<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/NCT04408638</url>
  </required_header>
  <id_info>
    <org_study_id>GO41944</org_study_id>
    <secondary_id>2020-001021-31</secondary_id>
    <nct_id>NCT04408638</nct_id>
  </id_info>
  <brief_title>A Phase III Study Evaluating Glofitamab in Combination With Gemcitabine + Oxaliplatin vs Rituximab in Combination With Gemcitabine + Oxaliplatin in Participants With Relapsed/Refractory Diffuse Large B-Cell Lymphoma</brief_title>
  <official_title>A Phase III, Open-Label, Multicenter, Randomized Study Evaluating the Efficacy and Safety of Glofitamab in Combination With Gemcitabine Plus Oxaliplatin Versus Rituximab in Combination With Gemcitabine and Oxaliplatin in Patients With Relapsed/Refractory Diffuse Large B-Cell Lymphoma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hoffmann-La Roche</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hoffmann-La Roche</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will evaluate the efficacy and safety of glofitamab in combination with&#xD;
      gemcitabine plus oxaliplatin (Glofit-GemOx) compared with rituximab in combination with&#xD;
      gemcitabine plus oxaliplatin (R-GemOx) in patients with R/R DLBCL.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">February 23, 2021</start_date>
  <completion_date type="Anticipated">April 15, 2025</completion_date>
  <primary_completion_date type="Anticipated">April 15, 2025</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>Overall survival (OS), defined as the time from randomization to date of death from any cause</measure>
    <time_frame>Up to 3.5 years</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Progression-free survival (PFS), defined as the time from randomization to the first occurrence of disease progression or death from any cause, whichever occurs first, as determined by the Independent Review Committee (IRC)</measure>
    <time_frame>Up to 3.5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PFS, defined as the time from randomization to the first occurrence of disease progression or death from any cause, whichever occurs first, as determined by the investigator</measure>
    <time_frame>Up to 3.5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Complete response (CR) rate, defined as the proportion of patients whose best overall response is a CR on positron emission tomography/computed tomography (PET/CT) during the study, as determined by the IRC</measure>
    <time_frame>Up to 3.5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CR rate, defined as the proportion of patients whose best overall response is a CR on positron emission tomography/computed tomography (PET/CT) during the study, as determined by the investigator</measure>
    <time_frame>Up to 3.5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Objective response rate (ORR), defined as the proportion of patients whose best overall response is a partial response (PR) or a CR during the study, as determined by the IRC</measure>
    <time_frame>Up to 3.5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ORR, defined as the proportion of patients whose best overall response is a partial response (PR) or a CR during the study, as determined by the investigator</measure>
    <time_frame>Up to 3.5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of objective response (DOR), defined as the time from the first occurrence of a documented objective response (CR or PR) to disease progression, or death from any cause, whichever occurs first</measure>
    <time_frame>Up to 3.5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of CR, defined as the time from the first occurrence of a documented CR to disease progression, or death from any cause, whichever occurs first</measure>
    <time_frame>Up to 3.5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to deterioration in physical functioning and fatigue, as measured by the European Organisation for Research and Treatment of Cancer Quality of Life-Core 30 Questionnaire (EORTC QLQ-C30)</measure>
    <time_frame>Up to 3.5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to deterioration in lymphoma symptoms, as measured by the Functional Assessment of Cancer Therapy-Lymphoma subscale (FACT-Lym LymS)</measure>
    <time_frame>Up to 3.5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants with Adverse Events</measure>
    <time_frame>Up to 3.5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tolerability, as assessed by dose interruptions, dose reductions, and dose intensity, and study treatment discontinuation because of adverse events</measure>
    <time_frame>Up to 3.5 years</time_frame>
