{"doc_desc":{"title":"Etude pharmaco-\u00e9pid\u00e9miologique prospective visant \u00e0 d\u00e9crire la prise en charge des patients atteints de leuc\u00e9mie lympho\u00efde chronique (LLC) en rechute ou r\u00e9fractaire et trait\u00e9s par MabThera\u00ae","idno":"FRESH-PEF74091-fr","producers":[{"name":"Camille BACHOT","affiliation":"F. HOFFMANN-LA ROCHE AG"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF74091-fr","IDno":{"metadata_no":[{"agency":"PEF","code":"74091"},{"agency":"FReSH","code":"FRESH-PEF74091"},{"agency":"NCT","code":"NCT01488162"}]},"title":"Etude pharmaco-\u00e9pid\u00e9miologique prospective visant \u00e0 d\u00e9crire la prise en charge des patients atteints de leuc\u00e9mie lympho\u00efde chronique (LLC) en rechute ou r\u00e9fractaire et trait\u00e9s par MabThera\u00ae","alternate_title":"PERLE"},"study_authorization":{"agency":[{"name":"Autre"}]},"authoring_entity":[],"oth_id":[{"name":""}],"production_statement":{"prod_place":"Portail Epid\u00e9miologie France (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","lastname":"Medical data center","firstname":"","type":"contact","email":"data_sharing.france@roche.com","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":"H\u00e9matologie","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":"Tumeurs de tissus h\u00e9matopo\u00ef\u00e9tiques ou lympho\u00efdes","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/944754984","title":"CIM-11"}]},{"topic":"D\u00e9terminants li\u00e9s au syst\u00e8me de sant\u00e9 : Consommation des soins","vocab":"health determinant"},{"topic":"D\u00e9terminants li\u00e9s au syst\u00e8me de sant\u00e9","vocab":"health determinant"}],"purpose":"Objectif principal : D\u00e9crire les sch\u00e9mas de chimioth\u00e9rapie associ\u00e9s \u00e0 MabThera\u00ae chez les patients atteints de leuc\u00e9mie lympho\u00efde chronique (LLC) en rechute ou r\u00e9fractaire ayant d\u00e9j\u00e0 re\u00e7u un traitement de premi\u00e8re ou de deuxi\u00e8me ligne contenant MabThera\u00ae. Objectifs secondaires : - D\u00e9crire l'efficacit\u00e9 du traitement : r\u00e9ponse globale, r\u00e9ponse compl\u00e8te, r\u00e9ponse partielle, survie sans progression, d\u00e9lai jusqu'au prochain traitement, survie globale dans la cohorte totale et dans les sous-groupes suivants : r\u00e9fractaire (Oui\/Non), \u00e2ge (< ou >= 70 ans), d\u00e9l\u00e9tion 17p (Oui\/Non), d\u00e9l\u00e9tion 11q (Oui\/Non). - D\u00e9crire le choix du r\u00e9gime de chimioth\u00e9rapie dans les sous-groupes de patients d\u00e9finis comme : r\u00e9fractaires (Oui\/Non), \u00e2ge (< ou >= 70 ans), d\u00e9l\u00e9tion 17p (Oui\/Non), d\u00e9l\u00e9tion 11q (Oui\/Non). - D\u00e9crire les sch\u00e9mas th\u00e9rapeutiques de MabThera\u00ae (dose, nombre de cycles), - D\u00e9crire la s\u00e9curit\u00e9 du traitement : tous les \u00e9v\u00e9nements ind\u00e9sirables survenus au cours de l'\u00e9tude, - D\u00e9crire les hospitalisations li\u00e9es \u00e0 un \u00e9v\u00e9nement ind\u00e9sirable pendant la p\u00e9riode de l'\u00e9tude. Objectifs exploratoires : -L'analyse de la dur\u00e9e maximale de r\u00e9ponse \u00e0 la derni\u00e8re ligne de traitement avant l'inclusion sera r\u00e9alis\u00e9e quantitativement et par classes, globalement et par \u00e2ge, chez tous les patients et en fonction du nombre de lignes de traitement ant\u00e9rieures. - Le crit\u00e8re principal sera \u00e9galement d\u00e9crit selon les sous-groupes suivants : - le dernier traitement ant\u00e9rieur \u00e0 la rechute actuelle comprenait le m\u00eame traitement chimioth\u00e9rapeutique que le premier traitement d'induction. - r\u00e9sultat de la clairance de la cr\u00e9atinine normalis\u00e9e < 60 (ml\/min\/1,73 m\u00b2) au d\u00e9part (oui\/non) (insuffisance r\u00e9nale). - Chez les patients positifs \u00e0 l\u2019antig\u00e8ne de l\u2019h\u00e9patite B (HBs) ou positifs aux anticorps anti-HBc, une analyse de la prophylaxie contre le virus de l\u2019h\u00e9patite B (VHB) ainsi que du traitement du VHB sera r\u00e9alis\u00e9e lors de chaque visite. - R\u00e9gression multinomiale sur le choix de la chimioth\u00e9rapie administr\u00e9e au premier cycle - Mod\u00e8le logistique de la r\u00e9ponse","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":"Individus","universe":"{\n    \"level_sex_clusion_I\": [\n        {\n            \"value\": \"Masculin\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D008297\"\n            }\n        },\n        {\n            \"value\": \"F\u00e9minin\",\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\": \"Adulte (19 \u00e0 24 ans)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D055815\"\n            }\n        },\n        {\n            \"value\": \"Adulte (25 \u00e0 44 ans)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000328\"\n            }\n        },\n        {\n            \"value\": \"Adulte (45 \u00e0 64 ans)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D008875\"\n            }\n        },\n        {\n            \"value\": \"Personne \u00e2g\u00e9e (65 \u00e0 79 ans)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000368\"\n            }\n        },\n        {\n            \"value\": \"Grand \u00e2ge (80 ans et plus)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000369\"\n            }\n        }\n    ],\n    \"level_type_clusion_I\": \"Patients\",\n    \"level_type_clusion_other\": \"\",\n    \"clusion_I\": \"Crit\u00e8res d'inclusion : - Patient adulte (\u00e2ge >= 18 ans) - Pr\u00e9sentant une leuc\u00e9mie lympho\u00efde chronique confirm\u00e9e par l'immunoph\u00e9notypage des lymphocytes circulants (score de Matutes >= 4) - En rechute ou r\u00e9fractaire apr\u00e8s une premi\u00e8re ou une deuxi\u00e8me ligne de traitement - recevant au moins une ligne de traitement contenant MabThera\u00ae. - Traitement par MabThera\u00ae pr\u00e9vu pour la rechute actuelle - Avoir re\u00e7u une information orale et \u00e9crite sur l'\u00e9tude et n'avoir soulev\u00e9 aucune objection au traitement informatique de ses donn\u00e9es personnelles. \",\n    \"clusion_E\": \"Patient atteint du syndrome de Richter - Patient dont l'esp\u00e9rance de vie est < 6 mois - Patient ayant re\u00e7u 3 lignes de traitement ant\u00e9rieures ou plus* - Patient ayant d\u00e9j\u00e0 particip\u00e9 \u00e0 cette \u00e9tude\"\n}","data_kind":"['Donn\u00e9es cliniques']","quality_statement":{"standards":[{"name":"['similaire \u00e0 CDISC']","committee":"","governance":""}],"other_quality_statement":"['Bonnes pratiques cliniques\/Bonnes Pratiques de Pharmacovigilance (GCP\/GVP)']"}},"study_development":{"development_activity":[]},"method":{"data_collection":{"time_method":"","frequency":"","sampling_procedure":"['{\"concept\":{\"vocabURI\":\"Other\",\"vocab\":\"CESSDA\"},\"value\":\"Autre\"}']","sample_frame":{"frame_unit":{"unit_type":"['Via les professionnels d&#x27;exercice lib\u00e9ral']"}},"coll_mode":["{\"concept\":{\"vocabURI\":\"Transcription\",\"vocab\":\"CESSDA\"},\"value\":\"Transcription et saisie d\u2019informations dans un enregistrement structur\u00e9\"}"],"research_instrument":"Acc\u00e8s restreint sur projet sp\u00e9cifique","sources":[],"target_sample_size":"< 500 individus","response_rate":"327"},"method_notes":"Etude observationnelle","study_class":"Inconnu","notes":[{"subject":"research type","values":["Etude observationnelle"]}]},"data_access":{"dataset_availability":{"access_place":"","complete":"","status":"{\"value\":\"Acc\u00e8s 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de donn\u00e9es recueillies : ant\u00e9c\u00e9dents m\u00e9dicaux et troubles concomitants, cycles de traitement administr\u00e9s, donn\u00e9es des tests de laboratoire, efficacit\u00e9, \u00e9valuation du patient, effets ind\u00e9sirables, arr\u00eat pr\u00e9coce permanent, ant\u00e9c\u00e9dents de leuc\u00e9mie lympho\u00efde chronique, v\u00e9rification des crit\u00e8res de s\u00e9lection avant l'inclusion, programme de traitement initialement pr\u00e9vu pour le traitement de cette rechute (ou de cet \u00e9tat r\u00e9fractaire) de leuc\u00e9mie lympho\u00efde chronique, rechute actuelle (ou \u00e9tat r\u00e9fractaire) de leuc\u00e9mie lympho\u00efde chronique, traitements ant\u00e9rieurs de la leuc\u00e9mie lympho\u00efde chronique, donn\u00e9es d\u00e9mographiques, traitement prophylactique ou anti-infectieux, transplantations de cellules souches h\u00e9matopo\u00ef\u00e9tiques, syndrome de 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