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/NCT06024694</url>
    </required_header>
    <id_info>
      <org_study_id>Observational Retrospective</org_study_id>
      <nct_id>NCT06024694</nct_id>
    </id_info>
    <brief_title>Primary Mediastinal Large B-cell Lymphoma With CNS Involvement</brief_title>
    <official_title>Retrospective Multicenter International Study on Prognostic Factors, Management And Outcome Of Primary Mediastinal Large B-Cell Lymphoma (PMLBCL) Patients With Central Nervous System (CNS) Involvement</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>IRCCS San Raffaele</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>IRCCS San Raffaele</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        retrospective study focused on patients with a known diagnosis of PMLBCL which experienced a&#xD;
        CNS relapse during the course of their disease to obtain information about the clinical&#xD;
        characteristics, the management at diagnosis and at each relapses , and the outcome of these&#xD;
        cases. The aim of the study is to put together the large International series on CNS+ PMLBCL&#xD;
        data, coming from 6 different countries , on clinical factors, anti-lymphoma therapy&#xD;
        administered alone or concomitant with CNS prophylaxis , the information about the site of re&#xD;
        biopsy when available , the dose intensity of lymphoma therapy received at relapse and the&#xD;
        outcome of patients.&#xD;
  &#xD;
        Both patients treated in routine practice or within clinical trials will be considered.&#xD;
        Moreover to better characterized the pathological features of this rare entity a central&#xD;
        pathological review of the initial diagnosis and when available of for histological confirmed&#xD;
        relapse will be considered.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">June 10, 2022</start_date>
    <completion_date type="Anticipated">June 10, 2024</completion_date>
    <primary_completion_date type="Anticipated">June 10, 2024</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Other</observational_model>
      <time_perspective>Retrospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Clinical characteristics 1</measure>
      <time_frame>2 YEARS</time_frame>
      <description>to describe the PMLBCL characteristics at diagnosis and at CNS relapse ( first relapse or second and subsequent recurrences) and the treatment received to describe the median time to CNS relapse to define prognostic factors of outcome of CNS relapse in PMLBCL patients</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Clinical characteristics 2</measure>
      <time_frame>2 YEARS</time_frame>
      <description>to correlate treatment strategy with survival end-points</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Clinical characteristics 3</measure>
      <time_frame>2 YEARS</time_frame>
      <description>to evaluate the Progression Free Survical ( PFS) after CNS events</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Clinical characteristics 4</measure>
      <time_frame>2 YEARS</time_frame>
      <description>to evaluate Overall Survival ( OS) after CNS relapse to centra! pathological reviewed the initial diagnosis and the relapse and to correlate biological and molecular factors with CNS recurrence</description>
    </primary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">45</enrollment>
    <condition>Primary Mediastinal Large B-cell Lymphoma (PMBCL)</condition>
    <arm_group>
      <arm_group_label>patients diagnosed with PMLBL</arm_group_label>
      <description>Patients whose diagnosis met the histological criteria of PMLBL according WHO classification with a diagnosis of CNS involvement at relapse/progression</description>
    </arm_group>
    <eligibility>
      <study_pop>
        <textblock>
          Patients whose diagnosis met the histological criteria of PMLBL according WHO&#xD;
          classification with a diagnosis of CNS involvement at relapse/progression.&#xD;
  &#xD;
          Patients eligible to the study will be retrospectively identified by the site researches by&#xD;
          interrogating the local site sources.&#xD;
  &#xD;
          Availability of local pathological report at time of diagnosis and restaging will be&#xD;
