<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/NCT02199184</url>
  </required_header>
  <id_info>
    <org_study_id>2014-0123</org_study_id>
    <secondary_id>NCI-2014-01707</secondary_id>
    <secondary_id>2014-0123</secondary_id>
    <secondary_id>P30CA016672</secondary_id>
    <nct_id>NCT02199184</nct_id>
  </id_info>
  <brief_title>Dose Adjusted EPOCH Regimen in Combination With Ofatumumab or Rituximab in Treating Patients With Newly Diagnosed or Relapsed or Refractory Burkitt Lymphoma or Relapsed or Refractory Acute Lymphoblastic Leukemia</brief_title>
  <official_title>Phase II Study of the Dose Adjusted EPOCH Regimen in Combination With Ofatumumab/Rituximab as Therapy for Patients With Newly Diagnosed or Relapsed/Refractory Burkitt Leukemia or Relapsed/Refractory Acute Lymphoblastic Leukemia</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>No</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 a dose adjusted regimen consisting of etoposide,&#xD;
      prednisone, vincristine sulfate, cyclophosphamide, and doxorubicin hydrochloride (EPOCH)&#xD;
      works in combination with ofatumumab or rituximab in treating patients with Burkitt lymphoma&#xD;
      that is newly diagnosed, or has returned after a period of improvement (relapsed), or has not&#xD;
      responded to previous treatment (refractory) or relapsed or refractory acute lymphoblastic&#xD;
      leukemia. Drugs used in chemotherapy, such as etoposide, prednisone, vincristine sulfate,&#xD;
      cyclophosphamide, and doxorubicin hydrochloride, work in different ways to stop the growth of&#xD;
      cancer cells, either by killing the cells, by stopping them from dividing, or by stopping&#xD;
      them from spreading. Monoclonal antibodies, such as ofatumumab and rituximab, may interfere&#xD;
      with the ability of cancer cells to grow and spread. Giving more than one drug (combination&#xD;
      chemotherapy) together with monoclonal antibody therapy may kill more cancer cells.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PRIMARY OBJECTIVE:&#xD;
&#xD;
      I. To evaluate the clinical efficacy of the combination of dose adjusted (DA)-EPOCH +&#xD;
      ofatumumab in patients with newly diagnosed or relapsed/refractory Burkitt leukemia or&#xD;
      relapsed/refractory acute lymphoblastic leukemia (ALL) defined by complete response rate.&#xD;
&#xD;
      SECONDARY OBJECTIVE:&#xD;
&#xD;
      I. To evaluate the safety of this combination, the overall survival and event-free survival&#xD;
      rates.&#xD;
&#xD;
      OUTLINE:&#xD;
&#xD;
      Patients receive DA-EPOCH regimen comprising doxorubicin hydrochloride intravenously (IV),&#xD;
      vincristine sulfate IV, and etoposide IV continuously over 96 hours on days 1-4;&#xD;
      cyclophosphamide IV over 1-2 hours on day 5; and prednisone orally (PO) twice daily (BID) on&#xD;
      days 1-5. Patients also receive ofatumumab IV over 2 hours on days 1, 2, and 11 of cycle 1;&#xD;
      on days 1 and 8 of cycles 2 and 4; and on days 1 and 11 of cycle 3 for a total of 9&#xD;
      injections. Patients may receive rituximab instead of ofatumumab if their insurance provider&#xD;
      does not cover the cost of ofatumumab. Patients receive rituximab IV over 2 hours on days 1&#xD;
      and 11 of cycles 1 and 3 and on days 2 and 8 of cycles 2 and 4. Treatment repeats every 21-28&#xD;
      days for up to 8 cycles in the absence of disease progression or unacceptable toxicity.&#xD;
&#xD;
      After completion of study treatment, patients are followed up every 2-4 months for 1 year and&#xD;
      then every 4-8 months for 2 years.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">January 14, 2015</start_date>
  <completion_date type="Anticipated">June 30, 2023</completion_date>
  <primary_completion_date type="Anticipated">June 30, 2023</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Complete response rates</measure>