  </secondary_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>Glofit-GemOx</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive up to 8 cycles of glofitamab (Glofit) in combination with gemcitabine and oxaliplatin (GemOx), followed by up to 4 cycles of glofitamab monotherapy. A single dose of obinutuzumab will be administered 7 days prior to the first dose of glofitamab. Treatment is administered in 21-day cycles.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>R-GemOx</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive rituxumab (R) in combination with gemcitabine and oxaliplatin (GemOx) for up to 8 cycles. Treatment is administered in 21-day cycles.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Obinutuzumab</intervention_name>
    <description>Participants will receive a single dose of intravenous (IV) obinutuzumab pre-treatment 7 days prior to the first dose of glofitamab.</description>
    <arm_group_label>Glofit-GemOx</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Glofitamab</intervention_name>
    <description>Participants will receive IV glofitamab for up to 12 cycles.</description>
    <arm_group_label>Glofit-GemOx</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Rituxumab</intervention_name>
    <description>Participants will receive IV rituxumab on Day 1 of each cycle for up to 8 cycles.</description>
    <arm_group_label>R-GemOx</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Tocilizumab</intervention_name>
    <description>Participants will receive IV tocilizumab as needed for treatment of cytokine-release syndrome (CRS).</description>
    <arm_group_label>Glofit-GemOx</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Gemcitabine</intervention_name>
    <description>Participants will receive IV gemcitabine prior to oxaliplatin administration for up to 8 cycles.</description>
    <arm_group_label>Glofit-GemOx</arm_group_label>
    <arm_group_label>R-GemOx</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Oxaliplatin</intervention_name>
    <description>Participants will receive IV oxaliplatin after gemcitabine administration for up to 8 cycles.</description>
    <arm_group_label>Glofit-GemOx</arm_group_label>
    <arm_group_label>R-GemOx</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria&#xD;
&#xD;
          -  Histologically confirmed diffuse large B-cell lymphoma (DLBCL), not otherwise&#xD;
             specified&#xD;
&#xD;
          -  Relapsed/refractory (R/R) disease, defined as follows: Relapsed = disease that has&#xD;
             recurred ≥6 months after completion of the last line of therapy; Refractory = disease&#xD;
             that either progressed during the last line of therapy or progressed within 6 months&#xD;
             (&lt;6 months) of the last line of prior therapy&#xD;
&#xD;
          -  At least one (≥1) line of prior systemic therapy&#xD;
&#xD;
          -  Participants who have failed only one prior line of therapy must not be a candidate&#xD;
             for high-dose chemotherapy followed by autologous stem cell transplant, as defined by&#xD;
             the study protocol&#xD;
&#xD;
          -  Confirmed availability of tumor tissue, unless unobtainable per investigator&#xD;
             assessment. Freshly collected biopsy is preferred. Archival tissue is acceptable&#xD;
&#xD;
          -  At least one bi-dimensionally measurable (≥1.5 cm) nodal lesion, or one&#xD;
             bi-dimensionally measurable (≥1 cm) extranodal lesion, as measured on computed&#xD;
             tomography (CT) scan&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2&#xD;
&#xD;
          -  Adequate hematologic function (unless attributable to the underlying disease, as&#xD;
             established by extensive bone marrow involvement or associated with hypersplenism&#xD;
             secondary to the involvement of the spleen by DLBCL per the investigator), as defined&#xD;
             by the study protocol&#xD;
&#xD;
          -  Negative SARS-CoV-2 antigen or PCR test within 7 days prior to enrollment&#xD;
&#xD;
          -  Adequate renal function, defined as an estimated creatinine clearance ≥30 mL/min&#xD;
&#xD;
        Exclusion Criteria&#xD;
&#xD;
          -  Patient has failed only one prior line of therapy and is a candidate for stem cell&#xD;
             transplantation&#xD;
&#xD;
          -  History of transformation of indolent disease to DLBCL&#xD;
&#xD;
          -  High-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements, and&#xD;
             high-grade B-cell lymphoma not otherwise specified, as defined by 2016 WHO guidelines&#xD;
&#xD;
          -  Primary mediastinal B-cell lymphoma&#xD;
&#xD;
          -  History of severe allergic or anaphylactic reactions to humanized or murine monoclonal&#xD;
             antibodies (or recombinant antibody-related fusion proteins) or known sensitivity or&#xD;
             allergy to murine products&#xD;
