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<docDscr>
  <citation>
    <titlStmt>
      <titl>Prospective pharmaco-epidemiological study aiming to describe the management of relapsed or refractory chronic lymphocytic leukemia (CLL) patients retreated with MabThera®</titl>
      <IDNo>FRESH-PEF74091-en</IDNo>
    </titlStmt>
    <prodStmt>
      <producer abbr="" affiliation="F. HOFFMANN-LA ROCHE AG" role="">Camille BACHOT</producer>
    </prodStmt>
    <verStmt>
      <version></version>
    </verStmt>
  </citation>
</docDscr>
<stdyDscr>
  <citation>
    <titlStmt>
      <titl>
                Prospective pharmaco-epidemiological study aiming to describe the management of relapsed or refractory chronic lymphocytic leukemia (CLL) patients retreated with MabThera®            </titl>
      <altTitl>
                    PERLE                </altTitl>
      <IDNo agency="FReSH-lang">
                FRESH-PEF74091-en            </IDNo>
      <IDNo agency="PEF">
                    74091                </IDNo>
      <IDNo agency="FReSH">
                    FRESH-PEF74091                </IDNo>
      <IDNo agency="NCT">
                    NCT01488162                </IDNo>
    </titlStmt>
    <rspStmt>
      <othId affiliation="" type="">
                                    </othId>
    </rspStmt>
    <prodStmt>
      <producer role="sponsor">
                                            F. HOFFMANN-LA ROCHE AG                    
                                    </producer>
      <prodPlac>
                Epidemiology France Portal (PEF)            </prodPlac>
    </prodStmt>
    <distStmt>
      <distrbtr abbr="null">
                    null</distrbtr>
      <contact affiliation="F. HOFFMANN-LA ROCHE AG" email="data_sharing.france@roche.com">
                    ;Medical data center
                                            <ExtLink title="ROR" URI="https://ror.org/01mqmer16" role="organisation id"/>
                                            <ExtLink title="SIREN" URI="775752140" role="organisation id"/>
                                    </contact>
      <depDate date="2026-06-17"/>
      <distDate date="2026-06-17"/>
    </distStmt>
    <biblCit format="">
            </biblCit>
    <holdings URI="null"/>
    <notes> </notes>
  </citation>
  <stdyInfo>
    <studyBudget/>
    <subject>
      <keyword vocab="" vocabURI="">
                    rituximab</keyword>
      <topcClas vocab="health theme">
                        Hematology                                                        <ExtLink title="ESV" URI="http://data.europa.eu/8mn/euroscivoc/9239f328-78c9-40a5-a0b9-8e66fd9b6245"/>
                                                            <ExtLink title="MeSH" URI="http://id.nlm.nih.gov/mesh/D006402"/>
                                                </topcClas>
      <topcClas vocab="cim-11">
                        Neoplasms of haematopoietic or lymphoid tissues                                            </topcClas>
      <topcClas vocab="health determinant">
                        Healthcare system determinants: Use of care                    </topcClas>
      <topcClas vocab="health determinant">
                        Healthcare system determinants                    </topcClas>
    </subject>
    <abstract contentType="purpose">Primary Objective: To describe the chemotherapy regimens combined with MabThera® in relapsed or refractory CLL patients having previously received a first or second-line treatment containing MabThera® Secondary Objectives: - Describe efficacy of treatment: overall response (OR), complete response (CR), partial response (PR), progression-free survival (PFS), time to next treatment (TTNT), overall survival (OS) in the total cohort and in the following subgroups: refractory (Yes/No), age (&lt; or &gt;= 70 years), 17p deletion (Yes/No), 11q deletion (Yes/No). - Describe the choice of chemotherapy regimen in patient subgroups defined as: refractory (Yes/No), age (&lt; or &gt;= 70 years), 17p deletion (Yes/No), 11q deletion (Yes/No) - Describe MabThera® treatment regimens (dose, number of cycles), - Describe safety of treatment: all adverse events occurring during the study, - Describe hospitalizations related to an adverse event throughout the study period. Exploratory Objectives: -Analysis of maximal response duration at last line before inclusion will be performed quantitatively and by classes, overall and by age, in all patients and according to number of previous lines of treatment. - Primary criterion will be also described according to the following subgroups: - last previous treatment before current relapse included the same/not the same chemotherapy treatment as first induction treatment - report of Normalized creatinine clearance result &lt; 60 (ml/min/1.73 m²) at baseline (yes/no) (renal insufficiency). - In patients with HBs antigen positive or anti-HBc antibody positive, analysis of HBV prophylaxis and HBV treatment will be performed by visit - Multinomial regression on choice of chemotherapy given at first cycle - Logistic model on response</abstract>