    <time_frame>Up to 3 years</time_frame>
    <description>Will be estimated along with the 95% credible intervals.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Incidence of adverse events</measure>
    <time_frame>Up to 3 years</time_frame>
    <description>Safety data will be summarized using frequency and percentage.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall survival time</measure>
    <time_frame>Up to 3 years</time_frame>
    <description>Will be estimated using the Kaplan-Meier method.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Event-free survival</measure>
    <time_frame>Up to 3 years</time_frame>
    <description>Will be estimated using the Kaplan-Meier method.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Complete response duration</measure>
    <time_frame>Up to 3 years</time_frame>
    <description>Will be estimated using the Kaplan-Meier method.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">40</enrollment>
  <condition>AIDS-Related Burkitt Lymphoma</condition>
  <condition>Atypical Burkitt/Burkitt-Like Lymphoma</condition>
  <condition>High Grade B-Cell Lymphoma With MYC and BCL2 or BCL6 Rearrangements</condition>
  <condition>High Grade B-Cell Lymphoma With MYC, BCL2, and BCL6 Rearrangements</condition>
  <condition>Recurrent Acute Lymphoblastic Leukemia</condition>
  <condition>Recurrent Burkitt Lymphoma</condition>
  <condition>Refractory Acute Lymphoblastic Leukemia</condition>
  <condition>Refractory Burkitt Lymphoma</condition>
  <arm_group>
    <arm_group_label>Treatment (DA-EPOCH and ofatumumab or rituximab)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients receive DA-EPOCH regimen comprising doxorubicin hydrochloride IV, vincristine sulfate IV, and etoposide IV continuously over 96 hours on days 1-4; cyclophosphamide IV over 1-2 hours on day 5; and prednisone PO BID on days 1-5. Patients also receive ofatumumab IV over 2 hours on days 1, 2, and 11 of cycle 1; on days 1 and 8 of cycles 2 and 4; and on days 1 and 11 of cycle 3 for a total of 9 injections. Patients may receive rituximab instead of ofatumumab if their insurance provider does not cover the cost of ofatumumab. Patients receive rituximab IV over 2 hours on days 1 and 11 of cycles 1 and 3 and on days 2 and 8 of cycles 2 and 4. Treatment repeats every 21-28 days for up to 8 cycles in the absence of disease progression or unacceptable toxicity.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cyclophosphamide</intervention_name>
    <description>Given IV</description>
    <arm_group_label>Treatment (DA-EPOCH and ofatumumab or rituximab)</arm_group_label>
    <other_name>(-)-Cyclophosphamide</other_name>
    <other_name>2H-1,3,2-Oxazaphosphorine, 2-[bis(2-chloroethyl)amino]tetrahydro-, 2-oxide, monohydrate</other_name>
    <other_name>Carloxan</other_name>
    <other_name>Ciclofosfamida</other_name>
    <other_name>Ciclofosfamide</other_name>
    <other_name>Cicloxal</other_name>
    <other_name>Clafen</other_name>
    <other_name>Claphene</other_name>
    <other_name>CP monohydrate</other_name>
    <other_name>CTX</other_name>
    <other_name>CYCLO-cell</other_name>
    <other_name>Cycloblastin</other_name>
    <other_name>Cycloblastine</other_name>
    <other_name>Cyclophospham</other_name>
    <other_name>Cyclophosphamid monohydrate</other_name>
    <other_name>Cyclophosphamide Monohydrate</other_name>
    <other_name>Cyclophosphamidum</other_name>
    <other_name>Cyclophosphan</other_name>
    <other_name>Cyclophosphane</other_name>
    <other_name>Cyclophosphanum</other_name>
    <other_name>Cyclostin</other_name>
    <other_name>Cyclostine</other_name>
    <other_name>Cytophosphan</other_name>
    <other_name>Cytophosphane</other_name>
    <other_name>Cytoxan</other_name>
    <other_name>Fosfaseron</other_name>
    <other_name>Genoxal</other_name>
