<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/NCT03795571</url>
  </required_header>
  <id_info>
    <org_study_id>R2-GOD regimen</org_study_id>
    <nct_id>NCT03795571</nct_id>
  </id_info>
  <brief_title>Lenalidomide, Rituximab, Gemcitabine, Oxaliplatin and Dexamethasone in Relapse and Refractory DLBCL</brief_title>
  <acronym>R2-GOD</acronym>
  <official_title>Lenalidomide, Rituximab, Gemcitabine, Oxaliplatin and Dexamethasone (R2-GOD) in Treatment of Relapse/Refractory DLBCL:A Phase I Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The First Affiliated Hospital with Nanjing Medical University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The First Affiliated Hospital with Nanjing Medical University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Previous study showed that Lenalidomide or R-GDP could achieve response in Relapse and&#xD;
      Refractory DLBCL.The investigators therefore design this phase I study to investigate the&#xD;
      safety and efficacy of R2-GOD in relapsed diffuse large-cell lymphoma.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 1, 2019</start_date>
  <completion_date type="Anticipated">December 31, 2019</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2019</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>maximum tolerated dose and dose limited toxicity</measure>
    <time_frame>28 days after first cycle of R2-GOD regimen</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overall response rate,</measure>
    <time_frame>6 months</time_frame>
    <description>overall response rate after treated by R-GemOx or R-miniCHOP overall response rate after treated by R2-GOD regimen regimen</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progressive free survival</measure>
    <time_frame>2 years</time_frame>
    <description>from date of inclusion to date of progression, relapse, or death from any causePFS：from date of inclusion to date of progression, relapse, or death from any cause</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall survival</measure>
    <time_frame>2 years</time_frame>
    <description>from the date of inclusion to date of death, irrespective of cause</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">12</enrollment>
  <condition>Diffuse Large B-cell Lymphoma Recurrent</condition>
  <condition>Diffuse Large B Cell Lymphoma Refractory</condition>
  <arm_group>
    <arm_group_label>R2-GOD</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Rituximab</intervention_name>
    <description>Rituximab 375mg/m2，d0</description>
    <arm_group_label>R2-GOD</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Gemcitabine</intervention_name>
    <description>Gemcitabine 1000mg/m2，d1，d5</description>
    <arm_group_label>R2-GOD</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Oxaliplatin</intervention_name>
    <description>Oxaliplatin 75mg/m2，d1</description>
    <arm_group_label>R2-GOD</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dexamethasone</intervention_name>
    <description>Dexamethasone 40mg/d，d1~d4</description>
    <arm_group_label>R2-GOD</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Lenalidomide Oral Capsule</intervention_name>
    <description>Lenalidomide 10mg/d、15mg/d、20mg/d、25mg/d d1~d10； 21days a cycle</description>
    <arm_group_label>R2-GOD</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 18-65 years old;&#xD;
&#xD;
          -  ECOG PS 0- 2;&#xD;
&#xD;
          -  Histologically confirmed diffuse large B cell lymphoma（With exception of Primary&#xD;
             mediastinal large B cell lymphoma、Primary central nervous system lymphoma、HIV-related&#xD;
             lymphoma),relapse or refractory,defined as:&#xD;
&#xD;