          considered for eligibility.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Histologically confirmed diagnosis of Primary Mediastinal Large B Cell Lymphoma&#xD;
               (PMLBCL) according WHO Classification&#xD;
  &#xD;
            -  Had a recurrence/progression with Central Nervous System (CNS) involvement&#xD;
  &#xD;
            -  Availability of details on clinical presentation, treatment details and outcome&#xD;
  &#xD;
            -  Availability of details on pathological data for central review&#xD;
  &#xD;
            -  Age ≥18 years&#xD;
  &#xD;
          Exclusion Criteria&#xD;
  &#xD;
            -  Patients with CNS lymphoma other than PMLBCL subtype&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>80 Years</maximum_age>
    </eligibility>
    <overall_contact>
      <last_name>Andres Ferreri</last_name>
      <phone>0226435603</phone>
      <email>ferreri.clinicaltrials@hsr.it</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Stefania Trinca</last_name>
      <phone>0226434289</phone>
      <email>trinca.stefania@hsr.it</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Ospedale San Raffaele</name>
        <address>
          <city>Milan</city>
          <zip>20132</zip>
          <country>Italy</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Andrés Jose Maria Ferreri, MD</last_name>
        <phone>00390226437649</phone>
        <email>ferreri.andres@hsr.it</email>
      </contact>
      <contact_backup>
        <last_name>Teresa Calimeri, MD</last_name>
        <phone>00390226437642</phone>
        <email>calimeri.teresa@hsr.it</email>
      </contact_backup>
    </location>
    <location_countries>
      <country>Italy</country>
    </location_countries>
    <reference>
      <citation>Cazals-Hatem D, Lepage E, Brice P, Ferrant A, d'Agay MF, Baumelou E, Briere J, Blanc M, Gaulard P, Biron P, Schlaifer D, Diebold J, Audouin J. Primary mediastinal large B-cell lymphoma. A clinicopathologic study of 141 cases compared with 916 nonmediastinal large B-cell lymphomas, a GELA (&quot;Groupe d'Etude des Lymphomes de l'Adulte&quot;) study. Am J Surg Pathol. 1996 Jul;20(7):877-88. doi: 10.1097/00000478-199607000-00012.</citation>
      <PMID>8669537</PMID>
    </reference>
    <reference>
      <citation>Falini B, Venturi S, Martelli M, Santucci A, Pileri S, Pescarmona E, Giovannini M, Mazza P, Martelli MF, Pasqualucci L, et al. Mediastinal large B-cell lymphoma: clinical and immunohistological findings in 18 patients treated with different third-generation regimens. Br J Haematol. 1995 Apr;89(4):780-9. doi: 10.1111/j.1365-2141.1995.tb08415.x.</citation>
      <PMID>7539625</PMID>
    </reference>
    <reference>
      <citation>Swerdlow SH, Campo E, Pileri SA, Harris NL, Stein H, Siebert R, Advani R, Ghielmini M, Salles GA, Zelenetz AD, Jaffe ES. The 2016 revision of the World Health Organization classification of lymphoid neoplasms. Blood. 2016 May 19;127(20):2375-90. doi: 10.1182/blood-2016-01-643569. Epub 2016 Mar 15.</citation>
      <PMID>26980727</PMID>
    </reference>
    <reference>
      <citation>Bishop PC, Wilson WH, Pearson D, Janik J, Jaffe ES, Elwood PC. CNS involvement in primary mediastinal large B-cell lymphoma. J Clin Oncol. 1999 Aug;17(8):2479-85. doi: 10.1200/JCO.1999.17.8.2479.</citation>
      <PMID>10561312</PMID>
    </reference>
    <reference>
      <citation>Zinzani PL, Martelli M, Bertini M, Gianni AM, Devizzi L, Federico M, Pangalis G, Michels J, Zucca E, Cantonetti M, Cortelazzo S, Wotherspoon A, Ferreri AJ, Zaja F, Lauria F, De Renzo A, Liberati MA, Falini B, Balzarotti M, Calderoni A, Zaccaria A, Gentilini P, Fattori PP, Pavone E, Angelopoulou MK, Alinari L, Brugiatelli M, Di Renzo N, Bonifazi F, Pileri SA, Cavalli F; International Extranodal Lymphoma Study Group (IELSG). Induction chemotherapy strategies for primary mediastinal large B-cell lymphoma with sclerosis: a retrospective multinational study on 426 previously untreated patients. Haematologica. 2002 Dec;87(12):1258-64.</citation>
      <PMID>12495899</PMID>
    </reference>
    <reference>
      <citation>Martelli M, Ferreri A, Di Rocco A, Ansuinelli M, Johnson PWM. Primary mediastinal large B-cell lymphoma. Crit Rev Oncol Hematol. 2017 May;113:318-327. doi: 10.1016/j.critrevonc.2017.01.009. Epub 2017 Jan 21.</citation>
      <PMID>28318892</PMID>
    </reference>
    <reference>
