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behandeling met venetoclax/obinutuzumab (12 kuren), behandeling met venetoclax/pirtobrutinib (15 kuren) en een MRD gestuurde behandeling met venetoclax/pirtobrutinib met elkaar worden vergeleken bij patiënten met niet eerder behandelde chronische lymfatische leukemie (CLL) of kleincellig lymfocytair lymfoom (SLL) met als doel om op basis van de aanwezigheid van restziekte de duur van de behandeling aan te passen en het resultaat van de behandeling te verbeteren (CLL18/MOIRAI)","language":18,"languageDescription":"Dutch"},{"id":12310764,"uuid":"8305d22b-3bdf-4239-9e8c-511d8e6b5943","attributeTranslation":"Essai de phase 3, multicentrique, randomisé, prospectif et ouvert, comparant venetoclax/ obinutuzumab durée fixe (12 cycles) vs. venetoclax/ pirtobrutinib durée fixe (15 cycles) vs. venetoclax/ pirtobrutinib guidé par la MRD \nchez des patients atteints de leucémie lymphoïde chronique (LLC) ou de lymphome lymphocytique (LL) non antérieurement traités, visant à établir la maladie 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comparer l'efficacité de Vene-toclax/Pirobrutinib guidé par la MRD par rapport à Venetoclax/Pirtobrutinib à durée fixe (15 cycles) et de Venetoclax/Pirtobrutinib guidé par la MRD par rapport à Venetoclax/Obinutuzumab à durée fixe (12 cycles) en mesurant la survie sans progression (SSP) chez des patients atteints de leucémie lym-phoïde chronique (LLC) ou de lymphome lymphocytique (LL) non antérieu-rement traités.","language":10,"languageDescription":"French"},{"id":12310761,"uuid":"a45e988d-08e7-4974-aa30-f6b679915455","attributeTranslation":"De primaire doelstelling van het onderzoek is vergelijking van de werkzaamheid van MRD-geleide venetoclax/pirtobrutinib vs. venetoclax/pirtobrutinib met vaste behandelduur (15 kuren), en MRD-geleide venetoclax/pirtobrutinib vs. venetoclax/obinutuzumab met vaste behandelduur (12 kuren), door bepaling van de progressievrije overleving (PFS) bij patiënten met niet eerder behandelde chronische lymfatische leukemie (CLL)/kleincellig lymfocytair lymfoom 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czasowych","language":19,"languageDescription":"Polish"}]},{"id":519469,"number":3,"secondaryObjective":"Complete response (CR) rate as assessed by iwCLL guidelines at the final restaging (three months after end of treatment) and at selected other time points","secondaryObjectiveTranslations":[{"id":12310777,"uuid":"83d05f8b-ece3-475f-a2f8-9d2fef2d67fb","attributeTranslation":"Complete respons (CR), beoordeeld met de criteria van iwCLL bij de laatste herbeoordeling (3 maanden na het eind van de behandeling) en op andere geselecteerde tijdstippen.","language":18,"languageDescription":"Dutch"},{"id":12310778,"uuid":"83d05f8b-ece3-475f-a2f8-9d2fef2d67fb","attributeTranslation":"Tasa de respuesta completa (CR) evaluada según las directrices iwCLL en la estadificación final (tres meses después de finalizar el tratamiento) y en otros puntos temporales seleccionados.","language":7,"languageDescription":"Spanish"},{"id":12310779,"uuid":"83d05f8b-ece3-475f-a2f8-9d2fef2d67fb","attributeTranslation":"Odpowiedź całkowita (CR) oceniana według wytycznych iwCLL przy ostatniej ponownej ocenie (trzy miesiące po zakończeniu leczenia) i w innych wybranych punktach czasowych","language":19,"languageDescription":"Polish"},{"id":12310776,"uuid":"83d05f8b-ece3-475f-a2f8-9d2fef2d67fb","attributeTranslation":"Réponse complète (CR) tel qu’évaluée par les guidelines de l'iwCLL lors de l’évaluation finale (trois mois après la fin du traitement) et à d'autres moments sélectionnés.","language":10,"languageDescription":"French"}]},{"id":519470,"number":4,"secondaryObjective":"Duration of response (DOR) as assessed by iwCLL