               -  relapse after standard first-line immunochemotherapy( R-CHOP or R-CHOP like)&#xD;
&#xD;
               -  SD as best response after 4 cycles or PD after 2 cycles of first-line&#xD;
                  immunochemotherapy;&#xD;
&#xD;
          -  a measurable or evaluable disease at the time of enrollment(diameter ≥ 1.5cm）；&#xD;
&#xD;
          -  Eligible for subsequent autologous stem cell transplantation；&#xD;
&#xD;
          -  Female subjects in childbearing age, their serum or urine pregnancy test must be&#xD;
             negative. All patients must agree to take effective contraceptive measures during the&#xD;
             trial measures&#xD;
&#xD;
          -  Expected survival ≥ 12 weeks；&#xD;
&#xD;
          -  Understand and voluntarily sign an informed consent form, able to adhere to the study&#xD;
             visit schedule and other protocol requirements&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Women who are pregnant or lactating. Patients have breeding intent in 12 months or&#xD;
             cannot take effective contraceptive measures during the trial measures；&#xD;
&#xD;
          -  Uncontrollable active infection within four week. Prophylactic antibiotic, antiviral&#xD;
             and antifungal treatment is permissible. Active hepatitis B or hepatitis C virus&#xD;
             infection, as well as acquired, congenital immune deficiency diseases, including but&#xD;
             not limited to HIV-infected persons；&#xD;
&#xD;
          -  Used of systemic anti-tumor treatment within four weeks；&#xD;
&#xD;
          -  CNS or meningeal involvement;&#xD;
&#xD;
          -  Poor hepatic and/or renal function, defined as total bilirubin, ALT, AST, Cr more than&#xD;
             two fold of upper normal level,Ccr&lt; 50 mL/min unless these abnormalities were related&#xD;
             to the lymphoma;&#xD;
&#xD;
          -  Poor bone-marrow reserve, defined as neutrophil count less than 1.5×10⁹/L or platelet&#xD;
             count less than 75×10⁹/L, unless caused by bone marrow infiltration;&#xD;
&#xD;
          -  New York Heart Association class III or IV cardiac failure; or Ejection fraction less&#xD;
             than 50%;or history of following disease in past 6 months: acute coronary&#xD;
             syndrome、acute heart failure、severe ventricular arrhythmia；&#xD;
&#xD;
          -  Known sensitivity or allergy to investigational Product;&#xD;
&#xD;
          -  Major surgery within three weeks;&#xD;
&#xD;
          -  Presence of Grade III nervous toxicity within past two weeks;&#xD;
&#xD;
          -  Active and severe infectious diseases;&#xD;
&#xD;
          -  History of DVT or PE within past 12 months；&#xD;
&#xD;
          -  Any potential drug abuse, medical, psychological or social conditions which may&#xD;
             disturb this investigation and assessment;&#xD;
&#xD;
          -  In any conditions which investigator considered ineligible for this study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Wei Xu, PhD&amp; MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>The first Affiliated Hospital Of Nanjing Medical University(JiangSu Province Hospital)</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Huayuan Zhu, PhD&amp; MD</last_name>
    <phone>86 25 68306034</phone>
    <email>huayuan.zhu@hotmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>The first Affiliated Hospital Of Nanjing Medical University(JiangSu Province Hospital</name>
      <address>
        <city>Nanjing</city>
        <state>Jiangsu</state>
        <zip>210000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Huayuan Zhu, PhD，MD</last_name>
      <phone>+86 68136034</phone>
      <email>huayuan.zhu@hotmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <reference>
