<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/NCT02194751</url>
  </required_header>
  <id_info>
    <org_study_id>X13-21008</org_study_id>
    <nct_id>NCT02194751</nct_id>
  </id_info>
  <brief_title>Oncoquest-L Vaccine in Patients With Previously Untreated Stage III or IV, Asymptomatic, Non-bulky Follicular Lymphoma</brief_title>
  <official_title>Oncoquest-L Vaccine in Patients With Previously Untreated Stage III or IV, Asymptomatic, Non-bulky Follicular Lymphoma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>XEME Biopharma Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>XEME Biopharma Inc.</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 the overall tumor response of vaccine therapy in patientswith&#xD;
      previously untreated Stage III or IV, asymptomatic, non-bulky follicular lymphoma. The&#xD;
      vaccine contains an extract of the patient's own cancer cells and the immunostimulant&#xD;
      protein, interleukin-2 (IL-2). It is hoped that when injected under the skin, the vaccine&#xD;
      will enable the patient's immune system to recognize and destroy the cancer cells. The trial&#xD;
      will also assess the safety of the vaccine, the time from vaccine treatment until the patient&#xD;
      requires another type of anti-lymphoma treatment, progression-free survival, and the&#xD;
      anti-tumor immune response.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a single-arm open-label pilot Phase II study. Following informed consent, eligible&#xD;
      subjects will undergo excisional biopsy of a lymphoma-containing lymph node for diagnosis and&#xD;
      for generation of the Oncoquest-L vaccine. Patients will receive subcutaneous injections&#xD;
      consisting of their autologous tumor-derived Oncoquest-L vaccine starting at approximately 4&#xD;
      to 8 weeks after the biopsy. The first two doses will be given at a 2-week interval and the&#xD;
      remaining 3 doses at monthly intervals. Patients will be monitored for response by performing&#xD;
      imaging studies at baseline and 1 month after the fifth vaccination (Week 19). Additional&#xD;
      imaging studies will be performed every 3 months for the first year and every 6 months during&#xD;
      the second year until relapse or disease progression whichever occurs sooner.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Not yet recruiting</overall_status>
  <start_date type="Anticipated">July 2021</start_date>
  <completion_date type="Anticipated">June 2026</completion_date>
  <primary_completion_date type="Anticipated">June 2024</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>Overall tumor response rate</measure>
    <time_frame>Up to 2 years</time_frame>
    <description>Tumor measurements will be performed at enrollment (baseline); then, tumor measurements and response assessments will occur 4 weeks after the 5th vaccination. Thereafter, tumor measurements and response assessments will occur every 3 months during the 1st year and then every 6 months during the 2nd year until relapse or disease progression, whichever occurs first.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Assessment of complete and partial tumor response rates</measure>
    <time_frame>Up to 2 years</time_frame>
    <description>Tumor measurements will be performed at enrollment (baseline); then, tumor measurements and response assessments will occur 4 weeks after the 5th vaccination. Thereafter, tumor measurements and response assessments will occur every 3 months during the 1st year and then every 6 months during the 2nd year until relapse or disease progression, whichever occurs first.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of time until initiation of radiotherapy or systemic therapy</measure>
    <time_frame>Up to 2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety evaluation will include frequency, severity, and relationship of adverse events to vaccination; vital signs (blood pressure, respiration, pulse, and temperature); and laboratory test results (including, hematology and clinical chemistry)</measure>
    <time_frame>From the time of informed consent up to 2 years</time_frame>
    <description>Safety parameters (e.g., adverse events, vital signs, and laboratory test results) will be recorded from the time patient signs informed consent, at every clinic visit during study treatment, 4 weeks after the 5th vaccination, and thereafter every 3 months during the 1st year and then every 6 months during the 2nd year.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tests to measure tumor-specific antibody production and T cell and B cell responses to vaccination</measure>
    <time_frame>From 8 weeks prior to the 1st vaccination to Week 19 following the 1st vaccination.</time_frame>
    <description>Antibody production will be reported as increased titers of antibodies, B cells will be expressed as % B cell populations, T cell responses will be expressed as increases of tumor-specific T cells and changes in expression and quantity of cytokines (proteins that indicate changes in the immune response). Blood samples will be collected within 8 weeks prior to the 1st vaccination (baseline); within 7 days prior to the 5th vaccination; and 4 weeks after the 5th vaccination.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Follicular Lymphoma</condition>
  <arm_group>
    <arm_group_label>Oncoquest-L vaccine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will receive a total of 5 single injections of Oncoquest-L; the first 2 doses administered will be separated by a 2-week interval and the remaining 3 doses will be administered each at 1-month intervals. With each dose of Oncoquest-L vaccine, the vaccine will be administered subcutaneously at 2 different sites in the upper arms or upper legs, with alternation of the injection sites with each administration.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Oncoquest-L vaccine</intervention_name>
