Clincosm LogoSign in Get a demo

A Study of INCB050465 in Subjects With Relapsed or Refractory Marginal Zone Lymphoma (CITADEL-204)

Sponsor
Incyte Corporation (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT03144674
Collaborator
(none)
110
Enrollment
86
Locations
2
Arms
63.4
Anticipated Duration (Months)
1.3
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of two parsaclisib treatment regimens in participants diagnosed with relapsed or refractory marginal zone lymphoma (MZL) who are naive to or were previously treated with a Bruton's tyrosine kinase (BTK) inhibitor.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
110 participants
Allocation:
Non-Randomized
Intervention Model:
Sequential Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase 2, Open-Label, 2-Cohort Study of INCB050465, a PI3Kδ Inhibitor, in Subjects With Relapsed or Refractory Marginal Zone Lymphoma With or Without Prior Exposure to a BTK Inhibitor (CITADEL-204)
Actual Study Start Date :
Dec 18, 2017
Actual Primary Completion Date :
Jan 15, 2021
Anticipated Study Completion Date :
Mar 31, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Cohort 1- Closed to Further enrollment

Participants who have received prior ibrutinib.

Drug: Parsaclisib
Parsaclisib at the protocol-defined dose.
Other Names:
  • INCB050465

    		•
    Experimental: Cohort 2

    Participants who have not received a prior BTK inhibitor.

    Drug: Parsaclisib
    Parsaclisib at the protocol-defined dose.
    Other Names:
  • INCB050465

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Objective Response Rate (ORR) Based on Lugano Classification Criteria [Up to approximately 161 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),assign 5mm×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 161 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) Based on Lugano Classification Criteria [Up to approximately 161 weeks]

      CRR is defined as the percentage of participants with a CR 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 161 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 161 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 161 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 161 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 or older (except in South Korea, aged 19 or older).

    • Histologically confirmed marginal zone lymphoma, including extranodal, nodal, and splenic subtypes.

    • Radiographically measurable lymphadenopathy or extranodal lymphoid malignancy (defined as the presence of ≥ 1 lesion that measures > 1.5 cm in the longest transverse diameter and ≥ 1.0 cm in the longest perpendicular diameter.

    • Participants with splenic MZL who do not meet the radiographically measurable disease criteria described herein are eligible for participation provided that bone marrow infiltration of MZL is histologically confirmed.

    • Participants must be willing to undergo an incisional or excisional lymph node or tissue biopsy or provide a lymph node or tissue biopsy from the most recent available archival tissue.

    • Eastern Cooperative Oncology Group performance status 0 to 2.

    Exclusion Criteria:

    • Evidence of diffuse large B-cell transformation.

    • History of central nervous system lymphoma (either primary or metastatic) or leptomeningeal disease.

    • Prior treatment with idelalisib, other selective 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 the first dose of study treatment.

    • Active graft versus host disease.

