<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04434937</url>
  </required_header>
  <id_info>
    <org_study_id>INCB 50465-213</org_study_id>
    <nct_id>NCT04434937</nct_id>
  </id_info>
  <brief_title>Open-Label Study of Parsaclisib, in Japanese Participants With Relapsed or Refractory Follicular Lymphoma (CITADEL-213)</brief_title>
  <official_title>A Phase 2, Multicenter, Open-Label Study of Parsaclisib, a PI3Kδ Inhibitor, in Japanese Participants With Relapsed or Refractory Follicular Lymphoma (CITADEL-213)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Incyte Biosciences Japan GK</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Incyte Corporation</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to assess the efficacy and safety of parsaclisib in Japanese&#xD;
      participants with relapsed or refractory follicular lymphoma&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">September 30, 2020</start_date>
  <completion_date type="Anticipated">October 31, 2023</completion_date>
  <primary_completion_date type="Actual">February 16, 2023</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Objective response rate (ORR)</measure>
    <time_frame>Up to approximately 2 years</time_frame>
    <description>Defined as the percentage of participants with a CR or PR as defined by revised response criteria for lymphoma (Cheson et al 2014), as determined by an IRC</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Complete response rate (CRR)</measure>
    <time_frame>Up to approximately 2 years</time_frame>
    <description>Defined as the percentage of participants with a CR as defined by revised response criteria for lymphomas (Cheson et al 2014), as determined by an IRC.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of response (DOR)</measure>
    <time_frame>Up to approximately 2 years</time_frame>
    <description>Defined as the 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 radiographic disease assessment provided by an IRC.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression-free survival (PFS)</measure>
    <time_frame>Up to approximately 2 years</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall survival</measure>
    <time_frame>Up to approximately 2 years</time_frame>
    <description>Defined as the time from the date of the first dose of study treatment until death from any cause</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Best percentage change in target lesion size</measure>
    <time_frame>Up to approximately 2 years</time_frame>
    <description>Best percentage change in target lesion size from baseline, where target lesion size is measured by the sum of the product of the diameters of all target lesion sizes.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with treatment-emergent adverse events (TEAEs)</measure>
    <time_frame>Up to approximately 2 years</time_frame>
    <description>TEAE defined as any adverse event either reported for the first time or worsening of a pre-existing event after first dose of study drug.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">42</enrollment>
  <condition>Lymphoma</condition>
  <arm_group>
    <arm_group_label>parsaclisib</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>parsaclisib will be taken orally QD with water without regard to food except on mornings of PK clinic visits</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>parsaclisib</intervention_name>
    <description>parsaclisib will be taken orally QD with water without regard to food except on mornings of PK clinic visits</description>
    <arm_group_label>parsaclisib</arm_group_label>
    <other_name>INCB050465</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or female Japanese participant who must be ≥ 18 years of age&#xD;
&#xD;
          -  Ability to comprehend and willingness to sign a written ICF and comply with all study&#xD;
             visits and procedures&#xD;
&#xD;
          -  Histologically confirmed, relapsed or refractory, FL Grade 1, 2, and 3a&#xD;
&#xD;
          -  Ineligible for HSCT&#xD;
&#xD;
          -  Must have been treated with at least 2 prior systemic therapies for FL&#xD;
&#xD;
          -  Radiographically measurable lymphadenopathy or extranodal lymphoid malignancy (defined&#xD;
             as the presence of ≥ 1 lesion that measures &gt; 1.5 cm in the LD and ≥ 1.0 cm in the&#xD;
             LPD, respectively) as assessed by CT or MRI&#xD;
&#xD;
          -  Participants must be willing to undergo an incisional, excisional, or core needle&#xD;
             lymph node or tissue biopsy or provide a lymph node or tissue biopsy collected after&#xD;
             the completion of last therapy. An earlier archived lymph node or tissue biopsy is&#xD;
             acceptable if hospitalization is required for biopsy (eg. no superficial lymph node)&#xD;
             and SUVmax by FDG-PET is &lt; 14&#xD;
&#xD;
          -  ECOG performance status 0 to 2&#xD;
&#xD;
          -  Life expectancy ≥ 12 weeks&#xD;
&#xD;
          -  Adequate hematologic, hepatic, and renal functions ANC ≥ 1.0 × 109/L Hemoglobin ≥ 8.0&#xD;
             g/dL. Platelet count ≥ 50 × 109/L. Total bilirubin ≤ 1.5 × ULN. Participants with&#xD;
             documented history of Gilbert's syndrome and in whom total bilirubin elevations are&#xD;
             accompanied by elevated indirect bilirubin are eligible.&#xD;
&#xD;
        ALT/AST ≤ 2.5× ULN or ≤ 5 × ULN in the presence of liver involvement. Calculated creatinine&#xD;
        clearance ≥ 40 mL/min by the Cockcroft-Gault Equation or the estimated glomerular&#xD;
        filtration rate ≥ 40 mL/min/1.73 m2 using the Modification of Diet in Renal Disease&#xD;
        formula.&#xD;
&#xD;
          -  Female participants agree to use medically acceptable contraceptive measures, should&#xD;
             not be breastfeeding, and must have a negative pregnancy test before the start of&#xD;
             study drug administration.&#xD;
&#xD;
          -  Female participants of childbearing potential must understand and accept that&#xD;
             pregnancy must be avoided during participation in the study.&#xD;