    <other_name>Genuxal</other_name>
    <other_name>Ledoxina</other_name>
    <other_name>Mitoxan</other_name>
    <other_name>Neosar</other_name>
    <other_name>Revimmune</other_name>
    <other_name>Syklofosfamid</other_name>
    <other_name>WR- 138719</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Doxorubicin Hydrochloride</intervention_name>
    <description>Given IV</description>
    <arm_group_label>Treatment (DA-EPOCH and ofatumumab or rituximab)</arm_group_label>
    <other_name>5,12-Naphthacenedione, 10-[(3-amino-2,3,6-trideoxy-alpha-L-lyxo-hexopyranosyl)oxy]-7,8, 9,10-tetrahydro-6,8,11-trihydroxy-8-(hydroxyacetyl)-1-methoxy-, hydrochloride, (8S-cis)- (9CI)</other_name>
    <other_name>ADM</other_name>
    <other_name>Adriacin</other_name>
    <other_name>Adriamycin</other_name>
    <other_name>Adriamycin Hydrochloride</other_name>
    <other_name>Adriamycin PFS</other_name>
    <other_name>Adriamycin RDF</other_name>
    <other_name>ADRIAMYCIN, HYDROCHLORIDE</other_name>
    <other_name>Adriamycine</other_name>
    <other_name>Adriblastina</other_name>
    <other_name>Adriblastine</other_name>
    <other_name>Adrimedac</other_name>
    <other_name>Chloridrato de Doxorrubicina</other_name>
    <other_name>DOX</other_name>
    <other_name>DOXO-CELL</other_name>
    <other_name>Doxolem</other_name>
    <other_name>Doxorubicin HCl</other_name>
    <other_name>Doxorubicin.HCl</other_name>
    <other_name>Doxorubin</other_name>
    <other_name>Farmiblastina</other_name>
    <other_name>FI 106</other_name>
    <other_name>FI-106</other_name>
    <other_name>hydroxydaunorubicin</other_name>
    <other_name>Rubex</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Etoposide</intervention_name>
    <description>Given IV</description>
    <arm_group_label>Treatment (DA-EPOCH and ofatumumab or rituximab)</arm_group_label>
    <other_name>Demethyl Epipodophyllotoxin Ethylidine Glucoside</other_name>
    <other_name>EPEG</other_name>
    <other_name>Lastet</other_name>
    <other_name>Toposar</other_name>
    <other_name>Vepesid</other_name>
    <other_name>VP 16</other_name>
    <other_name>VP 16-213</other_name>
    <other_name>VP-16</other_name>
    <other_name>VP-16-213</other_name>
    <other_name>VP16</other_name>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Ofatumumab</intervention_name>
    <description>Given IV</description>
    <arm_group_label>Treatment (DA-EPOCH and ofatumumab or rituximab)</arm_group_label>
    <other_name>Arzerra</other_name>
    <other_name>GSK1841157</other_name>
    <other_name>HuMax-CD20</other_name>
    <other_name>HuMax-CD20, 2F2</other_name>
    <other_name>Kesimpta</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Prednisone</intervention_name>
    <description>Given PO</description>
    <arm_group_label>Treatment (DA-EPOCH and ofatumumab or rituximab)</arm_group_label>
    <other_name>.delta.1-Cortisone</other_name>
    <other_name>1, 2-Dehydrocortisone</other_name>
    <other_name>Adasone</other_name>
    <other_name>Cortancyl</other_name>
    <other_name>Dacortin</other_name>
    <other_name>DeCortin</other_name>
    <other_name>Decortisyl</other_name>
    <other_name>Decorton</other_name>
    <other_name>Delta 1-Cortisone</other_name>
    <other_name>Delta-Dome</other_name>
    <other_name>Deltacortene</other_name>
    <other_name>Deltacortisone</other_name>
    <other_name>Deltadehydrocortisone</other_name>
    <other_name>Deltasone</other_name>
    <other_name>Deltison</other_name>
    <other_name>Deltra</other_name>
    <other_name>Econosone</other_name>
    <other_name>Lisacort</other_name>
    <other_name>Meprosona-F</other_name>
    <other_name>Metacortandracin</other_name>
    <other_name>Meticorten</other_name>
    <other_name>Ofisolona</other_name>
    <other_name>Orasone</other_name>
    <other_name>Panafcort</other_name>
    <other_name>Panasol-S</other_name>