    • Subjects positive for hepatitis B surface antigen or hepatitis B core antibody will be eligible if they are negative for HBV-DNA. Subjects positive for anti-HCV antibody will be eligible if they are negative for HCV-RNA.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Alabama At Birmingham Comprehensive Cancer Center Birmingham Alabama United States 35294
    2 Arizona Oncology Associates Tempe Arizona United States 85284
    3 Torrance Health Association Redondo Beach California United States 90277
    4 Sansum Clinic Santa Barbara California United States 93105
    5 Central Coast Medical Oncology Santa Maria California United States 93454
    6 UCLA Healthcare Hematology-Oncology Santa Monica California United States 90404
    7 St. Joseph Heritage Healthcare Santa Rosa California United States 95403
    8 Innovative Clinical Research Institute Whittier California United States 90603
    9 Loyola University Medical Center Whittier California United States 90603
    10 Valley View Hospital Glenwood Springs Colorado United States 81601
    11 St. Mary'S Hospital Regional Cancer Center Grand Junction Colorado United States 81501
    12 University of Miami Sylvester Comprehensive Cancer Center Miami Florida United States 33136
    13 Advanced Pharma Cr Miami Florida United States 33147
    14 Boca Raton Clinical Research Medical Inc. Plantation Florida United States 33322
    15 Asclepes Research Centers Weeki Wachee Florida United States 34607
    16 Robert H. Lurie Comprehensive Cancer Center of Northwestern University Chicago Illinois United States 60611
    17 Rush University Medical Center - Consultants in Hematology Chicago Illinois United States 60612
    18 Clinical Trials of Swla Llc Lake Charles Louisiana United States 70601
    19 University of Michigan Cancer Center Ann Arbor Michigan United States 48109
    20 Henry Ford Health System Detroit Michigan United States 48202
    21 Saint Luke'S Hospital of Kansas City Kansas City Missouri United States 64111
    22 COMPREHENSIVE CANCER CeNTERS OF NEVADA - TWAIN Las Vegas Nevada United States 89169
    23 Clinical Research Alliance New Hyde Park New York United States 11042
    24 Nyu Cancer Institute New York New York United States 10016
    25 Hematology Oncology Associates of Rockland Nyack New York United States 10960
    26 White Plains Hospital White Plains New York United States 10601
    27 Duke University Medical Center Durham North Carolina United States 27705
    28 Gabrail Cancer Center Canton Ohio United States 44718
    29 Gettysburg Cancer Center Gettysburg Pennsylvania United States 17325
    30 Charleston Hematology Oncology Associates Pa Charleston South Carolina United States 29414
    31 Renovatio Clinical The Woodlands Texas United States 77380
    32 University of Washington - Seattle Cancer Care Alliance Seattle Washington United States 98109
    33 Medical College of Wisconsin Milwaukee Wisconsin United States 53226
    34 Aou Maggiore Della Carita Rosario Argentina S2000KZE
    35 Icon Cancer Care Auchenflower Queensland Australia 04066
    36 Royal Adelaide Hospital Adelaide South Australia Australia 05000
    37 Calvary North Adelaide Hospital North Adelaide South Australia Australia 05006
    38 Cliniques Universitaires Ucl Saint-Luc Brussels Belgium 01200
    39 Universitair Ziekenhuis Gent Gent Belgium 9000
    40 Universitaire Ziekenhuis Leuven - Gasthuisberg Leuven Belgium 03000
    41 Aalborg University Hospital Aalborg Denmark 09000
    42 Zealand University Hospital Roskilde Denmark 04000
    43 Avicenne Hospital Bobigny France 93000
    44 Centre Hospitalier Universitaire Henri Mondor Creteil France 94010
    45 Chu Limoges - H�Pital Le Cluzeau Limoges Cedex France 87042
    46 Hopital Saint-Louis Paris France 75010
    47 H�Pital Universitaire Piti�-Salp�Tri�Re Paris France 75013
    48 Hospices Civils de Lyon Centre Hospitalier Lyon Sud Pierre-benite France 69495
    49 Centre Henri Becquerel Rouen France 76038
    50 Institute Gustave Roussy (Igr) Villejuif France 94800
    51 Universit�Tsklinikum Essen Essen Germany 45147
    52 Universitatsmedizin Gottingen Gottingen Germany 37075
    53 Universit�Tsklinikum Schleswig-Holstein Kiel Germany 24105
    54 Klinikum Ludwigshafen Ludwigshafen Germany 67063
    55 Universitatsmedizin Der Johannes Gutenberg-Universitat Mainz Iii Mainz Germany 55131
    56 Universit�Tsklinikum Ulm ULM Germany 89081
    57 Rambam Medical Center Haifa Israel 31096
    58 Hadassah Hebrew University Medical Center Ein Karem Hadassah Jerusalem Israel 91120
    59 Rabin Medical Center - Beilinson Hospital Petach Tikva Israel 4841492
    60 Chaim Sheba Medical Center Ramat Gan Israel 52621
    61 Tel Aviv Sourasky Medical Center Tel Aviv Israel 64239
    62 University of Bologna, Institute of Haematology �L. E A. Ser�Gnoli� Bologna Italy 40138
    63 Istituto Scientifico Romagnolo Per Lo Studio E La Cura Dei Tumori Meldola Italy 47014
    64 Fondazione Centro San Raffaele - Milano Milano Italy 20132
    65 Fondazione Irccs Istituto Nazionale Dei Tumori Milano Italy 20133
    66 Azienda Ospedaliera San Gerardo Di Monza Monza Italy 20900
    67 Azienda Ospedaliera Ospedali Riuniti "Villa Sofia - Cervello" Palermo Italy 90146
    68 Presidio Ospedaliero Pescara Pescara Italy 65124
    69 Ospedale Delle Croci - Ematologia Ravenna Ravenna Italy 48121
    70 Sapienza University Rome Italy 00161
    71 Centrum Onkologii-Instytut Im. Marii Sklodowskiej-Curie Gdansk Poland 02-781
    72 Szpitale Wojew�Dzkie W Gdyni Sp�?Ka Z Ograniczon? Odpowiedzialno?Ci? Gdansk Poland 80-952
    73 Malopolskie Centrum Medyczne S.C. Krakow Poland 30-510
    74 Klinika Transplantacji Komorel Krwiotworczych Warsaw Poland 02-776
    75 Centrum Onkologii-Instytut Im. Marii Sklodowskiej-Curie Warszawa Poland 02-781
    76 Hospital General Universitari Vall D Hebron Barcelona Spain 08035
    77 Ico Institut Catala D Oncologia Barcelona Spain 08908
    78 Hgu Gregorio Maranon Madrid Spain 28007
    79 Hospital Universitario Hm Sanchinarro Madrid Spain 28050
    80 Hospital Universitario Quironsalud Madrid Madrid Spain 28223
    81 Hospital Puerta de Hierro Majadahonda Spain 28222
    82 Hospital Universitario de Salamanca Salamanca Spain 37007
    83 Birmingham Heartlands Hospital Birmingham United Kingdom B9 5SS
    84 Kent Oncology Centre - Maidstone Hospital Maidstone United Kingdom ME16 9QQ
    85 Norfolk and Norwich University Hospital Norwich United Kingdom NR4 7UY
    86 University of Southampton Southampton United Kingdom SO16 6YD

    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:
    NCT03144674
    Other Study ID Numbers:
    • INCB 50465-204 (CITADEL-204)
    • Parsaclisib
    First Posted:
    May 9, 2017
    Last Update Posted:
    Jul 29, 2022
    Last Verified:
    Jul 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Incyte Corporation
    Marginal zone lymphoma
    phosphatidylinositol 3-kinase (PI3K)δ inhibitor
    indolent (slow-growing) non-Hodgkin lymphoma B-cell lymphoma
    Additional relevant MeSH terms:
    Lymphoma
    Lymphoma, B-Cell, Marginal Zone

