<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/NCT04432506</url>
  </required_header>
  <id_info>
    <org_study_id>2019-1051</org_study_id>
    <secondary_id>NCI-2020-04369</secondary_id>
    <secondary_id>2019-1051</secondary_id>
    <nct_id>NCT04432506</nct_id>
  </id_info>
  <brief_title>Anakinra for the Reduction of CAR-T Toxicity in Patients With Relapsed or Refractory Large B-cell Lymphoma</brief_title>
  <official_title>Pilot Study of Anakinra to Mitigate CAR-T Toxicity in Subjects With Relapsed or Refractory Large B-Cell Lymphoma</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 the side effects and best dose of anakinra and to see how well it&#xD;
      works in reducing side effects (toxicity) associated with a CAR-T cell treatment called&#xD;
      axicabtagene ciloleucel in patients with large B-cell lymphoma that has come back (relapsed)&#xD;
      or has not responded to treatment (refractory). Anakinra is a drug typically used to treat&#xD;
      rheumatoid arthritis but may also help in reducing CAR-T cell therapy toxicity. Giving&#xD;
      anakinra in combination with axicabtagene ciloleucel may help control relapsed or refractory&#xD;
      large B-cell lymphoma.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PRIMARY OBJECTIVE:&#xD;
&#xD;
      I. To assess safety and tolerability of anakinra in reducing incidence of cytokine release&#xD;
      syndrome (CRS) within 30 days after infusion of chimeric antigen receptor (CAR) T cells in&#xD;
      subjects with relapsed or refractory large B-cell lymphoma.&#xD;
&#xD;
      SECONDARY OBJECTIVES:&#xD;
&#xD;
      I. To determine incidence of all grades and duration of both CRS and immune-cell associated&#xD;
      neurotoxicity syndrome (ICANS).&#xD;
&#xD;
      II. To determine the complete response rate (CRR), overall response rate (ORR),&#xD;
      progression-free survival (PFS) and overall survival (OS).&#xD;
&#xD;
      EXPLORATORY OBJECTIVES:&#xD;
&#xD;
      I. To determine the effects of anakinra on the cytokine and chemokine profile in peripheral&#xD;
      blood after CAR-T therapy.&#xD;
&#xD;
      II. To determine the effects of anakinra on the expansion and persistence of CAR T cells.&#xD;
&#xD;
      III. To correlate baseline characteristics with toxicity, response and survival after&#xD;
      anakinra combined with CAR-T therapy.&#xD;
&#xD;
      OUTLINE: This is a dose-escalation study of anakinra.&#xD;
&#xD;
      Patients receive cyclophosphamide intravenously (IV) over 60 minutes and fludarabine IV over&#xD;
      30 minutes on days -5 to -3 in the absence of disease progression or unacceptable toxicity.&#xD;
      Patients then receive axicabtagene ciloleucel IV over 30 minutes or less on day 0 and&#xD;
      anakinra subcutaneously (SC) on days 0-6 in the absence of disease progression or&#xD;
      unacceptable toxicity.&#xD;
&#xD;
      After completion of study treatment, patients are followed up at 2 and 4 weeks, and then at&#xD;
      2, 3, 6, 9, 12, 18, and 24 months.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">July 27, 2020</start_date>
  <completion_date type="Anticipated">January 31, 2025</completion_date>
  <primary_completion_date type="Anticipated">January 31, 2025</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>Incidence of any grade cytokine release syndrome (CRS)</measure>
    <time_frame>Within 30 days after infusion of CAR T cells</time_frame>
    <description>Will be tabulated according to the National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE) version (v)5.0. CRS will be assessed by both Lee 2014 criteria as well as American Society for Transplantation and Cellular Therapy (ASTCT) Consensus Grading system.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Incidence of different grades and duration of both CRS and immune cell-associated neurotoxicity syndrome (ICANS)</measure>
    <time_frame>Up to 1 year</time_frame>
    <description>Will be tabulated according to the NCI CTCAE v5.0. CRS will be assessed by both Lee 2014 criteria as well as ASTCT Consensus Grading system. ICANS will be assessed by both CTCAE v5.0 as well as ASTCT Consensus Grading system.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall response rate</measure>
