<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/NCT03039114</url>
  </required_header>
  <id_info>
    <org_study_id>INCB 50465-102 (CITADEL-102)</org_study_id>
    <secondary_id>Parsaclisib</secondary_id>
    <nct_id>NCT03039114</nct_id>
  </id_info>
  <brief_title>Study Evaluating Safety and Efficacy of INCB050465 Combined With Bendamustine and Obinutuzumab in Relapsed or Refractory Follicular Lymphoma (CITADEL-102)</brief_title>
  <official_title>An Open-Label, Dose-Finding, and Cohort-Expansion Phase 1 Study Evaluating Safety and Efficacy of INCB050465 in Combination With Bendamustine and Obinutuzumab in Subjects With Relapsed or Refractory Follicular Lymphoma (CITADEL-102)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Incyte Corporation</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Incyte Corporation</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the safety and efficacy of parsaclisib when combined&#xD;
      with bendamustine and obinutuzumab in subjects with relapsed or refractory follicular&#xD;
      lymphoma (FL).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 15, 2017</start_date>
  <completion_date type="Actual">March 30, 2021</completion_date>
  <primary_completion_date type="Actual">March 30, 2021</primary_completion_date>
  <phase>Phase 1</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>Safety and tolerability of parsaclisib in combination with bendamustine and obinutuzumab in relapsed or refractory FL, assessed by number of subjects with adverse events (AEs)</measure>
    <time_frame>Screening through 30-35 days after end of treatment, up to approximately 34 months per subject</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Objective response rate based on Lugano classification criteria</measure>
    <time_frame>Protocol-defined timepoints throughout the treatment period, up to approximately 34 months per subject</time_frame>
    <description>Defined as percentage of subjects with a complete response (CR) and partial response (PR), as determined by investigator assessment of response</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Complete response rate based on Lugano classification criteria</measure>
    <time_frame>Protocol-defined timepoints throughout the treatment period, up to approximately 34 months per subject</time_frame>
    <description>Defined as percentage of subjects who achieve a best overall response of CR</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of response</measure>
    <time_frame>Protocol-defined timepoints throughout the treatment period, up to approximately 34 months per subject</time_frame>
    <description>Defined as time from first documented evidence of CR or PR until earliest date of disease progression or death due to any cause.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression-free survival</measure>
    <time_frame>Protocol-defined timepoints throughout the treatment period, up to approximately 34 months per subject</time_frame>
    <description>Defined as time from the date of the first dose of study drug until the earliest date of disease progression (determined by radiographic disease assessment/Lugano classification criteria) or death due to any cause.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall survival</measure>
    <time_frame>From the date of the first dose of study drug until death due to any cause, assessed up to approximately 34 months per subject</time_frame>
    <description>Defined as the time from the date of the first dose of study drug until death due to any cause.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">26</enrollment>
  <condition>Lymphoma</condition>
  <arm_group>
    <arm_group_label>Parsaclisib + Hexal and Gazyvaro</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Parsaclisib</intervention_name>
    <description>Parsaclisib at the protocol-defined starting dose administered once daily for 8 weeks followed by once weekly.</description>
    <arm_group_label>Parsaclisib + Hexal and Gazyvaro</arm_group_label>
    <other_name>INCB050465</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Hexal</intervention_name>
    <description>Bendamustine 90 mg/m^2 administered intravenously at protocol-defined timepoints.</description>
    <arm_group_label>Parsaclisib + Hexal and Gazyvaro</arm_group_label>
    <other_name>Bendamustine</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Gazyvaro</intervention_name>
    <description>Obinutuzumab 1000 mg by intravenous infusion at protocol-defined timepoints.</description>
    <arm_group_label>Parsaclisib + Hexal and Gazyvaro</arm_group_label>
    <other_name>Gazyva®</other_name>
    <other_name>Obinutuzumab</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Histologically confirmed FL.&#xD;
&#xD;
          -  Documented CD20+ FL.&#xD;
&#xD;
          -  Relapsed or refractory to any prior rituximab-containing regimen.&#xD;
&#xD;
          -  Previously treated with a maximum of 4 cancer-directed treatment regimens.&#xD;
&#xD;
          -  At least 1 measurable lesion &gt; 1.5 cm in at least 1 dimension by computed tomography&#xD;
             or magnetic resonance imaging.&#xD;
&#xD;
          -  Must be willing to undergo an incisional or excisional lymph node biopsy of accessible&#xD;
