<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/NCT03022123</url>
  </required_header>
  <id_info>
    <org_study_id>CSPC-DMS- DLBCL -02</org_study_id>
    <nct_id>NCT03022123</nct_id>
  </id_info>
  <brief_title>The Study of Pegylated Liposomal Doxorubicin Contrast Epirubicin for the Treatment of Diffuse Large B-cell Lymphoma</brief_title>
  <official_title>The Study of Pegylated Liposomal Doxorubicin Contrast Epirubicin for the Initial Treatment of Patients With Diffuse Large B-cell Lymphoma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hebei Medical University Fourth Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hebei Medical University Fourth Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      270 untreated patients, age between 18 and 65 years , with diffuse large B-cell lymphoma&#xD;
      (B-DLCL) were treated with a pegylated liposomal doxorubicin (PL-doxorubicin) modiﬁed&#xD;
      CHOP-rituximab regimen. PL-doxorubicin 35-40 mg/m(2)and epirubicin 70mg/m(2) were given in&#xD;
      combination with standard dosage of prednisone, vincristine, cyclophosphamide, rituximab&#xD;
      (according to CHOP-R regimen) every 21 days for six courses.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PL-doxorubicin 35-40 mg/m(2) and epirubicin 70mg/m(2) were given on day 1 in combination with&#xD;
      standard dosage of prednisone, vincristine, cyclophosphamide (according to CHOP regimen)&#xD;
      every 21days for six courses. The choice to adopt the dosage of 30 mg/m2(instead of 50 mg/m2&#xD;
      of conventionaldoxorubicin) was based on pharmacokinetic data and on the results of previous&#xD;
      studies in lymphoma.Rituximab 375 mg/m2 was given on day 0 in subsequent courses of therapy.&#xD;
      Granulocyte colony-stimulating factor was given in the presence of grade 4 neutropenia or&#xD;
      febrile neutropenia until hematological recovery. Treatment was stopped if lymphoma&#xD;
      progressed, the patient refused further participation,or if there was any other intercurrent&#xD;
      clinical condition or adverse event.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>November 2016</start_date>
  <completion_date type="Anticipated">March 2018</completion_date>
  <primary_completion_date type="Anticipated">November 2017</primary_completion_date>
  <phase>N/A</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>overall response rate</measure>
    <time_frame>up to 19 months</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">270</enrollment>
  <condition>Diffuse Large B-cell Lymphoma</condition>
  <arm_group>
    <arm_group_label>pegylated liposomal doxorubicin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>PL-doxorubicin 35-40 mg/m(2) was given on day 1 in combination with standard dosage of prednisone, vincristine, cyclophosphamide (according to CHOP regimen) every 21 days for six courses;Rituximab 375 mg/m(2) was given on day 0.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Epirubicin</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Epirubicin 70 mg/m(2) was given on day 1 in combination with standard dosage of prednisone, vincristine, cyclophosphamide (according to CHOP regimen) every 21 days for six courses;Rituximab 375 mg/m(2) was given on day 0.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>PL-doxorubicin and epirubicin</intervention_name>
    <description>PL-doxorubicin 35-40 mg/m(2) and epirubicin 70 mg/m(2) were given in combination with standard dosage of prednisone, vincristine, cyclophosphamide, rituximab (according to CHOP-R regimen) every 21 days for six courses.</description>
    <arm_group_label>Epirubicin</arm_group_label>
    <arm_group_label>pegylated liposomal doxorubicin</arm_group_label>
    <other_name>prednisone</other_name>
    <other_name>vincristine</other_name>
    <other_name>cyclophosphamide</other_name>
    <other_name>rituximab</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age between 18 and 65 years&#xD;
&#xD;
          -  Diagnosis of previously-untreated DLBCL(patients with a transformed untreated&#xD;
             low-grade lymphoproliferative disease were accepted)&#xD;
&#xD;
          -  ECOG performance status &lt; 3 (and higher if due to lym-phoma)&#xD;
&#xD;
          -  No symptomatic cardiac arrythmias or heart failure&#xD;
&#xD;
          -  Acceptable renal, hepatic and pulmonary function&#xD;
&#xD;
          -  Standard laboratory and radiological staging procedures and left ventricular ejection&#xD;
             fraction analysis by echocardiography or scintigraphy were required before therapy in&#xD;
             all cases&#xD;
&#xD;
          -  The protocol was approved by the ethics review committee of each partici- pating&#xD;
             center&#xD;
&#xD;
          -  All patients gave informed written consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with a previous history of cardiac disease;&#xD;
&#xD;
          -  HIV-HBsAg-HCV positivity, central nervous system involvement or any other major&#xD;