guidelines","secondaryObjectiveTranslations":[{"id":12310781,"uuid":"1560f814-4035-4135-9f47-af787c7abd71","attributeTranslation":"Duración de la respuesta (DOR) según las directrices iwCLL","language":7,"languageDescription":"Spanish"},{"id":12310783,"uuid":"1560f814-4035-4135-9f47-af787c7abd71","attributeTranslation":"Durée de la réponse (DoR) tel qu’évaluée par les guidelines de l'iwCLL","language":10,"languageDescription":"French"},{"id":12310782,"uuid":"1560f814-4035-4135-9f47-af787c7abd71","attributeTranslation":"Czas trwania odpowiedzi (DOR) oceniany zgodnie z wytycznymi iwCLL","language":19,"languageDescription":"Polish"},{"id":12310780,"uuid":"1560f814-4035-4135-9f47-af787c7abd71","attributeTranslation":"Duur van respons (DOR), beoordeeld met de criteria van iwCLL.","language":18,"languageDescription":"Dutch"}]},{"id":519471,"number":5,"secondaryObjective":"Time to next treatment (TTNT)","secondaryObjectiveTranslations":[{"id":12310787,"uuid":"1caa3d51-9ce9-44aa-8d65-b18b496c95bb","attributeTranslation":"Tijd tot volgende behandeling (TTNT)","language":18,"languageDescription":"Dutch"},{"id":12310786,"uuid":"1caa3d51-9ce9-44aa-8d65-b18b496c95bb","attributeTranslation":"Czas do następnego leczenia (TTNT)","language":19,"languageDescription":"Polish"},{"id":12310784,"uuid":"1caa3d51-9ce9-44aa-8d65-b18b496c95bb","attributeTranslation":"Tiempo hasta el siguiente tratamiento (TTNT)","language":7,"languageDescription":"Spanish"},{"id":12310785,"uuid":"1caa3d51-9ce9-44aa-8d65-b18b496c95bb","attributeTranslation":"Délai avant le prochain traitement anti-lymphomateux (TTNT)","language":10,"languageDescription":"French"}]},{"id":519472,"number":6,"secondaryObjective":"Treatment-free survival (TFS)","secondaryObjectiveTranslations":[{"id":12310790,"uuid":"9acfeb15-010d-4e7a-bfb7-7097c92bae1e","attributeTranslation":"Behandelingsvrije overleving (TFS)","language":18,"languageDescription":"Dutch"},{"id":12310789,"uuid":"9acfeb15-010d-4e7a-bfb7-7097c92bae1e","attributeTranslation":"Czas przeżycia bez leczenia (TFS)","language":19,"languageDescription":"Polish"},{"id":12310788,"uuid":"9acfeb15-010d-4e7a-bfb7-7097c92bae1e","attributeTranslation":"Supervivencia libre de tratamiento (TFS)","language":7,"languageDescription":"Spanish"},{"id":12310791,"uuid":"9acfeb15-010d-4e7a-bfb7-7097c92bae1e","attributeTranslation":"Survie sans traitement (TFS)","language":10,"languageDescription":"French"}]},{"id":519473,"number":7,"secondaryObjective":"Overall survival (OS)","secondaryObjectiveTranslations":[{"id":12310795,"uuid":"34400dfa-143e-46c1-b74e-f4d452bcef3a","attributeTranslation":"Totale overleving (OS)","language":18,"languageDescription":"Dutch"},{"id":12310794,"uuid":"34400dfa-143e-46c1-b74e-f4d452bcef3a","attributeTranslation":"Całkowity czas przeżycia (OS)","language":19,"languageDescription":"Polish"},{"id":12310792,"uuid":"34400dfa-143e-46c1-b74e-f4d452bcef3a","attributeTranslation":"Survie globale (OS)","language":10,"languageDescription":"French"},{"id":12310793,"uuid":"34400dfa-143e-46c1-b74e-f4d452bcef3a","attributeTranslation":"Supervivencia en general (OS)","language":7,"languageDescription":"Spanish"}]},{"id":519474,"number":8,"secondaryObjective":"Safety and tolerability of MRD-guided Ven-Pirto, fixed-duration Ven-Pirto, and fixed-duration Ven-Obi","secondaryObjectiveTranslations":[{"id":12310799,"uuid":"4542f93b-c58b-49ad-9eb5-e61b5b31e2fa","attributeTranslation":"Ocena bezpieczeństwa i tolerancji Ven-Pirto pod kontrolą MRD, Ven-Pirto o stałym czasie trwania i Ven-Obi o stałym czasie trwania","language":19,"languageDescription":"Polish"},{"id":12310797,"uuid":"4542f93b-c58b-49ad-9eb5-e61b5b31e2fa","attributeTranslation":"Évaluer la sûreté et la tolérance du Ven-Pirto guidés par la MRD, du Ven-Pirto à durée fixe et du Ven-Obi à durée