    <other_name>Paracort</other_name>
    <other_name>Perrigo Prednisone</other_name>
    <other_name>PRED</other_name>
    <other_name>Predicor</other_name>
    <other_name>Predicorten</other_name>
    <other_name>Prednicen-M</other_name>
    <other_name>Prednicort</other_name>
    <other_name>Prednidib</other_name>
    <other_name>Prednilonga</other_name>
    <other_name>Predniment</other_name>
    <other_name>Prednisone Intensol</other_name>
    <other_name>Prednisonum</other_name>
    <other_name>Prednitone</other_name>
    <other_name>Promifen</other_name>
    <other_name>Rayos</other_name>
    <other_name>Servisone</other_name>
    <other_name>SK-Prednisone</other_name>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Rituximab</intervention_name>
    <description>Given IV</description>
    <arm_group_label>Treatment (DA-EPOCH and ofatumumab or 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>Riabni</other_name>
    <other_name>Rituxan</other_name>
    <other_name>Rituximab ABBS</other_name>
    <other_name>Rituximab ARRX</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 SIBP-02</other_name>
    <other_name>rituximab biosimilar TQB2303</other_name>
    <other_name>Rituximab PVVR</other_name>
    <other_name>rituximab-abbs</other_name>
    <other_name>Rituximab-arrx</other_name>
    <other_name>Rituximab-pvvr</other_name>
    <other_name>RTXM83</other_name>
    <other_name>Ruxience</other_name>
    <other_name>Truxima</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Vincristine Sulfate</intervention_name>
    <description>Given IV</description>
    <arm_group_label>Treatment (DA-EPOCH and ofatumumab or rituximab)</arm_group_label>
    <other_name>Kyocristine</other_name>
    <other_name>Leurocristine Sulfate</other_name>
    <other_name>Leurocristine, sulfate</other_name>
    <other_name>Oncovin</other_name>
    <other_name>Vincasar</other_name>
    <other_name>Vincosid</other_name>
    <other_name>Vincrex</other_name>
    <other_name>Vincristine, sulfate</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Burkitt's or Burkitt-like leukemia/lymphoma, either previously untreated, or&#xD;
             relapsed/refractory, or human immunodeficiency virus (HIV)-related; patients with&#xD;
             double or triple hit high-grade leukemia/lymphoma are eligible also; patients HIV&#xD;
             positive will be described and reported separately or relapsed/refractory acute&#xD;
             lymphoblastic leukemia (ALL).&#xD;
&#xD;
          -  Zubrod performance status =&lt; 3 (Eastern Cooperative Oncology Group [ECOG] scale)&#xD;
&#xD;
          -  Creatinine less than or equal to 2.0 mg/dL (unless considered tumor related)&#xD;
&#xD;
          -  Bilirubin less than or equal to 2.0 mg/dL (unless considered tumor related)&#xD;
&#xD;
          -  Adequate cardiac function defined as no history of clinically significant arrhythmia,&#xD;
             or history of myocardial infarction (MI) within 3 months prior to study enrollment;&#xD;
             cardiac function will be assessed by history and physical examination&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant or nursing women&#xD;
&#xD;
          -  Active and uncontrolled disease/infection as judged by the treating physician&#xD;
&#xD;
          -  Unable or unwilling to sign the consent form&#xD;
&#xD;
          -  Subjects who have current active hepatic or biliary disease (with exception of&#xD;
             patients with Gilbert's syndrome, asymptomatic gallstones, liver metastases or stable&#xD;
             chronic liver disease per investigator assessment)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Elias Jabbour</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>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.mdanderson.org</url>
    <description>MD Anderson Cancer Center Website</description>
  </link>