             clinicalcondition;&#xD;
&#xD;
          -  Other than lymphoma, which might have precluded a regular therapeutic course, were&#xD;
             excluded from the study.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Liu Lihong, archiater</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hebei Medical University Fourth Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Liu Lihong, archiater</last_name>
    <role>Study Director</role>
    <affiliation>Hebei Medical University Fourth Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Liu Lihong, archiater</last_name>
    <phone>13831177920</phone>
  </overall_contact>
  <location>
    <facility>
      <name>Fourth Hospital of Hebei Medical University</name>
      <address>
        <city>Shi Jiazhuang</city>
        <state>Hebei</state>
        <zip>050000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Liu Lihong, archiater</last_name>
      <phone>13831177920</phone>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>October 2016</verification_date>
  <study_first_submitted>January 9, 2017</study_first_submitted>
  <study_first_submitted_qc>January 13, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 16, 2017</study_first_posted>
  <last_update_submitted>January 13, 2017</last_update_submitted>
  <last_update_submitted_qc>January 13, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 16, 2017</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, B-Cell</mesh_term>
    <mesh_term>Lymphoma, Large B-Cell, Diffuse</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Prednisone</mesh_term>
    <mesh_term>Cyclophosphamide</mesh_term>
    <mesh_term>Doxorubicin</mesh_term>
    <mesh_term>Vincristine</mesh_term>
    <mesh_term>Epirubicin</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT03022123
org study id: CSPC-DMS- DLBCL -02
nct id: NCT03022123
lead sponsor: 
has dmc: Yes
270 untreated patients, age between 18 and 65 years , with diffuse large B-cell lymphoma
      (B-DLCL) were treated with a pegylated liposomal doxorubicin (PL-doxorubicin) modiﬁed
      CHOP-rituximab regimen. PL-doxorubicin 35-40 mg/m(2)and epirubicin 70mg/m(2) were given in
      combination with standard dosage of prednisone, vincristine, cyclophosphamide, rituximab
      (according to CHOP-R regimen) every 21 days for six courses.
PL-doxorubicin 35-40 mg/m(2) and epirubicin 70mg/m(2) were given on day 1 in combination with
      standard dosage of prednisone, vincristine, cyclophosphamide (according to CHOP regimen)
      every 21days for six courses. The choice to adopt the dosage of 30 mg/m2(instead of 50 mg/m2
      of conventionaldoxorubicin) was based on pharmacokinetic data and on the results of previous
      studies in lymphoma.Rituximab 375 mg/m2 was given on day 0 in subsequent courses of therapy.
      Granulocyte colony-stimulating factor was given in the presence of grade 4 neutropenia or
      febrile neutropenia until hematological recovery. Treatment was stopped if lymphoma
      progressed, the patient refused further participation,or if there was any other intercurrent
      clinical condition or adverse event.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: overall response rate
time frame: up to 19 months
arm group label: pegylated liposomal doxorubicin
arm group type: Experimental
description: PL-doxorubicin 35-40 mg/m(2) was given on day 1 in combination with standard dosage of prednisone, vincristine, cyclophosphamide (according to CHOP regimen) every 21 days for six courses;Rituximab 375 mg/m(2) was given on day 0.
arm group label: Epirubicin
arm group type: Active Comparator
description: Epirubicin 70 mg/m(2) was given on day 1 in combination with standard dosage of prednisone, vincristine, cyclophosphamide (according to CHOP regimen) every 21 days for six courses;Rituximab 375 mg/m(2) was given on day 0.
intervention type: Drug
intervention name: PL-doxorubicin and epirubicin
description: PL-doxorubicin 35-40 mg/m(2) and epirubicin 70 mg/m(2) were given in combination with standard dosage of prednisone, vincristine, cyclophosphamide, rituximab (according to CHOP-R regimen) every 21 days for six courses.
arm group label: Epirubicin
arm group label: pegylated liposomal doxorubicin
other name: prednisone
other name: vincristine
other name: cyclophosphamide
other name: rituximab
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Liu Lihong, archiater
role: Principal Investigator
affiliation: Hebei Medical University Fourth Hospital
last name: Liu Lihong, archiater
role: Study Director
affiliation: Hebei Medical University Fourth Hospital
last name: Liu Lihong, archiater
phone: 13831177920
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Sponsor
mesh term: Lymphoma
mesh term: Lymphoma, B-Cell
mesh term: Lymphoma, Large B-Cell, Diffuse
mesh term: Prednisone
mesh term: Cyclophosphamide
mesh term: Doxorubicin
mesh term: Vincristine
mesh term: Epirubicin
sharing ipd: No