0/31 (0%) 0 2/77 (2.6%) 2 2/161 (1.2%) 2
    Vascular disorders
    Deep vein thrombosis 0/12 (0%) 0 0/41 (0%) 0 1/31 (3.2%) 1 0/77 (0%) 0 1/161 (0.6%) 1
    Hypotension 0/12 (0%) 0 1/41 (2.4%) 1 0/31 (0%) 0 1/77 (1.3%) 1 2/161 (1.2%) 2
    Other (Not Including Serious) Adverse Events
    Cohort 1: Treatment A (Exposed to Ibrutinib) Cohort 1: Treatment B (Exposed to Ibrutinib)E Cohort 2: Treatment A (Bruton's Tyrosine Kinase Inhibitor Naïve) Cohort 2: Treatment B (Bruton's Tyrosine Kinase Inhibitor Naïve) Total
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 9/12 (75%) 28/41 (68.3%) 26/31 (83.9%) 61/77 (79.2%) 124/161 (77%)
    Blood and lymphatic system disorders
    Anaemia 3/12 (25%) 4 8/41 (19.5%) 10 3/31 (9.7%) 3 6/77 (7.8%) 9 20/161 (12.4%) 26
    Eosinophilia 0/12 (0%) 0 0/41 (0%) 0 2/31 (6.5%) 2 2/77 (2.6%) 2 4/161 (2.5%) 4
    Neutropenia 2/12 (16.7%) 2 5/41 (12.2%) 8 3/31 (9.7%) 4 9/77 (11.7%) 10 19/161 (11.8%) 24
    Thrombocytopenia 1/12 (8.3%) 1 3/41 (7.3%) 5 2/31 (6.5%) 2 5/77 (6.5%) 6 11/161 (6.8%) 14
    Cardiac disorders
    Atrial flutter 1/12 (8.3%) 1 0/41 (0%) 0 0/31 (0%) 0 0/77 (0%) 0 1/161 (0.6%) 1
    Tachycardia 1/12 (8.3%) 1 2/41 (4.9%) 2 0/31 (0%) 0 1/77 (1.3%) 1 4/161 (2.5%) 4
    Ear and labyrinth disorders
    Ear discomfort 1/12 (8.3%) 1 0/41 (0%) 0 0/31 (0%) 0 0/77 (0%) 0 1/161 (0.6%) 1
    Vertigo 1/12 (8.3%) 1 0/41 (0%) 0 0/31 (0%) 0 1/77 (1.3%) 1 2/161 (1.2%) 2
    Gastrointestinal disorders
    Abdominal distension 1/12 (8.3%) 1 1/41 (2.4%) 1 0/31 (0%) 0 1/77 (1.3%) 1 3/161 (1.9%) 3
    Abdominal pain 0/12 (0%) 0 3/41 (7.3%) 3 1/31 (3.2%) 1 3/77 (3.9%) 3 7/161 (4.3%) 7
    Colitis 1/12 (8.3%) 1 0/41 (0%) 0 0/31 (0%) 0 2/77 (2.6%) 2 3/161 (1.9%) 3
    Constipation 0/12 (0%) 0 4/41 (9.8%) 5 3/31 (9.7%) 3 11/77 (14.3%) 12 18/161 (11.2%) 20
    Diarrhoea 2/12 (16.7%) 3 10/41 (24.4%) 14 6/31 (19.4%) 8 23/77 (29.9%) 31 41/161 (25.5%) 56
    Dyspepsia 0/12 (0%) 0 0/41 (0%) 0 2/31 (6.5%) 2 2/77 (2.6%) 2 4/161 (2.5%) 4
    Dysphagia 0/12 (0%) 0 2/41 (4.9%) 2 2/31 (6.5%) 2 1/77 (1.3%) 1 5/161 (3.1%) 5
    Eructation 1/12 (8.3%) 1 0/41 (0%) 0 0/31 (0%) 0 0/77 (0%) 0 1/161 (0.6%) 1
    Nausea 2/12 (16.7%) 2 2/41 (4.9%) 3 4/31 (12.9%) 4 6/77 (7.8%) 6 14/161 (8.7%) 15
    Stomatitis 1/12 (8.3%) 1 1/41 (2.4%) 1 1/31 (3.2%) 1 2/77 (2.6%) 2 5/161 (3.1%) 5