    <description>Patients will receive a total of 5 single administrations of Oncoquest-L; the first 2 doses administered will be separated by a 2-week interval and the remaining 3 doses will be administered each at 1-month intervals. With each dose of Oncoquest-L vaccine, the vaccine will be administered subcutaneously at 2 different sites in the upper arms or upper legs, with alternation of the injection sites with each administration. For each vaccination, a total of 1.0 mL of vaccine will be administered, divided into 2 subcutaneous injections of 0.5 mL each at 2 different injection sites.</description>
    <arm_group_label>Oncoquest-L vaccine</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Follicular lymphoma (FL) grade 1, 2, or 3a diagnosed within 12 months of study&#xD;
             enrollment&#xD;
&#xD;
          2. Age ≥ 18 years&#xD;
&#xD;
          3. Previously untreated Stage III or IV FL&#xD;
&#xD;
          4. A single peripheral lymph node of at least 1 x 1 cm in size accessible for excisional&#xD;
             biopsy&#xD;
&#xD;
          5. Measurable or evaluable disease after obtaining tissue for vaccine production&#xD;
&#xD;
          6. Performance status (ECOG) of 0 or 1&#xD;
&#xD;
          7. Asymptomatic disease without B symptoms or severe pruritus&#xD;
&#xD;
          8. Low tumor burden as defined by the following criteria:&#xD;
&#xD;
               -  Normal lactic dehydrogenase&#xD;
&#xD;
               -  Largest tumor mass &lt; 7 cm&#xD;
&#xD;
               -  Involvement of &lt; 3 nodal sites with a diameter ≥ 3 cm&#xD;
&#xD;
               -  No clinically significant pleural effusion or ascites&#xD;
&#xD;
               -  Spleen size of ≤ 16 cm by CT scan&#xD;
&#xD;
               -  Circulating tumor cells &lt; 5.0 x 109/L&#xD;
&#xD;
               -  No clinically significant organ compression&#xD;
&#xD;
          9. Adequate hematopoietic parameters:&#xD;
&#xD;
               -  Absolute neutrophil count ≥ 1.5 x 109/L&#xD;
&#xD;
               -  Platelet count ≥ 100 x 109/L&#xD;
&#xD;
               -  Hemoglobin ≥ 10 g/dL&#xD;
&#xD;
         10. Serum creatinine ≤ 2 x upper limit of normal (ULN)&#xD;
&#xD;
         11. Total bilirubin ≤ 2 x ULN unless considered secondary to Gilbert's syndrome. Aspartate&#xD;
             aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase ≤ 2 x ULN&#xD;
&#xD;
         12. Fertile patients must use effective contraception during and for 12 months after&#xD;
             completion of therapy&#xD;
&#xD;
         13. For fertile female patients, a negative pregnancy test result at enrollment&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Active HIV, hepatitis B, hepatitis C or other active infectious process&#xD;
&#xD;
          2. Pregnant or nursing women&#xD;
&#xD;
          3. Patients with previous history of malignancy within the past 2 years except curatively&#xD;
             treated squamous or basal cell carcinoma of the skin or curatively treated carcinoma&#xD;
             in situ of the cervix.&#xD;
&#xD;
          4. Any medical or psychiatric condition that in the opinion of the principal investigator&#xD;
             would compromise the patient's ability to tolerate this treatment&#xD;
&#xD;
          5. Concurrent treatment with immunosuppressive therapy&#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>Brion Randolph, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Southeastern Regional Medical Center at Cancer Treatment Centers of America</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Karen Rados</last_name>
    <phone>770-400-6629</phone>
    <email>Karon.Rados@ctca-hope.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Mittie Mitchell, RN</last_name>
    <phone>770-400-7194</phone>
    <email>Mittie.Mitchell@ctca-hope.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Southeastern Regional Medical Center at CTCA</name>
      <address>
        <city>Newnan</city>
        <state>Georgia</state>
        <zip>30265</zip>
        <country>United States</country>
      </address>
    </facility>
    <contact>
      <last_name>Karen Rados</last_name>
      <phone>770-400-6629</phone>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 14, 2014</study_first_submitted>
  <study_first_submitted_qc>July 16, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 18, 2014</study_first_posted>
  <last_update_submitted>April 7, 2021</last_update_submitted>
  <last_update_submitted_qc>April 7, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">April 8, 2021</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, Follicular</mesh_term>
  </condition_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/NCT02194751
org study id: X13-21008
nct id: NCT02194751
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
This Phase II trial studies the overall tumor response of vaccine therapy in patientswith
      previously untreated Stage III or IV, asymptomatic, non-bulky follicular lymphoma. The
      vaccine contains an extract of the patient's own cancer cells and the immunostimulant
      protein, interleukin-2 (IL-2). It is hoped that when injected under the skin, the vaccine
      will enable the patient's immune system to recognize and destroy the cancer cells. The trial
      will also assess the safety of the vaccine, the time from vaccine treatment until the patient
      requires another type of anti-lymphoma treatment, progression-free survival, and the
      anti-tumor immune response.
