<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/NCT01729806</url>
  </required_header>
  <id_info>
    <org_study_id>NCI-2012-02213</org_study_id>
    <secondary_id>NCI-2012-02213</secondary_id>
    <secondary_id>PHI-69</secondary_id>
    <secondary_id>CDR0000743246</secondary_id>
    <secondary_id>NCI# 9197</secondary_id>
    <secondary_id>9197</secondary_id>
    <secondary_id>9197</secondary_id>
    <secondary_id>P30CA033572</secondary_id>
    <secondary_id>U01CA062505</secondary_id>
    <secondary_id>UM1CA186704</secondary_id>
    <secondary_id>UM1CA186717</secondary_id>
    <nct_id>NCT01729806</nct_id>
  </id_info>
  <brief_title>Ipilimumab and Rituximab in Treating Patients With Relapsed or Refractory B-cell Lymphoma</brief_title>
  <official_title>A Phase I Study of Ipilimumab in Combination With Rituximab in Patients With Relapsed/Refractory CD20+ B-Cell Lymphoma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Cancer Institute (NCI)</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This partially randomized phase I trial studies the side effects and best dose of ipilimumab&#xD;
      when given together with rituximab in treating patients with B-cell lymphoma that has&#xD;
      returned or has not responded to treatment. Monoclonal antibodies, such as ipilimumab and&#xD;
      rituximab, may interfere with the ability of cancer cells to grow and spread.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PRIMARY OBJECTIVES:&#xD;
&#xD;
      I. To determine a recommended phase II dose for ipilimumab in combination with rituximab.&#xD;
&#xD;
      SECONDARY OBJECTIVES:&#xD;
&#xD;
      I. To obtain preliminary information on the effect of adding ipilimumab to rituximab in&#xD;
      regard to: immune response; clinical anti-tumor response/overall remission rate (ORR)&#xD;
      (complete remission + partial remission); progression free survival (PFS).&#xD;
&#xD;
      OUTLINE: This is a dose-escalation study of ipilimumab followed by a randomized study.&#xD;
&#xD;
      PART I:&#xD;
&#xD;
      INDUCTION: Patients receive ipilimumab intravenously (IV) over 90 minutes once every 3 weeks&#xD;
      for 12 weeks and rituximab IV over 2-6 hours once weekly for 4 weeks.&#xD;
&#xD;
      MAINTENANCE: Patients receive ipilimumab IV over 90 minutes and rituximab IV over 2-6 hours&#xD;
      once every 12 weeks for up to 1 year.&#xD;
&#xD;
      PART II: Patients are randomized to 1 of 2 treatment arms.&#xD;
&#xD;
      ARM A: Patients receive rituximab IV over 2-6 hours once weekly in weeks 1-4 and ipilimumab&#xD;
      IV over 90 minutes once weekly in weeks 1, 4, 7, and 10. Patients then receive ipilimumab IV&#xD;
      over 90 minutes and rituximab IV over 2-6 hours once every 12 weeks for up to 1 year in the&#xD;
      absence of disease progression or unacceptable toxicity.&#xD;
&#xD;
      ARM B: Patients receive rituximab IV over 2-6 hours once weekly in weeks 1-4 and ipilimumab&#xD;
      IV over 90 minutes once weekly in weeks 3, 6, 9, and 12. Patients then receive ipilimumab IV&#xD;
      over 90 minutes and rituximab IV over 2-6 hours once every 12 weeks for up to 1 year in the&#xD;
      absence of disease progression or unacceptable toxicity.&#xD;
&#xD;
      After completion of study treatment, patients are followed up for 12 months.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 19, 2012</start_date>
  <completion_date type="Actual">March 30, 2018</completion_date>
  <primary_completion_date type="Actual">March 30, 2018</primary_completion_date>
  <phase>Phase 1</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>Incidence of toxicities according to the Common Terminology Criteria for Adverse Events version 4</measure>
    <time_frame>Up to 12 months</time_frame>
    <description>Tables will be created to summarize the toxicities and side effects by dose, course, organ and severity.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Immune response as measured by the frequency of activated T-cells, absolute lymphocyte count, antibody dependent cell-mediated cytotoxicity, and kinetics and magnitude of B-cell depletion</measure>
    <time_frame>Up to 14 weeks</time_frame>