    Study Results

    Participant Flow

    Recruitment Details Participants took part in the study at approximately 46 investigative sites in the United States, Italy, Israel, France, Spain, Poland, Belgium, Great Britain, and Germany from 18 December 2017 and are planned to continue in the study till 1 March 2023. Data is reported up to primary completion date, 15 January 2021. This study is ongoing.
    Pre-assignment Detail A total of 110 participants diagnosed with relapsed or refractory marginal zone lymphoma were enrolled into two cohorts based on previous treatment with ibrutinib as Cohort 1: those who were exposed to ibrutinib before enrollment and Cohort 2: those who were not exposed to Bruton's tyrosine kinase (BTK) inhibitor before enrollment. 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 (Bruton's Tyrosine Kinase Inhibitor Naïve) Cohort 2: Treatment B (Bruton's Tyrosine Kinase 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 tablets QD, 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 20 mg tablets QW, for up to 52 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 tablets QD, for up to 52 weeks. Participants who were not exposed to BTK inhibitor before enrollment were included in this group.
    Period Title: Overall Study
    STARTED 4 6 28 72
    COMPLETED 0 0 0 0
    NOT COMPLETED 4 6 28 72

    Baseline Characteristics

    Arm/Group Title Cohort 1: Treatment A (Exposed to Ibrutinib) Cohort 1: Treatment B (Exposed to Ibrutinib) 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 tablets QD, 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 20 mg tablets QW, for up to 52 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 tablets QD, for up to 52 weeks. Participants who were not exposed to BTK inhibitor before enrollment were included in this group. Total of all reporting groups
    Overall Participants 4 6 28 72 110
    Age (years) [Mean (Full Range) ]
    Mean (Full Range) [years]
    73.5
    72.2
    68.1
    69.8
    70.9
    Sex: Female, Male (Count of Participants)
    Female
    2
    50%
    4
    66.7%
    16
    57.1%
    31
    43.1%
    53
    48.2%
    Male
    2
    50%
    2
    33.3%
    12
    42.9%
    41
    56.9%
    57
    51.8%
    Ethnicity (NIH/OMB) (Count of Participants)
    Hispanic or Latino
    0
    0%
    2
    33.3%
    3
    10.7%
    4
    5.6%
    9
    8.2%
    Not Hispanic or Latino
    3
    75%
    4
    66.7%
    19
    67.9%
    57
    79.2%
    83
    75.5%
    Unknown or Not Reported
    1
    25%
    0
    0%
    6
    21.4%
    11
    15.3%
    18
    16.4%
    Race (NIH/OMB) (Count of Participants)
    American Indian or Alaska Native
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Asian
    0
    0%
    0
    0%
    0
    0%
    1
    1.4%
    1
    0.9%
    Native Hawaiian or Other Pacific Islander
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Black or African American
    0
    0%
    1
    16.7%
    0
    0%
    1
    1.4%
    2
    1.8%
    White
    3
    75%
    5
    83.3%
    23
    82.1%
    60
    83.3%
    91
    82.7%
    More than one race
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Unknown or Not Reported
    1
    25%
    0
    0%
    5
    17.9%
    10
    13.9%
    16
    14.5%

    Outcome Measures

    1. Primary Outcome
    Title Objective Response Rate (ORR) Based on Lugano Classification Criteria
    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),assign 5mm×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 161 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 (Bruton's Tyrosine Kinase Inhibitor Naïve) Cohort 2: Treatment B (Bruton's Tyrosine Kinase 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 tablets QD, 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 20 mg tablets QW, for up to 52 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 tablets QD, for up to 52 weeks. Participants who were not exposed to BTK inhibitor before enrollment were included in this group.
    Measure Participants 4 6 28 72
    Number (95% Confidence Interval) [percentage of participants]
    50.0
    1250%
    33.3
    555%
    57.1
    203.9%
    58.3
    81%
    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 161 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 (Bruton's Tyrosine Kinase Inhibitor Naïve) Cohort 2: Treatment B (Bruton's Tyrosine Kinase 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 tablets QD, 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 20 mg tablets QW, for up to 52 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 tablets QD, for up to 52 weeks. Participants who were not exposed to BTK inhibitor before enrollment were included in this group.
    Measure Participants 2 2 16 42
    Median (95% Confidence Interval) [months]
    NA
    NA
    11.99
    12.19
    3. Secondary Outcome
    Title Complete Response Rate (CRR) Based on Lugano Classification Criteria
    Description CRR is defined as the percentage of participants with a CR 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 161 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 (Bruton's Tyrosine Kinase Inhibitor Naïve) Cohort 2: Treatment B (Bruton's Tyrosine Kinase 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 tablets QD, 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 20 mg tablets QW, for up to 52 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 tablets QD, for up to 52 weeks. Participants who were not exposed to BTK inhibitor before enrollment were included in this group.
    Measure Participants 4 6 28 72
    Number (95% Confidence Interval) [percentage of participants]
    0.0
    0%
    0.0
    0%
    10.7
    38.2%
    4.2
    5.8%
    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 161 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 (Bruton's Tyrosine Kinase Inhibitor Naïve) Cohort 2: Treatment B (Bruton's Tyrosine Kinase 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 tablets QD, 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 20 mg tablets QW, for up to 52 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 tablets QD, for up to 52 weeks. Participants who were not exposed to BTK inhibitor before enrollment were included in this group.
    Measure Participants 4 6 28 72
    Median (95% Confidence Interval) [months]
    NA
    NA
    19.42
    16.53
    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 161 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 (Bruton's Tyrosine Kinase Inhibitor Naïve) Cohort 2: Treatment B (Bruton's Tyrosine Kinase 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 tablets QD, 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 20 mg tablets QW, for up to 52 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 tablets QD, for up to 52 weeks. Participants who were not exposed to BTK inhibitor before enrollment were included in this group.
    Measure Participants 4 6 28 72
    Median (95% Confidence Interval) [months]
    NA
    NA
    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 161 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 splenomegaly and data available for analyses.
    Arm/Group Title Cohort 1: Ibrutinib Experienced (Treatment A) Cohort 1: Ibrutinib Experienced (Treatment B) Cohort 2: Bruton's Tyrosine Kinase Inhibitor Naïve (Treatment A) Cohort 2: Bruton's Tyrosine Kinase Inhibitor Naïve (Treatment B)
    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 tablets QD, 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 20 mg tablets QW, for up to 52 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 tablets QD, for up to 52 weeks. Participants who were not exposed to BTK inhibitor before enrollment were included in this group.
    Measure Participants 4 5 21 50
    Mean (Standard Deviation) [percent change in lesion size]
    -48.83
    (21.193)
    -54.84
    (21.454)
    -71.21
    (19.125)
    -67.02
    (20.146)
    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 161 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 (Bruton's Tyrosine Kinase Inhibitor Naïve) Cohort 2: Treatment B (Bruton's Tyrosine Kinase 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 tablets QD, 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 20 mg tablets QW, for up to 52 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 tablets QD, for up to 52 weeks. Participants who were not exposed to BTK inhibitor before enrollment were included in this group.
    Measure Participants 4 6 28 72
    TEAEs
    100.0
    2500%
    83.3
    1388.3%
    92.9
    331.8%
    97.2
    135%
    SAEs
    50.0
    1250%
    33.3
    555%
    25.0
    89.3%
    55.6
    77.2%