      <citation>Aoki T, Izutsu K, Suzuki R, Nakaseko C, Arima H, Shimada K, Tomita A, Sasaki M, Takizawa J, Mitani K, Igarashi T, Maeda Y, Fukuhara N, Ishida F, Niitsu N, Ohmachi K, Takasaki H, Nakamura N, Kinoshita T, Nakamura S, Ogura M. Prognostic significance of pleural or pericardial effusion and the implication of optimal treatment in primary mediastinal large B-cell lymphoma: a multicenter retrospective study in Japan. Haematologica. 2014 Dec;99(12):1817-25. doi: 10.3324/haematol.2014.111203. Epub 2014 Sep 12.</citation>
      <PMID>25216682</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 24, 2022</study_first_submitted>
    <study_first_submitted_qc>August 29, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 6, 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">September 6, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>IRCCS San Raffaele</investigator_affiliation>
      <investigator_full_name>Andrés José Maria Ferreri</investigator_full_name>
      <investigator_title>Lymphoma Unit Director</investigator_title>
    </responsible_party>
    <keyword>PMBCL</keyword>
    <keyword>CNS</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>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
    </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/NCT06024694
  org study id: Observational Retrospective
  nct id: NCT06024694
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  retrospective study focused on patients with a known diagnosis of PMLBCL which experienced a
        CNS relapse during the course of their disease to obtain information about the clinical
        characteristics, the management at diagnosis and at each relapses , and the outcome of these
        cases. The aim of the study is to put together the large International series on CNS+ PMLBCL
        data, coming from 6 different countries , on clinical factors, anti-lymphoma therapy
        administered alone or concomitant with CNS prophylaxis , the information about the site of re
        biopsy when available , the dose intensity of lymphoma therapy received at relapse and the
        outcome of patients.
  
        Both patients treated in routine practice or within clinical trials will be considered.
        Moreover to better characterized the pathological features of this rare entity a central
        pathological review of the initial diagnosis and when available of for histological confirmed
        relapse will be considered.
  observational model: Other
  time perspective: Retrospective
  measure: Clinical characteristics 1
  time frame: 2 YEARS
  description: to describe the PMLBCL characteristics at diagnosis and at CNS relapse ( first relapse or second and subsequent recurrences) and the treatment received to describe the median time to CNS relapse to define prognostic factors of outcome of CNS relapse in PMLBCL patients
  measure: Clinical characteristics 2
  time frame: 2 YEARS
  description: to correlate treatment strategy with survival end-points
  measure: Clinical characteristics 3
  time frame: 2 YEARS
  description: to evaluate the Progression Free Survical ( PFS) after CNS events
  measure: Clinical characteristics 4
  time frame: 2 YEARS
  description: to evaluate Overall Survival ( OS) after CNS relapse to centra! pathological reviewed the initial diagnosis and the relapse and to correlate biological and molecular factors with CNS recurrence
  arm group label: patients diagnosed with PMLBL
  description: Patients whose diagnosis met the histological criteria of PMLBL according WHO classification with a diagnosis of CNS involvement at relapse/progression
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 80 Years
  last name: Andres Ferreri
  phone: 0226435603
  email: ferreri.clinicaltrials@hsr.it
  last name: Stefania Trinca
  phone: 0226434289
  email: trinca.stefania@hsr.it
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  country: Italy
  citation: Cazals-Hatem D, Lepage E, Brice P, Ferrant A, d'Agay MF, Baumelou E, Briere J, Blanc M, Gaulard P, Biron P, Schlaifer D, Diebold J, Audouin J. Primary mediastinal large B-cell lymphoma. A clinicopathologic study of 141 cases compared with 916 nonmediastinal large B-cell lymphomas, a GELA ("Groupe d'Etude des Lymphomes de l'Adulte") study. Am J Surg Pathol. 1996 Jul;20(7):877-88. doi: 10.1097/00000478-199607000-00012.