    <time_frame>Up to 24 months</time_frame>
    <description>Will be assessed using the Cheson 2014 Lugano Classification response criteria for malignant lymphoma.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Complete response rate</measure>
    <time_frame>Up to 24 months</time_frame>
    <description>Will be assessed using the Cheson 2014 Lugano Classification response criteria for malignant lymphoma.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression free survival</measure>
    <time_frame>From the start of treatment to disease progression or death due to any cause whichever happened first, assessed up to 24 months</time_frame>
    <description>Will be assessed using the Cheson 2014 Lugano Classification response criteria for malignant lymphoma. Will be estimated using the method of Kaplan and Meier.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall survival</measure>
    <time_frame>From the start of treatment to death due to any cause, assessed up to 24 months</time_frame>
    <description>Will be assessed using the Cheson 2014 Lugano Classification response criteria for malignant lymphoma. Will be estimated using the method of Kaplan and Meier.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Hematopoietic and Lymphoid Cell Neoplasm</condition>
  <condition>Recurrent Diffuse Large B-Cell Lymphoma</condition>
  <condition>Recurrent High Grade B-Cell Lymphoma</condition>
  <condition>Recurrent Primary Mediastinal (Thymic) Large B-Cell Lymphoma</condition>
  <condition>Recurrent Transformed Follicular Lymphoma to Diffuse Large B-Cell Lymphoma</condition>
  <condition>Refractory Diffuse Large B-Cell Lymphoma</condition>
  <condition>Refractory High Grade B-Cell Lymphoma</condition>
  <condition>Refractory Primary Mediastinal (Thymic) Large B-Cell Lymphoma</condition>
  <condition>Refractory Transformed Follicular Lymphoma to Diffuse Large B-Cell Lymphoma</condition>
  <arm_group>
    <arm_group_label>Treatment (cyclophosphamide, fludarabine, axi-cel, anakinra)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients receive cyclophosphamide IV over 60 minutes and fludarabine IV over 30 minutes on days -5 to -3 in the absence of disease progression or unacceptable toxicity. Patients then receive axicabtagene ciloleucel IV over 30 minutes or less on day 0 and anakinra SC on days 0-6 in the absence of disease progression or unacceptable toxicity.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Anakinra</intervention_name>
    <description>Given SC</description>
    <arm_group_label>Treatment (cyclophosphamide, fludarabine, axi-cel, anakinra)</arm_group_label>
    <other_name>Kinaret</other_name>
    <other_name>Kineret</other_name>
    <other_name>rIL-1ra</other_name>
    <other_name>rIL1RN</other_name>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Axicabtagene Ciloleucel</intervention_name>
    <description>Given IV</description>
    <arm_group_label>Treatment (cyclophosphamide, fludarabine, axi-cel, anakinra)</arm_group_label>
    <other_name>KTE C19</other_name>
    <other_name>KTE-C19</other_name>
    <other_name>KTE-C19 CAR</other_name>
    <other_name>Yescarta</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cyclophosphamide</intervention_name>
    <description>Given IV</description>
    <arm_group_label>Treatment (cyclophosphamide, fludarabine, axi-cel, anakinra)</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>Fludarabine</intervention_name>
    <description>Given IV</description>
    <arm_group_label>Treatment (cyclophosphamide, fludarabine, axi-cel, anakinra)</arm_group_label>
    <other_name>Fluradosa</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Relapsed or refractory diffuse large B-cell lymphoma (DLBCL), primary mediastinal&#xD;
             B-cell lymphoma (PMBCL), transformed follicular lymphoma (tFL), or high-grade B-cell&#xD;
             lymphoma (HGBCL), at least 2 prior lines of systemic therapy&#xD;
&#xD;
          -  Planned to receive standard of care therapy with axicabtagene ciloleucel&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1&#xD;
&#xD;