    <abstract contentType="abstract">null</abstract>
    <sumDscr>
      <collDate event="start" date="2011-01-01"/>
      <collDate event="end" date="2016-01-01"/>
      <nation abbr="fr">
                    France
                                            <concept vocab="ISO" vocabURI="fr"/>
                                    </nation>
      <geogUnit/>
      <anlyUnit>
                Individuals            </anlyUnit>
      <universe level="type" clusion="I">Patients population                    </universe>
      <universe level="sex" clusion="I">Male                                                            <concept vocab="MeSH" vocabURI="http://id.nlm.nih.gov/mesh/D008297"/>
                                                    </universe>
      <universe level="sex" clusion="I">Female                                                            <concept vocab="MeSH" vocabURI="http://id.nlm.nih.gov/mesh/D005260"/>
                                                    </universe>
      <universe level="age" clusion="I">Young Adult (19 to 24 years)                                                            <concept vocab="MeSH" vocabURI="http://id.nlm.nih.gov/mesh/D055815"/>
                                                    </universe>
      <universe level="age" clusion="I">Adult (25 to 44 years)                                                            <concept vocab="MeSH" vocabURI="http://id.nlm.nih.gov/mesh/D000328"/>
                                                    </universe>
      <universe level="age" clusion="I">Middle Aged (45 to 64 years)                                                            <concept vocab="MeSH" vocabURI="http://id.nlm.nih.gov/mesh/D008875"/>
                                                    </universe>
      <universe level="age" clusion="I">Aged (65 to 79 years)                                                            <concept vocab="MeSH" vocabURI="http://id.nlm.nih.gov/mesh/D000368"/>
                                                    </universe>
      <universe level="age" clusion="I">Aged, 80 and over (80 years and more)                                                            <concept vocab="MeSH" vocabURI="http://id.nlm.nih.gov/mesh/D000369"/>
                                                    </universe>
      <universe clusion="I">Inclusion criteria: - Adult patient (age &gt;= 18 years) - Presenting with chronic lymphocytic leukemia confirmed by immunophenotyping of circulating lymphocytes (Matutes score &gt;= 4) - In relapse or refractory after a first or second line of treatment - Receiving at least one line of treatment containing MabThera® - MabThera® treatment planned for current relapse - Having received oral and written information about the study and having raised no objections to computer processing of his/her personal data.                      </universe>
      <universe clusion="E">Patient with Richter syndrome - Patient with life expectancy &lt; 6 months - Patient who received 3 or more previous treatment lines* - Patient previously enrolled in this study                    </universe>
      <dataKind>Clinical data</dataKind>
    </sumDscr>
    <qualityStatement>
      <standardsCompliance>
        <standard>
          <standardName>CDISC like</standardName>
        </standard>
      </standardsCompliance>
      <otherQualityStatement>GCP/GVP</otherQualityStatement>
    </qualityStatement>
  </stdyInfo>
  <method>
    <dataColl>
      <sampProc>Other                                                            <concept vocab="CESSDA" vocabURI="Other"/>
                                                    </sampProc>
      <sampleFrame>
        <frameUnit>
          <unitType>Through independent healthcare practitioners</unitType>
        </frameUnit>
      </sampleFrame>
      <targetSampleSize>
        <sampleSizeFormula>&lt; 500 individuals                        </sampleSizeFormula>
      </targetSampleSize>
      <collMode>Converting or copying information into a structured record                                                            <concept vocab="CESSDA" vocabURI="Transcription"/>
                                                    </collMode>
    </dataColl>
    <notes>Observational Study</notes>
    <notes subject="research type">
                        Observational Study                    </notes>
    <anlyInfo>
      <respRate>327</respRate>
    </anlyInfo>
    <stdyClas>Unknown</stdyClas>
  </method>
  <dataAccs>
    <setAvail>
      <avlStatus>
                            Restricted access                                                    </avlStatus>
    </setAvail>
  </dataAccs>
  <othrStdyMat>
    <relMat>Access on specific project only</relMat>
  </othrStdyMat>
</stdyDscr>
<dataDscr>
</dataDscr></codeBook>