&#xD;
          -  Male participants should avoid fathering children from screening through at least 93&#xD;
             days after the last dose of study treatment.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Known histological transformation from indolent NHL to DLBCL&#xD;
&#xD;
          -  History of central nervous system lymphoma (either primary or metastatic)&#xD;
&#xD;
          -  Prior treatment with the following:&#xD;
&#xD;
               1. Selective PI3Kδ or pan-PI3K inhibitors (eg, idelalisib, copanlisib, duvelisib,&#xD;
                  etc).&#xD;
&#xD;
               2. Bruton's tyrosine kinase inhibitor (eg, ibrutinib).&#xD;
&#xD;
          -  Allogeneic SCT within the last 6 months, or autologous SCT within the last 3 months&#xD;
             before the date of study treatment administration&#xD;
&#xD;
          -  Active graft-versus-host disease&#xD;
&#xD;
          -  Use of immunosuppressive therapy within 28 days of the date of study treatment&#xD;
             administration&#xD;
&#xD;
          -  Concurrent anticancer therapy&#xD;
&#xD;
          -  Significant concurrent, uncontrolled medical condition including, but not limited to,&#xD;
             renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, neurological,&#xD;
             cerebral, or psychiatric disease&#xD;
&#xD;
          -  Current or previous other malignancy within 3 years of study entry, except cured basal&#xD;
             or squamous cell skin cancer, superficial bladder cancer, prostate intraepithelial&#xD;
             neoplasm, carcinoma in situ of the cervix, or other noninvasive or indolent malignancy&#xD;
             without sponsor approval.&#xD;
&#xD;
          -  Hepatitis B (HBV) or HCV infection&#xD;
&#xD;
          -  Current New York Heart Association Class II to IV congestive heart failure or&#xD;
             uncontrolled arrhythmia&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Incyte Medical Monitor</last_name>
    <role>Study Director</role>
    <affiliation>Incyte Biosciences Japan GK</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Ja-Aichi Anjo Kosei Hospital</name>
      <address>
        <city>Anjo</city>
        <zip>446-8602</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Fukui Hospital</name>
      <address>
        <city>Fukui</city>
        <zip>910-1193</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jcho Kyushu Hospital</name>
      <address>
        <city>Fukuoka</city>
        <zip>806-8501</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Hospital Organization Kyushu Cancer Center</name>
      <address>
        <city>Fukuoka</city>
        <zip>811-1395</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fukushima Medical University Hospital</name>
      <address>
        <city>Fukushima</city>
        <zip>960-1295</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kansai Medical University Hospital</name>
      <address>
        <city>Hirakata</city>
        <zip>573-1191</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hokuyukai Sapporo Hokuyu Hospital</name>
      <address>
        <city>Hokkaido</city>
        <zip>003-0006</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hyogo College of Medicine Hospital</name>
      <address>
        <city>Hyogo</city>
        <zip>663-8501</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nho Mito Medical Center</name>
      <address>
        <city>Ibaraki</city>
        <zip>311-3193</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tokai University Hospital</name>
      <address>
        <city>Isehara</city>
        <zip>259-1193</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jiaikai Imamura General Hospital</name>
      <address>
        <city>Kagoshima</city>
        <zip>890-0064</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kobe City Medical Center General Hospital</name>
      <address>
        <city>Kobe</city>
        <zip>650-0047</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital Kyoto Prefectural University of Medicine</name>
      <address>
        <city>Kyoto</city>
        <zip>602-8566</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nho Matsumoto Medical Center</name>
      <address>
        <city>Matsumoto</city>
        <zip>399-8701</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nho Shikoku Cancer Center</name>
      <address>
        <city>Matsuyama</city>
        <zip>791-0280</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nagano Red Cross Hospital</name>
      <address>
        <city>Nagano</city>
        <zip>380-8582</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Hospital Organization Nagoya Medical Center</name>
      <address>
        <city>Nagoya</city>
        <zip>460-0001</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Japanese Red Cross Nagoya Daini Hospital</name>
      <address>
        <city>Nagoya</city>
        <zip>466-8650</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Red Cross Nagoya Daini Hospital</name>
      <address>
        <city>Nagoya</city>
        <zip>4668650</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tenri Hospital</name>
      <address>
        <city>Nara</city>
        <zip>632-8552</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Miyagi Cancer Center</name>
      <address>
        <city>Natori</city>
        <zip>981-1293</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Niigata Cancer Center Hospital</name>
      <address>
        <city>Niigata</city>
        <zip>951-8566</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ogaki Municipal Hospital</name>
      <address>
        <city>Ogaki</city>
        <zip>5038502</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Okayama University Hospital</name>
      <address>
        <city>Okayama</city>
        <zip>700-8558</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nho Hokkaido Cancer Center</name>
      <address>
        <city>Sapporo</city>
        <zip>003-0804</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tohoku University Hospital</name>
      <address>
        <city>Sendai-shi</city>