&#xD;
          -  Contraindication to obinutuzumab, rituximab, gemcitabine or oxaliplatin, or&#xD;
             tocilizumab&#xD;
&#xD;
          -  Prior treatment with glofitamab or other bispecific antibodies targeting both CD20 and&#xD;
             CD3&#xD;
&#xD;
          -  Peripheral neuropathy assessed to be Grade &gt;1 according to National Cancer Institute&#xD;
             Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0 at enrollment&#xD;
&#xD;
          -  Treatment with radiotherapy, chemotherapy, immunotherapy, immunosuppressive therapy,&#xD;
             or any investigational agent for the purposes of treating cancer within 2 weeks prior&#xD;
             to first study treatment&#xD;
&#xD;
          -  Treatment with monoclonal antibodies for the purposes of treating cancer within 4&#xD;
             weeks prior to first study treatment&#xD;
&#xD;
          -  Primary or secondary central nervous system (CNS) lymphoma at the time of recruitment&#xD;
             or history of CNS lymphoma&#xD;
&#xD;
          -  Current or history of CNS disease, such as stroke, epilepsy, CNS vasculitis, or&#xD;
             neurodegenerative disease&#xD;
&#xD;
          -  Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection&#xD;
             (excluding fungal infections of nail beds) at study enrollment or any major episode of&#xD;
             infection (as evaluated by the investigator) within 4 weeks prior to the first study&#xD;
             treatment&#xD;
&#xD;
          -  Positive SARS-CoV-2 infection within 30 days prior to the first study treatment,&#xD;
             including asymptomatic SARS-CoV-2 infection&#xD;
&#xD;
          -  Documented SARS-CoV-2 infection within 6 months of first study treatment&#xD;
&#xD;
          -  Suspected or latent tuberculosis&#xD;
&#xD;
          -  Positive for hepatitis B virus (HBV), hepatitis C virus (HCV), or human&#xD;
             immunodeficiency virus (HIV)&#xD;
&#xD;
          -  Known or suspected chronic active Epstein-Barr viral infection&#xD;
&#xD;
          -  Known or suspected history of hemophagocytic lymphohistiocytosis (HLH)&#xD;
&#xD;
          -  Known history of progressive multifocal leukoencephalopathy&#xD;
&#xD;
          -  Adverse events from prior anti-cancer therapy not resolved to Grade 1 or better (with&#xD;
             the exception of alopecia and anorexia)&#xD;
&#xD;
          -  Administration of a live, attenuated vaccine within 4 weeks before first study&#xD;
             treatment administration or anticipation that such a live, attenuated vaccine will be&#xD;
             required during the study&#xD;
&#xD;
          -  Prior solid organ transplantation&#xD;
&#xD;
          -  Prior allogeneic stem cell transplant&#xD;
&#xD;
          -  Active autoimmune disease requiring treatment&#xD;
&#xD;
          -  Prior treatment with systemic immunosuppressive medications (including, but not&#xD;
             limited to, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor&#xD;
             necrosis factor agents), within 4 weeks prior to first dose of study treatment&#xD;
&#xD;
          -  Corticosteroid therapy within 2 weeks prior to first dose of study treatment&#xD;
             (exceptions defined by study protocol)&#xD;
&#xD;
          -  Recent major surgery (within 4 weeks before the first study treatment) other than for&#xD;
             diagnosis&#xD;
&#xD;
          -  Clinically significant history of cirrhotic liver disease&#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>Clinical Trials</last_name>
    <role>Study Director</role>
    <affiliation>Hoffmann-La Roche</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Reference Study ID Number: GO41944 https://forpatients.roche.com/</last_name>
    <phone>888-662-6728</phone>
    <email>global-roche-genentech-trials@gene.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>University of Alabama at Birmingham</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35294-3300</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Banner Health MD Anderson AZ</name>
      <address>
        <city>Gilbert</city>
        <state>Arizona</state>
        <zip>85234</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>Community Cancer Institute (CCI)</name>
      <address>
        <city>Fresno</city>
        <state>California</state>
        <zip>93720</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Baptist Medical Center - Jacksonville</name>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <zip>32207-8202</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Baptist - MD Anderson Cancer Center</name>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <zip>32207</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Ochsner Medical Center</name>
      <address>
