<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/NCT03018626</url>
  </required_header>
  <id_info>
    <org_study_id>NFL2016-B1</org_study_id>
    <nct_id>NCT03018626</nct_id>
  </id_info>
  <brief_title>R-ACVBP and DA-EPOCH-R in Patients With Non-GCB DLBCL</brief_title>
  <official_title>Study of R-ACVBP and DA-EPOCH-R in Patients With Newly Diagnosed Non-germinal Center B-cell-like Diffuse Large B-cell Lymphoma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Nanfang Hospital, Southern Medical University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Nanfang Hospital, Southern Medical University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a randomized, open-label, multi-center, phase 3 study evaluating the efficacy of&#xD;
      R-ACVBP and DA-EPOCH-R in patients with newly diagnosed non-germinal b-cell-like diffuse&#xD;
      large B-cell lymphoma&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Diffuse large B-cell lymphoma (DLBCL) is the most common type of non-Hodgkin's lymphoma.&#xD;
      According to Hans' algorithms, DLBCL can be identified as 2 subtypes: germinal&#xD;
      b-cell-like(GCB) and non-germinal b-cell-like(non-GCB). Approximately 50 to 60% of diffuse&#xD;
      large-B cell lymphoma(DLBCL) was non-GCB subtype DLBCL. Although the introduction of&#xD;
      rituximab in immunochemotherapy has dramatically improved the outcome of patients with DLBCL,&#xD;
      The survival was still poor in non-GCB DLBCL patients treated with R-CHOP.&#xD;
&#xD;
      The LNH03-2B study has shown that R-ACVBP regimen gave a longer PFS (93% vs. 74% at 3 years,&#xD;
      p=0.0074) and a longer OS (97% vs. 83% at 3 years, p=0.0067) than R-CHOP in young patients&#xD;
      with non-GCB DLBCL. It also showed that R-ACVBP regimen gave a longer PFS (87% vs. 73% at 3&#xD;
      years, p=0.0074) and a longer OS (92% vs. 84% at 3 years, p=0.0067) than R-CHOP in young&#xD;
      low-intermediate risk DLBCL patients. The LNH2003-3 study has shown that in high-risk (2/3&#xD;
      IPI factors) DLBCL patients treated with R-ACVBP followed by auto-ASCT results in a 74% PFS&#xD;
      and 76% OS. Hematological toxic effects of the intensive regimen were raised but manageable.&#xD;
&#xD;
      The CALGB study showed that in DLBCL patients at least 18 years of age and at least stage II,&#xD;
      DA-EPOCH-R regimen is effective in both GCB and non-GCB subtypes, with a 5-years TTP 67%, EFS&#xD;
      58% and OS 68% in non-GCB subtype DLBCL. It is encouraging that PETHEMA Group study showed&#xD;
      that in the long-term follow-up of untreated DLBCL patients with poor prognosis, DA-EPOCH-R&#xD;
      achieved a 70.8% EFS and 76.4% OS at 10 years in non-GCB subtype DLBCL.&#xD;
&#xD;
      However the efficacy of R-ACVBP compared to DA-EPOCH-R in patients with newly diagnosed&#xD;
      non-germinal b-cell-like diffuse large B-cell lymphoma remains unknown. All the&#xD;
      above-mentioned results led us to propose a randomized trial comparing R-ACVBP to DA-EPOCH-R&#xD;
      in previously untreated patients with non-GCB DLBCL.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">July 27, 2017</start_date>
  <completion_date type="Anticipated">January 2021</completion_date>
  <primary_completion_date type="Anticipated">January 2020</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Progression-free survival</measure>
    <time_frame>3 years</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overall survival</measure>
    <time_frame>3 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Complete remission rate</measure>