    <citation>Feldman T, Mato AR, Chow KF, Protomastro EA, Yannotti KM, Bhattacharyya P, Yang X, Donato ML, Rowley SD, Carini C, Valentinetti M, Smith J, Gadaleta G, Bejot C, Stives S, Timberg M, Kdiry S, Pecora AL, Beaven AW, Goy A. Addition of lenalidomide to rituximab, ifosfamide, carboplatin, etoposide (RICER) in first-relapse/primary refractory diffuse large B-cell lymphoma. Br J Haematol. 2014 Jul;166(1):77-83. doi: 10.1111/bjh.12846. Epub 2014 Mar 25.</citation>
    <PMID>24661044</PMID>
  </reference>
  <reference>
    <citation>Martin A, Redondo AM, Dlouhy I, Salar A, Gonzalez-Barca E, Canales M, Montes-Moreno S, Ocio EM, Lopez-Guillermo A, Caballero D; Spanish Group for Lymphomas and Autologous Bone Marrow (GELTAMO). Lenalidomide in combination with R-ESHAP in patients with relapsed or refractory diffuse large B-cell lymphoma: a phase 1b study from GELTAMO group. Br J Haematol. 2016 Apr;173(2):245-52. doi: 10.1111/bjh.13945. Epub 2016 Feb 5.</citation>
    <PMID>26847165</PMID>
  </reference>
  <reference>
    <citation>Crump M, Kuruvilla J, Couban S, MacDonald DA, Kukreti V, Kouroukis CT, Rubinger M, Buckstein R, Imrie KR, Federico M, Di Renzo N, Howson-Jan K, Baetz T, Kaizer L, Voralia M, Olney HJ, Turner AR, Sussman J, Hay AE, Djurfeldt MS, Meyer RM, Chen BE, Shepherd LE. Randomized comparison of gemcitabine, dexamethasone, and cisplatin versus dexamethasone, cytarabine, and cisplatin chemotherapy before autologous stem-cell transplantation for relapsed and refractory aggressive lymphomas: NCIC-CTG LY.12. J Clin Oncol. 2014 Nov 1;32(31):3490-6. doi: 10.1200/JCO.2013.53.9593. Epub 2014 Sep 29.</citation>
    <PMID>25267740</PMID>
  </reference>
  <reference>
    <citation>Shen QD, Zhu HY, Wang L, Fan L, Liang JH, Cao L, Wu W, Xia Y, Li JY, Xu W. Gemcitabine-oxaliplatin plus rituximab (R-GemOx) as first-line treatment in elderly patients with diffuse large B-cell lymphoma: a single-arm, open-label, phase 2 trial. Lancet Haematol. 2018 Jun;5(6):e261-e269. doi: 10.1016/S2352-3026(18)30054-1. Epub 2018 May 8.</citation>
    <PMID>29752199</PMID>
  </reference>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>January 1, 2019</study_first_submitted>
  <study_first_submitted_qc>January 3, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 7, 2019</study_first_posted>
  <last_update_submitted>February 13, 2019</last_update_submitted>
  <last_update_submitted_qc>February 13, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 15, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>The First Affiliated Hospital with Nanjing Medical University</investigator_affiliation>
    <investigator_full_name>WEI XU</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>lenalidomide</keyword>
  <keyword>R-GOD</keyword>
  <keyword>DLBCL</keyword>
  <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>Dexamethasone</mesh_term>
    <mesh_term>Rituximab</mesh_term>
    <mesh_term>Gemcitabine</mesh_term>
    <mesh_term>Oxaliplatin</mesh_term>
    <mesh_term>Lenalidomide</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03795571
org study id: R2-GOD regimen
nct id: NCT03795571
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Previous study showed that Lenalidomide or R-GDP could achieve response in Relapse and
      Refractory DLBCL.The investigators therefore design this phase I study to investigate the
      safety and efficacy of R2-GOD in relapsed diffuse large-cell lymphoma.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: maximum tolerated dose and dose limited toxicity
time frame: 28 days after first cycle of R2-GOD regimen
measure: Overall response rate,
time frame: 6 months
description: overall response rate after treated by R-GemOx or R-miniCHOP overall response rate after treated by R2-GOD regimen regimen