    <description>Regression methods (adapted for repeated measures) will be used to describe the changes over time. In addition to summarizing the changes over time within each arm, these regression models will contain contrasts to compare the two arms in terms of changes.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical anti-tumor response (complete response and partial response as per international workshop lymphoma response criteria [Cheson 2007])</measure>
    <time_frame>Up to 12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression-free survival</measure>
    <time_frame>From when the patient started treatment to the time the patient is first recorded as having disease relapse/progression, or to the date of death if the patient dies due to causes other than disease progression, assessed up to 12 months</time_frame>
    <description>Progression-free survival will be summarized using Kaplan-Meier plots.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">32</enrollment>
  <condition>CD20 Positive</condition>
  <condition>Recurrent B-Cell Non-Hodgkin Lymphoma</condition>
  <condition>Refractory B-Cell Non-Hodgkin Lymphoma</condition>
  <arm_group>
    <arm_group_label>Arm A (ipilimumab and rituximab)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients receive rituximab IV over 2-6 hours once weekly in weeks 1-4 and ipilimumab IV over 90 minutes once weekly in weeks 1, 4, 7, and 10. Patients then receive ipilimumab IV over 90 minutes and rituximab IV over 2-6 hours once every 12 weeks for up to 1 year in the absence of disease progression or unacceptable toxicity.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm B (ipilimumab and rituximab)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients receive rituximab IV over 2-6 hours once weekly in weeks 1-4 and ipilimumab IV over 90 minutes once weekly in weeks 3, 6, 9, and 12. Patients then receive ipilimumab IV over 90 minutes and rituximab IV over 2-6 hours once every 12 weeks for up to 1 year in the absence of disease progression or unacceptable toxicity.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Ipilimumab</intervention_name>
    <description>Given IV</description>
    <arm_group_label>Arm A (ipilimumab and rituximab)</arm_group_label>
    <arm_group_label>Arm B (ipilimumab and rituximab)</arm_group_label>
    <other_name>Anti-Cytotoxic T-Lymphocyte-Associated Antigen-4 Monoclonal Antibody</other_name>
    <other_name>BMS-734016</other_name>
    <other_name>MDX-010</other_name>
    <other_name>MDX-CTLA4</other_name>
    <other_name>Yervoy</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Laboratory Biomarker Analysis</intervention_name>
    <description>Correlative studies</description>
    <arm_group_label>Arm A (ipilimumab and rituximab)</arm_group_label>
    <arm_group_label>Arm B (ipilimumab and rituximab)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Rituximab</intervention_name>
    <description>Given IV</description>
    <arm_group_label>Arm A (ipilimumab and rituximab)</arm_group_label>
    <arm_group_label>Arm B (ipilimumab and rituximab)</arm_group_label>
    <other_name>ABP 798</other_name>
    <other_name>BI 695500</other_name>
    <other_name>C2B8 Monoclonal Antibody</other_name>
    <other_name>Chimeric Anti-CD20 Antibody</other_name>
    <other_name>CT-P10</other_name>
    <other_name>IDEC-102</other_name>
    <other_name>IDEC-C2B8</other_name>
    <other_name>IDEC-C2B8 Monoclonal Antibody</other_name>
    <other_name>MabThera</other_name>
    <other_name>Monoclonal Antibody IDEC-C2B8</other_name>
    <other_name>PF-05280586</other_name>
    <other_name>Rituxan</other_name>
    <other_name>Rituximab Biosimilar ABP 798</other_name>
    <other_name>Rituximab Biosimilar BI 695500</other_name>
    <other_name>Rituximab Biosimilar CT-P10</other_name>
    <other_name>Rituximab Biosimilar GB241</other_name>
    <other_name>Rituximab Biosimilar IBI301</other_name>
    <other_name>Rituximab Biosimilar PF-05280586</other_name>
    <other_name>Rituximab Biosimilar RTXM83</other_name>
    <other_name>Rituximab Biosimilar SAIT101</other_name>
    <other_name>RTXM83</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Previously treated, histologically confirmed cluster of differentiation (CD)20+ B cell&#xD;
