<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/NCT04458610</url>
  </required_header>
  <id_info>
    <org_study_id>2019-0012</org_study_id>
    <secondary_id>NCI-2020-05053</secondary_id>
    <secondary_id>2019-0012</secondary_id>
    <nct_id>NCT04458610</nct_id>
  </id_info>
  <brief_title>Zanubrutinib and Rituximab for the Treatment of Previously Untreated Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma</brief_title>
  <official_title>BTK Inhibitor Zanubrutinib (BGB-3111) in Combination With Rituximab for Previously Untreated Patients With Chronic Lymphocytic Leukemia (CLL)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>M.D. Anderson Cancer Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>M.D. Anderson Cancer Center</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 phase II trial studies how well zanubrutinib and rituximab work in treating patients&#xD;
      with chronic lymphocytic leukemia or small lymphocytic lymphoma for which the patient has not&#xD;
      received treatment in the past (previously untreated). Zanubrutinib may stop the growth of&#xD;
      cancer cells by blocking some of the enzymes needed for cell growth. Rituximab is a&#xD;
      monoclonal antibody that may interfere with the ability of cancer cells to grow and spread.&#xD;
      The study is being done to find out if zanubrutinib combined with rituximab can help control&#xD;
      previously untreated chronic lymphocytic leukemia or small lymphocytic lymphoma.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PRIMARY OBJECTIVE:&#xD;
&#xD;
      I. To determine the proportion of patients who have treatment-free remission 6 months after&#xD;
      discontinuation of zanubrutinib.&#xD;
&#xD;
      SECONDARY OBJECTIVES:&#xD;
&#xD;
      I. To determine clinical factors associated with a treatment-free remission of more than 6&#xD;
      months after discontinuation of zanubrutinib.&#xD;
&#xD;
      II. To determine the treatment-free remission length. III. To evaluate the efficacy of&#xD;
      re-treatment with zanubrutinib plus rituximab in patients who relapse.&#xD;
&#xD;
      OUTLINE:&#xD;
&#xD;
      FRONTLINE THERAPY: Patients receive zanubrutinib orally (PO) twice daily (BID) on days 1-28.&#xD;
      Patients also receive rituximab intravenously (IV) over 3-4 hours on days 1, 8, 15, and 22 of&#xD;
      cycle 1 and on day 1 of subsequent cycles. Treatment repeats every 28 days for up to 6 cycles&#xD;
      in the absence of disease progression or unacceptable toxicity. Beginning cycle 7, patients&#xD;
      with complete response (CR) continue zanubrutinib PO BID on days 1-28 for up to 6 additional&#xD;
      cycles in the absence of disease progression or unacceptable toxicity. Beginning cycle 7,&#xD;
      patients with partial response (PR) or stable disease (SD) continue zanubrutinib PO BID on&#xD;
      days 1-28 and rituximab IV over 3-4 hours on day 1 for up to 6 additional cycles in the&#xD;
      absence of disease progression or unacceptable toxicity. Beginning cycle 13, patients with CR&#xD;
      continue zanubrutinib PO BID on days 1-28 for up to 6 additional cycles in the absence of&#xD;
      disease progression or unacceptable toxicity. Beginning cycle 13, patients with PR or SD&#xD;
      continue zanubrutinib PO BID on days 1-28 for up to 12 additional cycles in the absence of&#xD;
      disease progression or unacceptable toxicity. Patients who do not have a PR after 24 cycles&#xD;
      either continue zanubrutinib if there is a clinical benefit, or pursue alternative therapy&#xD;
      per treating physician discretion.&#xD;
&#xD;
      RE-TREATMENT FOR RELAPSED DISEASE: Patients with disease relapse and active disease that&#xD;
      requires salvage therapy may restart zanubrutinib PO BID on days 1-28 and rituximab IV over&#xD;
      3-4 hours on day 1. Treatment repeats every 28 days for up to 6 cycles in the absence of&#xD;
      disease progression or unacceptable toxicity. Beginning cycle 7, patients continue&#xD;
      zanubrutinib PO BID on days 1-28 for up to 18 additional cycles in the absence of disease&#xD;
      progression or unacceptable toxicity and then discontinue if in CR. Beginning cycle 25,&#xD;