    <time_frame>about 13 weeks after initial chemotherapy</time_frame>
    <description>4 cycles after chemotherapy</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">402</enrollment>
  <condition>Lymphoma, Large B-Cell, Diffuse</condition>
  <arm_group>
    <arm_group_label>DA-EPOCH-R</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>DA-EPOCH-R regimen: rituximab (375 mg/m2) given intravenously (IV) on day 0, etoposide(50 mg/m2), doxorubicin(10 mg/m2) and vincristine(0.4 mg/m2) given continuous intravenously (CIV) from day 1-4(96 hours), cyclophosphamide(750 mg/m2)/dayg IV on days 5, prednisone (60 mg/m2) given orally bid on days 1 through to 5.All patients received granulocyte colony-stimulating factor (G-CSF) beginning on day 6 and continued until the ANC was more than 5 × 109/L above the nadir level. The adjustment paradigm was based on the ANC nadir in the previous cycle as previously described(Wilson, Grossbard et al. 2002)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Modified R-ACVBP</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>R-ACVBP regimen: rituximab (375 mg/m2) given intravenously (IV) on day 0, doxorubicin (75 mg/m2) and cyclophosphamide (1,200 mg/m2) given intravenously (IV) on day 1, vindesine (2 mg/m2) given on days 1 and 5, bleomycin (10 mg) given IV on days 1 and 5, prednisone (60 mg/m2) given orally on days 1 through to 5.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Rituximab</intervention_name>
    <description>rituximab (375 mg/m2) given intravenously (IV) on day 0</description>
    <arm_group_label>DA-EPOCH-R</arm_group_label>
    <arm_group_label>Modified R-ACVBP</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Etoposide</intervention_name>
    <description>Etoposide(50 mg/m2) given continuous intravenously (CIV) from day 1-4(96 hours)</description>
    <arm_group_label>DA-EPOCH-R</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Doxorubicin</intervention_name>
    <description>Doxorubicin(10 mg/m2) given continuous intravenously (CIV) from day 1-4(96 hours)</description>
    <arm_group_label>DA-EPOCH-R</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Vincristine</intervention_name>
    <description>Vincristine(0.4 mg/m2) given continuous intravenously (CIV) from day 1-4(96 hours)</description>
    <arm_group_label>DA-EPOCH-R</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cyclophosphamide</intervention_name>
    <description>Cyclophosphamide(750 mg/m2)/dayg IV on days 5</description>
    <arm_group_label>DA-EPOCH-R</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Prednisone</intervention_name>
    <description>prednisone (100 mg) given orally bid on days 1 through to 5.</description>
    <arm_group_label>DA-EPOCH-R</arm_group_label>
    <arm_group_label>Modified R-ACVBP</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Doxorubicin</intervention_name>
    <description>Doxorubicin (75 mg/m2) given intravenously (IV) on day 1,</description>
    <arm_group_label>Modified R-ACVBP</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cyclophosphamide</intervention_name>
    <description>Cyclophosphamide (1,200 mg/m2) given intravenously (IV) on day 1,</description>
    <arm_group_label>Modified R-ACVBP</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Vindesine</intervention_name>
    <description>Vindesine (2 mg/m2) given on days 1 and 5</description>
    <arm_group_label>Modified R-ACVBP</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Bleomycin</intervention_name>