    Adverse Events

    Time Frame From first dose of study drug up to approximately 178 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) 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 tablets QD, 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 20 mg tablets QW, for up to 52 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 tablets QD, for up to 52 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) 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 3/4 (75%) 2/6 (33.3%) 1/28 (3.6%) 11/72 (15.3%) 17/110 (15.5%)
    Serious Adverse Events
    Cohort 1: Treatment A (Exposed to Ibrutinib) Cohort 1: Treatment B (Exposed to Ibrutinib) 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 2/4 (50%) 2/6 (33.3%) 7/28 (25%) 40/72 (55.6%) 51/110 (46.4%)
    Blood and lymphatic system disorders
    Anaemia 0/4 (0%) 0 0/6 (0%) 0 0/28 (0%) 0 2/72 (2.8%) 2 2/110 (1.8%) 2
    Eosinophilia 0/4 (0%) 0 0/6 (0%) 0 0/28 (0%) 0 1/72 (1.4%) 1 1/110 (0.9%) 1
    Febrile neutropenia 0/4 (0%) 0 1/6 (16.7%) 1 1/28 (3.6%) 1 4/72 (5.6%) 4 6/110 (5.5%) 6
    Hyperviscosity syndrome 1/4 (25%) 1 0/6 (0%) 0 0/28 (0%) 0 0/72 (0%) 0 1/110 (0.9%) 1
    Microangiopathic haemolytic anaemia 0/4 (0%) 0 0/6 (0%) 0 0/28 (0%) 0 1/72 (1.4%) 1 1/110 (0.9%) 1
    Cardiac disorders
    Acute myocardial infarction 0/4 (0%) 0 0/6 (0%) 0 0/28 (0%) 0 1/72 (1.4%) 1 1/110 (0.9%) 1
    Atrial fibrillation 0/4 (0%) 0 0/6 (0%) 0 0/28 (0%) 0 3/72 (4.2%) 3 3/110 (2.7%) 3
    Sinus bradycardia 0/4 (0%) 0 0/6 (0%) 0 0/28 (0%) 0 1/72 (1.4%) 1 1/110 (0.9%) 1
    Sinus tachycardia 0/4 (0%) 0 0/6 (0%) 0 0/28 (0%) 0 1/72 (1.4%) 1 1/110 (0.9%) 1
    Supraventricular tachycardia 0/4 (0%) 0 0/6 (0%) 0 0/28 (0%) 0 1/72 (1.4%) 1 1/110 (0.9%) 1
    Eye disorders
    Retinal haemorrhage 1/4 (25%) 1 0/6 (0%) 0 0/28 (0%) 0 0/72 (0%) 0 1/110 (0.9%) 1
    Gastrointestinal disorders
    Abdominal pain 0/4 (0%) 0 0/6 (0%) 0 0/28 (0%) 0 2/72 (2.8%) 2 2/110 (1.8%) 2
    Colitis 0/4 (0%) 0 0/6 (0%) 0 0/28 (0%) 0 6/72 (8.3%) 6 6/110 (5.5%) 6
    Diarrhoea 0/4 (0%) 0 0/6 (0%) 0 0/28 (0%) 0 4/72 (5.6%) 4 4/110 (3.6%) 4
    Duodenitis 0/4 (0%) 0 0/6 (0%) 0 0/28 (0%) 0 2/72 (2.8%) 2 2/110 (1.8%) 2
    Enterocolitis 0/4 (0%) 0 0/6 (0%) 0 0/28 (0%) 0 1/72 (1.4%) 1 1/110 (0.9%) 1
    Gastritis 0/4 (0%) 0 0/6 (0%) 0 0/28 (0%) 0 2/72 (2.8%) 2 2/110 (1.8%) 2
    Intestinal infarction 0/4 (0%) 0 0/6 (0%) 0 0/28 (0%) 0 1/72 (1.4%) 1 1/110 (0.9%) 1
    General disorders
    Fatigue 0/4 (0%) 0 0/6 (0%) 0 0/28 (0%) 0 1/72 (1.4%) 1 1/110 (0.9%) 1
    General physical health deterioration 0/4 (0%) 0 0/6 (0%) 0 1/28 (3.6%) 1 0/72 (0%) 0 1/110 (0.9%) 1
    Pain 0/4 (0%) 0 0/6 (0%) 0 0/28 (0%) 0 1/72 (1.4%) 1 1/110 (0.9%) 1
    Pyrexia 0/4 (0%) 0 0/6 (0%) 0 0/28 (0%) 0 2/72 (2.8%) 2 2/110 (1.8%) 2
    Hepatobiliary disorders
    Cholecystitis 0/4 (0%) 0 0/6 (0%) 0 0/28 (0%) 0 1/72 (1.4%) 1 1/110 (0.9%) 1
    Infections and infestations
    Appendicitis 0/4 (0%) 0 0/6 (0%) 0 0/28 (0%) 0 1/72 (1.4%) 1 1/110 (0.9%) 1