             adenopathy or provide the most recent, available archived tumor biopsy.&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Clinical evidence of transformation to a more aggressive subtype of lymphoma or Grade&#xD;
             3B FL.&#xD;
&#xD;
          -  History of central nervous system lymphoma (either primary or metastatic).&#xD;
&#xD;
          -  Allogeneic stem cell transplant within the last 6 months, or active graft-versus-host&#xD;
             disease following allogeneic transplant or autologous stem cell transplant within the&#xD;
             last 3 months before the date of the first dose of study drug administration.&#xD;
&#xD;
          -  Use of any potent cytochrome P450 3A4 inhibitors or inducers within 14 days or 5&#xD;
             half-lives (whichever is longer) before the first dose of study drug.&#xD;
&#xD;
          -  Prior treatment with a selective PI3Kδ inhibitor or a pan PI3K inhibitor.&#xD;
&#xD;
          -  Prior treatment with bendamustine (within 12 months of the start of study treatment).&#xD;
             Subjects with prior bendamustine treatment (&gt; 12 months before the start of study&#xD;
             treatment) are eligible if they meet the following criteria:&#xD;
&#xD;
               -  Did not discontinue because of tolerability concerns.&#xD;
&#xD;
               -  Achieved either partial or CR to the bendamustine regimen of at least 12 months&#xD;
                  in duration before relapse/progression.&#xD;
&#xD;
               -  Experienced progression following a regimen containing an alkylating agent.&#xD;
&#xD;
          -  Received prior obinutuzumab.&#xD;
&#xD;
          -  Received rituximab within 4 weeks of study start.&#xD;
&#xD;
          -  Prior treatment-related toxicities that have not resolved to ≤ Grade 1 before the date&#xD;
             of study drug administration except for stable chronic toxicities (≤ Grade 2) not&#xD;
             expected to resolve (eg, stable Grade 2 peripheral neurotoxicity).&#xD;
&#xD;
          -  Received any prior monoclonal antibody (except an anti-CD20 antibody) within 90 days&#xD;
             before the date of study start.&#xD;
&#xD;
          -  History of severe allergic or anaphylactic reactions to monoclonal antibody therapy&#xD;
             (eg, subjects in whom re-administration with rituximab would be contraindicated for&#xD;
             safety reasons).&#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>Fitzroy Dawkins, MD</last_name>
    <role>Study Director</role>
    <affiliation>Incyte Corporation</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Banner Health</name>
      <address>
        <city>Gilbert</city>
        <state>Arizona</state>
        <zip>85234</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of California, San Diego</name>
      <address>
        <city>La Jolla</city>
        <state>California</state>
        <zip>92093</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Kansas Cancer Center</name>
      <address>
        <city>Fairway</city>
        <state>Kansas</state>
        <zip>66205</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Center for Cancer and Blood Disorders (CCBD) - Bethesda</name>
      <address>
        <city>Bethesda</city>
        <state>Maryland</state>
        <zip>20817</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Research Alliance</name>
      <address>
        <city>Lake Success</city>
        <state>New York</state>
        <zip>11042</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Froedtert &amp; Medical College of Wisconsin &amp; Affiliated Hospitals</name>
      <address>
        <city>Milwaukee</city>
        <state>Wisconsin</state>
        <zip>53226</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>FN Ostrava / Ostrava</name>
      <address>
        <city>Ostrava</city>
        <zip>70852</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Aarhus University Hospital</name>
      <address>
        <city>Aarhus</city>
        <zip>DK-8000</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rigshospitalet</name>
      <address>
        <city>Copenhagen</city>
        <zip>DK-2100</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Finsen Centre, National Hospital</name>
      <address>
        <city>Copenhagen</city>
        <zip>DK-2100</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Semmelweis Egyetem</name>
      <address>
        <city>Budapest</city>
        <zip>1083</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro di Riferimento Oncologico</name>
      <address>
        <city>Aviano</city>
        <zip>33081</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliero Universitaria Di Bologna</name>
      <address>
        <city>Bologna</city>
        <zip>40138</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Policlinico S. Orsola-Ematologia LA Seragnoli</name>
      <address>
        <city>Bologna</city>
        <zip>40138</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>A.O. Spedali Civili</name>
      <address>
        <city>Brescia</city>
        <zip>25123</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UO Ematologia ASST Spedali Civili</name>
      <address>
        <city>Brescia</city>
        <zip>25123</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Germans Trias Pujol</name>