measure: Progressive free survival
time frame: 2 years
description: from date of inclusion to date of progression, relapse, or death from any causePFS：from date of inclusion to date of progression, relapse, or death from any cause
measure: Overall survival
time frame: 2 years
description: from the date of inclusion to date of death, irrespective of cause
arm group label: R2-GOD
arm group type: Experimental
intervention type: Drug
intervention name: Rituximab
description: Rituximab 375mg/m2，d0
arm group label: R2-GOD
intervention type: Drug
intervention name: Gemcitabine
description: Gemcitabine 1000mg/m2，d1，d5
arm group label: R2-GOD
intervention type: Drug
intervention name: Oxaliplatin
description: Oxaliplatin 75mg/m2，d1
arm group label: R2-GOD
intervention type: Drug
intervention name: Dexamethasone
description: Dexamethasone 40mg/d，d1~d4
arm group label: R2-GOD
intervention type: Drug
intervention name: Lenalidomide Oral Capsule
description: Lenalidomide 10mg/d、15mg/d、20mg/d、25mg/d d1~d10； 21days a cycle
arm group label: R2-GOD
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Wei Xu, PhD& MD
role: Principal Investigator
affiliation: The first Affiliated Hospital Of Nanjing Medical University(JiangSu Province Hospital)
last name: Huayuan Zhu, PhD& MD
phone: 86 25 68306034
email: huayuan.zhu@hotmail.com
facility: 
status: Recruiting
contact: 
country: China
citation: Feldman T, Mato AR, Chow KF, Protomastro EA, Yannotti KM, Bhattacharyya P, Yang X, Donato ML, Rowley SD, Carini C, Valentinetti M, Smith J, Gadaleta G, Bejot C, Stives S, Timberg M, Kdiry S, Pecora AL, Beaven AW, Goy A. Addition of lenalidomide to rituximab, ifosfamide, carboplatin, etoposide (RICER) in first-relapse/primary refractory diffuse large B-cell lymphoma. Br J Haematol. 2014 Jul;166(1):77-83. doi: 10.1111/bjh.12846. Epub 2014 Mar 25.
PMID: 24661044
citation: Martin A, Redondo AM, Dlouhy I, Salar A, Gonzalez-Barca E, Canales M, Montes-Moreno S, Ocio EM, Lopez-Guillermo A, Caballero D; Spanish Group for Lymphomas and Autologous Bone Marrow (GELTAMO). Lenalidomide in combination with R-ESHAP in patients with relapsed or refractory diffuse large B-cell lymphoma: a phase 1b study from GELTAMO group. Br J Haematol. 2016 Apr;173(2):245-52. doi: 10.1111/bjh.13945. Epub 2016 Feb 5.
PMID: 26847165
citation: Crump M, Kuruvilla J, Couban S, MacDonald DA, Kukreti V, Kouroukis CT, Rubinger M, Buckstein R, Imrie KR, Federico M, Di Renzo N, Howson-Jan K, Baetz T, Kaizer L, Voralia M, Olney HJ, Turner AR, Sussman J, Hay AE, Djurfeldt MS, Meyer RM, Chen BE, Shepherd LE. Randomized comparison of gemcitabine, dexamethasone, and cisplatin versus dexamethasone, cytarabine, and cisplatin chemotherapy before autologous stem-cell transplantation for relapsed and refractory aggressive lymphomas: NCIC-CTG LY.12. J Clin Oncol. 2014 Nov 1;32(31):3490-6. doi: 10.1200/JCO.2013.53.9593. Epub 2014 Sep 29.
PMID: 25267740
citation: Shen QD, Zhu HY, Wang L, Fan L, Liang JH, Cao L, Wu W, Xia Y, Li JY, Xu W. Gemcitabine-oxaliplatin plus rituximab (R-GemOx) as first-line treatment in elderly patients with diffuse large B-cell lymphoma: a single-arm, open-label, phase 2 trial. Lancet Haematol. 2018 Jun;5(6):e261-e269. doi: 10.1016/S2352-3026(18)30054-1. Epub 2018 May 8.
PMID: 29752199
responsible party type: Principal Investigator
investigator affiliation: The First Affiliated Hospital with Nanjing Medical University
investigator full name: WEI XU
investigator title: Professor
mesh term: Lymphoma
mesh term: Lymphoma, B-Cell
mesh term: Lymphoma, Large B-Cell, Diffuse
mesh term: Dexamethasone
mesh term: Rituximab
mesh term: Gemcitabine
mesh term: Oxaliplatin
mesh term: Lenalidomide
sharing ipd: Undecided