fixe.","language":10,"languageDescription":"French"},{"id":12310798,"uuid":"4542f93b-c58b-49ad-9eb5-e61b5b31e2fa","attributeTranslation":"Evalueren van de veiligheid en verdraagbaarheid van MRD-geleide Ven-Pirto, Ven-Pirto met vaste behandelduur en Ven-Obi met vaste behandelduur.","language":18,"languageDescription":"Dutch"},{"id":12310796,"uuid":"4542f93b-c58b-49ad-9eb5-e61b5b31e2fa","attributeTranslation":"Evaluar la seguridad y tolerabilidad de Ven-Pirto guiado por EMR, Ven-Pirto de duración fija y Ven-Obi de duración fija.","language":7,"languageDescription":"Spanish"}]},{"id":519475,"number":9,"secondaryObjective":"Best response as assessed by iwCLL guidelines until one year after end of treatment","secondaryObjectiveTranslations":[{"id":12310802,"uuid":"60f00b4b-500f-4ebb-8271-9fa6e6183a21","attributeTranslation":"Mejor respuesta evaluada según las directrices iwCLL hasta un año después del fin del tratamiento.","language":7,"languageDescription":"Spanish"},{"id":12310803,"uuid":"60f00b4b-500f-4ebb-8271-9fa6e6183a21","attributeTranslation":"Meilleure réponse possible tel qu’évalué par les guidelines de l'iwCLL jusqu'à 1 an après la fin du traitement","language":10,"languageDescription":"French"},{"id":12310801,"uuid":"60f00b4b-500f-4ebb-8271-9fa6e6183a21","attributeTranslation":"Najlepsza odpowiedź oceniana według wytycznych iwCLL do 1 roku po zakończeniu leczenia.","language":19,"languageDescription":"Polish"},{"id":12310800,"uuid":"60f00b4b-500f-4ebb-8271-9fa6e6183a21","attributeTranslation":"Beste respons beoordeeld met de criteria van iwCLL tot 1 jaar na einde behandeling","language":18,"languageDescription":"Dutch"}]}]},"eligibilityCriteria":{"principalInclusionCriteria":[{"id":987633,"number":1,"principalInclusionCriteria":"Documented CLL/SLL requiring treatment according to iwCLL criteria with a CLL phenotype cell count >10-2 tracked by flow cytometry at screening.","principalInclusionCriteriaTranslations":[{"id":12310723,"uuid":"9dcce903-34b7-4918-bd23-37a9d1fe9837","attributeTranslation":"Gedocumenteerde CLL/SLL waarvoor behandeling nodig is volgens de iwCLL-criteria en waarbij het aantal cellen van het CLL-fenotype > 10-2 is, vastgesteld door flowcytometrie bij screening.","language":18,"languageDescription":"Dutch"},{"id":12310724,"uuid":"9dcce903-34b7-4918-bd23-37a9d1fe9837","attributeTranslation":"CLL/SLL documentada que requiera tratamiento según los criterios de iwCLL con un recuento celular de fenotipo CLL >10-2 rastreado por citometría de flujo en el momento del cribado.","language":7,"languageDescription":"Spanish"},{"id":12310725,"uuid":"9dcce903-34b7-4918-bd23-37a9d1fe9837","attributeTranslation":"Udokumentowane rozpoznanie przewlekłej białaczki limfocytowej (CLL) / chłoniaka z małych limfocytów (SLL) wymagające leczenia zgodnie z kryteriami iwCLL z liczebnością komórek białaczkowych >10-2 wykrytych metodą cytometrii przesiewowej podczas badań przesiewowych.","language":19,"languageDescription":"Polish"},{"id":12310726,"uuid":"9dcce903-34b7-4918-bd23-37a9d1fe9837","attributeTranslation":"LLC/LL documentée nécessitant un traitement selon les critères de l'iwCLL avec, au screening, un nombre de cellules de phénotype CLL > 10-2 décompté par cytométrie en flux.","language":10,"languageDescription":"French"}]},{"id":987634,"number":2,"principalInclusionCriteria":"Adequate bone marrow function as indicated by: - an absolute neutrophil count ≥ 1 x 10⁹/l - a hemoglobin value ≥8.0 g/dL without transfusions during the last 7 days unless directly attributable to CLL/SLL (e.g. bone marrow infiltration) and  - a platelet count ≥ 25 x 10⁹/l unless due to the CLL/SLL, in this case, platelet count should be ≥ 10.000/µl without transfusion during the last 7 days.","principalInclusionCriteriaTranslations":[{"id":12310728,"uuid":"e0db187e-ce2e-4983-8467-e27710ee0cd3","attributeTranslation":"Función