          -  Measurable disease of &gt;= 1.5 cm&#xD;
&#xD;
          -  At least two weeks or 5 half-lives, whichever is shorter, must have elapsed since any&#xD;
             prior systemic therapy at the time the subject is planned for axicabtagene ciloleucel&#xD;
             (axi-cel) therapy, except for systemic immune checkpoint inhibitory / immune&#xD;
             stimulatory therapy. At least 3 half-lives must have elapsed from any prior systemic&#xD;
             immune checkpoint inhibitory / immune stimulatory therapy at the time the subject is&#xD;
             planned for leukapheresis (e.g. ipilimumab, nivolumab, pembrolizumab, atezolizumab,&#xD;
             OX40 agonists, 4-1BB agonists, etc)&#xD;
&#xD;
          -  Toxicities due to prior therapy must be stable and recovered to =&lt; grade 1 (except for&#xD;
             clinically non-significant toxicities such as alopecia)&#xD;
&#xD;
          -  Absolute neutrophil count of &gt;= 1.0 x 10^9/L&#xD;
&#xD;
          -  Platelet count of &gt;= 60 x 10^9/L&#xD;
&#xD;
          -  Creatinine clearance (as estimated by Cockcroft Gault) &gt;= 45 mL/minute (min)&#xD;
&#xD;
          -  Serum alanine transaminase (ALT) / aspartate transaminase (AST) =&lt; 2.5 upper limit of&#xD;
             normal (ULN)&#xD;
&#xD;
          -  Total bilirubin =&lt; 1.5 mg/dL, except in subjects with Gilbert's syndrome&#xD;
&#xD;
          -  Cardiac ejection fraction &gt;= 50% with no evidence of pericardial effusion&#xD;
&#xD;
          -  Baseline oxygen saturation &gt; 92% on room air&#xD;
&#xD;
          -  No evidence, suspicion, and/or history of lymphoma involving the central nervous&#xD;
             system (CNS)&#xD;
&#xD;
          -  Females of childbearing potential must have a negative serum or urine pregnancy test&#xD;
             (females who have undergone surgical sterilization or who have been postmenopausal for&#xD;
             at least 2 years are not considered to be of childbearing potential)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of malignancy other than nonmelanoma skin cancer or carcinoma in situ (e.g.&#xD;
             cervix, bladder, breast) unless disease free for at least 3 years&#xD;
&#xD;
          -  History of Richter's transformation of chronic lymphocytic leukemia (CLL)&#xD;
&#xD;
          -  Autologous stem cell transplantation within 6 weeks of planned axi-cel infusion&#xD;
&#xD;
          -  History of allogeneic stem cell transplantation&#xD;
&#xD;
          -  Prior CD19 targeted therapy&#xD;
&#xD;
          -  Prior chimeric antigen receptor therapy or other genetically modified T cell therapy&#xD;
&#xD;
          -  Presence of fungal, bacterial, viral, or other infection that is uncontrolled or&#xD;
             requiring IV antimicrobials for management. Simple urinary tract infection (UTI) and&#xD;
             uncomplicated bacterial pharyngitis are permitted if responding to active treatment&#xD;
             and after consultation with the principal investigator&#xD;
&#xD;
          -  Known history of infection with human immunodeficiency virus (HIV) or hepatitis B&#xD;
             (hepatitis B virus surface antigen [HBsAg] positive) or hepatitis C virus (anti-HCV&#xD;
             positive). A history of hepatitis B or hepatitis C is permitted if the viral load is&#xD;
             undetectable per quantitative polymerase chain reaction (PCR) and/or nucleic acid&#xD;
             testing&#xD;
&#xD;
          -  Known history of tuberculosis. A negative Quantiferon or purified protein derivative&#xD;
             (PPD) up to 2 months before start of anakinra is enough if no specific risk factors&#xD;
&#xD;
          -  Presence of any indwelling line or drain (e.g., percutaneous nephrostomy tube,&#xD;
             indwelling foley catheter, biliary drain, or pleural/peritoneal/pericardial catheter).&#xD;
             Dedicated central venous access catheters such as a Port-a-Cath or Hickman catheter&#xD;
             are permitted&#xD;
&#xD;
          -  Subjects with detectable cerebrospinal fluid malignant cells, or brain metastases, or&#xD;
             with a history of CNS lymphoma, cerebrospinal fluid malignant cells or brain&#xD;
