xml: <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/NCT06004167</url>
    </required_header>
    <id_info>
      <org_study_id>23-364</org_study_id>
      <nct_id>NCT06004167</nct_id>
    </id_info>
    <brief_title>Adaptive Bridging RT in R/R B-cell Lymphoma (Pre-CAR T)</brief_title>
    <official_title>5-5-5 Adaptive Bridging Radiation Therapy (ABRT) for Relapsed/Refractory B-cell Lymphoma Prior to CAR T-cell Therapy</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Massachusetts General Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Varian Medical Systems</agency>
        <agency_class>Industry</agency_class>
      </collaborator>
    </sponsors>
    <source>Massachusetts General Hospital</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>Yes</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Participants are invited to take part in this research study because they have relapsed&#xD;
        (cancer has come back) or refractory (cancer has not responded to treatment) B-cell Lymphoma&#xD;
        and will be undergoing CAR T-cell Therapy.&#xD;
  &#xD;
        This research is being done to see if a new radiation therapy administration schedule will&#xD;
        positively impact the logistics, time, cost, and side effects of radiation therapy.&#xD;
  &#xD;
        In this research study, participants will receive radiation therapy once weekly for 5 weeks.&#xD;
        This is a novel administration schedule and we're looking to see how this schedule impacts&#xD;
        side effects participants may experience, the time spent receiving radiation therapy, how&#xD;
        much radiation therapy participants can receive, and how effective this new schedule is.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This is a feasibility/pilot study of 5 Gy adaptive radiation administered every 5 business&#xD;
        days (1 week apart) for 5 weeks prior to standard of care CAR T-cell therapy infusion.&#xD;
        Approximately 10 participants with Relapsed/Refractory B-cell Lymphoma will take part in this&#xD;
        research study. The primary objective is to assess the feasibility of once weekly radiation&#xD;
        therapy for 5 weeks.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">February 14, 2024</start_date>
    <completion_date type="Anticipated">September 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">July 1, 2024</primary_completion_date>
    <phase>N/A</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>Feasibility</measure>
      <time_frame>20 months</time_frame>
      <description>Feasibility is being measured based on the percentage of patients being able to undergo ABRT</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Adverse Events</measure>
      <time_frame>20 months</time_frame>
      <description>Adverse events will be classified and graded according to the CTCAE v.5.0.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Objective Response Rate (ORR)</measure>
      <time_frame>15 months</time_frame>
      <description>ORR is being measured using the day 30 and day 90 PET scans and assessed by Lugano lymphoma response criteria</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">10</enrollment>
    <condition>Lymphoma, B-Cell</condition>
    <condition>Relapsed Cancer</condition>
    <condition>Refractory Lymphoma</condition>
    <condition>Diffuse Large B Cell Lymphoma</condition>
    <condition>Mediastinal Large B-cell Lymphoma</condition>
    <condition>High-grade B-cell Lymphoma</condition>
    <condition>Follicular Lymphoma</condition>
    <condition>Mantle Cell Lymphoma</condition>
    <arm_group>
      <arm_group_label>5-5-5 Adaptive Bridging Radiation Therapy (ABRT)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>5 Gy of adaptive radiation delivered every 5 business days (1 week apart) for up to 5 weeks prior to CAR T-cell therapy infusion</description>
    </arm_group>
    <intervention>
      <intervention_type>Radiation</intervention_type>
      <intervention_name>Adaptive Bridging Radiation Therapy (ABRT)</intervention_name>
      <description>Radiation Therapy</description>
      <arm_group_label>5-5-5 Adaptive Bridging Radiation Therapy (ABRT)</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Diagnosis of relapsed or refractory B-cell lymphoma (including, but not limited to&#xD;
               diffuse large B-cell lymphoma (DLBCL) not otherwise specified, primary mediastinal&#xD;
               large B-cell lymphoma, high grade B-cell lymphoma, DLBCL arising from follicular&#xD;
               lymphoma, follicular, and mantle cell lymphoma)&#xD;
  &#xD;
            -  Being planned to undergo CAR T-cell therapy (patients can be enrolled prior to&#xD;
               apheresis)&#xD;
  &#xD;
            -  At least 1 measurable lesion according to the Lugano criteria35. Lesions that have&#xD;
               been previously irradiated will be considered measurable only if progression has been&#xD;
               documented following completion of radiation therapy. Re-irradiation is allowed for&#xD;
               these patients. More than 1 lesion can be targeted as per radiation oncologist&#xD;
               discretion. If disease is palpable, physical examination alone may be sufficient&#xD;
               measurement for disease if a recent PET/CT or CT is not available as a radiologic&#xD;
               measurement of the disease can be obtained during CT simulation.&#xD;
  &#xD;
            -  Age ≥ 18 years&#xD;
  &#xD;
            -  Eastern Cooperative Oncology Group (ECOG) performance status of less than or equal to&#xD;
               3.&#xD;
  &#xD;
            -  Ability to understand and the willingness to sign a written informed consent document&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Any medical condition likely to interfere with assessment of safety or efficacy of RT.&#xD;
  &#xD;
            -  CNS-only disease as the site for bridging radiation therapy (which cannot be reliably&#xD;
