<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/NCT02238873</url>
  </required_header>
  <id_info>
    <org_study_id>PEGFIL</org_study_id>
    <nct_id>NCT02238873</nct_id>
  </id_info>
  <brief_title>Pegfilgrastim on Day +3 Compared to Day +1 After Salvage Chemotherapy for Patients With Refractory or Relapsed Aggressive Lymphoma</brief_title>
  <official_title>Pegfilgrastim on Day +3 Compared to Day +1 for Patients With Refractory or Relapsed Aggressive Lymphoma Receiving Salvage Chemotherapy - a Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Rabin Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Tel-Aviv Sourasky Medical Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Soroka University Medical Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Rabin Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Granulocyte colony stimulating factors (GCSFs) stimulate the level of white blood cells,&#xD;
      specifically neutrophils. GCSF support for patients receiving chemotherapy was shown to&#xD;
      decrease the rate of fever during low neutrophil count (neutropenia), and in some cancer&#xD;
      types may decrease mortality. Pegfilgrastim is a pegylated form of the GCSF named filgrastim.&#xD;
      Pegfilgrastim is used to stimulate bone marrow to produce more neutrophils to fight infection&#xD;
      in patients undergoing chemotherapy. It has a much longer half-life than the parent&#xD;
      filgrastim. It is removed from the body within the neutrophils. According to the American&#xD;
      Society of Clinical Oncology 2006 guidelines pegfilgrastim should be given 24 hours after the&#xD;
      completion of chemotherapy i.e.before neutrophil count starts to drop. Therefore it is&#xD;
      cleared before and after neutropenia. Comparative low quality studies suggest that deferring&#xD;
      pegfilgrastim delivery until neutrophil counts start dropping may result in improved its&#xD;
      efficacy. This was further tested in a few small randomized controlled trials (high quality&#xD;
      studies, considered the &quot;gold standard&quot; of studies) in different settings (including first&#xD;
      chemotherapy for lymphoma, and solid cancer) with inconsistent results. Pegfilgrastim (given&#xD;
      24 hours after completion of chemotherapy) is a standard part of any salvage chemotherapy for&#xD;
      patient with refractory or relapsed aggressive lymphoma. The investigators plan a randomized&#xD;
      controlled trial comparing the efficacy of pegfilgrastim given 72 hours (day +3) vs. 24 hours&#xD;
      (day +1) after completion of salvage chemotherapy in patients with refractory or relapsed&#xD;
      aggressive lymphoma. The investigators will evaluate whether that change of pegfilgrastim&#xD;
      schedule affects the risk of fever during neutropenia, neutrophil count, length of&#xD;
      hospitalization, mortality, and safety.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>October 2014</start_date>
  <primary_completion_date type="Anticipated">January 2018</primary_completion_date>
  <phase>Phase 3</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>Prevention</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Febrile neutropenia</measure>
    <time_frame>30 days</time_frame>
    <description>Number of participants with fever and neutropenia</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Neutrophil count &lt;500/ mcL</measure>
    <time_frame>day 8 to 10</time_frame>
    <description>Number of participants with neutrophil count below 500 /mcL</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mortality</measure>
    <time_frame>30 days</time_frame>
    <description>Number of participants who died by day 30</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Neutrophil count &lt;100/ mcL</measure>
    <time_frame>day 8 to 10</time_frame>
    <description>Number of patients with neutrophil count below 100/ mcL</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of febrile days</measure>
    <time_frame>30 days</time_frame>
    <description>a febrile day defined by at least one documented temperature measurement &gt;38ºC</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Development of clinically documented infections (CDI), microbiologically-documented infections (MDI) and clinically-significant bloodstream infections (BSI), not present at the time of randomization</measure>
    <time_frame>30 days</time_frame>
    <description>Number of participants with CDI, MCI or BSI. CDI, MDI and BSI will be defined in accordance with the CDC surveillance definitions for healthcare-associated infections</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospitalization</measure>
    <time_frame>30 days</time_frame>
    <description>Number of hospitalization days of each participant (excluding days of hospitalization for chemotherapy)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse events</measure>
    <time_frame>30 days</time_frame>
    <description>ECOG common toxicity criteria grading Number of patients with an adverse event (AE). Number of patients with grade 3-4 AE</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">300</enrollment>
  <condition>Lymphoma</condition>
  <condition>Neutropenia</condition>
  <arm_group>
    <arm_group_label>Pegfilgrastim +1</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Pegfilgrastim will be given 24 hours (day +1) after completion of salvage chemotherapy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Pegfilgrastim +3</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Pegfilgrastim will be given 72 hours (day +3) after completion of salvage chemotherapy</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Pegfilgrastim</intervention_name>
    <arm_group_label>Pegfilgrastim +1</arm_group_label>
    <arm_group_label>Pegfilgrastim +3</arm_group_label>
    <other_name>Neulastim</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Adult patients (age 18 years or above)&#xD;
&#xD;
          -  Refractory or relapsed aggressive lymphoma, including Hodgkin's and non-Hodgkin's&#xD;
             lymphoma&#xD;
&#xD;
          -  Candidate for salvage chemotherapy. Salvage chemotherapy includes one of the following&#xD;
             regimens: Ifosfamide, etoposide, vincristine (ICE), Cisplatin, cytarabine, and&#xD;
             dexamethasone (DHAP), Etoposide, methylprednisolone, cytarabine, cisplatin (ESHAP).&#xD;