adecuada de la médula ósea, indicada por:\n-\tun recuento absoluto de neutrófilos ≥ 1 x 10⁹/l\n-\tun valor de hemoglobina ≥8,0 g/dL sin transfusiones durante los últimos 7 días, a menos que sea directamente atribuible a LLC/SLL (por ejemplo, infiltración de la médula ósea) y \n-\tun recuento de plaquetas ≥ 25 x 10⁹/l a menos que se deba a la LLC/LSB; en este caso, el recuento de plaquetas debe ser ≥ 10000/µl sin transfusiones durante los últimos 7 días.","language":7,"languageDescription":"Spanish"},{"id":12310727,"uuid":"e0db187e-ce2e-4983-8467-e27710ee0cd3","attributeTranslation":"Adequate beenmergfunctie, aangetoond met:\n-\tabsoluut aantal neutrofielen ≥ 1 x 10⁹/l,\n-\themoglobinewaarde ≥ 8,0 g/dl zonder transfusie in de afgelopen 7 dagen, tenzij direct toe te schrijven aan CLL/SLL (bv. beenmerginfiltratie), en \n-\taantal bloedplaatjes ≥ 25 x 10⁹/l, tenzij als gevolg van CLL/SLL; in dat geval moet het aantal bloedplaatjes ≥ 10.000/µl zijn zonder transfusie in de afgelopen 7 dagen.","language":18,"languageDescription":"Dutch"},{"id":12310729,"uuid":"e0db187e-ce2e-4983-8467-e27710ee0cd3","attributeTranslation":"Odpowiednie parametry czynnościowe szpiku kostnego zdefiniowane jak poniżej:\n-\tbezwzględna liczba neutrofili ≥ 1 x 10⁹/l\n-\themoglobina ≥8.0 g/dL bez wsparcia transfuzyjnego w ciągu ostatnich 7 dni, chyba że związane bezpośrednio z chorobą podstawową CLL/SLL (np. rozległe zajęcie szpiku) oraz\n-\tpłytki krwi ≥ 25 x 10⁹/l, w sytuacji związku z CLL/SLL liczba płytek krwi powinna być ≥ 10000/µl bez wsparcia transfuzyjnego w ciągu ostatnich 7 dni.","language":19,"languageDescription":"Polish"},{"id":12310730,"uuid":"e0db187e-ce2e-4983-8467-e27710ee0cd3","attributeTranslation":"Bon fonctionnement de la moelle osseuse indiqué par:\n-\tun nombre absolu de taux de neutrophiles ≥ 1 x 10⁹/l\n-\tune valeur d'hémoglobine ≥8.0 g/dL sans transfusion au cours des 7 derniers jours, sauf si directement attribuable à la LLC/LL (par exemple, infiltration de la moelle osseuse) et \n-\tune numération plaquettaire ≥ 25 x 10⁹/l sauf si elle est due à la LLC/LL; dans ce cas, la numération plaquettaire doit être ≥ 10000/µl sans transfusion au cours des 7 derniers jours","language":10,"languageDescription":"French"}]},{"id":987635,"number":3,"principalInclusionCriteria":"Adequate renal function, as indicated by a creatinine clearance ≥30ml/min calculated according to the MDRD-formula or an equally accurate method (e.g. 24 hr. urine collection)","principalInclusionCriteriaTranslations":[{"id":12310733,"uuid":"2a7072b6-c4ec-4820-be16-e2e6f1b4c779","attributeTranslation":"Odpowiednia czynność nerek wskazana przez poziom klirensu kreatyniny ≥30ml/min obliczonego zgodnie ze wzorem MDRD lub równie dokładną metodą (np. 24-godzinna zbiórka moczu).","language":19,"languageDescription":"Polish"},{"id":12310731,"uuid":"2a7072b6-c4ec-4820-be16-e2e6f1b4c779","attributeTranslation":"Adequate nierfunctie, aangetoond met een creatinineklaring ≥ 30 ml/min berekend met de MDRD-formule of een gelijkwaardige methode (bv. 24uurs-urinemonster).","language":18,"languageDescription":"Dutch"},{"id":12310734,"uuid":"2a7072b6-c4ec-4820-be16-e2e6f1b4c779","attributeTranslation":"Fonction rénale adéquate, indiquée par une clairance de la créatinine ≥ 30ml/min calculée selon la formule MDRD ou une méthode ayant une précision équivalente (par exemple, collecte d'urine sur 24 heures)","language":10,"languageDescription":"French"},{"id":12310732,"uuid":"2a7072b6-c4ec-4820-be16-e2e6f1b4c779","attributeTranslation":"Función renal adecuada, indicada por un aclaramiento de creatinina ≥30ml/min calculado según la fórmula MDRD o un método igual de preciso (por ejemplo, recogida de orina en 24 