  <verification_date>December 2022</verification_date>
  <study_first_submitted>July 22, 2014</study_first_submitted>
  <study_first_submitted_qc>July 23, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 24, 2014</study_first_posted>
  <last_update_submitted>December 7, 2022</last_update_submitted>
  <last_update_submitted_qc>December 7, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">December 8, 2022</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>Burkitt Lymphoma</mesh_term>
    <mesh_term>Lymphoma</mesh_term>
    <mesh_term>Leukemia</mesh_term>
    <mesh_term>Precursor Cell Lymphoblastic Leukemia-Lymphoma</mesh_term>
    <mesh_term>Leukemia, Lymphoid</mesh_term>
    <mesh_term>Lymphoma, B-Cell</mesh_term>
    <mesh_term>Recurrence</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Prednisone</mesh_term>
    <mesh_term>Cortisone</mesh_term>
    <mesh_term>Cyclophosphamide</mesh_term>
    <mesh_term>Rituximab</mesh_term>
    <mesh_term>Doxorubicin</mesh_term>
    <mesh_term>Liposomal doxorubicin</mesh_term>
    <mesh_term>Etoposide</mesh_term>
    <mesh_term>Vincristine</mesh_term>
    <mesh_term>Etoposide phosphate</mesh_term>
    <mesh_term>Ofatumumab</mesh_term>
    <mesh_term>Podophyllotoxin</mesh_term>
    <mesh_term>Antineoplastic Agents, Immunological</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/NCT02199184
org study id: 2014-0123
secondary id: NCI-2014-01707
secondary id: 2014-0123
secondary id: P30CA016672
nct id: NCT02199184
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
This phase II trial studies how well a dose adjusted regimen consisting of etoposide,
      prednisone, vincristine sulfate, cyclophosphamide, and doxorubicin hydrochloride (EPOCH)
      works in combination with ofatumumab or rituximab in treating patients with Burkitt lymphoma
      that is newly diagnosed, or has returned after a period of improvement (relapsed), or has not
      responded to previous treatment (refractory) or relapsed or refractory acute lymphoblastic
      leukemia. Drugs used in chemotherapy, such as etoposide, prednisone, vincristine sulfate,
      cyclophosphamide, and doxorubicin hydrochloride, work in different ways to stop the growth of
      cancer cells, either by killing the cells, by stopping them from dividing, or by stopping
      them from spreading. Monoclonal antibodies, such as ofatumumab and rituximab, may interfere
      with the ability of cancer cells to grow and spread. Giving more than one drug (combination
      chemotherapy) together with monoclonal antibody therapy may kill more cancer cells.
PRIMARY OBJECTIVE:

      I. To evaluate the clinical efficacy of the combination of dose adjusted (DA)-EPOCH +
      ofatumumab in patients with newly diagnosed or relapsed/refractory Burkitt leukemia or
      relapsed/refractory acute lymphoblastic leukemia (ALL) defined by complete response rate.

      SECONDARY OBJECTIVE:

      I. To evaluate the safety of this combination, the overall survival and event-free survival
      rates.

      OUTLINE:

      Patients receive DA-EPOCH regimen comprising doxorubicin hydrochloride intravenously (IV),
      vincristine sulfate IV, and etoposide IV continuously over 96 hours on days 1-4;
      cyclophosphamide IV over 1-2 hours on day 5; and prednisone orally (PO) twice daily (BID) on
      days 1-5. Patients also receive ofatumumab IV over 2 hours on days 1, 2, and 11 of cycle 1;
      on days 1 and 8 of cycles 2 and 4; and on days 1 and 11 of cycle 3 for a total of 9
      injections. Patients may receive rituximab instead of ofatumumab if their insurance provider
      does not cover the cost of ofatumumab. Patients receive rituximab IV over 2 hours on days 1
      and 11 of cycles 1 and 3 and on days 2 and 8 of cycles 2 and 4. Treatment repeats every 21-28
      days for up to 8 cycles in the absence of disease progression or unacceptable toxicity.