             Chemotherapy dose reduction will be allowed.&#xD;
&#xD;
          -  Chemotherapy with or without immunotherapy&#xD;
&#xD;
          -  Therapy in hospital or at the outpatient clinic&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Indolent lymphoma; we will exclude patients with transformed lymphoma.&#xD;
&#xD;
          -  Treatment with GCSFs for the primary disease (e.g. aplastic anemia, MDS).&#xD;
&#xD;
          -  Uncontrolled infection&#xD;
&#xD;
          -  Pregnant women&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Liat Vidal-Fisher, MD</last_name>
    <phone>972-50-4065313</phone>
    <email>vidallit@yahoo.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Rabin Medical Center</name>
      <address>
        <city>Petah Tikva</city>
        <zip>49100</zip>
        <country>Israel</country>
      </address>
    </facility>
    <contact>
      <last_name>Liat Vidal, MD</last_name>
      <phone>972-50-4065313</phone>
      <email>vidallit@yahoo.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <verification_date>October 2014</verification_date>
  <study_first_submitted>September 8, 2014</study_first_submitted>
  <study_first_submitted_qc>September 11, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 12, 2014</study_first_posted>
  <last_update_submitted>October 1, 2014</last_update_submitted>
  <last_update_submitted_qc>October 1, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 2, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Rabin Medical Center</investigator_affiliation>
    <investigator_full_name>LIAT VIDAL FISHER</investigator_full_name>
    <investigator_title>MD MSc</investigator_title>
  </responsible_party>
  <keyword>lymphoma</keyword>
  <keyword>neutropenia</keyword>
  <keyword>pegfilgrastim</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lymphoma</mesh_term>
    <mesh_term>Neutropenia</mesh_term>
  </condition_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/NCT02238873
org study id: PEGFIL
nct id: NCT02238873
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
Granulocyte colony stimulating factors (GCSFs) stimulate the level of white blood cells,
      specifically neutrophils. GCSF support for patients receiving chemotherapy was shown to
      decrease the rate of fever during low neutrophil count (neutropenia), and in some cancer
      types may decrease mortality. Pegfilgrastim is a pegylated form of the GCSF named filgrastim.
      Pegfilgrastim is used to stimulate bone marrow to produce more neutrophils to fight infection
      in patients undergoing chemotherapy. It has a much longer half-life than the parent
      filgrastim. It is removed from the body within the neutrophils. According to the American
      Society of Clinical Oncology 2006 guidelines pegfilgrastim should be given 24 hours after the
      completion of chemotherapy i.e.before neutrophil count starts to drop. Therefore it is
      cleared before and after neutropenia. Comparative low quality studies suggest that deferring
      pegfilgrastim delivery until neutrophil counts start dropping may result in improved its
      efficacy. This was further tested in a few small randomized controlled trials (high quality
      studies, considered the "gold standard" of studies) in different settings (including first
      chemotherapy for lymphoma, and solid cancer) with inconsistent results. Pegfilgrastim (given
      24 hours after completion of chemotherapy) is a standard part of any salvage chemotherapy for
      patient with refractory or relapsed aggressive lymphoma. The investigators plan a randomized
      controlled trial comparing the efficacy of pegfilgrastim given 72 hours (day +3) vs. 24 hours
      (day +1) after completion of salvage chemotherapy in patients with refractory or relapsed
      aggressive lymphoma. The investigators will evaluate whether that change of pegfilgrastim
      schedule affects the risk of fever during neutropenia, neutrophil count, length of
      hospitalization, mortality, and safety.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Outcomes Assessor)
measure: Febrile neutropenia
time frame: 30 days
description: Number of participants with fever and neutropenia
measure: Neutrophil count <500/ mcL
time frame: day 8 to 10
description: Number of participants with neutrophil count below 500 /mcL
measure: Mortality
time frame: 30 days
description: Number of participants who died by day 30
measure: Neutrophil count <100/ mcL
time frame: day 8 to 10
description: Number of patients with neutrophil count below 100/ mcL
measure: Number of febrile days
time frame: 30 days
description: a febrile day defined by at least one documented temperature measurement >38ºC
measure: Development of clinically documented infections (CDI), microbiologically-documented infections (MDI) and clinically-significant bloodstream infections (BSI), not present at the time of randomization
time frame: 30 days
description: Number of participants with CDI, MCI or BSI. CDI, MDI and BSI will be defined in accordance with the CDC surveillance definitions for healthcare-associated infections
measure: Hospitalization
time frame: 30 days
description: Number of hospitalization days of each participant (excluding days of hospitalization for chemotherapy)
measure: Adverse events
time frame: 30 days
description: ECOG common toxicity criteria grading Number of patients with an adverse event (AE). Number of patients with grade 3-4 AE
arm group label: Pegfilgrastim +1
arm group type: Active Comparator
description: Pegfilgrastim will be given 24 hours (day +1) after completion of salvage chemotherapy
arm group label: Pegfilgrastim +3
arm group type: Experimental
description: Pegfilgrastim will be given 72 hours (day +3) after completion of salvage chemotherapy
intervention type: Drug
intervention name: Pegfilgrastim
arm group label: Pegfilgrastim +1
arm group label: Pegfilgrastim +3
other name: Neulastim
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: No
last name: Liat Vidal-Fisher, MD
phone: 972-50-4065313
email: vidallit@yahoo.com
facility: 
contact: 
country: Israel
responsible party type: Principal Investigator
investigator affiliation: Rabin Medical Center
investigator full name: LIAT VIDAL FISHER
investigator title: MD MSc
mesh term: Lymphoma
mesh term: Neutropenia