    <description>Bleomycin (10 mg) given IV on days 1 and 5</description>
    <arm_group_label>Modified R-ACVBP</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient with histologically proven CD20+ diffuse large B cell lymphoma (WHO&#xD;
             Classification),&#xD;
&#xD;
          -  aaIPI&gt;1,&#xD;
&#xD;
          -  Age &gt;18 and &lt; 61 years,&#xD;
&#xD;
          -  Negative HIV serologies 4 weeks&#xD;
&#xD;
          -  Ability to understand and willingness to sign a written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any other histological type of lymphoma. Any history of treated or non-treated&#xD;
             indolent lymphoma.&#xD;
&#xD;
          -  Central nervous system or meningeal involvement by lymphoma.&#xD;
&#xD;
          -  Contraindication to any drug contained in the chemotherapy regimens.&#xD;
&#xD;
          -  Any serious active disease (according to the investigator's decision).&#xD;
&#xD;
          -  Poor renal function (creatinin level&gt;150µmol/l), poor hepatic function (total&#xD;
             bilirubin level&gt;30mmol/l, transaminases&gt;2.5 maximum normal level) unless these&#xD;
             abnormalities are related to the lymphoma.&#xD;
&#xD;
          -  Poor bone marrow reserve as defined by neutrophils &lt;1.5 G/l or platelets &lt;100 G/l,&#xD;
             unless related to bone marrow infiltration.&#xD;
&#xD;
          -  Treatment with any investigational drug within 30 days before planned first cycle of&#xD;
             chemotherapy and during the study.&#xD;
&#xD;
          -  Pregnant or lactating women.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ru Feng, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Hematology, Nanfang Hospital, Southern Medical University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Ru Feng, M.D.</last_name>
    <email>ruth1626@hotmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Xiaolei Wei, PH.D.</last_name>
    <email>smuxiaoleiwei@163.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Ru Feng</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <zip>510515</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ru Feng, M.D.</last_name>
      <phone>+86 13725119762</phone>
      <email>ruth1626@hotmail.com</email>
    </contact>
    <contact_backup>
      <last_name>Xiaolei Wei, M.D.</last_name>
      <phone>+86 13826407312</phone>
      <email>smuxiaoleiwei@163.com</email>
    </contact_backup>
    <investigator>
      <last_name>Ru Feng, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <reference>
    <citation>Wilson WH, Grossbard ML, Pittaluga S, Cole D, Pearson D, Drbohlav N, Steinberg SM, Little RF, Janik J, Gutierrez M, Raffeld M, Staudt L, Cheson BD, Longo DL, Harris N, Jaffe ES, Chabner BA, Wittes R, Balis F. Dose-adjusted EPOCH chemotherapy for untreated large B-cell lymphomas: a pharmacodynamic approach with high efficacy. Blood. 2002 Apr 15;99(8):2685-93. doi: 10.1182/blood.v99.8.2685.</citation>
    <PMID>11929754</PMID>
  </reference>
  <reference>
    <citation>Recher C, Coiffier B, Haioun C, Molina TJ, Ferme C, Casasnovas O, Thieblemont C, Bosly A, Laurent G, Morschhauser F, Ghesquieres H, Jardin F, Bologna S, Fruchart C, Corront B, Gabarre J, Bonnet C, Janvier M, Canioni D, Jais JP, Salles G, Tilly H; Groupe d'Etude des Lymphomes de l'Adulte. Intensified chemotherapy with ACVBP plus rituximab versus standard CHOP plus rituximab for the treatment of diffuse large B-cell lymphoma (LNH03-2B): an open-label randomised phase 3 trial. Lancet. 2011 Nov 26;378(9806):1858-67. doi: 10.1016/S0140-6736(11)61040-4.</citation>