      patients with PR or SD may continue zanubrutinib PO BID on days 1-28 for up to 36 additional&#xD;
      cycles in the absence of disease progression or unacceptable toxicity.&#xD;
&#xD;
      After completion of study treatment, patients are followed up at 60 days, and then every 120&#xD;
      days for up to 5 years or until disease progression or start of a new treatment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">May 26, 2020</start_date>
  <completion_date type="Anticipated">May 26, 2024</completion_date>
  <primary_completion_date type="Anticipated">May 26, 2024</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <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>Success rate</measure>
    <time_frame>At 6 months after discontinuation of zanubrutinib</time_frame>
    <description>Will estimate the proportion of patients who have treatment-free remission 6 months after discontinuation of zanubrutinib. Success rate will be estimated with 95% credible interval and confidence interval.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Clinical factors associated with a treatment-free remission of more than 6 months after discontinuation of zanubrutinib</measure>
    <time_frame>Up to 5 years after discontinuation of zanubrutinib</time_frame>
    <description>To assess the contribution of various factors to relapse risk, will use Cox's proportional hazards analysis of predictors that have a p value &lt; 0.2 in the univariate analysis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Treatment-free remission length</measure>
    <time_frame>Up to 5 years after discontinuation of zanubrutinib</time_frame>
    <description>The median treatment-free remission duration will be calculated by Kaplan-Meier analysis, and stratified groups will be compared with the log-rank test.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall response</measure>
    <time_frame>After 6 cycles of treatment (each cycle is 28 days)</time_frame>
    <description>Defined as complete response or partial response after patients received 6 cycles of treatments.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma</condition>
  <arm_group>
    <arm_group_label>Treatment (zanubrutinib, rituximab)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>See Detailed Description.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Rituximab</intervention_name>
    <description>Given IV</description>
    <arm_group_label>Treatment (zanubrutinib, 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 ABBS</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 JHL1101</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>rituximab biosimilar TQB2303</other_name>
    <other_name>rituximab-abbs</other_name>
    <other_name>RTXM83</other_name>
    <other_name>Truxima</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Zanubrutinib</intervention_name>
    <description>Given PO</description>
    <arm_group_label>Treatment (zanubrutinib, rituximab)</arm_group_label>
    <other_name>BGB-3111</other_name>
    <other_name>Brukinsa</other_name>
    <other_name>BTK-InhB</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients must have a diagnosis chronic lymphocytic leukemia (CLL)/small lymphocytic&#xD;
             lymphoma (SLL) and be previously untreated&#xD;
&#xD;
          -  Patients must have an indication for treatment by 2018 International Workshop on&#xD;
             Chronic Lymphocytic Leukemia (IWCLL) Criteria&#xD;
&#xD;
          -  Patients must understand and voluntarily sign an informed consent, and be able to&#xD;
             comply with study procedures and follow-up examinations&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0-2&#xD;
&#xD;
          -  Patients of childbearing potential must be willing to practice highly effective birth&#xD;
             control (e.g., condoms, implants, injectables, combined oral contraceptives,&#xD;
             intrauterine devices [IUDs], sexual abstinence, or sterilized partner) during the&#xD;
             study and for 30 days after the last dose of study drug. Women of childbearing&#xD;
             potential include any female who has experienced menarche and who has not undergone&#xD;
