{"doc_desc":{"title":"Prospective pharmaco-epidemiological study aiming to describe the management of relapsed or refractory chronic lymphocytic leukemia (CLL) patients retreated with MabThera\u00ae","idno":"FRESH-PEF74091-en","producers":[{"name":"Camille BACHOT","affiliation":"F. HOFFMANN-LA ROCHE AG"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF74091-en","IDno":{"metadata_no":[{"agency":"PEF","code":"74091"},{"agency":"FReSH","code":"FRESH-PEF74091"},{"agency":"NCT","code":"NCT01488162"}]},"title":"Prospective pharmaco-epidemiological study aiming to describe the management of relapsed or refractory chronic lymphocytic leukemia (CLL) patients retreated with MabThera\u00ae","alternate_title":"PERLE"},"study_authorization":{"agency":[]},"authoring_entity":[],"oth_id":[{"name":""}],"production_statement":{"prod_place":"Epidemiology France Portal (PEF)","producers":[{"name":"F. HOFFMANN-LA ROCHE AG","extlink":[{"title":"SIREN","uri":"775752140","role":"sponsor id"}],"role":"sponsor"}],"funding_agencies":[{"name":""}]},"distribution_statement":{"contact":[{"name":";Medical data center","email":"data_sharing.france@roche.com","type":"contact","affiliationName":"F. HOFFMANN-LA ROCHE AG","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/01mqmer16","role":"organisation id","title":"ROR"},{"uri":"775752140","role":"organisation id","title":"SIREN"}]}]},"study_info":{"keywords":[{"keyword":"rituximab"}],"topics":[{"topic":"Hematology","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/9239f328-78c9-40a5-a0b9-8e66fd9b6245"},{"title":"MeSH","uri":"http:\/\/id.nlm.nih.gov\/mesh\/D006402"}]},{"topic":"Neoplasms of haematopoietic or lymphoid tissues","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/944754984","title":"CIM-11"}]},{"topic":"Healthcare system determinants: Use of care","vocab":"health determinant"},{"topic":"Healthcare system determinants","vocab":"health determinant"}],"purpose":"Primary Objective: To describe the chemotherapy regimens combined with MabThera\u00ae in relapsed or refractory CLL patients having previously received a first or second-line treatment containing MabThera\u00ae 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 (< or >= 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 (< or >= 70 years), 17p deletion (Yes\/No), 11q deletion (Yes\/No) - Describe MabThera\u00ae 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 < 60 (ml\/min\/1.73 m\u00b2) 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":"","coll_dates":[{"start":"2011-01-01","end":"2016-01-01"}],"nation":[{"name":"France","abbreviation":"fr","extLink":{"vocab":"ISO","vocabURI":"fr"}}],"geog_coverage":"","analysis_unit":"Individuals","universe":"{\n    \"level_sex_clusion_I\": [\n        {\n            \"value\": \"Male\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D008297\"\n            }\n        },\n        {\n            \"value\": \"Female\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D005260\"\n            }\n        }\n    ],\n    \"level_age_clusion_I\": [\n        {\n            \"value\": \"Young Adult (19 to 24 years)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D055815\"\n            }\n        },\n        {\n            \"value\": \"Adult (25 to 44 years)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000328\"\n            }\n        },\n        {\n            \"value\": \"Middle Aged (45 to 64 years)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D008875\"\n            }\n        },\n        {\n            \"value\": \"Aged (65 to 79 years)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000368\"\n            }\n        },\n        {\n            \"value\": \"Aged, 80 and over (80 years and more)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000369\"\n            }\n        }\n    ],\n    \"level_type_clusion_I\": \"Patients population\",\n    \"level_type_clusion_other\": \"\",\n    \"clusion_I\": \"Inclusion criteria: - Adult patient (age >= 18 years) - Presenting with chronic lymphocytic leukemia confirmed by immunophenotyping of circulating lymphocytes (Matutes score >= 4) - In relapse or refractory after a first or second line of treatment - Receiving at least one line of treatment containing MabThera\u00ae - MabThera\u00ae 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.  \",\n    \"clusion_E\": \"Patient with Richter syndrome - Patient with life expectancy < 6 months - Patient who received 3 or more previous treatment lines* - Patient previously enrolled in this study\"\n}","data_kind":"['Clinical data']","quality_statement":{"standards":[{"name":"['CDISC like']","committee":"","governance":""}],"other_quality_statement":"['GCP\/GVP']"}},"study_development":{"development_activity":[]},"method":{"data_collection":{"time_method":"","frequency":"","sampling_procedure":"['{\"concept\":{\"vocabURI\":\"Other\",\"vocab\":\"CESSDA\"},\"value\":\"Other\"}']","sample_frame":{"frame_unit":{"unit_type":"['Through independent healthcare practitioners']"}},"coll_mode":["{\"concept\":{\"vocabURI\":\"Transcription\",\"vocab\":\"CESSDA\"},\"value\":\"Converting or copying information into a structured record\"}"],"research_instrument":"Access on specific project only","sources":[],"target_sample_size":"< 500 individuals","response_rate":"327"},"method_notes":"Observational Study","study_class":"Unknown","notes":[{"subject":"research type","values":["Observational Study"]}]},"data_access":{"dataset_availability":{"access_place":"","complete":"","status":"{\"value\":\"Restricted access\",\"extLink\":[{\"title\":\"COAR\",\"uri\":\"http:\/\/purl.org\/coar\/access_right\/c_16ec\"}]}"},"dataset_use":{"restrictions":"","conditions":"","conf_dec":[{"txt":""}],"spec_perm":[{"txt":"","required":""}],"contact":[{"name":""}],"deposit_req":"","cit_req":""},"notes":""}},"additional":{"IsImport":true,"versionLang":"en","originLang":"en","autoTranslation":false,"status":"imported","creationDate":"02-11-2021","lastUpdatedAuto":null,"lastUpdatedManual":"07-07-2025","isContributorPI":"No","contributorName":"Camille BACHOT","contributorAffiliation":"F. HOFFMANN-LA ROCHE AG","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":[]},"relatedDocument":[],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":[],"otherFundingAgentType":[]},"sponsor":{"sponsorType":["Industry"],"otherSponsorType":[""]},"governance":{"committee":"Yes"},"collaborations":{"networkConsortium":""},"theme":{"complementaryInformation":"","RareDiseases":""},"activeFollowUp":{"isActiveFollowUp":"Yes","followUpModeOther":""},"interventionalStudy":{"researchPurpose":[],"trialPhase":[],"interventionalStudyModel":"","isClinicalTrial":"","otherResearchPurpose":""},"isInclusionGroups":"","allocation":{"allocationMode":"","allocationUnit":""},"masking":{"maskingType":"","blindedMaskingDetails":[]},"arms":[],"intervention":[],"inclusionGroups":[],"collectionProcess":{"collectionModeDetails":"eCRF","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":"No"},"geographicalCoverage":{"geoDetail":""},"dataTypes":{"clinicalDataDetails":"Type of data collected : previous medical history and concomitant disorders, cycles of therapy administered, laboratory test data, efficacy, evaluation of patient, adverse events, early permanent discontinuation, history of CLL, verification of screening criteria before inclusion, treatment programme initially planned for treatment of this relapse (or of this refractory condition) of CLL, current relapse (or refractory condition) of CLL, previous treatments of CLL, demographic data, prophylaxis or anti-infective treatment, hematopoietic stem cell transplantations, Richter\u2019s syndrome.","biologicalDataDetails":"","isDataInBiobank":"No","biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":"Yes","fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}