    Bronchitis viral 0/4 (0%) 0 0/6 (0%) 0 0/28 (0%) 0 1/72 (1.4%) 1 1/110 (0.9%) 1
    COVID-19 pneumonia 0/4 (0%) 0 0/6 (0%) 0 0/28 (0%) 0 1/72 (1.4%) 1 1/110 (0.9%) 1
    Cytomegalovirus colitis 0/4 (0%) 0 0/6 (0%) 0 0/28 (0%) 0 1/72 (1.4%) 1 1/110 (0.9%) 1
    Cytomegalovirus infection 0/4 (0%) 0 0/6 (0%) 0 0/28 (0%) 0 1/72 (1.4%) 1 1/110 (0.9%) 1
    Cytomegalovirus infection reactivation 0/4 (0%) 0 0/6 (0%) 0 0/28 (0%) 0 2/72 (2.8%) 2 2/110 (1.8%) 2
    Device related infection 0/4 (0%) 0 0/6 (0%) 0 0/28 (0%) 0 1/72 (1.4%) 1 1/110 (0.9%) 1
    Enterobacter sepsis 0/4 (0%) 0 0/6 (0%) 0 0/28 (0%) 0 1/72 (1.4%) 1 1/110 (0.9%) 1
    Enterocolitis viral 0/4 (0%) 0 0/6 (0%) 0 0/28 (0%) 0 1/72 (1.4%) 1 1/110 (0.9%) 1
    Pneumonia 1/4 (25%) 1 0/6 (0%) 0 2/28 (7.1%) 2 7/72 (9.7%) 8 10/110 (9.1%) 11
    Pneumonia viral 0/4 (0%) 0 0/6 (0%) 0 0/28 (0%) 0 1/72 (1.4%) 1 1/110 (0.9%) 1
    Sepsis 0/4 (0%) 0 1/6 (16.7%) 1 0/28 (0%) 0 2/72 (2.8%) 2 3/110 (2.7%) 3
    Upper respiratory tract infection 0/4 (0%) 0 0/6 (0%) 0 0/28 (0%) 0 2/72 (2.8%) 2 2/110 (1.8%) 2
    Urinary tract infection 0/4 (0%) 0 0/6 (0%) 0 0/28 (0%) 0 1/72 (1.4%) 1 1/110 (0.9%) 1
    Yersinia infection 0/4 (0%) 0 0/6 (0%) 0 0/28 (0%) 0 1/72 (1.4%) 1 1/110 (0.9%) 1
    Injury, poisoning and procedural complications
    Fall 0/4 (0%) 0 0/6 (0%) 0 0/28 (0%) 0 1/72 (1.4%) 1 1/110 (0.9%) 1
    Splenic rupture 0/4 (0%) 0 0/6 (0%) 0 0/28 (0%) 0 1/72 (1.4%) 1 1/110 (0.9%) 1
    Investigations
    Blood calcium increased 0/4 (0%) 0 0/6 (0%) 0 1/28 (3.6%) 1 0/72 (0%) 0 1/110 (0.9%) 1
    Faecal volume increased 0/4 (0%) 0 0/6 (0%) 0 0/28 (0%) 0 1/72 (1.4%) 1 1/110 (0.9%) 1
    Transaminases increased 0/4 (0%) 0 0/6 (0%) 0 0/28 (0%) 0 1/72 (1.4%) 1 1/110 (0.9%) 1
    Metabolism and nutrition disorders
    Dehydration 0/4 (0%) 0 0/6 (0%) 0 0/28 (0%) 0 1/72 (1.4%) 1 1/110 (0.9%) 1
    Failure to thrive 0/4 (0%) 0 0/6 (0%) 0 0/28 (0%) 0 1/72 (1.4%) 1 1/110 (0.9%) 1
    Hypercalcaemia 0/4 (0%) 0 2/6 (33.3%) 2 0/28 (0%) 0 0/72 (0%) 0 2/110 (1.8%) 2
    Hypoglycaemia 0/4 (0%) 0 0/6 (0%) 0 0/28 (0%) 0 1/72 (1.4%) 1 1/110 (0.9%) 1
    Tumour lysis syndrome 0/4 (0%) 0 0/6 (0%) 0 0/28 (0%) 0 1/72 (1.4%) 1 1/110 (0.9%) 1
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Bowen's disease 0/4 (0%) 0 0/6 (0%) 0 0/28 (0%) 0 1/72 (1.4%) 1 1/110 (0.9%) 1
    Breast cancer 0/4 (0%) 0 0/6 (0%) 0 1/28 (3.6%) 1 0/72 (0%) 0 1/110 (0.9%) 1
    Invasive ductal breast carcinoma 0/4 (0%) 0 0/6 (0%) 0 0/28 (0%) 0 1/72 (1.4%) 1 1/110 (0.9%) 1
    Squamous cell carcinoma of lung 0/4 (0%) 0 0/6 (0%) 0 0/28 (0%) 0 1/72 (1.4%) 1 1/110 (0.9%) 1
    Nervous system disorders
    Encephalopathy 0/4 (0%) 0 1/6 (16.7%) 1 0/28 (0%) 0 0/72 (0%) 0 1/110 (0.9%) 1
    Syncope 0/4 (0%) 0 1/6 (16.7%) 1 1/28 (3.6%) 1 0/72 (0%) 0 2/110 (1.8%) 2
    Psychiatric disorders
    Mental status changes 0/4 (0%) 0 0/6 (0%) 0 0/28 (0%) 0 1/72 (1.4%) 1 1/110 (0.9%) 1