             successful surgical sterilization (hysterectomy, bilateral tubal ligation, or&#xD;
             bilateral oophorectomy) or is not postmenopausal&#xD;
&#xD;
          -  Total bilirubin =&lt; 1.5 x institutional upper limit of normal (ULN) except for patients&#xD;
             with bilirubin elevation due to Gilbert's disease who will be allowed to participate&#xD;
&#xD;
          -  An alanine aminotransferase (ALT) =&lt; 2.5 x ULN&#xD;
&#xD;
          -  An estimated creatinine clearance (CrCl) of &gt; 30 mL/min, as calculated by the&#xD;
             Cockcroft-Gault equation unless disease related&#xD;
&#xD;
          -  Free of prior malignancies for 3 years with exception of currently treated basal cell&#xD;
             or squamous cell carcinoma of the skin, or carcinoma &quot;in situ&quot; of the cervix or&#xD;
             breast. If patients have another malignancy that was treated within the last 3 years,&#xD;
             such patients can be enrolled, after consultation with the principal investigator, if&#xD;
             the likelihood of requiring systemic therapy for this other malignancy within 2 years&#xD;
             is less than 10%, as determined by an expert in that particular malignancy&#xD;
&#xD;
          -  A urine pregnancy test (within 7 days of day 1) is required for women with&#xD;
             childbearing potential&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant or breast-feeding females&#xD;
&#xD;
          -  Prior therapy with zanubrutinib or other kinase inhibitors that target BCR signaling&#xD;
             (such as ibrutinib, idelalisib)&#xD;
&#xD;
          -  Prior CLL-directed treatment including chemotherapy, chemo-immunotherapy, monoclonal&#xD;
             antibody therapy, radiotherapy, high-dose corticosteroid therapy (more than 60 mg&#xD;
             prednisone daily or equivalent), or immunotherapy within 21 days prior to enrollment&#xD;
             or concurrent with this trial. Patients that receive zanubrutinib salvage therapy&#xD;
             cannot have received any other CLL-directed therapy besides frontline zanubrutinib&#xD;
             plus rituximab&#xD;
&#xD;
          -  Investigational agent received within 30 days prior to the first dose of study drug.&#xD;
             If received any investigational agent prior to this time point, drug-related&#xD;
             toxicities must have recovered to grade 1 or less prior to first dose of study drug&#xD;
&#xD;
          -  Systemic fungal, bacterial, viral, or other infection not controlled by antimicrobial&#xD;
             therapy, in the assessment of the treating physician(s) and/or the principal&#xD;
             investigator&#xD;
&#xD;
          -  Patients with uncontrolled autoimmune hemolytic anemia (AIHA) or autoimmune&#xD;
             thrombocytopenia (ITP), i.e. with laboratory signs of active hemolysis or&#xD;
             thrombocytopenia, requiring support with blood products and/or with rapid decline in&#xD;
             hemoglobin (&gt; 1 gram/dL per day) or platelet counts (&gt; 10,000/uL per day)&#xD;
&#xD;
          -  Patients with severe hematopoietic insufficiency, as defined by an absolute neutrophil&#xD;
             count of less than 500/uL, unless disease-related, and/or a platelet count of less&#xD;
             than 30,000/uL at time of screening for this protocol&#xD;
&#xD;
          -  Any other severe concurrent disease, or have a history of serious organ dysfunction or&#xD;
             disease involving the heart, kidney, liver or other organ system that may place the&#xD;
             patient at undue risk to undergo therapy with zanubrutinib and rituximab&#xD;
&#xD;
          -  Significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias,&#xD;
             congestive heart failure, or myocardial infarction within 6 months of screening, or&#xD;
             any class 3 or 4 cardiac disease as defined by the New York Heart Association&#xD;
             Functional Classification. Patients with a history of paroxysmal atrial fibrillation&#xD;
             (PAF) or deep vein thrombosis or pulmonary embolism (DVT/PE) can be included if they&#xD;
             had no signs of PAF or DVT/PE in the last 6 months before enrolment. Patients with&#xD;