        <city>New Orleans</city>
        <state>Louisiana</state>
        <zip>70121</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>University of Maryland Medical Center</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21201</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21287</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Massachusetts General Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02114</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>University of Mississippi Medical Center</name>
      <address>
        <city>Jackson</city>
        <state>Mississippi</state>
        <zip>39216</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Rutgers Cancer Institute of New Jersey</name>
      <address>
        <city>New Brunswick</city>
        <state>New Jersey</state>
        <zip>08901</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Icahn School of Medicine at Mount Sinai</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10029</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Duke University Medical Center</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27705</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Allegheny General Hospital</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15212</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>Providence Regional Cancer Partnership</name>
      <address>
        <city>Everett</city>
        <state>Washington</state>
        <zip>98201</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>Prince of Wales Hospital; Haematology</name>
      <address>
        <city>Randwick</city>
        <state>New South Wales</state>
        <zip>2031</zip>
        <country>Australia</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Royal Adelaide Hospital; Haematology Clinical Trials</name>
      <address>
        <city>Adelaide</city>
        <state>South Australia</state>
        <zip>5000</zip>
        <country>Australia</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Monash Health Monash Medical Centre</name>
      <address>
        <city>Clayton</city>
        <state>Victoria</state>
        <zip>3168</zip>
        <country>Australia</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>St Vincent's Hospital Melbourne</name>
      <address>
        <city>Fitzroy</city>
        <state>Victoria</state>
        <zip>3065</zip>
        <country>Australia</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Peter Maccallum Cancer Centre</name>
      <address>
        <city>Melbourne</city>
        <state>Victoria</state>
        <zip>3000</zip>
        <country>Australia</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Sir Charles Gairdner Hospital</name>
      <address>
        <city>Nedlands</city>
        <state>Western Australia</state>
        <zip>6009</zip>
        <country>Australia</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>UZ Gent</name>
      <address>
        <city>Gent</city>
        <zip>9000</zip>
        <country>Belgium</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>UZ Leuven Gasthuisberg</name>
      <address>
        <city>Leuven</city>
        <zip>3000</zip>
        <country>Belgium</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>CHU Sart-Tilman</name>
      <address>
        <city>Liège</city>
        <zip>4000</zip>
        <country>Belgium</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Beijing Cancer Hospital</name>
      <address>
        <city>Beijing</city>
        <zip>100142</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>Peking University Third Hospital</name>
      <address>
        <city>Beijing</city>
        <zip>100191</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>West China Hospital, Sichuan University</name>
      <address>
        <city>Chengdu</city>
        <zip>610041</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>Sun Yet-sen University Cancer Center</name>
      <address>
        <city>Guangzhou City</city>
        <zip>510663</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Harbin Medical University Cancer Hospital</name>
      <address>
        <city>Harbin</city>
        <zip>150081</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Jiangsu Province Hospital</name>
      <address>
        <city>Nanjing</city>
        <zip>210008</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>Fudan University Shanghai Cancer Center</name>
      <address>
        <city>Shanghai City</city>
        <zip>200120</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Tianjin Cancer Hospital</name>
      <address>
        <city>Tianjin</city>
        <zip>300060</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Wuhan Union Hospital Tongji Medical College, Huazhong University of Science and Technology</name>