This is a single-arm open-label pilot Phase II study. Following informed consent, eligible
      subjects will undergo excisional biopsy of a lymphoma-containing lymph node for diagnosis and
      for generation of the Oncoquest-L vaccine. Patients will receive subcutaneous injections
      consisting of their autologous tumor-derived Oncoquest-L vaccine starting at approximately 4
      to 8 weeks after the biopsy. The first two doses will be given at a 2-week interval and the
      remaining 3 doses at monthly intervals. Patients will be monitored for response by performing
      imaging studies at baseline and 1 month after the fifth vaccination (Week 19). Additional
      imaging studies will be performed every 3 months for the first year and every 6 months during
      the second year until relapse or disease progression whichever occurs sooner.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Overall tumor response rate
time frame: Up to 2 years
description: Tumor measurements will be performed at enrollment (baseline); then, tumor measurements and response assessments will occur 4 weeks after the 5th vaccination. Thereafter, tumor measurements and response assessments will occur every 3 months during the 1st year and then every 6 months during the 2nd year until relapse or disease progression, whichever occurs first.
measure: Assessment of complete and partial tumor response rates
time frame: Up to 2 years
description: Tumor measurements will be performed at enrollment (baseline); then, tumor measurements and response assessments will occur 4 weeks after the 5th vaccination. Thereafter, tumor measurements and response assessments will occur every 3 months during the 1st year and then every 6 months during the 2nd year until relapse or disease progression, whichever occurs first.
measure: Assessment of time until initiation of radiotherapy or systemic therapy
time frame: Up to 2 years
measure: Safety evaluation will include frequency, severity, and relationship of adverse events to vaccination; vital signs (blood pressure, respiration, pulse, and temperature); and laboratory test results (including, hematology and clinical chemistry)
time frame: From the time of informed consent up to 2 years
description: Safety parameters (e.g., adverse events, vital signs, and laboratory test results) will be recorded from the time patient signs informed consent, at every clinic visit during study treatment, 4 weeks after the 5th vaccination, and thereafter every 3 months during the 1st year and then every 6 months during the 2nd year.
measure: Tests to measure tumor-specific antibody production and T cell and B cell responses to vaccination
time frame: From 8 weeks prior to the 1st vaccination to Week 19 following the 1st vaccination.
description: Antibody production will be reported as increased titers of antibodies, B cells will be expressed as % B cell populations, T cell responses will be expressed as increases of tumor-specific T cells and changes in expression and quantity of cytokines (proteins that indicate changes in the immune response). Blood samples will be collected within 8 weeks prior to the 1st vaccination (baseline); within 7 days prior to the 5th vaccination; and 4 weeks after the 5th vaccination.
arm group label: Oncoquest-L vaccine
arm group type: Experimental
description: Patients will receive a total of 5 single injections of Oncoquest-L; the first 2 doses administered will be separated by a 2-week interval and the remaining 3 doses will be administered each at 1-month intervals. With each dose of Oncoquest-L vaccine, the vaccine will be administered subcutaneously at 2 different sites in the upper arms or upper legs, with alternation of the injection sites with each administration.
intervention type: Biological
intervention name: Oncoquest-L vaccine
description: Patients will receive a total of 5 single administrations of Oncoquest-L; the first 2 doses administered will be separated by a 2-week interval and the remaining 3 doses will be administered each at 1-month intervals. With each dose of Oncoquest-L vaccine, the vaccine will be administered subcutaneously at 2 different sites in the upper arms or upper legs, with alternation of the injection sites with each administration. For each vaccination, a total of 1.0 mL of vaccine will be administered, divided into 2 subcutaneous injections of 0.5 mL each at 2 different injection sites.
arm group label: Oncoquest-L vaccine
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Brion Randolph, MD
role: Principal Investigator
affiliation: Southeastern Regional Medical Center at Cancer Treatment Centers of America
last name: Karen Rados
phone: 770-400-6629
email: Karon.Rados@ctca-hope.com
last name: Mittie Mitchell, RN
phone: 770-400-7194
email: Mittie.Mitchell@ctca-hope.com
facility: 
contact: 
country: United States
responsible party type: Sponsor
mesh term: Lymphoma
mesh term: Lymphoma, Follicular