    Renal and urinary disorders
    Acute kidney injury 0/4 (0%) 0 1/6 (16.7%) 1 0/28 (0%) 0 2/72 (2.8%) 2 3/110 (2.7%) 3
    Oliguria 0/4 (0%) 0 0/6 (0%) 0 0/28 (0%) 0 1/72 (1.4%) 1 1/110 (0.9%) 1
    Renal tubular necrosis 0/4 (0%) 0 0/6 (0%) 0 0/28 (0%) 0 1/72 (1.4%) 1 1/110 (0.9%) 1
    Respiratory, thoracic and mediastinal disorders
    Acute respiratory failure 0/4 (0%) 0 0/6 (0%) 0 0/28 (0%) 0 1/72 (1.4%) 1 1/110 (0.9%) 1
    Dyspnoea 0/4 (0%) 0 0/6 (0%) 0 0/28 (0%) 0 1/72 (1.4%) 1 1/110 (0.9%) 1
    Pneumonitis 0/4 (0%) 0 0/6 (0%) 0 0/28 (0%) 0 1/72 (1.4%) 1 1/110 (0.9%) 1
    Skin and subcutaneous tissue disorders
    Eczema 0/4 (0%) 0 0/6 (0%) 0 0/28 (0%) 0 1/72 (1.4%) 1 1/110 (0.9%) 1
    Rash 0/4 (0%) 0 0/6 (0%) 0 0/28 (0%) 0 2/72 (2.8%) 3 2/110 (1.8%) 3
    Rash maculo-papular 0/4 (0%) 0 0/6 (0%) 0 0/28 (0%) 0 1/72 (1.4%) 1 1/110 (0.9%) 1
    Toxic skin eruption 0/4 (0%) 0 0/6 (0%) 0 0/28 (0%) 0 1/72 (1.4%) 1 1/110 (0.9%) 1
    Vascular disorders
    Hypotension 0/4 (0%) 0 0/6 (0%) 0 0/28 (0%) 0 1/72 (1.4%) 1 1/110 (0.9%) 1
    Peripheral ischaemia 0/4 (0%) 0 0/6 (0%) 0 0/28 (0%) 0 1/72 (1.4%) 1 1/110 (0.9%) 1
    Other (Not Including Serious) Adverse Events
    Cohort 1: Treatment A (Exposed to Ibrutinib) Cohort 1: Treatment B (Exposed to Ibrutinib) 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 4/4 (100%) 5/6 (83.3%) 25/28 (89.3%) 67/72 (93.1%) 101/110 (91.8%)
    Blood and lymphatic system disorders
    Anaemia 0/4 (0%) 0 0/6 (0%) 0 3/28 (10.7%) 4 10/72 (13.9%) 12 13/110 (11.8%) 16
    Neutropenia 0/4 (0%) 0 1/6 (16.7%) 1 3/28 (10.7%) 4 10/72 (13.9%) 19 14/110 (12.7%) 24
    Thrombocytopenia 0/4 (0%) 0 0/6 (0%) 0 3/28 (10.7%) 4 2/72 (2.8%) 2 5/110 (4.5%) 6
    Cardiac disorders
    Ventricular arrhythmia 0/4 (0%) 0 0/6 (0%) 0 2/28 (7.1%) 2 0/72 (0%) 0 2/110 (1.8%) 2
    Eye disorders
    Conjunctival haemorrhage 1/4 (25%) 1 0/6 (0%) 0 0/28 (0%) 0 1/72 (1.4%) 1 2/110 (1.8%) 2
    Vision blurred 0/4 (0%) 0 0/6 (0%) 0 0/28 (0%) 0 4/72 (5.6%) 4 4/110 (3.6%) 4
    Gastrointestinal disorders
    Abdominal pain 2/4 (50%) 2 1/6 (16.7%) 1 1/28 (3.6%) 1 10/72 (13.9%) 11 14/110 (12.7%) 15
    Abdominal pain upper 0/4 (0%) 0 0/6 (0%) 0 3/28 (10.7%) 3 3/72 (4.2%) 3 6/110 (5.5%) 6
    Colitis 0/4 (0%) 0 0/6 (0%) 0 0/28 (0%) 0 5/72 (6.9%) 6 5/110 (4.5%) 6
    Constipation 0/4 (0%) 0 0/6 (0%) 0 2/28 (7.1%) 3 11/72 (15.3%) 12 13/110 (11.8%) 15
    Diarrhoea 1/4 (25%) 1 2/6 (33.3%) 3 9/28 (32.1%) 16 35/72 (48.6%) 59 47/110 (42.7%) 79
    Dry mouth 0/4 (0%) 0 1/6 (16.7%) 1 2/28 (7.1%) 2 2/72 (2.8%) 2 5/110 (4.5%) 5
    Gastrooesophageal reflux disease 0/4 (0%) 0 1/6 (16.7%) 1 2/28 (7.1%) 2 4/72 (5.6%) 4 7/110 (6.4%) 7
    Nausea 0/4 (0%) 0 0/6 (0%) 0 3/28 (10.7%) 3 12/72 (16.7%) 16 15/110 (13.6%) 19
    Stomatitis 0/4 (0%) 0 0/6 (0%) 0 4/28 (14.3%) 4 4/72 (5.6%) 4 8/110 (7.3%) 8
    Vomiting 0/4 (0%) 0 0/6 (0%) 0 3/28 (10.7%) 4 5/72 (6.9%) 8 8/110 (7.3%) 12
    General disorders