      <address>
        <city>Wuhan City</city>
        <zip>430022</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Zhejiang Cancer Hospital</name>
      <address>
        <city>Zhejiang</city>
        <zip>310022</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Henan Cancer Hospital</name>
      <address>
        <city>Zhengzhou</city>
        <zip>450008</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Aarhus Universitetshospital Skejby; Blodsygdomme</name>
      <address>
        <city>Aarhus N</city>
        <zip>8200</zip>
        <country>Denmark</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Rigshospitalet; Hæmatologisk Klinik</name>
      <address>
        <city>København Ø</city>
        <zip>2100</zip>
        <country>Denmark</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Institut Bergonie; Hematologie Oncologie</name>
      <address>
        <city>Bordeaux</city>
        <zip>33076</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Hopital Henri Mondor; 51 Av Mal Lattre De Tassigny</name>
      <address>
        <city>Creteil</city>
        <zip>94010</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Hopital Claude Huriez; Hematologie</name>
      <address>
        <city>Lille</city>
        <zip>59037</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>CHU DE MONTPELLIER-ST ELOI; Département d'Hématologie Clinique</name>
      <address>
        <city>Montpellier</city>
        <zip>34295</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Lyon Sud</name>
      <address>
        <city>Pierre Benite</city>
        <zip>69495</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>CHU Pontchaillou; Service Hématologie</name>
      <address>
        <city>Rennes</city>
        <zip>35003</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Städtisches Klinikum Dessau</name>
      <address>
        <city>Dessau-Roßlau</city>
        <zip>06847</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>Universitatsklinikum Frankfurt</name>
      <address>
        <city>Frankfurt</city>
        <zip>60590</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Gießen und Marburg GmbH Standort Gießen Medizinische Klinik I</name>
      <address>
        <city>Giessen</city>
        <zip>35392</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Universitaetsklinikum Heidelberg</name>
      <address>
        <city>Heidelberg</city>
        <zip>69120</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>Universitaetsklinikum Regensburg</name>
      <address>
        <city>Regensburg</city>
        <zip>93053</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Katharinenhospital Stuttgart; Klinik für Hämatologie, Onkologie und Palliativmedizin</name>
      <address>
        <city>Stuttgart</city>
        <zip>70174</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Pusan National University Hospital</name>
      <address>
        <city>Busan</city>
        <zip>602-739</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>National Cancer Center</name>
      <address>
        <city>Goyang-si</city>
        <zip>10408</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Seoul National University Bundang Hospital</name>
      <address>
        <city>Seongnam-si</city>
        <zip>463-707</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Seoul National University Hospital</name>
      <address>
        <city>Seoul</city>
        <zip>03080</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Asan Medical Center</name>
      <address>
        <city>Seoul</city>
        <zip>05505</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Samsung Medical Center</name>
      <address>
        <city>Seoul</city>
        <zip>06351</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Uniwersyteckie Centrum Kliniczne</name>
      <address>
        <city>Gdansk</city>
        <country>Poland</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Centrum Onkologii Ziemi Lubelskiej im. ?w. Jana z Dukli</name>
      <address>
        <city>Lublin</city>
        <zip>20-090</zip>
        <country>Poland</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Oddzial Kliniczny Hematologii SPZOZ MSWiA z Warminsko-Mazurskim Centrum Onkologii w Olsztynie</name>
      <address>
        <city>Olsztyn</city>
        <zip>10-228</zip>
        <country>Poland</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Szpital Wojewodzki w Opolu, Oddzial Hematologii i Onkologii Hematologicznej</name>
      <address>
        <city>Opole</city>
        <zip>45-061</zip>
        <country>Poland</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>Uniwersytecki Szpital Kliniczny w Poznaniu; Oddzial Hematologii i Transplantacji Szpiku</name>
      <address>
        <city>Pozna?</city>
        <zip>60-569</zip>
