<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/NCT02221492</url>
  </required_header>
  <id_info>
    <org_study_id>ACT12781</org_study_id>
    <secondary_id>U1111-1152-4309</secondary_id>
    <nct_id>NCT02221492</nct_id>
  </id_info>
  <brief_title>Plerixafor Plus Granulocyte Colony-Stimulating Factor For Mobilization And Collection Of Peripheral Hematopoietic Stem Cells In Japanese Participants With Non-Hodgkin Lymphoma</brief_title>
  <official_title>A Randomized, Open-label, Two-arm Parallel Group, Comparative Study for Assessing the Clinical Benefit of Subcutaneous Injection of Plerixafor Plus G-CSF for Mobilization and Collection of Peripheral Hematopoietic Stem Cells in Japanese Patients With Non-Hodgkin Lymphoma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Genzyme, a Sanofi Company</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sanofi</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Primary Objective:&#xD;
&#xD;
      To determine if non-Hodgkin Lymphoma (NHL) participants mobilized with granulocyte&#xD;
      colony-stimulating factor (G-CSF) plus plerixafor 240 μg/kg are more likely to achieve a&#xD;
      target number of greater than or equal to 5 x 10^6 cluster differential (CD) 34+ cells/kg in&#xD;
      4 or fewer days of apheresis than NHL participants mobilized with G-CSF alone.&#xD;
&#xD;
      Secondary Objectives:&#xD;
&#xD;
        -  To evaluate the safety of G-CSF plus plerixafor arm compared to G-CSF arm in NHL&#xD;
           participants.&#xD;
&#xD;
        -  To compare the 2 treatment arms with respect to the number of participants who achieved&#xD;
           a minimum of 2 x 10^6 CD34+ cells/kg in 4 or fewer days of apheresis.&#xD;
&#xD;
        -  To compare the 2 treatment arms with respect to the number of days of apheresis required&#xD;
           to reach the target of greater than or equal to 5 x 10^6 CD34+ cells/kg.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Total study duration for a participant can be approximately up to 68 days.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2014</start_date>
  <completion_date type="Actual">March 2016</completion_date>
  <primary_completion_date type="Actual">March 2016</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Proportion of participants who achieve a collection of greater than or equal to 5 x10^6 cells/kg CD34+ cells in less than or equal to 4 days of apheresis</measure>
    <time_frame>Day 5 to Day 8 of the apheresis/treatment period</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Proportion of participants who achieve a collection of a minimum target of 2 x10^6 cells/kg CD34+ cells in less than or equal to 4 days of apheresis</measure>
    <time_frame>Day 5 to Day 8 of the apheresis/treatment period</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of days of apheresis to collect 5 x10^6 cells/kg CD34+ cells</measure>
    <time_frame>Day 5 to Day 8 of the apheresis/treatment period</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of days of apheresis to collect 2 x10^6 cells/kg CD34+ cells</measure>
    <time_frame>Day 5 to Day 8 of the apheresis/treatment period</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total number of CD34+ cells/kg collected over up to 4 apheresis</measure>
    <time_frame>Day 5 to Day 8 of the apheresis/treatment period</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The relative increase (ratio) of peripheral blood (PB) CD34+ cell count (cells/μL)</measure>
    <time_frame>From Day 4 morning to Day 5 morning for both arms, from Day 4 morning to Day 4 evening for GP arm only, and from Day 4 evening to Day 5 morning for GP arm only</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with adverse events</measure>
    <time_frame>Up to 68 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in clinical laboratory measurements</measure>
    <time_frame>Up to 68 days</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">32</enrollment>
  <condition>Lymphoma</condition>
  <arm_group>
    <arm_group_label>granulocyte colony-stimulating factor alone</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>G-CSF administered up to 8 days</description>
  </arm_group>
  <arm_group>
    <arm_group_label>granulocyte colony-stimulating factor plus plerixafor</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>G-CSF administered up to 8 days (Day 1 to Day 8) and plerixafor administered for 4 days (Day 4 to Day 7)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>plerixafor GZ316455</intervention_name>
    <description>Pharmaceutical form:vial Route of administration: subcutaneous injection</description>
    <arm_group_label>granulocyte colony-stimulating factor plus plerixafor</arm_group_label>
    <other_name>Mozobil</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Filgrastim</intervention_name>
    <description>Pharmaceutical form:vial Route of administration: subcutaneous injection</description>
    <arm_group_label>granulocyte colony-stimulating factor alone</arm_group_label>
    <arm_group_label>granulocyte colony-stimulating factor plus plerixafor</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
          -  Age 20 to 75.&#xD;
&#xD;
          -  Japanese participants with histological or pathological diagnosis of NHL.&#xD;
&#xD;
          -  First or second complete response (CR) or partial response (PR).&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  Leukemia participants.&#xD;
&#xD;
          -  Myelodysplastic syndrome (MDS) participants.&#xD;
&#xD;
          -  Less than 2 weeks since completion of last cycle of chemotherapy.&#xD;
&#xD;
          -  Failed previous hematopoietic stem cell (HSC) collections or collection attempts.&#xD;
&#xD;
          -  Prior autologous or allogeneic transplant.&#xD;
&#xD;
          -  Diagnosis of another malignancy.&#xD;
&#xD;
          -  Known hypersensitivity to plerixafor, G-CSF or their components.&#xD;
&#xD;
          -  Bone marrow involvement greater than 5%.&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group (ECOG) performance status greater than 1.&#xD;
&#xD;
          -  Not yet recovered from all acute toxic effects of prior Chemotherapy.&#xD;
&#xD;
          -  White blood cell (WBC) count less than or equal to 2.5 × 10^9 cells/L.&#xD;