      <address>
        <city>Barcelona</city>
        <zip>08916</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Gregorio Marañón</name>
      <address>
        <city>Madrid</city>
        <zip>28009</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Fundación Jiménez Díaz</name>
      <address>
        <city>Madrid</city>
        <zip>28040</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario La Paz</name>
      <address>
        <city>Madrid</city>
        <zip>28046</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Virgen del Rocío</name>
      <address>
        <city>Sevilla</city>
        <zip>41013</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Czechia</country>
    <country>Denmark</country>
    <country>Hungary</country>
    <country>Italy</country>
    <country>Spain</country>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2021</verification_date>
  <study_first_submitted>January 31, 2017</study_first_submitted>
  <study_first_submitted_qc>January 31, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 1, 2017</study_first_posted>
  <last_update_submitted>December 1, 2021</last_update_submitted>
  <last_update_submitted_qc>December 1, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">December 2, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Follicular lymphoma</keyword>
  <keyword>relapsed</keyword>
  <keyword>refractory</keyword>
  <keyword>non-Hodgkin lymphoma</keyword>
  <keyword>phosphatidylinositol 3-kinase (PI3K)</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>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bendamustine Hydrochloride</mesh_term>
    <mesh_term>Obinutuzumab</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </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/NCT03039114
org study id: INCB 50465-102 (CITADEL-102)
secondary id: Parsaclisib
nct id: NCT03039114
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
The purpose of this study is to evaluate the safety and efficacy of parsaclisib when combined
      with bendamustine and obinutuzumab in subjects with relapsed or refractory follicular
      lymphoma (FL).
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Safety and tolerability of parsaclisib in combination with bendamustine and obinutuzumab in relapsed or refractory FL, assessed by number of subjects with adverse events (AEs)
time frame: Screening through 30-35 days after end of treatment, up to approximately 34 months per subject
measure: Objective response rate based on Lugano classification criteria
time frame: Protocol-defined timepoints throughout the treatment period, up to approximately 34 months per subject
description: Defined as percentage of subjects with a complete response (CR) and partial response (PR), as determined by investigator assessment of response
measure: Complete response rate based on Lugano classification criteria
time frame: Protocol-defined timepoints throughout the treatment period, up to approximately 34 months per subject
description: Defined as percentage of subjects who achieve a best overall response of CR
measure: Duration of response
time frame: Protocol-defined timepoints throughout the treatment period, up to approximately 34 months per subject
description: Defined as time from first documented evidence of CR or PR until earliest date of disease progression or death due to any cause.
measure: Progression-free survival
time frame: Protocol-defined timepoints throughout the treatment period, up to approximately 34 months per subject
description: Defined as time from the date of the first dose of study drug until the earliest date of disease progression (determined by radiographic disease assessment/Lugano classification criteria) or death due to any cause.
measure: Overall survival
time frame: From the date of the first dose of study drug until death due to any cause, assessed up to approximately 34 months per subject
description: Defined as the time from the date of the first dose of study drug until death due to any cause.
arm group label: Parsaclisib + Hexal and Gazyvaro
arm group type: Experimental
intervention type: Drug
intervention name: Parsaclisib
description: Parsaclisib at the protocol-defined starting dose administered once daily for 8 weeks followed by once weekly.
arm group label: Parsaclisib + Hexal and Gazyvaro
other name: INCB050465
intervention type: Drug
intervention name: Hexal
description: Bendamustine 90 mg/m^2 administered intravenously at protocol-defined timepoints.
arm group label: Parsaclisib + Hexal and Gazyvaro
other name: Bendamustine
intervention type: Drug
intervention name: Gazyvaro
description: Obinutuzumab 1000 mg by intravenous infusion at protocol-defined timepoints.
arm group label: Parsaclisib + Hexal and Gazyvaro
other name: Gazyva®
other name: Obinutuzumab
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Fitzroy Dawkins, MD
role: Study Director
affiliation: Incyte Corporation
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country: Czechia
country: Denmark
country: Hungary
country: Italy
country: Spain
country: United States
responsible party type: Sponsor
mesh term: Lymphoma
mesh term: Lymphoma, Follicular
mesh term: Bendamustine Hydrochloride
mesh term: Obinutuzumab
sharing ipd: Undecided