        <country>Poland</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Instytut Hematologii i Transfuzjologii; Klinika Hematologii</name>
      <address>
        <city>Warszawa</city>
        <zip>02-776</zip>
        <country>Poland</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Uniwersytecki Szpital Kliniczny; Klinika Hematologii, Nowotworów Krwi i Transplantacji Szpiku</name>
      <address>
        <city>Wroc?aw</city>
        <zip>50-367</zip>
        <country>Poland</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>PanOncology Trials; Hospital Oncológico, Puerto Rico Medical Center</name>
      <address>
        <city>San Juan</city>
        <zip>00935</zip>
        <country>Puerto Rico</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Marques de Valdecilla; Servicio de Hematologia</name>
      <address>
        <city>Santander</city>
        <state>Cantabria</state>
        <zip>39008</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Hospital Universitari Vall d'Hebron; Servicio de Hematologia</name>
      <address>
        <city>Barcelona</city>
        <zip>08035</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Hospital Clínic i Provincial; Servicio de Hematología y Oncología</name>
      <address>
        <city>Barcelona</city>
        <zip>08036</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario la Paz; Servicio de Hematologia</name>
      <address>
        <city>Madrid</city>
        <zip>28046</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Virgen del Rocio; Servicio de Hematologia</name>
      <address>
        <city>Sevilla</city>
        <zip>41013</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Hospital Clinico Universitario de Valencia; Servicio de Onco-hematologia</name>
      <address>
        <city>Valencia</city>
        <zip>46010</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Inselspital Bern, Insel-Gruppe AG</name>
      <address>
        <city>Bern</city>
        <zip>3010</zip>
        <country>Switzerland</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Universitätsspital Zürich</name>
      <address>
        <city>Zürich</city>
        <zip>8091</zip>
        <country>Switzerland</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Chang Gung Medical Foundation - Kaohsiung; Oncology; Division of Hematology-Oncology</name>
      <address>
        <city>Kaoisung</city>
        <zip>833</zip>
        <country>Taiwan</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Chang Gung Medical Foundation - Linkou; Division of Hematology- Oncology</name>
      <address>
        <city>Taoyuan</city>
        <zip>333</zip>
        <country>Taiwan</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Taichung Veterans General Hospital</name>
      <address>
        <city>Xitun Dist.</city>
        <zip>40705</zip>
        <country>Taiwan</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Beatson West of Scotland Cancer Centre</name>
      <address>
        <city>Glasgow</city>
        <zip>G12 0YN</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>St James's Institute of Oncology; Dept of Haematology</name>
      <address>
        <city>Leeds</city>
        <zip>LS9 7TF</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>UCLH - Clinical Trials Pharmacy B&amp;D Centre</name>
      <address>
        <city>London</city>
        <zip>N7 9NH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Christie Hospital; Department of Haematology and Transplant</name>
      <address>
        <city>Manchester</city>
        <zip>M20 4BX</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Nottingham City Hospital; Dept of Haematology</name>
      <address>
        <city>Nottingham</city>
        <zip>NG5 1PB</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Southampton General Hospital</name>
      <address>
        <city>Southampton</city>
        <zip>SO16 6YD</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location_countries>
    <country>Australia</country>
    <country>Belgium</country>
    <country>China</country>
    <country>Denmark</country>
    <country>France</country>
    <country>Germany</country>
    <country>Korea, Republic of</country>
    <country>Poland</country>
    <country>Puerto Rico</country>
    <country>Spain</country>
    <country>Switzerland</country>
    <country>Taiwan</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2023</verification_date>
  <study_first_submitted>May 26, 2020</study_first_submitted>
  <study_first_submitted_qc>May 26, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 29, 2020</study_first_posted>
  <last_update_submitted>September 1, 2023</last_update_submitted>
  <last_update_submitted_qc>September 1, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">September 5, 2023</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>Gemcitabine</mesh_term>