    Asthenia 0/4 (0%) 0 0/6 (0%) 0 4/28 (14.3%) 4 3/72 (4.2%) 3 7/110 (6.4%) 7
    Chest pain 0/4 (0%) 0 0/6 (0%) 0 0/28 (0%) 0 4/72 (5.6%) 5 4/110 (3.6%) 5
    Fatigue 1/4 (25%) 1 1/6 (16.7%) 1 3/28 (10.7%) 4 10/72 (13.9%) 10 15/110 (13.6%) 16
    Oedema peripheral 0/4 (0%) 0 1/6 (16.7%) 1 2/28 (7.1%) 2 8/72 (11.1%) 8 11/110 (10%) 11
    Pyrexia 0/4 (0%) 0 1/6 (16.7%) 2 4/28 (14.3%) 7 9/72 (12.5%) 13 14/110 (12.7%) 22
    Infections and infestations
    Conjunctivitis 0/4 (0%) 0 0/6 (0%) 0 2/28 (7.1%) 2 1/72 (1.4%) 1 3/110 (2.7%) 3
    Herpes zoster 0/4 (0%) 0 1/6 (16.7%) 1 1/28 (3.6%) 1 3/72 (4.2%) 3 5/110 (4.5%) 5
    Infected bite 0/4 (0%) 0 0/6 (0%) 0 2/28 (7.1%) 2 0/72 (0%) 0 2/110 (1.8%) 2
    Nasopharyngitis 1/4 (25%) 1 1/6 (16.7%) 1 4/28 (14.3%) 4 3/72 (4.2%) 3 9/110 (8.2%) 9
    Oral candidiasis 0/4 (0%) 0 1/6 (16.7%) 1 0/28 (0%) 0 1/72 (1.4%) 1 2/110 (1.8%) 2
    Oral herpes 1/4 (25%) 1 0/6 (0%) 0 0/28 (0%) 0 3/72 (4.2%) 4 4/110 (3.6%) 5
    Rhinitis 1/4 (25%) 1 0/6 (0%) 0 0/28 (0%) 0 1/72 (1.4%) 1 2/110 (1.8%) 2
    Sinusitis 0/4 (0%) 0 0/6 (0%) 0 2/28 (7.1%) 3 0/72 (0%) 0 2/110 (1.8%) 3
    Upper respiratory tract infection 1/4 (25%) 1 0/6 (0%) 0 0/28 (0%) 0 11/72 (15.3%) 13 12/110 (10.9%) 14
    Urinary tract infection 0/4 (0%) 0 0/6 (0%) 0 3/28 (10.7%) 3 6/72 (8.3%) 9 9/110 (8.2%) 12
    Injury, poisoning and procedural complications
    Chest injury 1/4 (25%) 1 0/6 (0%) 0 0/28 (0%) 0 0/72 (0%) 0 1/110 (0.9%) 1
    Fall 1/4 (25%) 1 0/6 (0%) 0 1/28 (3.6%) 2 3/72 (4.2%) 9 5/110 (4.5%) 12
    Investigations
    Alanine aminotransferase increased 0/4 (0%) 0 0/6 (0%) 0 1/28 (3.6%) 3 7/72 (9.7%) 11 8/110 (7.3%) 14
    Aspartate aminotransferase increased 0/4 (0%) 0 0/6 (0%) 0 1/28 (3.6%) 3 6/72 (8.3%) 9 7/110 (6.4%) 12
    Blood alkaline phosphatase increased 0/4 (0%) 0 0/6 (0%) 0 0/28 (0%) 0 4/72 (5.6%) 5 4/110 (3.6%) 5
    Blood lactate dehydrogenase increased 1/4 (25%) 1 0/6 (0%) 0 1/28 (3.6%) 1 2/72 (2.8%) 2 4/110 (3.6%) 4
    Electrocardiogram QT prolonged 0/4 (0%) 0 1/6 (16.7%) 1 0/28 (0%) 0 1/72 (1.4%) 1 2/110 (1.8%) 2
    Gamma-glutamyltransferase increased 1/4 (25%) 1 0/6 (0%) 0 0/28 (0%) 0 3/72 (4.2%) 3 4/110 (3.6%) 4
    Neutrophil count decreased 0/4 (0%) 0 1/6 (16.7%) 2 2/28 (7.1%) 7 3/72 (4.2%) 6 6/110 (5.5%) 15
    Platelet count decreased 0/4 (0%) 0 0/6 (0%) 0 2/28 (7.1%) 2 3/72 (4.2%) 6 5/110 (4.5%) 8
    Metabolism and nutrition disorders
    Decreased appetite 1/4 (25%) 1 0/6 (0%) 0 2/28 (7.1%) 2 11/72 (15.3%) 12 14/110 (12.7%) 15
    Dehydration 0/4 (0%) 0 0/6 (0%) 0 0/28 (0%) 0 4/72 (5.6%) 4 4/110 (3.6%) 4
    Hyperglycaemia 0/4 (0%) 0 1/6 (16.7%) 2 0/28 (0%) 0 4/72 (5.6%) 5 5/110 (4.5%) 7
    Hyperkalaemia 0/4 (0%) 0 0/6 (0%) 0 1/28 (3.6%) 1 6/72 (8.3%) 8 7/110 (6.4%) 9
    Hypoglycaemia 0/4 (0%) 0 1/6 (16.7%) 1 0/28 (0%) 0 0/72 (0%) 0 1/110 (0.9%) 1
    Hypokalaemia 0/4 (0%) 0 0/6 (0%) 0 0/28 (0%) 0 4/72 (5.6%) 11 4/110 (3.6%) 11
    Musculoskeletal and connective tissue disorders
