<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/NCT01700608</url>
  </required_header>
  <id_info>
    <org_study_id>011012</org_study_id>
    <nct_id>NCT01700608</nct_id>
  </id_info>
  <brief_title>Prospective Observational Study on Plerixafor After Chemotherapy</brief_title>
  <official_title>Prospective Observational Study on Plerixafor After Chemotherapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fondazione IRCCS Istituto Nazionale dei Tumori, Milano</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Fondazione IRCCS Istituto Nazionale dei Tumori, Milano</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Plerixafor is a new CXCR4 inhibitor that is able to improve peripheral blood stem cell (PBSC)&#xD;
      mobilization when combined with granulocyte-colony-stimulating factor (G-CSF). The 'on&#xD;
      demand' use of plerixafor at the hematopoietic recovery after chemotherapy + G-CSF may be&#xD;
      more efficient and cost-effective, but the timing of administration and criteria for patient&#xD;
      selection are still under investigation. We collected the data of lymphoma and myeloma&#xD;
      patients treated with plerixafor at the hematopoietic recovery after chemotherapy + G-CSF.&#xD;
      The decision of adding plerixafor was based on PB CD34+ cells at the time of hematopoietic&#xD;
      recovery after chemotherapy in patients at their first or subsequent attempt, according to&#xD;
      the attending physician choice. The primary endpoint was the assessment of the rate of&#xD;
      patients who were able to collect &gt;=2 x 10^6 CD34+/kg.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Plerixafor is a new CXCR4 inhibitor that is able to improve peripheral blood stem cell (PBSC)&#xD;
      mobilization when combined with granulocyte-colony-stimulating factor (G-CSF). The 'on&#xD;
      demand' use of plerixafor at the hematopoietic recovery after chemotherapy + G-CSF may be&#xD;
      more efficient and cost-effective, but the timing of administration and criteria for patient&#xD;
      selection are still under investigation. We collected the data of lymphoma and myeloma&#xD;
      patients treated with plerixafor at the hematopoietic recovery after chemotherapy + G-CSF.&#xD;
      The decision of adding plerixafor was based on PB CD34+ cells at the time of hematopoietic&#xD;
      recovery after chemotherapy in patients at their first or subsequent attempt, according to&#xD;
      the attending physician choice. The primary endpoint was the assessment of the rate of&#xD;
      patients who were able to collect &gt;=2 x 10^6 CD34+/kg. Secondary endpoint was the assessment&#xD;
      of the rate of patients collecting &gt; 4 x 10^6 CD34+/kg and the median number of apheresis to&#xD;
      reach the target.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2008</start_date>
  <completion_date type="Actual">April 2012</completion_date>
  <primary_completion_date type="Actual">April 2012</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Number of patients who were able to collect &gt;= 2 x 10^6 CD34+/kg</measure>
    <time_frame>From day 1 to day 25 after mobilizing chemotherapy</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of patients who were able to collect &gt; 4 x 10^6 CD34+/kg.</measure>
    <time_frame>From day 1 to day 25 after mobilizing chemotherapy</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>To determine the median number of apheresis to reach &gt;= 2-4 x 10^6 CD34+/kg</measure>
    <time_frame>From day 1 to day 25 after mobilizing chemotherapy</time_frame>
  </other_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">27</enrollment>
  <condition>Lymphoma</condition>
  <condition>Myeloma</condition>
  <arm_group>
    <arm_group_label>plerixafor treated patients</arm_group_label>
    <description>lymphoma and myeloma patients</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>plerixafor</intervention_name>
    <description>plerixafor 240 mcg/kg/day at the hematopoietic recovery after chemotherapy</description>
    <arm_group_label>plerixafor treated patients</arm_group_label>
    <other_name>Mozobil</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        lymphoma and myeloma patients treated with plerixafor at the hematopoietic recovery after&#xD;
        chemotherapy and G-CSF&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  lymphoma and myeloma patients treated with plerixafor at the hematopoietic recovery&#xD;
             after chemotherapy and G-CSF&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patients treated only with G-CSF and plerixafor without chemotherapy&#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>Paolo Corradini, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Fondazione IRCCS Istituto Nazionale dei Tumori, Milano</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Fondazione IRCCS Istituto Nazionale dei Tumori</name>
      <address>
        <city>Milan</city>
        <zip>20133</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>October 2012</verification_date>
  <study_first_submitted>October 1, 2012</study_first_submitted>
  <study_first_submitted_qc>October 2, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 4, 2012</study_first_posted>
  <last_update_submitted>October 2, 2012</last_update_submitted>
  <last_update_submitted_qc>October 2, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 4, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Fondazione IRCCS Istituto Nazionale dei Tumori, Milano</investigator_affiliation>
    <investigator_full_name>Paolo Corradini</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <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/NCT01700608
org study id: 011012
nct id: NCT01700608
lead sponsor: 
has dmc: No
Plerixafor is a new CXCR4 inhibitor that is able to improve peripheral blood stem cell (PBSC)
      mobilization when combined with granulocyte-colony-stimulating factor (G-CSF). The 'on
      demand' use of plerixafor at the hematopoietic recovery after chemotherapy + G-CSF may be
      more efficient and cost-effective, but the timing of administration and criteria for patient
      selection are still under investigation. We collected the data of lymphoma and myeloma
      patients treated with plerixafor at the hematopoietic recovery after chemotherapy + G-CSF.
      The decision of adding plerixafor was based on PB CD34+ cells at the time of hematopoietic
      recovery after chemotherapy in patients at their first or subsequent attempt, according to
      the attending physician choice. The primary endpoint was the assessment of the rate of
      patients who were able to collect >=2 x 10^6 CD34+/kg.
Plerixafor is a new CXCR4 inhibitor that is able to improve peripheral blood stem cell (PBSC)
      mobilization when combined with granulocyte-colony-stimulating factor (G-CSF). The 'on
      demand' use of plerixafor at the hematopoietic recovery after chemotherapy + G-CSF may be
      more efficient and cost-effective, but the timing of administration and criteria for patient
      selection are still under investigation. We collected the data of lymphoma and myeloma
      patients treated with plerixafor at the hematopoietic recovery after chemotherapy + G-CSF.
      The decision of adding plerixafor was based on PB CD34+ cells at the time of hematopoietic
      recovery after chemotherapy in patients at their first or subsequent attempt, according to
      the attending physician choice. The primary endpoint was the assessment of the rate of
      patients who were able to collect >=2 x 10^6 CD34+/kg. Secondary endpoint was the assessment
      of the rate of patients collecting > 4 x 10^6 CD34+/kg and the median number of apheresis to
      reach the target.
observational model: Case-Only
time perspective: Prospective
measure: Number of patients who were able to collect >= 2 x 10^6 CD34+/kg
time frame: From day 1 to day 25 after mobilizing chemotherapy
measure: Number of patients who were able to collect > 4 x 10^6 CD34+/kg.
time frame: From day 1 to day 25 after mobilizing chemotherapy
measure: To determine the median number of apheresis to reach >= 2-4 x 10^6 CD34+/kg
time frame: From day 1 to day 25 after mobilizing chemotherapy
arm group label: plerixafor treated patients
description: lymphoma and myeloma patients
intervention type: Drug
intervention name: plerixafor
description: plerixafor 240 mcg/kg/day at the hematopoietic recovery after chemotherapy
arm group label: plerixafor treated patients
other name: Mozobil
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Paolo Corradini, MD
role: Principal Investigator
affiliation: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
facility: 
country: Italy
responsible party type: Principal Investigator
investigator affiliation: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
investigator full name: Paolo Corradini
investigator title: Professor
mesh term: Plerixafor