    Vomiting 1/12 (8.3%) 1 3/41 (7.3%) 3 1/31 (3.2%) 1 2/77 (2.6%) 2 7/161 (4.3%) 7
    General disorders
    Asthenia 0/12 (0%) 0 8/41 (19.5%) 8 2/31 (6.5%) 2 10/77 (13%) 11 20/161 (12.4%) 21
    Fatigue 2/12 (16.7%) 2 2/41 (4.9%) 2 2/31 (6.5%) 2 8/77 (10.4%) 8 14/161 (8.7%) 14
    Oedema peripheral 2/12 (16.7%) 3 3/41 (7.3%) 4 2/31 (6.5%) 2 4/77 (5.2%) 4 11/161 (6.8%) 13
    Pyrexia 1/12 (8.3%) 1 5/41 (12.2%) 5 5/31 (16.1%) 5 11/77 (14.3%) 14 22/161 (13.7%) 25
    Infections and infestations
    Nasopharyngitis 2/12 (16.7%) 3 1/41 (2.4%) 2 2/31 (6.5%) 2 2/77 (2.6%) 2 7/161 (4.3%) 9
    Rhinitis 0/12 (0%) 0 1/41 (2.4%) 1 2/31 (6.5%) 2 0/77 (0%) 0 3/161 (1.9%) 3
    Upper respiratory tract infection 0/12 (0%) 0 1/41 (2.4%) 1 2/31 (6.5%) 2 2/77 (2.6%) 2 5/161 (3.1%) 5
    Urinary tract infection 1/12 (8.3%) 1 1/41 (2.4%) 2 3/31 (9.7%) 4 2/77 (2.6%) 2 7/161 (4.3%) 9
    Viral infection 1/12 (8.3%) 1 0/41 (0%) 0 0/31 (0%) 0 1/77 (1.3%) 1 2/161 (1.2%) 2
    Investigations
    Blood creatinine increased 0/12 (0%) 0 2/41 (4.9%) 3 2/31 (6.5%) 2 5/77 (6.5%) 5 9/161 (5.6%) 10
    Neutrophil count decreased 0/12 (0%) 0 0/41 (0%) 0 2/31 (6.5%) 2 2/77 (2.6%) 7 4/161 (2.5%) 9
    Platelet count decreased 1/12 (8.3%) 1 0/41 (0%) 0 2/31 (6.5%) 2 2/77 (2.6%) 2 5/161 (3.1%) 5
    Pseudomonas test positive 1/12 (8.3%) 1 0/41 (0%) 0 0/31 (0%) 0 0/77 (0%) 0 1/161 (0.6%) 1
    Respiratory rate increased 1/12 (8.3%) 1 0/41 (0%) 0 0/31 (0%) 0 0/77 (0%) 0 1/161 (0.6%) 1
    Weight decreased 2/12 (16.7%) 2 4/41 (9.8%) 4 0/31 (0%) 0 7/77 (9.1%) 8 13/161 (8.1%) 14
    Metabolism and nutrition disorders
    Decreased appetite 2/12 (16.7%) 2 4/41 (9.8%) 4 0/31 (0%) 0 6/77 (7.8%) 6 12/161 (7.5%) 12
    Hyperkalaemia 1/12 (8.3%) 1 1/41 (2.4%) 1 0/31 (0%) 0 0/77 (0%) 0 2/161 (1.2%) 2
    Hypernatraemia 1/12 (8.3%) 1 0/41 (0%) 0 0/31 (0%) 0 0/77 (0%) 0 1/161 (0.6%) 1
    Hyperuricaemia 1/12 (8.3%) 1 2/41 (4.9%) 4 2/31 (6.5%) 2 3/77 (3.9%) 5 8/161 (5%) 12
    Hypokalaemia 0/12 (0%) 0 1/41 (2.4%) 1 0/31 (0%) 0 8/77 (10.4%) 11 9/161 (5.6%) 12
    Hypophosphataemia 0/12 (0%) 0 1/41 (2.4%) 1 2/31 (6.5%) 2 1/77 (1.3%) 1 4/161 (2.5%) 4
    Malnutrition 1/12 (8.3%) 1 0/41 (0%) 0 0/31 (0%) 0 0/77 (0%) 0 1/161 (0.6%) 1
    Musculoskeletal and connective tissue disorders