horas).","language":7,"languageDescription":"Spanish"}]},{"id":987636,"number":4,"principalInclusionCriteria":"Adequate liver function as indicated by:  - a total bilirubin≤ 2 x the institutional upper limit of normal (ULN) value, and   -\tAST/ ALT ≤ 2.5 x the institutional ULN value, unless directly attributable to the patient’s CLL/SLL or to Gilbert’s Syndrome.","principalInclusionCriteriaTranslations":[{"id":12310736,"uuid":"ac9659da-c70f-408c-a3af-9a5171796dc5","attributeTranslation":"Función hepática adecuada, indicada por \n-\tuna bilirrubina total ≤ 2 x el valor del límite superior de la normalidad (LSN) institucional, y  \n-\tAST/ ALT ≤ 2,5 x el valor ULN institucional,\na menos que sea directamente atribuible a la LLC/SLL del paciente o al Síndrome de Gilbert.","language":7,"languageDescription":"Spanish"},{"id":12310738,"uuid":"ac9659da-c70f-408c-a3af-9a5171796dc5","attributeTranslation":"Adequate leverfunctie, aangetoond met: \n-\ttotaalbilirubine ≤ 2x de bovengrens van normaal (ULN) van de instelling, en  \n-\tASAT/ALAT ≤ 2,5x de ULN van de instelling,\n\ttenzij rechtstreeks toe te schrijven aan CLL/SLL of aan het Gilbert-syndroom.","language":18,"languageDescription":"Dutch"},{"id":12310735,"uuid":"ac9659da-c70f-408c-a3af-9a5171796dc5","attributeTranslation":"Odpowiednia czynność wątroby zdefiniowana jak poniżej:\n-\tBilirubina całkowita  ≤ 2 x górna granica normy zgodna z zakresem referencyjnym lokalnego laboratorium (ULN) oraz  \n-\tAST/ ALT  ≤ 2.5 x górna granica normy zgodna z zakresem referencyjnym lokalnego laboratorium (ULN),\n\tchyba że związane bezpośrednio z chorobą podstawową CLL/SLL lub syndromem Gilberta.","language":19,"languageDescription":"Polish"},{"id":12310737,"uuid":"ac9659da-c70f-408c-a3af-9a5171796dc5","attributeTranslation":"Fonction hépatique adéquate indiquée par: \n-\tune bilirubine totale ≤ 2 x la limite supérieure de la normale de l'établissement, et \n-\tASAT/ ALAT ≤ 2.5 x la limite supérieure de la valeur normale de l'établissement,\n\tsauf si elles sont directement attribuables à la LLC/LL du patient ou à un syndrome de Gilbert.","language":10,"languageDescription":"French"}]},{"id":987637,"number":5,"principalInclusionCriteria":"Negative serological testing for hepatitis B (HBsAg negative and anti-HBc negative; patients positive for anti-HBc may be included if PCR for HBV DNA is negative and HBV-DNA PCR is performed every month until 12 months after last dosage of obinutuzumab), negative testing for hepatitis-C (HCV-RNA PCR) and negative HIV test within 6 weeks prior to registration","principalInclusionCriteriaTranslations":[{"id":12310741,"uuid":"a674e3c5-c2ae-4a4b-a956-de67de9e975c","attributeTranslation":"Pruebas serológicas negativas para la hepatitis B (HBsAg negativo y anti-HBc negativo; los pacientes positivos para anti-HBc pueden incluirse si la PCR para el ADN del VHB es negativa y la PCR para el ADN del VHB se realiza mensualmente hasta 12 meses después de la última dosis de obinutuzumab), pruebas negativas para la hepatitis-C (PCR para el ARN del VHC) y prueba negativa del VIH en las 6 semanas anteriores al registro.","language":7,"languageDescription":"Spanish"},{"id":12310742,"uuid":"a674e3c5-c2ae-4a4b-a956-de67de9e975c","attributeTranslation":"Test sérologique pour l'hépatite B négatif (HBsAg négatif et anti-HBc négatif ; les patients positifs pour l'anti-HBc peuvent être inclus si la PCR ADN VHB est négative et si la PCR ADN VHB est effectuée tous les mois jusqu'à 12 mois après la dernière dose d'obinutuzumab), test pour l'hépatite C négatif (PCR ARN VHC) et test pour le VIH négatif dans les 6 semaines précédant le screening dans l’étude","language":10,"languageDescription":"French"},{"id":12310740,"uuid":"a674e3c5-c2ae-4a4b-a956-de67de9e975c","attributeTranslation":"Negatieve serologische test voor