        <zip>980-8574</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shizuoka Cancer Center</name>
      <address>
        <city>Shizuoka</city>
        <zip>411-8777</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nippon Medical School Hospital</name>
      <address>
        <city>Tokyo</city>
        <zip>113-8603</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Yokohama Municipal Citizens Hospital</name>
      <address>
        <city>Yokohama</city>
        <zip>221-0855</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Yokohama City University Medical Center</name>
      <address>
        <city>Yokohama</city>
        <zip>232-0024</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Japan</country>
  </location_countries>
  <verification_date>September 2023</verification_date>
  <study_first_submitted>June 15, 2020</study_first_submitted>
  <study_first_submitted_qc>June 15, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 17, 2020</study_first_posted>
  <last_update_submitted>September 7, 2023</last_update_submitted>
  <last_update_submitted_qc>September 7, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">September 11, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Follicular Lymphoma</keyword>
  <keyword>Parsaclisib</keyword>
  <keyword>PI3Kδ Inhibitor</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lymphoma</mesh_term>
    <mesh_term>Lymphoma, Follicular</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Incyte shares data with qualified external researchers after a research proposal is submitted. These requests are reviewed and approved by a review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.&#xD;
The trial data availability is according to the criteria and process described on https://www.incyte.com/our-company/compliance-and-transparency</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_time_frame>Data will be shared after the primary publication or 2 years after the study has ended for market authorized products and indications.</ipd_time_frame>
    <ipd_access_criteria>Data from eligible studies will be shared with qualified researchers according to the criteria and process described in the Data Sharing section of the www.incyteclinicaltrials.com website. For approved requests, the researchers will be granted access to anonymized data under the terms of a data sharing agreement.</ipd_access_criteria>
    <ipd_url>https://www.incyte.com/our-company/compliance-and-transparency</ipd_url>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04434937
org study id: INCB 50465-213
nct id: NCT04434937
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
The purpose of this study is to assess the efficacy and safety of parsaclisib in Japanese
      participants with relapsed or refractory follicular lymphoma
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Objective response rate (ORR)
time frame: Up to approximately 2 years
description: Defined as the percentage of participants with a CR or PR as defined by revised response criteria for lymphoma (Cheson et al 2014), as determined by an IRC
measure: Complete response rate (CRR)
time frame: Up to approximately 2 years
description: Defined as the percentage of participants with a CR as defined by revised response criteria for lymphomas (Cheson et al 2014), as determined by an IRC.
measure: Duration of response (DOR)
time frame: Up to approximately 2 years
description: Defined as the 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 radiographic disease assessment provided by an IRC.
measure: Progression-free survival (PFS)
time frame: Up to approximately 2 years
description: 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.
measure: Overall survival
time frame: Up to approximately 2 years
description: Defined as the time from the date of the first dose of study treatment until death from any cause
measure: Best percentage change in target lesion size
time frame: Up to approximately 2 years
description: Best percentage change in target lesion size from baseline, where target lesion size is measured by the sum of the product of the diameters of all target lesion sizes.
measure: Number of participants with treatment-emergent adverse events (TEAEs)
time frame: Up to approximately 2 years
description: TEAE defined as any adverse event either reported for the first time or worsening of a pre-existing event after first dose of study drug.
arm group label: parsaclisib
arm group type: Experimental
description: parsaclisib will be taken orally QD with water without regard to food except on mornings of PK clinic visits
intervention type: Drug
intervention name: parsaclisib
description: parsaclisib will be taken orally QD with water without regard to food except on mornings of PK clinic visits
arm group label: parsaclisib
other name: INCB050465
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Incyte Medical Monitor
role: Study Director
affiliation: Incyte Biosciences Japan GK
facility: 
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country: Japan
responsible party type: Sponsor
mesh term: Lymphoma
mesh term: Lymphoma, Follicular
sharing ipd: Yes
ipd description: Incyte shares data with qualified external researchers after a research proposal is submitted. These requests are reviewed and approved by a review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.
The trial data availability is according to the criteria and process described on https://www.incyte.com/our-company/compliance-and-transparency
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd time frame: Data will be shared after the primary publication or 2 years after the study has ended for market authorized products and indications.
ipd access criteria: Data from eligible studies will be shared with qualified researchers according to the criteria and process described in the Data Sharing section of the www.incyteclinicaltrials.com website. For approved requests, the researchers will be granted access to anonymized data under the terms of a data sharing agreement.
ipd url: https://www.incyte.com/our-company/compliance-and-transparency