    Arthralgia 0/12 (0%) 0 4/41 (9.8%) 4 2/31 (6.5%) 2 5/77 (6.5%) 5 11/161 (6.8%) 11
    Back pain 0/12 (0%) 0 2/41 (4.9%) 2 4/31 (12.9%) 4 6/77 (7.8%) 6 12/161 (7.5%) 12
    Muscle spasms 0/12 (0%) 0 2/41 (4.9%) 2 2/31 (6.5%) 2 2/77 (2.6%) 2 6/161 (3.7%) 6
    Myalgia 0/12 (0%) 0 0/41 (0%) 0 1/31 (3.2%) 2 4/77 (5.2%) 4 5/161 (3.1%) 6
    Pain in extremity 0/12 (0%) 0 2/41 (4.9%) 2 2/31 (6.5%) 2 2/77 (2.6%) 3 6/161 (3.7%) 7
    Nervous system disorders
    Headache 2/12 (16.7%) 2 2/41 (4.9%) 2 3/31 (9.7%) 4 1/77 (1.3%) 1 8/161 (5%) 9
    Psychiatric disorders
    Anxiety 1/12 (8.3%) 1 2/41 (4.9%) 2 0/31 (0%) 0 0/77 (0%) 0 3/161 (1.9%) 3
    Insomnia 2/12 (16.7%) 2 1/41 (2.4%) 1 0/31 (0%) 0 3/77 (3.9%) 3 6/161 (3.7%) 6
    Renal and urinary disorders
    Renal failure 2/12 (16.7%) 2 1/41 (2.4%) 2 0/31 (0%) 0 3/77 (3.9%) 5 6/161 (3.7%) 9
    Reproductive system and breast disorders
    Testicular oedema 1/12 (8.3%) 1 0/41 (0%) 0 0/31 (0%) 0 0/77 (0%) 0 1/161 (0.6%) 1
    Respiratory, thoracic and mediastinal disorders
    Cough 1/12 (8.3%) 1 5/41 (12.2%) 5 2/31 (6.5%) 2 9/77 (11.7%) 10 17/161 (10.6%) 18
    Dyspnoea 1/12 (8.3%) 1 3/41 (7.3%) 3 3/31 (9.7%) 3 2/77 (2.6%) 2 9/161 (5.6%) 9
    Skin and subcutaneous tissue disorders
    Erythema 0/12 (0%) 0 1/41 (2.4%) 1 0/31 (0%) 0 5/77 (6.5%) 5 6/161 (3.7%) 6
    Hyperhidrosis 1/12 (8.3%) 1 0/41 (0%) 0 1/31 (3.2%) 1 0/77 (0%) 0 2/161 (1.2%) 2
    Pruritus 1/12 (8.3%) 1 1/41 (2.4%) 2 0/31 (0%) 0 5/77 (6.5%) 5 7/161 (4.3%) 8
    Rash 1/12 (8.3%) 1 4/41 (9.8%) 4 1/31 (3.2%) 1 11/77 (14.3%) 13 17/161 (10.6%) 19
    Rash maculo-papular 0/12 (0%) 0 2/41 (4.9%) 2 2/31 (6.5%) 2 3/77 (3.9%) 3 7/161 (4.3%) 7
    Vascular disorders
    Hypertension 1/12 (8.3%) 1 1/41 (2.4%) 1 0/31 (0%) 0 4/77 (5.2%) 4 6/161 (3.7%) 6

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    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.

    Results Point of Contact

    Name/Title Study Director
    Organization Incyte Corporation
    Phone 1-855-463-3463
    Email medinfo@incyte.com
    Responsible Party:
    Incyte Corporation
    ClinicalTrials.gov Identifier:
    NCT03235544
    Other Study ID Numbers:
    • INCB 50465-205 (CITADEL-205)
    • Parsaclisib
    • 2017-003148-19
    First Posted:
    Aug 1, 2017
    Last Update Posted:
    Jul 13, 2022
    Last Verified:
    Jul 1, 2022