hepatitis B (HBsAg-negatief en anti-HBc-negatief; patiënten die positief zijn voor anti-HBc mogen meedoen als de PCR voor HBV-DNA negatief is en er maandelijks een HBV-DNA-PCR wordt gedaan tot 12 maanden na de laatste dosis obinutuzumab), negatieve test voor hepatitis-C (HCV-RNA-PCR) en negatieve HIV-test maximaal 6 weken vóór inschrijving.","language":18,"languageDescription":"Dutch"},{"id":12310739,"uuid":"a674e3c5-c2ae-4a4b-a956-de67de9e975c","attributeTranslation":"Negatywne wyniki badań serologicznych w kierunku zapalenia wątroby typu B (ujemny wynik HBsAg i ujemny wynik przeciwciał anty-HBc; pacjenci z dodatnim wynikiem przeciwciał anty-HBc mogą zostać włączeni do badania, jeśli PCR w kierunku DNA HBV jest ujemny, a PCR DNA HBV jest wykonywany co miesiąc do 12 miesięcy po ostatniej dawce obinutuzumabu), ujemny wynik badania w kierunku zapalenia wątroby typu C (PCR HCV-RNA) i ujemny wynik badania w kierunku HIV w ciągu 6 tygodni przed rejestracją.","language":19,"languageDescription":"Polish"}]},{"id":987638,"number":6,"principalInclusionCriteria":"Age ≥ 18 years","principalInclusionCriteriaTranslations":[{"id":12310746,"uuid":"8e2f7ab5-862e-4e32-a550-3e53d7e173bc","attributeTranslation":"Wiek ≥ 18 lat","language":19,"languageDescription":"Polish"},{"id":12310744,"uuid":"8e2f7ab5-862e-4e32-a550-3e53d7e173bc","attributeTranslation":"Age ≥ 18 ans","language":10,"languageDescription":"French"},{"id":12310743,"uuid":"8e2f7ab5-862e-4e32-a550-3e53d7e173bc","attributeTranslation":"Leeftijd ≥ 18 jaar.","language":18,"languageDescription":"Dutch"},{"id":12310745,"uuid":"8e2f7ab5-862e-4e32-a550-3e53d7e173bc","attributeTranslation":"Edad ≥ 18 años","language":7,"languageDescription":"Spanish"}]},{"id":987639,"number":7,"principalInclusionCriteria":"Eastern Cooperative Oncology Group Performance Status (ECOG) performance status","principalInclusionCriteriaTranslations":[{"id":12310749,"uuid":"9df798be-e016-4b50-ab1a-06dbfcc13c41","attributeTranslation":"Indice de Performance ECOG (Eastern Cooperative Oncology Group Performance Status) 0-2","language":10,"languageDescription":"French"},{"id":12310747,"uuid":"9df798be-e016-4b50-ab1a-06dbfcc13c41","attributeTranslation":"Eastern Cooperative Oncology Group (ECOG)-performancestatus 0-2.","language":18,"languageDescription":"Dutch"},{"id":12310748,"uuid":"9df798be-e016-4b50-ab1a-06dbfcc13c41","attributeTranslation":"Estado de rendimiento de 0 a 2 en la escala ECOG (Eastern Cooperative Oncology Group)","language":7,"languageDescription":"Spanish"},{"id":12310750,"uuid":"9df798be-e016-4b50-ab1a-06dbfcc13c41","attributeTranslation":"Pacjent z wynikiem oceny sprawności wg Eastern Cooperative Oncology Group (ECOG) w przedziale 0-2","language":19,"languageDescription":"Polish"}]},{"id":987640,"number":8,"principalInclusionCriteria":"Life expectancy ≥ 6 months","principalInclusionCriteriaTranslations":[{"id":12310754,"uuid":"ccbacb7b-447c-4034-b4c1-2cc557ee5714","attributeTranslation":"Espérance de vie ≥ 6 mois","language":10,"languageDescription":"French"},{"id":12310753,"uuid":"ccbacb7b-447c-4034-b4c1-2cc557ee5714","attributeTranslation":"Spodziewane przeżycie ≥ 6 miesięcy","language":19,"languageDescription":"Polish"},{"id":12310751,"uuid":"ccbacb7b-447c-4034-b4c1-2cc557ee5714","attributeTranslation":"Levensverwachting ≥ 6 maanden.","language":18,"languageDescription":"Dutch"},{"id":12310752,"uuid":"ccbacb7b-447c-4034-b4c1-2cc557ee5714","attributeTranslation":"Esperanza de vida ≥ 6 meses","language":7,"languageDescription":"Spanish"}]},{"id":987641,"number":9,"principalInclusionCriteria":"Ability and willingness to provide written informed consent and to adhere to the study visit schedule and other protocol requirements.","principalInclusionCriteriaTranslations":[{"id":12310757,"uuid":"b8cfdda2-a923-4778-affb-e34fa771ebcb","attributeTranslation":"In