    <mesh_term>Oxaliplatin</mesh_term>
    <mesh_term>Obinutuzumab</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).</ipd_description>
  </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/NCT04408638
org study id: GO41944
secondary id: 2020-001021-31
nct id: NCT04408638
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
This study will evaluate the efficacy and safety of glofitamab in combination with
      gemcitabine plus oxaliplatin (Glofit-GemOx) compared with rituximab in combination with
      gemcitabine plus oxaliplatin (R-GemOx) in patients with R/R DLBCL.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Overall survival (OS), defined as the time from randomization to date of death from any cause
time frame: Up to 3.5 years
measure: Progression-free survival (PFS), defined as the time from randomization to the first occurrence of disease progression or death from any cause, whichever occurs first, as determined by the Independent Review Committee (IRC)
time frame: Up to 3.5 years
measure: PFS, defined as the time from randomization to the first occurrence of disease progression or death from any cause, whichever occurs first, as determined by the investigator
time frame: Up to 3.5 years
measure: Complete response (CR) rate, defined as the proportion of patients whose best overall response is a CR on positron emission tomography/computed tomography (PET/CT) during the study, as determined by the IRC
time frame: Up to 3.5 years
measure: CR rate, defined as the proportion of patients whose best overall response is a CR on positron emission tomography/computed tomography (PET/CT) during the study, as determined by the investigator
time frame: Up to 3.5 years
measure: Objective response rate (ORR), defined as the proportion of patients whose best overall response is a partial response (PR) or a CR during the study, as determined by the IRC
time frame: Up to 3.5 years
measure: ORR, defined as the proportion of patients whose best overall response is a partial response (PR) or a CR during the study, as determined by the investigator
time frame: Up to 3.5 years
measure: Duration of objective response (DOR), defined as the time from the first occurrence of a documented objective response (CR or PR) to disease progression, or death from any cause, whichever occurs first
time frame: Up to 3.5 years
measure: Duration of CR, defined as the time from the first occurrence of a documented CR to disease progression, or death from any cause, whichever occurs first
time frame: Up to 3.5 years
measure: Time to deterioration in physical functioning and fatigue, as measured by the European Organisation for Research and Treatment of Cancer Quality of Life-Core 30 Questionnaire (EORTC QLQ-C30)
time frame: Up to 3.5 years
measure: Time to deterioration in lymphoma symptoms, as measured by the Functional Assessment of Cancer Therapy-Lymphoma subscale (FACT-Lym LymS)
time frame: Up to 3.5 years
measure: Percentage of Participants with Adverse Events
time frame: Up to 3.5 years
measure: Tolerability, as assessed by dose interruptions, dose reductions, and dose intensity, and study treatment discontinuation because of adverse events
time frame: Up to 3.5 years
arm group label: Glofit-GemOx
arm group type: Experimental
description: Participants will receive up to 8 cycles of glofitamab (Glofit) in combination with gemcitabine and oxaliplatin (GemOx), followed by up to 4 cycles of glofitamab monotherapy. A single dose of obinutuzumab will be administered 7 days prior to the first dose of glofitamab. Treatment is administered in 21-day cycles.
arm group label: R-GemOx
arm group type: Experimental
description: Participants will receive rituxumab (R) in combination with gemcitabine and oxaliplatin (GemOx) for up to 8 cycles. Treatment is administered in 21-day cycles.
intervention type: Drug
intervention name: Obinutuzumab
description: Participants will receive a single dose of intravenous (IV) obinutuzumab pre-treatment 7 days prior to the first dose of glofitamab.
arm group label: Glofit-GemOx
intervention type: Drug
intervention name: Glofitamab
description: Participants will receive IV glofitamab for up to 12 cycles.
arm group label: Glofit-GemOx
intervention type: Drug
intervention name: Rituxumab
description: Participants will receive IV rituxumab on Day 1 of each cycle for up to 8 cycles.
arm group label: R-GemOx
intervention type: Drug
intervention name: Tocilizumab
description: Participants will receive IV tocilizumab as needed for treatment of cytokine-release syndrome (CRS).
arm group label: Glofit-GemOx
intervention type: Drug
intervention name: Gemcitabine
description: Participants will receive IV gemcitabine prior to oxaliplatin administration for up to 8 cycles.