             lymphoma; bone marrow biopsies as the sole means of diagnosis are not acceptable, but&#xD;
             they may be submitted in conjunction with nodal biopsies or extra nodal biopsies; fine&#xD;
             needle aspirates are not acceptable&#xD;
&#xD;
          -  All patients must be informed of the investigative nature of the clinical trial and&#xD;
             give written informed consent in accordance with institutional and federal guidelines&#xD;
&#xD;
          -  Able to adhere to the study visit schedule and other protocol requirements&#xD;
&#xD;
          -  Karnofsky &gt;= 70%&#xD;
&#xD;
          -  Life expectancy expected to be greater than 3 months&#xD;
&#xD;
          -  Leukocytes &gt;= 3,000/mcL&#xD;
&#xD;
          -  Absolute neutrophil count &gt;= 1,000/mcL&#xD;
&#xD;
          -  Platelets &gt;= 50,000/mcL&#xD;
&#xD;
          -  Total bilirubin =&lt; 2.0 x institutional upper limit of normal&#xD;
&#xD;
          -  Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase&#xD;
             [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT])&#xD;
             =&lt; 2.5 x institutional upper limit of normal&#xD;
&#xD;
          -  Serum creatinine =&lt; 2.0 x upper limit of normal OR calculated creatinine clearance &gt;=&#xD;
             30 ml/min/1.73 M^2 by the modified Cockcroft and Gault formula OR creatinine clearance&#xD;
             &gt;= 30 mL/min obtained from a 24-hour urine collection&#xD;
&#xD;
          -  At least one measurable lesion according to international workshop lymphoma response&#xD;
             criteria; there must be measurable lymphadenopathy to follow with serial exam and/or&#xD;
             imaging&#xD;
&#xD;
          -  All previous cancer therapy, including radiation, hormonal therapy and surgery, must&#xD;
             have been discontinued at least 4 weeks prior to treatment in this study&#xD;
&#xD;
          -  Patients must have evidence of progression of disease during or after last treatment&#xD;
&#xD;
          -  Submission of original biopsy for review and verification by participating center&#xD;
             hematopathologist&#xD;
&#xD;
          -  Disease free of prior malignancies for &gt;= 3 years with exception of currently treated&#xD;
             basal cell, squamous cell carcinoma of the skin, or carcinoma &quot;in situ&quot; of the cervix&#xD;
             or breast&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for&#xD;
             nitrosoureas or mitomycin C) prior to entering the study or those who have not&#xD;
             recovered from adverse events due to agents administered more than 4 weeks earlier&#xD;
&#xD;
          -  Patients with a history of prior treatment with ipilimumab&#xD;
&#xD;
          -  Patients with a history of prior treatment with an anti-programmed cell death (PD) 1&#xD;
             antibody, CD137 agonist or other immune activating therapy such as anti-CD 40 antibody&#xD;
             are excluded unless 5 half-lives of the agent (minimum of 8 weeks) have intervened&#xD;
             since the therapy; patients who have received prior vaccine therapy are eligible&#xD;
&#xD;
          -  Patients who are receiving any other investigational agents&#xD;
&#xD;
          -  Autoimmune disease: patients with a history of inflammatory bowel disease, including&#xD;
             ulcerative colitis and Crohn's disease, are excluded from this study, as are patients&#xD;
             with a history of symptomatic disease (e.g., rheumatoid arthritis, systemic&#xD;
             progressive sclerosis [scleroderma], systemic lupus erythematosus, autoimmune&#xD;
             vasculitis [e.g., Wegener's granulomatosis]); central nervous system (CNS) or motor&#xD;
             neuropathy considered of autoimmune origin (e.g. Guillain-Barre syndrome and&#xD;
             myasthenia gravis, multiple sclerosis)&#xD;
&#xD;
          -  Patients with known immune impairment who may be unable to respond to anti-cytotoxic&#xD;
             T-lymphocyte antigen 4 (CTLA 4) antibody&#xD;
&#xD;
          -  Patients with known uncontrolled brain metastases are excluded; however, patients with&#xD;
             stable brain disease (off corticosteroids) at least 2 weeks after completion of&#xD;