             ongoing atrial fibrillation (AFib) or ongoing PAF or DVT/PE should be excluded&#xD;
&#xD;
          -  History of stroke or cerebral hemorrhage within 6 months&#xD;
&#xD;
          -  Evidence of bleeding diathesis or coagulopathy within 3 months&#xD;
&#xD;
          -  Major surgical procedure, open biopsy, or significant traumatic injury within 28 days&#xD;
             prior to day 1, anticipation of need for major surgical procedure during the course of&#xD;
             the study&#xD;
&#xD;
          -  Minor surgical procedures, fine needle aspirations or core biopsies within 7 days&#xD;
             prior to day 1. Bone marrow aspiration and/or biopsy are allowed&#xD;
&#xD;
          -  Serious, non-healing wound, ulcer, or bone fracture&#xD;
&#xD;
          -  Treatment with warfarin (Coumadin) or any other vitamin K antagonist. Patients who&#xD;
             recently received warfarin must be off warfarin for at least 7 days prior to start of&#xD;
             the study. Patients receiving novel oral anticoagulant (NOAC), also termed direct oral&#xD;
             anticoagulant (DOAC) are permitted to enroll. Patients who are currently on a vitamin&#xD;
             K antagonist must be switched to a non-vitamin K antagonist, such as a NOAC/DOAC&#xD;
&#xD;
          -  Patients with active hepatitis B (hepatitis B virus [HBV]) or hepatitis C&#xD;
&#xD;
          -  Patients with known human immunodeficiency virus (HIV) infection&#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>Jan A Burger</last_name>
    <role>Principal Investigator</role>
    <affiliation>M.D. Anderson Cancer Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>M D Anderson Cancer Center</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jan A. Burger</last_name>
      <phone>713-563-1487</phone>
      <email>jaburger@mdanderson.org</email>
    </contact>
    <investigator>
      <last_name>Jan A. Burger</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.mdanderson.org</url>
    <description>MD Anderson Cancer Center</description>
  </link>
  <verification_date>September 2023</verification_date>
  <study_first_submitted>July 2, 2020</study_first_submitted>
  <study_first_submitted_qc>July 2, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 7, 2020</study_first_posted>
  <last_update_submitted>September 14, 2023</last_update_submitted>
  <last_update_submitted_qc>September 14, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">September 15, 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>Leukemia</mesh_term>
    <mesh_term>Leukemia, Lymphoid</mesh_term>
    <mesh_term>Leukemia, Lymphocytic, Chronic, 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>Zanubrutinib</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/NCT04458610
org study id: 2019-0012
secondary id: NCI-2020-05053
secondary id: 2019-0012
nct id: NCT04458610
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
This phase II trial studies how well zanubrutinib and rituximab work in treating patients
      with chronic lymphocytic leukemia or small lymphocytic lymphoma for which the patient has not
      received treatment in the past (previously untreated). Zanubrutinib may stop the growth of
      cancer cells by blocking some of the enzymes needed for cell growth. Rituximab is a
      monoclonal antibody that may interfere with the ability of cancer cells to grow and spread.
      The study is being done to find out if zanubrutinib combined with rituximab can help control
      previously untreated chronic lymphocytic leukemia or small lymphocytic lymphoma.
PRIMARY OBJECTIVE:

      I. To determine the proportion of patients who have treatment-free remission 6 months after
      discontinuation of zanubrutinib.

      SECONDARY OBJECTIVES:

      I. To determine clinical factors associated with a treatment-free remission of more than 6
      months after discontinuation of zanubrutinib.

      II. To determine the treatment-free remission length. III. To evaluate the efficacy of
      re-treatment with zanubrutinib plus rituximab in patients who relapse.

      OUTLINE:

      FRONTLINE THERAPY: Patients receive zanubrutinib orally (PO) twice daily (BID) on days 1-28.