staat en bereid om schriftelijke geïnformeerde toestemming te geven en zich te houden aan het bezoekschema en de andere protocolvereisten.","language":18,"languageDescription":"Dutch"},{"id":12310758,"uuid":"b8cfdda2-a923-4778-affb-e34fa771ebcb","attributeTranslation":"Capacidad y voluntad de dar consentimiento informado por escrito y de cumplir el programa de visitas del estudio y otros requisitos del protocolo.","language":7,"languageDescription":"Spanish"},{"id":12310756,"uuid":"b8cfdda2-a923-4778-affb-e34fa771ebcb","attributeTranslation":"Możliwość i chęć udzielenia pisemnej świadomej zgody oraz przestrzegania harmonogramu wizyt i innych wymagań protokołu.","language":19,"languageDescription":"Polish"},{"id":12310755,"uuid":"b8cfdda2-a923-4778-affb-e34fa771ebcb","attributeTranslation":"Capacité et volonté à donner un consentement libre, éclairé et écrit et de respecter le calendrier des visites de l'étude et les autres exigences du protocole.","language":10,"languageDescription":"French"}]}],"principalExclusionCriteria":[{"id":1685707,"number":1,"principalExclusionCriteria":"Any prior CLL- or SLL-specific therapies, except for corticosteroid treatment administered due to necessary immediate intervention (within the last 10 days before start of study treatment only dose equivalents up to 20 mg prednisolone per day are permitted).","principalExclusionCriteriaTranslations":[{"id":12310659,"uuid":"19bf38da-f1fd-42f4-a365-55c4266a6b9d","attributeTranslation":"Eerdere voor CLL/SLL specifieke behandelingen,  behalve een corticosteroïdenbehandeling die werd toegediend als noodzakelijke onmiddellijke interventie (in de 10 dagen voor de start van de onderzoeksbehandeling zijn alleen dosisequivalenten tot 20 mg prednisolon per dag toegestaan).","language":18,"languageDescription":"Dutch"},{"id":12310660,"uuid":"19bf38da-f1fd-42f4-a365-55c4266a6b9d","attributeTranslation":"Cualquier tratamiento previo específico con LLC o SLL, excepto el tratamiento con corticosteroides administrado debido a una intervención inmediata necesaria (en los últimos 10 días antes del inicio del tratamiento del estudio sólo se permiten dosis equivalentes de hasta 20 mg de prednisolona al día).","language":7,"languageDescription":"Spanish"},{"id":12310661,"uuid":"19bf38da-f1fd-42f4-a365-55c4266a6b9d","attributeTranslation":"Wszelkie wcześniejsze terapie specyficzne dla przewlekłej białaczki limfocytowej (CLL) lub chłoniaka z małych limfocytów (SLL), z wyjątkiem leczenia kortykosteroidami stosowanego ze względu na konieczność natychmiastowej interwencji (w ciągu ostatnich 10 dni przed rozpoczęciem leczenia w ramach badania dopuszczalne są wyłącznie dawki równoważne do 20 mg prednizolonu na dobę).","language":19,"languageDescription":"Polish"},{"id":12310658,"uuid":"19bf38da-f1fd-42f4-a365-55c4266a6b9d","attributeTranslation":"Tout traitement antérieur spécifique à la LLC ou à la LL , à l'exception d'une corticothérapie administrée en raison de la nécessité d'une intervention immédiate (dans les 10 derniers jours précédant le début du traitement de l'étude, seuls les équivalents de dose allant jusqu'à 20 mg de prednisolone par jour sont autorisés).","language":10,"languageDescription":"French"}]},{"id":1685708,"number":10,"principalExclusionCriteria":"Fertile men or women of childbearing potential unless: - surgically sterile or ≥ 2 years after the onset of menopause, or -\twilling to use two methods of reliable contraception including one highly effective (Pearl Index <1) and one additional effective (barrier) method during study treatment and for the  required time period thereafter (at least one and up to 18 months after end of study treatment depending of study drug(s) used, see chapter 2.2.2.1 Known risks