    Arthralgia 0/4 (0%) 0 1/6 (16.7%) 1 4/28 (14.3%) 4 8/72 (11.1%) 10 13/110 (11.8%) 15
    Muscle spasms 0/4 (0%) 0 0/6 (0%) 0 2/28 (7.1%) 3 4/72 (5.6%) 4 6/110 (5.5%) 7
    Muscular weakness 0/4 (0%) 0 1/6 (16.7%) 1 0/28 (0%) 0 1/72 (1.4%) 2 2/110 (1.8%) 3
    Myalgia 0/4 (0%) 0 1/6 (16.7%) 1 1/28 (3.6%) 2 4/72 (5.6%) 4 6/110 (5.5%) 7
    Neck pain 0/4 (0%) 0 1/6 (16.7%) 1 1/28 (3.6%) 1 2/72 (2.8%) 2 4/110 (3.6%) 4
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Seborrhoeic keratosis 0/4 (0%) 0 0/6 (0%) 0 0/28 (0%) 0 5/72 (6.9%) 5 5/110 (4.5%) 5
    Nervous system disorders
    Dizziness 0/4 (0%) 0 0/6 (0%) 0 2/28 (7.1%) 2 8/72 (11.1%) 10 10/110 (9.1%) 12
    Headache 0/4 (0%) 0 0/6 (0%) 0 3/28 (10.7%) 3 10/72 (13.9%) 12 13/110 (11.8%) 15
    Paraesthesia 0/4 (0%) 0 1/6 (16.7%) 1 0/28 (0%) 0 1/72 (1.4%) 1 2/110 (1.8%) 2
    Syncope 0/4 (0%) 0 0/6 (0%) 0 2/28 (7.1%) 2 1/72 (1.4%) 1 3/110 (2.7%) 3
    Psychiatric disorders
    Depression 1/4 (25%) 1 0/6 (0%) 0 1/28 (3.6%) 1 1/72 (1.4%) 1 3/110 (2.7%) 3
    Insomnia 0/4 (0%) 0 0/6 (0%) 0 1/28 (3.6%) 1 5/72 (6.9%) 5 6/110 (5.5%) 6
    Respiratory, thoracic and mediastinal disorders
    Cough 0/4 (0%) 0 2/6 (33.3%) 3 4/28 (14.3%) 6 19/72 (26.4%) 21 25/110 (22.7%) 30
    Dyspnoea 1/4 (25%) 1 1/6 (16.7%) 1 1/28 (3.6%) 1 6/72 (8.3%) 6 9/110 (8.2%) 9
    Epistaxis 1/4 (25%) 3 0/6 (0%) 0 1/28 (3.6%) 1 3/72 (4.2%) 3 5/110 (4.5%) 7
    Oropharyngeal pain 0/4 (0%) 0 1/6 (16.7%) 1 1/28 (3.6%) 2 3/72 (4.2%) 4 5/110 (4.5%) 7
    Productive cough 0/4 (0%) 0 0/6 (0%) 0 1/28 (3.6%) 1 4/72 (5.6%) 7 5/110 (4.5%) 8
    Pulmonary embolism 2/4 (50%) 2 0/6 (0%) 0 1/28 (3.6%) 1 1/72 (1.4%) 1 4/110 (3.6%) 4
    Skin and subcutaneous tissue disorders
    Actinic keratosis 0/4 (0%) 0 0/6 (0%) 0 2/28 (7.1%) 3 0/72 (0%) 0 2/110 (1.8%) 3
    Alopecia 1/4 (25%) 1 0/6 (0%) 0 1/28 (3.6%) 1 2/72 (2.8%) 2 4/110 (3.6%) 4
    Dry skin 0/4 (0%) 0 0/6 (0%) 0 2/28 (7.1%) 2 5/72 (6.9%) 5 7/110 (6.4%) 7
    Eczema 0/4 (0%) 0 0/6 (0%) 0 2/28 (7.1%) 2 3/72 (4.2%) 4 5/110 (4.5%) 6
    Pruritus 0/4 (0%) 0 0/6 (0%) 0 5/28 (17.9%) 6 10/72 (13.9%) 11 15/110 (13.6%) 17
    Rash 1/4 (25%) 1 1/6 (16.7%) 1 5/28 (17.9%) 8 11/72 (15.3%) 12 18/110 (16.4%) 22
    Rash maculo-papular 0/4 (0%) 0 0/6 (0%) 0 2/28 (7.1%) 3 5/72 (6.9%) 6 7/110 (6.4%) 9
    Rash pruritic 0/4 (0%) 0 0/6 (0%) 0 1/28 (3.6%) 1 4/72 (5.6%) 4 5/110 (4.5%) 5
    Rosacea 1/4 (25%) 1 0/6 (0%) 0 0/28 (0%) 0 1/72 (1.4%) 1 2/110 (1.8%) 2
    Urticaria 0/4 (0%) 0 0/6 (0%) 0 2/28 (7.1%) 2 3/72 (4.2%) 3 5/110 (4.5%) 5
    Vascular disorders
    Hypertension 0/4 (0%) 0 0/6 (0%) 0 1/28 (3.6%) 1 6/72 (8.3%) 6 7/110 (6.4%) 7
    Hypotension 0/4 (0%) 0 0/6 (0%) 0 1/28 (3.6%) 1 4/72 (5.6%) 4 5/110 (4.5%) 5

    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:
    NCT03144674
    Other Study ID Numbers:
    • INCB 50465-204 (CITADEL-204)
    • Parsaclisib
    First Posted:
    May 9, 2017
    Last Update Posted:
    Jul 29, 2022
    Last Verified:
    Jul 1, 2022