      After completion of study treatment, patients are followed up every 2-4 months for 1 year and
      then every 4-8 months for 2 years.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Complete response rates
time frame: Up to 3 years
description: Will be estimated along with the 95% credible intervals.
measure: Incidence of adverse events
time frame: Up to 3 years
description: Safety data will be summarized using frequency and percentage.
measure: Overall survival time
time frame: Up to 3 years
description: Will be estimated using the Kaplan-Meier method.
measure: Event-free survival
time frame: Up to 3 years
description: Will be estimated using the Kaplan-Meier method.
measure: Complete response duration
time frame: Up to 3 years
description: Will be estimated using the Kaplan-Meier method.
arm group label: Treatment (DA-EPOCH and ofatumumab or rituximab)
arm group type: Experimental
description: Patients receive DA-EPOCH regimen comprising doxorubicin hydrochloride IV, vincristine sulfate IV, and etoposide IV continuously over 96 hours on days 1-4; cyclophosphamide IV over 1-2 hours on day 5; and prednisone PO BID on days 1-5. Patients also receive ofatumumab IV over 2 hours on days 1, 2, and 11 of cycle 1; on days 1 and 8 of cycles 2 and 4; and on days 1 and 11 of cycle 3 for a total of 9 injections. Patients may receive rituximab instead of ofatumumab if their insurance provider does not cover the cost of ofatumumab. Patients receive rituximab IV over 2 hours on days 1 and 11 of cycles 1 and 3 and on days 2 and 8 of cycles 2 and 4. Treatment repeats every 21-28 days for up to 8 cycles in the absence of disease progression or unacceptable toxicity.
intervention type: Drug
intervention name: Cyclophosphamide
description: Given IV
arm group label: Treatment (DA-EPOCH and ofatumumab or rituximab)
other name: (-)-Cyclophosphamide
other name: 2H-1,3,2-Oxazaphosphorine, 2-[bis(2-chloroethyl)amino]tetrahydro-, 2-oxide, monohydrate
other name: Carloxan
other name: Ciclofosfamida
other name: Ciclofosfamide
other name: Cicloxal
other name: Clafen
other name: Claphene
other name: CP monohydrate
other name: CTX
other name: CYCLO-cell
other name: Cycloblastin
other name: Cycloblastine
other name: Cyclophospham
other name: Cyclophosphamid monohydrate
other name: Cyclophosphamide Monohydrate
other name: Cyclophosphamidum
other name: Cyclophosphan
other name: Cyclophosphane
other name: Cyclophosphanum
other name: Cyclostin
other name: Cyclostine
other name: Cytophosphan
other name: Cytophosphane
other name: Cytoxan
other name: Fosfaseron
other name: Genoxal
other name: Genuxal
other name: Ledoxina
other name: Mitoxan
other name: Neosar
other name: Revimmune
other name: Syklofosfamid
other name: WR- 138719
intervention type: Drug
intervention name: Doxorubicin Hydrochloride
description: Given IV
arm group label: Treatment (DA-EPOCH and ofatumumab or rituximab)
other name: 5,12-Naphthacenedione, 10-[(3-amino-2,3,6-trideoxy-alpha-L-lyxo-hexopyranosyl)oxy]-7,8, 9,10-tetrahydro-6,8,11-trihydroxy-8-(hydroxyacetyl)-1-methoxy-, hydrochloride, (8S-cis)- (9CI)
other name: ADM
other name: Adriacin
other name: Adriamycin
other name: Adriamycin Hydrochloride
other name: Adriamycin PFS
other name: Adriamycin RDF
other name: ADRIAMYCIN, HYDROCHLORIDE
other name: Adriamycine
other name: Adriblastina
other name: Adriblastine
other name: Adrimedac
other name: Chloridrato de Doxorrubicina
other name: DOX
other name: DOXO-CELL
other name: Doxolem
other name: Doxorubicin HCl
other name: Doxorubicin.HCl
other name: Doxorubin
other name: Farmiblastina
other name: FI 106
other name: FI-106