  PMID: 8669537
  citation: Falini B, Venturi S, Martelli M, Santucci A, Pileri S, Pescarmona E, Giovannini M, Mazza P, Martelli MF, Pasqualucci L, et al. Mediastinal large B-cell lymphoma: clinical and immunohistological findings in 18 patients treated with different third-generation regimens. Br J Haematol. 1995 Apr;89(4):780-9. doi: 10.1111/j.1365-2141.1995.tb08415.x.
  PMID: 7539625
  citation: Swerdlow SH, Campo E, Pileri SA, Harris NL, Stein H, Siebert R, Advani R, Ghielmini M, Salles GA, Zelenetz AD, Jaffe ES. The 2016 revision of the World Health Organization classification of lymphoid neoplasms. Blood. 2016 May 19;127(20):2375-90. doi: 10.1182/blood-2016-01-643569. Epub 2016 Mar 15.
  PMID: 26980727
  citation: Bishop PC, Wilson WH, Pearson D, Janik J, Jaffe ES, Elwood PC. CNS involvement in primary mediastinal large B-cell lymphoma. J Clin Oncol. 1999 Aug;17(8):2479-85. doi: 10.1200/JCO.1999.17.8.2479.
  PMID: 10561312
  citation: Zinzani PL, Martelli M, Bertini M, Gianni AM, Devizzi L, Federico M, Pangalis G, Michels J, Zucca E, Cantonetti M, Cortelazzo S, Wotherspoon A, Ferreri AJ, Zaja F, Lauria F, De Renzo A, Liberati MA, Falini B, Balzarotti M, Calderoni A, Zaccaria A, Gentilini P, Fattori PP, Pavone E, Angelopoulou MK, Alinari L, Brugiatelli M, Di Renzo N, Bonifazi F, Pileri SA, Cavalli F; International Extranodal Lymphoma Study Group (IELSG). Induction chemotherapy strategies for primary mediastinal large B-cell lymphoma with sclerosis: a retrospective multinational study on 426 previously untreated patients. Haematologica. 2002 Dec;87(12):1258-64.
  PMID: 12495899
  citation: Martelli M, Ferreri A, Di Rocco A, Ansuinelli M, Johnson PWM. Primary mediastinal large B-cell lymphoma. Crit Rev Oncol Hematol. 2017 May;113:318-327. doi: 10.1016/j.critrevonc.2017.01.009. Epub 2017 Jan 21.
  PMID: 28318892
  citation: Aoki T, Izutsu K, Suzuki R, Nakaseko C, Arima H, Shimada K, Tomita A, Sasaki M, Takizawa J, Mitani K, Igarashi T, Maeda Y, Fukuhara N, Ishida F, Niitsu N, Ohmachi K, Takasaki H, Nakamura N, Kinoshita T, Nakamura S, Ogura M. Prognostic significance of pleural or pericardial effusion and the implication of optimal treatment in primary mediastinal large B-cell lymphoma: a multicenter retrospective study in Japan. Haematologica. 2014 Dec;99(12):1817-25. doi: 10.3324/haematol.2014.111203. Epub 2014 Sep 12.
  PMID: 25216682
  responsible party type: Principal Investigator
  investigator affiliation: IRCCS San Raffaele
  investigator full name: Andrés José Maria Ferreri
  investigator title: Lymphoma Unit Director
  mesh term: Lymphoma
  mesh term: Lymphoma, B-Cell
  sharing ipd: Undecided