    <PMID>22118442</PMID>
  </reference>
  <reference>
    <citation>Fitoussi O, Belhadj K, Mounier N, Parrens M, Tilly H, Salles G, Feugier P, Ferme C, Ysebaert L, Gabarre J, Herbrecht R, Janvier M, Van Den Neste E, Morschhauser F, Casasnovas O, Ghesquieres H, Anglaret B, Brechignac S, Haioun C, Gisselbrecht C. Survival impact of rituximab combined with ACVBP and upfront consolidation autotransplantation in high-risk diffuse large B-cell lymphoma for GELA. Haematologica. 2011 Aug;96(8):1136-43. doi: 10.3324/haematol.2010.038109. Epub 2011 May 5.</citation>
    <PMID>21546499</PMID>
  </reference>
  <reference>
    <citation>Molina TJ, Canioni D, Copie-Bergman C, Recher C, Briere J, Haioun C, Berger F, Ferme C, Copin MC, Casasnovas O, Thieblemont C, Petrella T, Leroy K, Salles G, Fabiani B, Morschauser F, Mounier N, Coiffier B, Jardin F, Gaulard P, Jais JP, Tilly H. Young patients with non-germinal center B-cell-like diffuse large B-cell lymphoma benefit from intensified chemotherapy with ACVBP plus rituximab compared with CHOP plus rituximab: analysis of data from the Groupe d'Etudes des Lymphomes de l'Adulte/lymphoma study association phase III trial LNH 03-2B. J Clin Oncol. 2014 Dec 10;32(35):3996-4003. doi: 10.1200/JCO.2013.54.9493. Epub 2014 Nov 10.</citation>
    <PMID>25385729</PMID>
  </reference>
  <reference>
    <citation>Wilson WH, Jung SH, Porcu P, Hurd D, Johnson J, Martin SE, Czuczman M, Lai R, Said J, Chadburn A, Jones D, Dunleavy K, Canellos G, Zelenetz AD, Cheson BD, Hsi ED; Cancer Leukemia Group B. A Cancer and Leukemia Group B multi-center study of DA-EPOCH-rituximab in untreated diffuse large B-cell lymphoma with analysis of outcome by molecular subtype. Haematologica. 2012 May;97(5):758-65. doi: 10.3324/haematol.2011.056531. Epub 2011 Dec 1.</citation>
    <PMID>22133772</PMID>
  </reference>
  <reference>
    <citation>Wilson WH, Dunleavy K, Pittaluga S, Hegde U, Grant N, Steinberg SM, Raffeld M, Gutierrez M, Chabner BA, Staudt L, Jaffe ES, Janik JE. Phase II study of dose-adjusted EPOCH and rituximab in untreated diffuse large B-cell lymphoma with analysis of germinal center and post-germinal center biomarkers. J Clin Oncol. 2008 Jun 1;26(16):2717-24. doi: 10.1200/JCO.2007.13.1391. Epub 2008 Mar 31.</citation>
    <PMID>18378569</PMID>
  </reference>
  <reference>
    <citation>Purroy N, Bergua J, Gallur L, Prieto J, Lopez LA, Sancho JM, Garcia-Marco JA, Castellvi J, Montes-Moreno S, Batlle A, de Villambrosia SG, Carnicero F, Ferrando-Lamana L, Piris MA, Lopez A. Long-term follow-up of dose-adjusted EPOCH plus rituximab (DA-EPOCH-R) in untreated patients with poor prognosis large B-cell lymphoma. A phase II study conducted by the Spanish PETHEMA Group. Br J Haematol. 2015 Apr;169(2):188-98. doi: 10.1111/bjh.13273. Epub 2014 Dec 18.</citation>
    <PMID>25521006</PMID>
  </reference>
  <reference>
    <citation>Shiozawa E, Yamochi-Onizuka T, Takimoto M, Ota H. The GCB subtype of diffuse large B-cell lymphoma is less frequent in Asian countries. Leuk Res. 2007 Nov;31(11):1579-83. doi: 10.1016/j.leukres.2007.03.017. Epub 2007 Apr 19.</citation>
    <PMID>17448534</PMID>
  </reference>
  <reference>
    <citation>Gutierrez-Garcia G, Cardesa-Salzmann T, Climent F, Gonzalez-Barca E, Mercadal S, Mate JL, Sancho JM, Arenillas L, Serrano S, Escoda L, Martinez S, Valera A, Martinez A, Jares P, Pinyol M, Garcia-Herrera A, Martinez-Trillos A, Gine E, Villamor N, Campo E, Colomo L, Lopez-Guillermo A; Grup per l'Estudi dels Limfomes de Catalunya I Balears (GELCAB). Gene-expression profiling and not immunophenotypic algorithms predicts prognosis in patients with diffuse large B-cell lymphoma treated with immunochemotherapy. Blood. 2011 May 5;117(18):4836-43. doi: 10.1182/blood-2010-12-322362. Epub 2011 Mar 25.</citation>