             metastases&#xD;
&#xD;
          -  History or presence of CNS disorder such as seizure disorder, cerebrovascular&#xD;
             ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease with CNS&#xD;
             involvement&#xD;
&#xD;
          -  Subjects with cardiac atrial or cardiac ventricular lymphoma involvement&#xD;
&#xD;
          -  History of myocardial infarction, cardiac angioplasty or stenting, unstable angina, or&#xD;
             other clinically significant cardiac disease within 12 months of enrollment&#xD;
&#xD;
          -  Requirement for urgent therapy due to tumor mass effects such as bowel obstruction or&#xD;
             blood vessel compression&#xD;
&#xD;
          -  Primary immunodeficiency&#xD;
&#xD;
          -  History of autoimmune disease (e.g. Crohn's, rheumatoid arthritis, systemic lupus)&#xD;
             resulting in end organ injury or requiring systemic immunosuppression/systemic disease&#xD;
             modifying agents within the last 2 years&#xD;
&#xD;
          -  History of symptomatic deep vein thrombosis or pulmonary embolism within 6 months of&#xD;
             enrollment&#xD;
&#xD;
          -  Any medical condition likely to interfere with assessment of safety or efficacy of&#xD;
             study treatment&#xD;
&#xD;
          -  History of severe immediate hypersensitivity reaction to any of the agents used in&#xD;
             this study, including E coli-derived proteins&#xD;
&#xD;
          -  Live vaccine =&lt; 6 weeks prior to planned start of conditioning regimen&#xD;
&#xD;
          -  Women of child-bearing potential who are pregnant or breastfeeding because of the&#xD;
             potentially dangerous effects of the preparative chemotherapy on the fetus or infant&#xD;
&#xD;
          -  Subjects of both genders who are not willing to practice birth control from the time&#xD;
             of consent through 6 months after the completion of anakinra injections&#xD;
&#xD;
          -  In the investigator's judgment, the subject is unlikely to complete all&#xD;
             protocol-required study visits or procedures, including follow-up visits, or comply&#xD;
             with the study requirements for participation Trial Treatments&#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>Paolo Strati</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>University of Texas MD Anderson Cancer Center Website</description>
  </link>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>June 11, 2020</study_first_submitted>
  <study_first_submitted_qc>June 12, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 16, 2020</study_first_posted>
  <last_update_submitted>August 29, 2023</last_update_submitted>
  <last_update_submitted_qc>August 29, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 31, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lymphoma</mesh_term>
    <mesh_term>Lymphoma, Follicular</mesh_term>
    <mesh_term>Lymphoma, B-Cell</mesh_term>
    <mesh_term>Lymphoma, Large B-Cell, Diffuse</mesh_term>
    <mesh_term>Recurrence</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cyclophosphamide</mesh_term>
    <mesh_term>Fludarabine</mesh_term>
    <mesh_term>Axicabtagene ciloleucel</mesh_term>
    <mesh_term>Interleukin 1 Receptor Antagonist Protein</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/NCT04432506
org study id: 2019-1051
secondary id: NCI-2020-04369
secondary id: 2019-1051
nct id: NCT04432506
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
This phase II trial studies the side effects and best dose of anakinra and to see how well it
      works in reducing side effects (toxicity) associated with a CAR-T cell treatment called
      axicabtagene ciloleucel in patients with large B-cell lymphoma that has come back (relapsed)
      or has not responded to treatment (refractory). Anakinra is a drug typically used to treat
      rheumatoid arthritis but may also help in reducing CAR-T cell therapy toxicity. Giving
      anakinra in combination with axicabtagene ciloleucel may help control relapsed or refractory
      large B-cell lymphoma.
PRIMARY OBJECTIVE:

      I. To assess safety and tolerability of anakinra in reducing incidence of cytokine release
      syndrome (CRS) within 30 days after infusion of chimeric antigen receptor (CAR) T cells in
      subjects with relapsed or refractory large B-cell lymphoma.

      SECONDARY OBJECTIVES:

      I. To determine incidence of all grades and duration of both CRS and immune-cell associated
      neurotoxicity syndrome (ICANS).

      II. To determine the complete response rate (CRR), overall response rate (ORR),
      progression-free survival (PFS) and overall survival (OS).

      EXPLORATORY OBJECTIVES:

      I. To determine the effects of anakinra on the cytokine and chemokine profile in peripheral
      blood after CAR-T therapy.

      II. To determine the effects of anakinra on the expansion and persistence of CAR T cells.

      III. To correlate baseline characteristics with toxicity, response and survival after
      anakinra combined with CAR-T therapy.

      OUTLINE: This is a dose-escalation study of anakinra.

      Patients receive cyclophosphamide intravenously (IV) over 60 minutes and fludarabine IV over
      30 minutes on days -5 to -3 in the absence of disease progression or unacceptable toxicity.
      Patients then receive axicabtagene ciloleucel IV over 30 minutes or less on day 0 and
      anakinra subcutaneously (SC) on days 0-6 in the absence of disease progression or
      unacceptable toxicity.

      After completion of study treatment, patients are followed up at 2 and 4 weeks, and then at
      2, 3, 6, 9, 12, 18, and 24 months.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Incidence of any grade cytokine release syndrome (CRS)
time frame: Within 30 days after infusion of CAR T cells
description: Will be tabulated according to the National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE) version (v)5.0. CRS will be assessed by both Lee 2014 criteria as well as American Society for Transplantation and Cellular Therapy (ASTCT) Consensus Grading system.
measure: Incidence of different grades and duration of both CRS and immune cell-associated neurotoxicity syndrome (ICANS)
time frame: Up to 1 year
description: Will be tabulated according to the NCI CTCAE v5.0. CRS will be assessed by both Lee 2014 criteria as well as ASTCT Consensus Grading system. ICANS will be assessed by both CTCAE v5.0 as well as ASTCT Consensus Grading system.
measure: Overall response rate
time frame: Up to 24 months
description: Will be assessed using the Cheson 2014 Lugano Classification response criteria for malignant lymphoma.
measure: Complete response rate
time frame: Up to 24 months
description: Will be assessed using the Cheson 2014 Lugano Classification response criteria for malignant lymphoma.
measure: Progression free survival
time frame: From the start of treatment to disease progression or death due to any cause whichever happened first, assessed up to 24 months
description: Will be assessed using the Cheson 2014 Lugano Classification response criteria for malignant lymphoma. Will be estimated using the method of Kaplan and Meier.
measure: Overall survival
time frame: From the start of treatment to death due to any cause, assessed up to 24 months
description: Will be assessed using the Cheson 2014 Lugano Classification response criteria for malignant lymphoma. Will be estimated using the method of Kaplan and Meier.
arm group label: Treatment (cyclophosphamide, fludarabine, axi-cel, anakinra)
arm group type: Experimental
description: Patients receive cyclophosphamide IV over 60 minutes and fludarabine IV over 30 minutes on days -5 to -3 in the absence of disease progression or unacceptable toxicity. Patients then receive axicabtagene ciloleucel IV over 30 minutes or less on day 0 and anakinra SC on days 0-6 in the absence of disease progression or unacceptable toxicity.
intervention type: Biological
intervention name: Anakinra
description: Given SC
arm group label: Treatment (cyclophosphamide, fludarabine, axi-cel, anakinra)
other name: Kinaret
other name: Kineret
other name: rIL-1ra
other name: rIL1RN
intervention type: Biological
intervention name: Axicabtagene Ciloleucel
description: Given IV
arm group label: Treatment (cyclophosphamide, fludarabine, axi-cel, anakinra)
other name: KTE C19
other name: KTE-C19
other name: KTE-C19 CAR
other name: Yescarta
intervention type: Drug
intervention name: Cyclophosphamide
description: Given IV
arm group label: Treatment (cyclophosphamide, fludarabine, axi-cel, anakinra)
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: Fludarabine
description: Given IV
arm group label: Treatment (cyclophosphamide, fludarabine, axi-cel, anakinra)
other name: Fluradosa
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Paolo Strati
role: Principal Investigator
affiliation: M.D. Anderson Cancer Center
facility: 
country: United States
url: http://www.mdanderson.org
description: University of Texas MD Anderson Cancer Center Website
responsible party type: Sponsor
mesh term: Lymphoma
mesh term: Lymphoma, Follicular
mesh term: Lymphoma, B-Cell
mesh term: Lymphoma, Large B-Cell, Diffuse
mesh term: Recurrence
mesh term: Cyclophosphamide
mesh term: Fludarabine
mesh term: Axicabtagene ciloleucel
mesh term: Interleukin 1 Receptor Antagonist Protein