      Patients also receive rituximab intravenously (IV) over 3-4 hours on days 1, 8, 15, and 22 of
      cycle 1 and on day 1 of subsequent cycles. Treatment repeats every 28 days for up to 6 cycles
      in the absence of disease progression or unacceptable toxicity. Beginning cycle 7, patients
      with complete response (CR) continue zanubrutinib PO BID on days 1-28 for up to 6 additional
      cycles in the absence of disease progression or unacceptable toxicity. Beginning cycle 7,
      patients with partial response (PR) or stable disease (SD) continue zanubrutinib PO BID on
      days 1-28 and rituximab IV over 3-4 hours on day 1 for up to 6 additional cycles in the
      absence of disease progression or unacceptable toxicity. Beginning cycle 13, patients with CR
      continue zanubrutinib PO BID on days 1-28 for up to 6 additional cycles in the absence of
      disease progression or unacceptable toxicity. Beginning cycle 13, patients with PR or SD
      continue zanubrutinib PO BID on days 1-28 for up to 12 additional cycles in the absence of
      disease progression or unacceptable toxicity. Patients who do not have a PR after 24 cycles
      either continue zanubrutinib if there is a clinical benefit, or pursue alternative therapy
      per treating physician discretion.

      RE-TREATMENT FOR RELAPSED DISEASE: Patients with disease relapse and active disease that
      requires salvage therapy may restart zanubrutinib PO BID on days 1-28 and rituximab IV over
      3-4 hours on day 1. Treatment repeats every 28 days for up to 6 cycles in the absence of
      disease progression or unacceptable toxicity. Beginning cycle 7, patients continue
      zanubrutinib PO BID on days 1-28 for up to 18 additional cycles in the absence of disease
      progression or unacceptable toxicity and then discontinue if in CR. Beginning cycle 25,
      patients with PR or SD may continue zanubrutinib PO BID on days 1-28 for up to 36 additional
      cycles in the absence of disease progression or unacceptable toxicity.

      After completion of study treatment, patients are followed up at 60 days, and then every 120
      days for up to 5 years or until disease progression or start of a new treatment.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Success rate
time frame: At 6 months after discontinuation of zanubrutinib
description: Will estimate the proportion of patients who have treatment-free remission 6 months after discontinuation of zanubrutinib. Success rate will be estimated with 95% credible interval and confidence interval.
measure: Clinical factors associated with a treatment-free remission of more than 6 months after discontinuation of zanubrutinib
time frame: Up to 5 years after discontinuation of zanubrutinib
description: To assess the contribution of various factors to relapse risk, will use Cox's proportional hazards analysis of predictors that have a p value < 0.2 in the univariate analysis.
measure: Treatment-free remission length
time frame: Up to 5 years after discontinuation of zanubrutinib
description: The median treatment-free remission duration will be calculated by Kaplan-Meier analysis, and stratified groups will be compared with the log-rank test.
measure: Overall response
time frame: After 6 cycles of treatment (each cycle is 28 days)
description: Defined as complete response or partial response after patients received 6 cycles of treatments.
arm group label: Treatment (zanubrutinib, rituximab)
arm group type: Experimental
description: See Detailed Description.
intervention type: Biological
intervention name: Rituximab
description: Given IV
arm group label: Treatment (zanubrutinib, 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 ABBS
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 JHL1101
other name: Rituximab Biosimilar PF-05280586
other name: Rituximab Biosimilar RTXM83
other name: Rituximab Biosimilar SAIT101
other name: rituximab biosimilar TQB2303
other name: rituximab-abbs
other name: RTXM83
other name: Truxima
intervention type: Drug
intervention name: Zanubrutinib
description: Given PO
arm group label: Treatment (zanubrutinib, rituximab)
other name: BGB-3111
other name: Brukinsa
other name: BTK-InhB
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jan A Burger
role: Principal Investigator
affiliation: M.D. Anderson Cancer Center
facility: 
status: Recruiting
contact: 
investigator: 
country: United States
url: http://www.mdanderson.org
description: MD Anderson Cancer Center
responsible party type: Sponsor
mesh term: Lymphoma
mesh term: Leukemia
mesh term: Leukemia, Lymphoid
mesh term: Leukemia, Lymphocytic, Chronic, B-Cell
mesh term: Rituximab
mesh term: Antineoplastic Agents, Immunological
mesh term: Zanubrutinib
mesh term: Antibodies
mesh term: Immunoglobulins
mesh term: Antibodies, Monoclonal