&#xD;
          -  Absolute neutrophil count (ANC) less than or equal to 1.5 × 10^9 cells /L.&#xD;
&#xD;
          -  Platelet count less than or equal to 100 × 10^9 cells /L.&#xD;
&#xD;
          -  Creatinine clearance less than 50 mL/min.&#xD;
&#xD;
          -  Aspartate aminotransferase (AST), or alanine aminotransferase (ALT) greater than or&#xD;
             equal to 2.5 x upper limit of normal,Total Bilirubin greater than or equal to 2.5 x&#xD;
             upper limit of normal.&#xD;
&#xD;
          -  Cardiac and pulmonary status insufficient to undergo apheresis or transplantation.&#xD;
&#xD;
          -  Active central nervous system (CNS) involvement, active brain metastases, or any&#xD;
             history of carcinomatous meningitis.&#xD;
&#xD;
          -  Active infection, including unexplained fever (greater than 38 degrees C), or&#xD;
             antibiotic therapy within 7 days prior to the first dose of G-CSF.&#xD;
&#xD;
          -  Less than 6 weeks off nitrosoureas prior to first dose of G-CSF.&#xD;
&#xD;
          -  Conditions/situations such as received prior radio-immunotherapy with ibritumomab&#xD;
             tiuxetan or tositumomab iodine and received radiation therapy to the pelvis.&#xD;
&#xD;
          -  Significant concomitant illness, including psychiatric condition that, in the opinion&#xD;
             of the Investigator or Sponsor, would adversely affect the participant's participation&#xD;
             in the study.&#xD;
&#xD;
          -  Abnormal electrocardiogram (ECG) with clinically significant rhythm disturbance&#xD;
             (ventricular arrhythmias) or other conduction abnormality in the last year that, in&#xD;
             the opinion of the Investigator(s), warrants exclusion of the participant from the&#xD;
             trial.&#xD;
&#xD;
          -  Previously received experimental therapy within 4 weeks of randomization or who are&#xD;
             currently enrolled in another experimental protocol during the G-CSF and plerixafor&#xD;
             treatment period.&#xD;
&#xD;
          -  Any malignancy related to immunodeficiency virus (HIV) or solid organ transplant;&#xD;
             history of known HIV, viral hepatitis as documented at the detection of hepatitis B&#xD;
             surface antigen (HBsAg), hepatitis B surface antibody (HBsAb)[exclude patients who&#xD;
             clearly received vaccination], hepatitis B core antibody (HBcAb), and/or hepatitis C&#xD;
             virus (HCV) antibody at the time of the screening visit.&#xD;
&#xD;
          -  Unwillingness and inability to comply with scheduled visits, drug administration plan,&#xD;
             laboratory tests, other study procedures, and study restrictions.&#xD;
&#xD;
          -  Related to the active comparator and/or mandatory background therapies.&#xD;
&#xD;
          -  Received G-CSF within 7 days prior to the first dose of G-CSF for mobilization.&#xD;
&#xD;
          -  Related to the current knowledge of Sanofi compound.&#xD;
&#xD;
          -  Pregnant or breast-feeding women.&#xD;
&#xD;
          -  All participants, who are sexually active (males and females), must agree to an&#xD;
             effective method of contraception while on study treatment and for at least 3 months&#xD;
             following plerixafor treatment (including both female participants of child-bearing&#xD;
             potential and male participants with partners of childbearing potential).&#xD;
&#xD;
          -  Patient who has withdrawn consent before enrollment/randomization.&#xD;
&#xD;
          -  Despite screening of the patient, enrollment/randomization is stopped at the study&#xD;
             level.&#xD;
&#xD;
        The above information is not intended to contain all considerations relevant to a patient's&#xD;
        potential participation in a clinical trial.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Clinical Sciences &amp; Operations</last_name>
    <role>Study Director</role>
    <affiliation>Sanofi</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Investigational Site Number 392005</name>
      <address>
        <city>Chiba-Shi</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 392011</name>
      <address>
        <city>Fukuoka-Shi</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 392014</name>
      <address>
        <city>Fukuyama-Shi</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 392010</name>
      <address>
        <city>Hamamatsu-Shi</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 392006</name>
      <address>
        <city>Kamogawa-Shi</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 392003</name>
      <address>
        <city>Kobe-Shi</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 392008</name>
      <address>
        <city>Kurashiki-Shi</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 392015</name>
      <address>
        <city>Ota-Shi</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 392004</name>
      <address>
        <city>Sapporo-Shi</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 392001</name>
      <address>
        <city>Shibuya-Ku</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 392009</name>
      <address>
        <city>Suwa-Shi</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 392007</name>
      <address>
        <city>Toyohashi-Shi</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Japan</country>
  </location_countries>
  <verification_date>March 2016</verification_date>
  <study_first_submitted>August 19, 2014</study_first_submitted>
  <study_first_submitted_qc>August 19, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 20, 2014</study_first_posted>
  <last_update_submitted>March 29, 2016</last_update_submitted>
  <last_update_submitted_qc>March 29, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">March 30, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lymphoma</mesh_term>
    <mesh_term>Lymphoma, Non-Hodgkin</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Plerixafor</mesh_term>
  </intervention_browse>
  <!-- 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/NCT02221492
org study id: ACT12781
secondary id: U1111-1152-4309
nct id: NCT02221492
lead sponsor: 
has dmc: No
Primary Objective:

      To determine if non-Hodgkin Lymphoma (NHL) participants mobilized with granulocyte
      colony-stimulating factor (G-CSF) plus plerixafor 240 μg/kg are more likely to achieve a
      target number of greater than or equal to 5 x 10^6 cluster differential (CD) 34+ cells/kg in
      4 or fewer days of apheresis than NHL participants mobilized with G-CSF alone.

      Secondary Objectives:

        -  To evaluate the safety of G-CSF plus plerixafor arm compared to G-CSF arm in NHL
           participants.

        -  To compare the 2 treatment arms with respect to the number of participants who achieved
           a minimum of 2 x 10^6 CD34+ cells/kg in 4 or fewer days of apheresis.

        -  To compare the 2 treatment arms with respect to the number of days of apheresis required
           to reach the target of greater than or equal to 5 x 10^6 CD34+ cells/kg.
Total study duration for a participant can be approximately up to 68 days.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Proportion of participants who achieve a collection of greater than or equal to 5 x10^6 cells/kg CD34+ cells in less than or equal to 4 days of apheresis
time frame: Day 5 to Day 8 of the apheresis/treatment period
measure: Proportion of participants who achieve a collection of a minimum target of 2 x10^6 cells/kg CD34+ cells in less than or equal to 4 days of apheresis
time frame: Day 5 to Day 8 of the apheresis/treatment period
measure: Number of days of apheresis to collect 5 x10^6 cells/kg CD34+ cells
time frame: Day 5 to Day 8 of the apheresis/treatment period
measure: Number of days of apheresis to collect 2 x10^6 cells/kg CD34+ cells
time frame: Day 5 to Day 8 of the apheresis/treatment period
measure: Total number of CD34+ cells/kg collected over up to 4 apheresis
time frame: Day 5 to Day 8 of the apheresis/treatment period
measure: The relative increase (ratio) of peripheral blood (PB) CD34+ cell count (cells/μL)
time frame: From Day 4 morning to Day 5 morning for both arms, from Day 4 morning to Day 4 evening for GP arm only, and from Day 4 evening to Day 5 morning for GP arm only
measure: Number of participants with adverse events
time frame: Up to 68 days
measure: Change from baseline in clinical laboratory measurements
time frame: Up to 68 days
arm group label: granulocyte colony-stimulating factor alone
arm group type: Active Comparator
description: G-CSF administered up to 8 days
arm group label: granulocyte colony-stimulating factor plus plerixafor
arm group type: Experimental
description: G-CSF administered up to 8 days (Day 1 to Day 8) and plerixafor administered for 4 days (Day 4 to Day 7)
intervention type: Drug
intervention name: plerixafor GZ316455
description: Pharmaceutical form:vial Route of administration: subcutaneous injection
arm group label: granulocyte colony-stimulating factor plus plerixafor
other name: Mozobil
intervention type: Drug
intervention name: Filgrastim
description: Pharmaceutical form:vial Route of administration: subcutaneous injection
arm group label: granulocyte colony-stimulating factor alone
arm group label: granulocyte colony-stimulating factor plus plerixafor
criteria: 
gender: All
minimum age: 20 Years
maximum age: 75 Years
healthy volunteers: No
last name: Clinical Sciences & Operations
role: Study Director
affiliation: Sanofi
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Japan
responsible party type: Sponsor
mesh term: Lymphoma
mesh term: Lymphoma, Non-Hodgkin
mesh term: Plerixafor