             appropriate therapy for their brain metastases are eligible&#xD;
&#xD;
          -  History of allergic reactions attributed to compounds of similar chemical or biologic&#xD;
             composition to rituximab&#xD;
&#xD;
          -  Patients on systemic corticosteroids (except for patients on stable doses of hormone&#xD;
             replacement therapy such as hydrocortisone), or other immunosuppressants (e.g.,&#xD;
             infliximab, mycophenolate mofetil) are excluded&#xD;
&#xD;
          -  Uncontrolled intercurrent illness including, but not limited to, ongoing or active&#xD;
             infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac&#xD;
             arrhythmia, or psychiatric illness/social situations that would limit compliance with&#xD;
             study requirements&#xD;
&#xD;
          -  Patients with chronic human immunodeficiency virus (HIV), hepatitis B or hepatitis C&#xD;
             infections are excluded&#xD;
&#xD;
          -  Pregnant women are excluded from this study&#xD;
&#xD;
          -  HIV-positive patients on combination antiretroviral therapy are ineligible&#xD;
&#xD;
          -  Rituximab within six weeks&#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>Joseph Tuscano</last_name>
    <role>Principal Investigator</role>
    <affiliation>City of Hope Comprehensive Cancer Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>City of Hope Comprehensive Cancer Center</name>
      <address>
        <city>Duarte</city>
        <state>California</state>
        <zip>91010</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>USC / Norris Comprehensive Cancer Center</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90033</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of California Davis Comprehensive Cancer Center</name>
      <address>
        <city>Sacramento</city>
        <state>California</state>
        <zip>95817</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>City of Hope South Pasadena</name>
      <address>
        <city>South Pasadena</city>
        <state>California</state>
        <zip>91030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Washington University School of Medicine</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63110</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Duke University Medical Center</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27710</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Penn State Milton S Hershey Medical Center</name>
      <address>
        <city>Hershey</city>
        <state>Pennsylvania</state>
        <zip>17033-0850</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2018</verification_date>
  <study_first_submitted>November 14, 2012</study_first_submitted>
  <study_first_submitted_qc>November 14, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 20, 2012</study_first_posted>
  <last_update_submitted>April 10, 2018</last_update_submitted>
  <last_update_submitted_qc>April 10, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">April 11, 2018</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, Non-Hodgkin</mesh_term>
    <mesh_term>Lymphoma, B-Cell</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Rituximab</mesh_term>
    <mesh_term>Antineoplastic Agents, Immunological</mesh_term>
    <mesh_term>Ipilimumab</mesh_term>
    <mesh_term>Antibodies</mesh_term>
    <mesh_term>Immunoglobulins</mesh_term>
    <mesh_term>Antibodies, Monoclonal</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/NCT01729806
org study id: NCI-2012-02213
secondary id: NCI-2012-02213
secondary id: PHI-69
secondary id: CDR0000743246
secondary id: NCI# 9197
secondary id: 9197
secondary id: 9197
secondary id: P30CA033572
secondary id: U01CA062505
secondary id: UM1CA186704
secondary id: UM1CA186717
nct id: NCT01729806
lead sponsor: 
has dmc: No
This partially randomized phase I trial studies the side effects and best dose of ipilimumab
      when given together with rituximab in treating patients with B-cell lymphoma that has
      returned or has not responded to treatment. Monoclonal antibodies, such as ipilimumab and
      rituximab, may interfere with the ability of cancer cells to grow and spread.
PRIMARY OBJECTIVES:

      I. To determine a recommended phase II dose for ipilimumab in combination with rituximab.

      SECONDARY OBJECTIVES:

      I. To obtain preliminary information on the effect of adding ipilimumab to rituximab in
      regard to: immune response; clinical anti-tumor response/overall remission rate (ORR)
      (complete remission + partial remission); progression free survival (PFS).

      OUTLINE: This is a dose-escalation study of ipilimumab followed by a randomized study.

      PART I:

      INDUCTION: Patients receive ipilimumab intravenously (IV) over 90 minutes once every 3 weeks
      for 12 weeks and rituximab IV over 2-6 hours once weekly for 4 weeks.

      MAINTENANCE: Patients receive ipilimumab IV over 90 minutes and rituximab IV over 2-6 hours
      once every 12 weeks for up to 1 year.

      PART II: Patients are randomized to 1 of 2 treatment arms.

      ARM A: Patients receive rituximab IV over 2-6 hours once weekly in weeks 1-4 and ipilimumab
      IV over 90 minutes once weekly in weeks 1, 4, 7, and 10. Patients then receive ipilimumab IV
      over 90 minutes and rituximab IV over 2-6 hours once every 12 weeks for up to 1 year in the
      absence of disease progression or unacceptable toxicity.

      ARM B: Patients receive rituximab IV over 2-6 hours once weekly in weeks 1-4 and ipilimumab
      IV over 90 minutes once weekly in weeks 3, 6, 9, and 12. Patients then receive ipilimumab IV
      over 90 minutes and rituximab IV over 2-6 hours once every 12 weeks for up to 1 year in the
      absence of disease progression or unacceptable toxicity.

      After completion of study treatment, patients are followed up for 12 months.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Incidence of toxicities according to the Common Terminology Criteria for Adverse Events version 4
time frame: Up to 12 months
description: Tables will be created to summarize the toxicities and side effects by dose, course, organ and severity.
measure: Immune response as measured by the frequency of activated T-cells, absolute lymphocyte count, antibody dependent cell-mediated cytotoxicity, and kinetics and magnitude of B-cell depletion
time frame: Up to 14 weeks
description: Regression methods (adapted for repeated measures) will be used to describe the changes over time. In addition to summarizing the changes over time within each arm, these regression models will contain contrasts to compare the two arms in terms of changes.
measure: Clinical anti-tumor response (complete response and partial response as per international workshop lymphoma response criteria [Cheson 2007])
time frame: Up to 12 months
measure: Progression-free survival
time frame: From when the patient started treatment to the time the patient is first recorded as having disease relapse/progression, or to the date of death if the patient dies due to causes other than disease progression, assessed up to 12 months
description: Progression-free survival will be summarized using Kaplan-Meier plots.
arm group label: Arm A (ipilimumab and rituximab)
arm group type: Experimental
description: Patients receive rituximab IV over 2-6 hours once weekly in weeks 1-4 and ipilimumab IV over 90 minutes once weekly in weeks 1, 4, 7, and 10. Patients then receive ipilimumab IV over 90 minutes and rituximab IV over 2-6 hours once every 12 weeks for up to 1 year in the absence of disease progression or unacceptable toxicity.
arm group label: Arm B (ipilimumab and rituximab)
arm group type: Experimental
description: Patients receive rituximab IV over 2-6 hours once weekly in weeks 1-4 and ipilimumab IV over 90 minutes once weekly in weeks 3, 6, 9, and 12. Patients then receive ipilimumab IV over 90 minutes and rituximab IV over 2-6 hours once every 12 weeks for up to 1 year in the absence of disease progression or unacceptable toxicity.
intervention type: Biological
intervention name: Ipilimumab
description: Given IV
arm group label: Arm A (ipilimumab and rituximab)
arm group label: Arm B (ipilimumab and rituximab)
other name: Anti-Cytotoxic T-Lymphocyte-Associated Antigen-4 Monoclonal Antibody
other name: BMS-734016
other name: MDX-010
other name: MDX-CTLA4
other name: Yervoy
intervention type: Other
intervention name: Laboratory Biomarker Analysis
description: Correlative studies
arm group label: Arm A (ipilimumab and rituximab)
arm group label: Arm B (ipilimumab and rituximab)
intervention type: Biological
intervention name: Rituximab
description: Given IV
arm group label: Arm A (ipilimumab and rituximab)
arm group label: Arm B (ipilimumab and rituximab)
other name: ABP 798
other name: BI 695500
other name: C2B8 Monoclonal Antibody
other name: Chimeric Anti-CD20 Antibody
other name: CT-P10
other name: IDEC-102
other name: IDEC-C2B8
other name: IDEC-C2B8 Monoclonal Antibody
other name: MabThera
other name: Monoclonal Antibody IDEC-C2B8
other name: PF-05280586
other name: Rituxan
other name: Rituximab Biosimilar ABP 798
other name: Rituximab Biosimilar BI 695500
other name: Rituximab Biosimilar CT-P10
other name: Rituximab Biosimilar GB241
other name: Rituximab Biosimilar IBI301
other name: Rituximab Biosimilar PF-05280586
other name: Rituximab Biosimilar RTXM83
other name: Rituximab Biosimilar SAIT101
other name: RTXM83
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Joseph Tuscano
role: Principal Investigator
affiliation: City of Hope Comprehensive Cancer Center
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Lymphoma
mesh term: Lymphoma, Non-Hodgkin
mesh term: Lymphoma, B-Cell
mesh term: Rituximab
mesh term: Antineoplastic Agents, Immunological
mesh term: Ipilimumab
mesh term: Antibodies
mesh term: Immunoglobulins
mesh term: Antibodies, Monoclonal