arm group label: Glofit-GemOx
arm group label: R-GemOx
intervention type: Drug
intervention name: Oxaliplatin
description: Participants will receive IV oxaliplatin after gemcitabine administration for up to 8 cycles.
arm group label: Glofit-GemOx
arm group label: R-GemOx
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Clinical Trials
role: Study Director
affiliation: Hoffmann-La Roche
last name: Reference Study ID Number: GO41944 https://forpatients.roche.com/
phone: 888-662-6728
email: global-roche-genentech-trials@gene.com
facility: 
status: Active, not recruiting
facility: 
status: Withdrawn
facility: 
status: Completed
facility: 
status: Active, not recruiting
facility: 
status: Completed
facility: 
status: Withdrawn
facility: 
status: Completed
facility: 
status: Active, not recruiting
facility: 
status: Active, not recruiting
facility: 
status: Active, not recruiting
facility: 
status: Completed
facility: 
status: Completed
facility: 
status: Active, not recruiting
facility: 
status: Withdrawn
facility: 
status: Withdrawn
facility: 
status: Active, not recruiting
facility: 
status: Active, not recruiting
facility: 
status: Active, not recruiting
facility: 
status: Active, not recruiting
facility: 
status: Active, not recruiting
facility: 
status: Active, not recruiting
facility: 
status: Withdrawn
facility: 
status: Active, not recruiting
facility: 
status: Active, not recruiting
facility: 
status: Withdrawn
facility: 
status: Active, not recruiting
facility: 
status: Withdrawn
facility: 
status: Active, not recruiting
facility: 
status: Active, not recruiting
facility: 
status: Withdrawn
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Active, not recruiting
facility: 
status: Recruiting
facility: 
status: Active, not recruiting
facility: 
status: Active, not recruiting
facility: 
status: Active, not recruiting
facility: 
status: Active, not recruiting
facility: 
status: Active, not recruiting
facility: 
status: Active, not recruiting
facility: 
status: Active, not recruiting
facility: 
status: Active, not recruiting
facility: 
status: Completed
facility: 
status: Withdrawn
facility: 
status: Recruiting
facility: 
status: Active, not recruiting
facility: 
status: Withdrawn
facility: 
status: Active, not recruiting
facility: 
status: Active, not recruiting
facility: 
status: Active, not recruiting
facility: 
status: Active, not recruiting
facility: 
status: Active, not recruiting
facility: 
status: Recruiting
facility: 
status: Active, not recruiting
facility: 
status: Active, not recruiting
facility: 
status: Active, not recruiting
facility: 
status: Active, not recruiting
facility: 
status: Active, not recruiting
facility: 
status: Withdrawn
facility: 
status: Active, not recruiting
facility: 
status: Active, not recruiting
facility: 
status: Active, not recruiting
facility: 
status: Completed
facility: 
status: Active, not recruiting
facility: 
status: Recruiting
facility: 
status: Active, not recruiting
facility: 
status: Completed
facility: 
status: Active, not recruiting
facility: 
status: Active, not recruiting
facility: 
status: Active, not recruiting
facility: 
status: Completed
facility: 
status: Completed
facility: 
status: Active, not recruiting
facility: 
status: Active, not recruiting
facility: 
status: Active, not recruiting
facility: 
status: Active, not recruiting
facility: 
status: Active, not recruiting
facility: 
status: Active, not recruiting
facility: 
status: Active, not recruiting
facility: 
status: Withdrawn
country: Australia
country: Belgium
country: China
country: Denmark
country: France
country: Germany
country: Korea, Republic of
country: Poland
country: Puerto Rico
country: Spain
country: Switzerland
country: Taiwan
country: United Kingdom
country: United States
responsible party type: Sponsor
mesh term: Lymphoma
mesh term: Lymphoma, B-Cell
mesh term: Lymphoma, Large B-Cell, Diffuse
mesh term: Gemcitabine
mesh term: Oxaliplatin
mesh term: Obinutuzumab
sharing ipd: Yes
ipd description: Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).