other name: hydroxydaunorubicin
other name: Rubex
intervention type: Drug
intervention name: Etoposide
description: Given IV
arm group label: Treatment (DA-EPOCH and ofatumumab or rituximab)
other name: Demethyl Epipodophyllotoxin Ethylidine Glucoside
other name: EPEG
other name: Lastet
other name: Toposar
other name: Vepesid
other name: VP 16
other name: VP 16-213
other name: VP-16
other name: VP-16-213
other name: VP16
intervention type: Biological
intervention name: Ofatumumab
description: Given IV
arm group label: Treatment (DA-EPOCH and ofatumumab or rituximab)
other name: Arzerra
other name: GSK1841157
other name: HuMax-CD20
other name: HuMax-CD20, 2F2
other name: Kesimpta
intervention type: Drug
intervention name: Prednisone
description: Given PO
arm group label: Treatment (DA-EPOCH and ofatumumab or rituximab)
other name: .delta.1-Cortisone
other name: 1, 2-Dehydrocortisone
other name: Adasone
other name: Cortancyl
other name: Dacortin
other name: DeCortin
other name: Decortisyl
other name: Decorton
other name: Delta 1-Cortisone
other name: Delta-Dome
other name: Deltacortene
other name: Deltacortisone
other name: Deltadehydrocortisone
other name: Deltasone
other name: Deltison
other name: Deltra
other name: Econosone
other name: Lisacort
other name: Meprosona-F
other name: Metacortandracin
other name: Meticorten
other name: Ofisolona
other name: Orasone
other name: Panafcort
other name: Panasol-S
other name: Paracort
other name: Perrigo Prednisone
other name: PRED
other name: Predicor
other name: Predicorten
other name: Prednicen-M
other name: Prednicort
other name: Prednidib
other name: Prednilonga
other name: Predniment
other name: Prednisone Intensol
other name: Prednisonum
other name: Prednitone
other name: Promifen
other name: Rayos
other name: Servisone
other name: SK-Prednisone
intervention type: Biological
intervention name: Rituximab
description: Given IV
arm group label: Treatment (DA-EPOCH and ofatumumab or 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: Riabni
other name: Rituxan
other name: Rituximab ABBS
other name: Rituximab ARRX
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 SIBP-02
other name: rituximab biosimilar TQB2303
other name: Rituximab PVVR
other name: rituximab-abbs
other name: Rituximab-arrx
other name: Rituximab-pvvr
other name: RTXM83
other name: Ruxience
other name: Truxima
intervention type: Drug
intervention name: Vincristine Sulfate
description: Given IV
arm group label: Treatment (DA-EPOCH and ofatumumab or rituximab)
other name: Kyocristine
other name: Leurocristine Sulfate
other name: Leurocristine, sulfate
other name: Oncovin
other name: Vincasar
other name: Vincosid
other name: Vincrex
other name: Vincristine, sulfate
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Elias Jabbour
role: Principal Investigator
affiliation: M.D. Anderson Cancer Center
facility: 
country: United States
url: http://www.mdanderson.org
description: MD Anderson Cancer Center Website
responsible party type: Sponsor
mesh term: Burkitt Lymphoma
mesh term: Lymphoma
mesh term: Leukemia
mesh term: Precursor Cell Lymphoblastic Leukemia-Lymphoma
mesh term: Leukemia, Lymphoid
mesh term: Lymphoma, B-Cell
mesh term: Recurrence
mesh term: Prednisone
mesh term: Cortisone
mesh term: Cyclophosphamide
mesh term: Rituximab
mesh term: Doxorubicin
mesh term: Liposomal doxorubicin
mesh term: Etoposide
mesh term: Vincristine
mesh term: Etoposide phosphate
mesh term: Ofatumumab
mesh term: Podophyllotoxin
mesh term: Antineoplastic Agents, Immunological
mesh term: Antibodies
mesh term: Immunoglobulins
mesh term: Antibodies, Monoclonal