    <PMID>21441466</PMID>
  </reference>
  <reference>
    <citation>Lenz G, Staudt LM. Aggressive lymphomas. N Engl J Med. 2010 Apr 15;362(15):1417-29. doi: 10.1056/NEJMra0807082.</citation>
    <PMID>20393178</PMID>
  </reference>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>November 2, 2016</study_first_submitted>
  <study_first_submitted_qc>January 10, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 12, 2017</study_first_posted>
  <last_update_submitted>July 26, 2017</last_update_submitted>
  <last_update_submitted_qc>July 26, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">July 28, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Nanfang Hospital, Southern Medical University</investigator_affiliation>
    <investigator_full_name>Ru Feng</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Non-germinal b-cell-like</keyword>
  <keyword>R-ACVBP</keyword>
  <keyword>DA-EPOCH-R</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lymphoma</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>Rituximab</mesh_term>
    <mesh_term>Doxorubicin</mesh_term>
    <mesh_term>Liposomal doxorubicin</mesh_term>
    <mesh_term>Etoposide</mesh_term>
    <mesh_term>Vincristine</mesh_term>
    <mesh_term>Bleomycin</mesh_term>
    <mesh_term>Vindesine</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/NCT03018626
org study id: NFL2016-B1
nct id: NCT03018626
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: No
This is a randomized, open-label, multi-center, phase 3 study evaluating the efficacy of
      R-ACVBP and DA-EPOCH-R in patients with newly diagnosed non-germinal b-cell-like diffuse
      large B-cell lymphoma
Diffuse large B-cell lymphoma (DLBCL) is the most common type of non-Hodgkin's lymphoma.
      According to Hans' algorithms, DLBCL can be identified as 2 subtypes: germinal
      b-cell-like(GCB) and non-germinal b-cell-like(non-GCB). Approximately 50 to 60% of diffuse
      large-B cell lymphoma(DLBCL) was non-GCB subtype DLBCL. Although the introduction of
      rituximab in immunochemotherapy has dramatically improved the outcome of patients with DLBCL,
      The survival was still poor in non-GCB DLBCL patients treated with R-CHOP.

      The LNH03-2B study has shown that R-ACVBP regimen gave a longer PFS (93% vs. 74% at 3 years,
      p=0.0074) and a longer OS (97% vs. 83% at 3 years, p=0.0067) than R-CHOP in young patients
      with non-GCB DLBCL. It also showed that R-ACVBP regimen gave a longer PFS (87% vs. 73% at 3
      years, p=0.0074) and a longer OS (92% vs. 84% at 3 years, p=0.0067) than R-CHOP in young
      low-intermediate risk DLBCL patients. The LNH2003-3 study has shown that in high-risk (2/3
      IPI factors) DLBCL patients treated with R-ACVBP followed by auto-ASCT results in a 74% PFS
      and 76% OS. Hematological toxic effects of the intensive regimen were raised but manageable.

      The CALGB study showed that in DLBCL patients at least 18 years of age and at least stage II,
      DA-EPOCH-R regimen is effective in both GCB and non-GCB subtypes, with a 5-years TTP 67%, EFS
      58% and OS 68% in non-GCB subtype DLBCL. It is encouraging that PETHEMA Group study showed
      that in the long-term follow-up of untreated DLBCL patients with poor prognosis, DA-EPOCH-R
      achieved a 70.8% EFS and 76.4% OS at 10 years in non-GCB subtype DLBCL.