               evaluated on CT). Patients with CNS disease with extra-axial involvement that can be&#xD;
               evaluated on CT remain eligible.&#xD;
  &#xD;
            -  Patient likely unable to lay supine for 45 minutes&#xD;
  &#xD;
            -  Women of child-bearing potential who are pregnant because of the potentially dangerous&#xD;
               effects of the preparative chemotherapy on the fetus or infant. Females who have&#xD;
               undergone surgical sterilization or who have been postmenopausal for at least 2 years&#xD;
               are not considered to be of childbearing potential&#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.&#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>Chirayu Patel, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Massachusetts General Hospital</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Chirayu Patel, MD</last_name>
      <phone>(617) 724-2430</phone>
      <email>cpatel@mgh.harvard.edu</email>
    </overall_contact>
    <location>
      <facility>
        <name>Dana-Farber Cancer Institute</name>
        <address>
          <city>Boston</city>
          <state>Massachusetts</state>
          <zip>02215</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Andrea Ng, MD</last_name>
        <phone>617-394-2668</phone>
        <email>andrea_ng@dfci.harvard.edu</email>
      </contact>
      <investigator>
        <last_name>Andrea Ng, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 16, 2023</study_first_submitted>
    <study_first_submitted_qc>August 16, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 22, 2023</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>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Massachusetts General Hospital</investigator_affiliation>
      <investigator_full_name>Chirayu Patel</investigator_full_name>
      <investigator_title>Principal Investigator</investigator_title>
    </responsible_party>
    <keyword>Relapsed/Refractory B-cell Lymphoma</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Lymphoma</mesh_term>
      <mesh_term>Lymphoma, B-Cell</mesh_term>
      <mesh_term>Lymphoma, Mantle-Cell</mesh_term>
      <mesh_term>Lymphoma, Large B-Cell, Diffuse</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
      <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
      <ipd_time_frame>Data can be shared no earlier than 1 year following the date of publication</ipd_time_frame>
      <ipd_access_criteria>Contact the Partners Innovations team at http://www.partners.org/innovation</ipd_access_criteria>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06004167
  org study id: 23-364
  nct id: NCT06004167
  lead sponsor: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: Yes
  Participants are invited to take part in this research study because they have relapsed
        (cancer has come back) or refractory (cancer has not responded to treatment) B-cell Lymphoma
        and will be undergoing CAR T-cell Therapy.
  
        This research is being done to see if a new radiation therapy administration schedule will
        positively impact the logistics, time, cost, and side effects of radiation therapy.
  
        In this research study, participants will receive radiation therapy once weekly for 5 weeks.
        This is a novel administration schedule and we're looking to see how this schedule impacts
        side effects participants may experience, the time spent receiving radiation therapy, how
        much radiation therapy participants can receive, and how effective this new schedule is.
  This is a feasibility/pilot study of 5 Gy adaptive radiation administered every 5 business
        days (1 week apart) for 5 weeks prior to standard of care CAR T-cell therapy infusion.
        Approximately 10 participants with Relapsed/Refractory B-cell Lymphoma will take part in this
        research study. The primary objective is to assess the feasibility of once weekly radiation
        therapy for 5 weeks.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Feasibility
  time frame: 20 months
  description: Feasibility is being measured based on the percentage of patients being able to undergo ABRT
  measure: Adverse Events
  time frame: 20 months
  description: Adverse events will be classified and graded according to the CTCAE v.5.0.
  measure: Objective Response Rate (ORR)
  time frame: 15 months
  description: ORR is being measured using the day 30 and day 90 PET scans and assessed by Lugano lymphoma response criteria
  arm group label: 5-5-5 Adaptive Bridging Radiation Therapy (ABRT)
  arm group type: Experimental
  description: 5 Gy of adaptive radiation delivered every 5 business days (1 week apart) for up to 5 weeks prior to CAR T-cell therapy infusion
  intervention type: Radiation
  intervention name: Adaptive Bridging Radiation Therapy (ABRT)
  description: Radiation Therapy
  arm group label: 5-5-5 Adaptive Bridging Radiation Therapy (ABRT)
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Chirayu Patel, MD
  role: Principal Investigator
  affiliation: Massachusetts General Hospital
  last name: Chirayu Patel, MD
  phone: (617) 724-2430
  email: cpatel@mgh.harvard.edu
  facility: 
  contact: 
  investigator: 
  country: United States
  responsible party type: Principal Investigator
  investigator affiliation: Massachusetts General Hospital
  investigator full name: Chirayu Patel
  investigator title: Principal Investigator
  mesh term: Lymphoma
  mesh term: Lymphoma, B-Cell
  mesh term: Lymphoma, Mantle-Cell
  mesh term: Lymphoma, Large B-Cell, Diffuse
  sharing ipd: Yes
  ipd description: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
  ipd info type: Study Protocol
  ipd info type: Statistical Analysis Plan (SAP)
  ipd info type: Informed Consent Form (ICF)
  ipd time frame: Data can be shared no earlier than 1 year following the date of publication
  ipd access criteria: Contact the Partners Innovations team at http://www.partners.org/innovation