      However the efficacy of R-ACVBP compared to DA-EPOCH-R in patients with newly diagnosed
      non-germinal b-cell-like diffuse large B-cell lymphoma remains unknown. All the
      above-mentioned results led us to propose a randomized trial comparing R-ACVBP to DA-EPOCH-R
      in previously untreated patients with non-GCB DLBCL.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Progression-free survival
time frame: 3 years
measure: Overall survival
time frame: 3 years
measure: Complete remission rate
time frame: about 13 weeks after initial chemotherapy
description: 4 cycles after chemotherapy
arm group label: DA-EPOCH-R
arm group type: Active Comparator
description: DA-EPOCH-R regimen: rituximab (375 mg/m2) given intravenously (IV) on day 0, etoposide(50 mg/m2), doxorubicin(10 mg/m2) and vincristine(0.4 mg/m2) given continuous intravenously (CIV) from day 1-4(96 hours), cyclophosphamide(750 mg/m2)/dayg IV on days 5, prednisone (60 mg/m2) given orally bid on days 1 through to 5.All patients received granulocyte colony-stimulating factor (G-CSF) beginning on day 6 and continued until the ANC was more than 5 × 109/L above the nadir level. The adjustment paradigm was based on the ANC nadir in the previous cycle as previously described(Wilson, Grossbard et al. 2002)
arm group label: Modified R-ACVBP
arm group type: Experimental
description: R-ACVBP regimen: rituximab (375 mg/m2) given intravenously (IV) on day 0, doxorubicin (75 mg/m2) and cyclophosphamide (1,200 mg/m2) given intravenously (IV) on day 1, vindesine (2 mg/m2) given on days 1 and 5, bleomycin (10 mg) given IV on days 1 and 5, prednisone (60 mg/m2) given orally on days 1 through to 5.
intervention type: Drug
intervention name: Rituximab
description: rituximab (375 mg/m2) given intravenously (IV) on day 0
arm group label: DA-EPOCH-R
arm group label: Modified R-ACVBP
intervention type: Drug
intervention name: Etoposide
description: Etoposide(50 mg/m2) given continuous intravenously (CIV) from day 1-4(96 hours)
arm group label: DA-EPOCH-R
intervention type: Drug
intervention name: Doxorubicin
description: Doxorubicin(10 mg/m2) given continuous intravenously (CIV) from day 1-4(96 hours)
arm group label: DA-EPOCH-R
intervention type: Drug
intervention name: Vincristine
description: Vincristine(0.4 mg/m2) given continuous intravenously (CIV) from day 1-4(96 hours)
arm group label: DA-EPOCH-R
intervention type: Drug
intervention name: Cyclophosphamide
description: Cyclophosphamide(750 mg/m2)/dayg IV on days 5
arm group label: DA-EPOCH-R
intervention type: Drug
intervention name: Prednisone
description: prednisone (100 mg) given orally bid on days 1 through to 5.
arm group label: DA-EPOCH-R
arm group label: Modified R-ACVBP
intervention type: Drug
intervention name: Doxorubicin
description: Doxorubicin (75 mg/m2) given intravenously (IV) on day 1,
arm group label: Modified R-ACVBP
intervention type: Drug
intervention name: Cyclophosphamide
description: Cyclophosphamide (1,200 mg/m2) given intravenously (IV) on day 1,
arm group label: Modified R-ACVBP
intervention type: Drug
intervention name: Vindesine
description: Vindesine (2 mg/m2) given on days 1 and 5
arm group label: Modified R-ACVBP
intervention type: Drug
intervention name: Bleomycin
description: Bleomycin (10 mg) given IV on days 1 and 5
arm group label: Modified R-ACVBP
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
last name: Ru Feng, M.D.
role: Principal Investigator
affiliation: Department of Hematology, Nanfang Hospital, Southern Medical University
last name: Ru Feng, M.D.
email: ruth1626@hotmail.com
last name: Xiaolei Wei, PH.D.
email: smuxiaoleiwei@163.com
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
country: China
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PMID: 21546499
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PMID: 25385729
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PMID: 22133772
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PMID: 18378569
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PMID: 25521006
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PMID: 20393178
responsible party type: Principal Investigator
investigator affiliation: Nanfang Hospital, Southern Medical University
investigator full name: Ru Feng
investigator title: Professor
mesh term: Lymphoma
mesh term: Lymphoma, Large B-Cell, Diffuse
mesh term: Prednisone
mesh term: Cyclophosphamide
mesh term: Rituximab
mesh term: Doxorubicin
mesh term: Liposomal doxorubicin
mesh term: Etoposide
mesh term: Vincristine
mesh term: Bleomycin
mesh term: Vindesine