relevant with all study drugs).","principalExclusionCriteriaTranslations":[{"id":12310665,"uuid":"3c089627-5310-46a2-93bc-b5ad07d709cc","attributeTranslation":"Vruchtbare mannen of vrouwen die zwanger kunnen worden, tenzij:\n-\tze operatief gesteriliseerd zijn, of de menopauze ≥ 2 jaar geleden begonnen is, of\n-\tze bereid zijn 2 betrouwbare anticonceptiemethoden te gebruiken, waarvan één zeer effectieve (Pearl-index < 1) en één aanvullend effectieve (barrière-) methode, gedurende de onderzoeksbehandeling en de vereiste periode daarna (minimaal 1 en maximaal 18 maanden na het eind van de onderzoeksbehandeling, afhankelijk van de gebruikte onderzoeksmedicatie).","language":18,"languageDescription":"Dutch"},{"id":12310662,"uuid":"3c089627-5310-46a2-93bc-b5ad07d709cc","attributeTranslation":"Hombres fértiles o mujeres en edad fértil a menos que:\na.\tquirúrgicamente estériles o ≥ 2 años después del inicio de la menopausia, o\nb.\tdispuestos a utilizar dos métodos anticonceptivos fiables, incluyendo uno altamente eficaz (Índice de Pearl <1) y otro método adicional eficaz (de barrera) durante el tratamiento del estudio y durante el periodo de tiempo posterior requerido (al menos uno y hasta 18 meses después de finalizar el tratamiento del estudio en función del fármaco o fármacos del estudio utilizados).","language":7,"languageDescription":"Spanish"},{"id":12310664,"uuid":"3c089627-5310-46a2-93bc-b5ad07d709cc","attributeTranslation":"Płodni mężczyźni lub kobiety w wieku rozrodczym, chyba że:\n-\tsą niepłodni chirurgicznie lub  ≥ 2 lata po wystąpieniu menopauzy, lub\n-\tsą gotowi stosować dwie niezawodne metody antykoncepcji, w tym jedną wysoce skuteczną (wskaźnik Pearla <1) i jedną dodatkową skuteczną (barierową) metodę podczas leczenia w ramach badania i przez wymagany okres czasu po jego zakończeniu (co najmniej jeden i do 18 miesięcy po zakończeniu leczenia w ramach badania, w zależności od stosowanych leków w ramach badania).","language":19,"languageDescription":"Polish"},{"id":12310663,"uuid":"3c089627-5310-46a2-93bc-b5ad07d709cc","attributeTranslation":"Homme fertile ou femme en âge de procréer, sauf si:\n- stérilité chirurgicale ou ≥ 2 ans après le début de la ménopause, ou\n- qui acceptent d’utiliser deux méthodes de contraception efficaces, dont une hautement efficace (indice de Pearl < 1) et une autre efficace (barrière) pendant le traitement de l'étude et pendant la période requise par la suite (pendant au moins un mois et jusqu'à 18 mois après la fin du traitement de l'étude, selon le(s) médicament(s) à l’étude reçu(s)).","language":10,"languageDescription":"French"}]},{"id":1685709,"number":11,"principalExclusionCriteria":"Vaccination with a live vaccine ≤ 28 days prior to registration","principalExclusionCriteriaTranslations":[{"id":12310666,"uuid":"05cc91ba-b73c-4a74-b3fb-90499756711d","attributeTranslation":"Vaccination par un vaccin vivant ≤ 28 jours avant le screening dans l’étude","language":10,"languageDescription":"French"},{"id":12310667,"uuid":"05cc91ba-b73c-4a74-b3fb-90499756711d","attributeTranslation":"Vaccinatie met een levend vaccin ≤ 28 dagen vóór registratie.","language":18,"languageDescription":"Dutch"},{"id":12310669,"uuid":"05cc91ba-b73c-4a74-b3fb-90499756711d","attributeTranslation":"Vacunación con una vacuna viva ≤ 28 días antes del registro","language":7,"languageDescription":"Spanish"},{"id":12310668,"uuid":"05cc91ba-b73c-4a74-b3fb-90499756711d","attributeTranslation":"Szczepienie szczepionką żywą ≤ 28 dni przed rejestracją","language":19,"languageDescription":"Polish"}]},{"id":1685710,"number":12,"principalExclusionCriteria":"Use of investigational agents which might interfere with the study drug within 28 days prior to registration","principalExclusionCriteriaTranslations":[{"id":12310671,"uuid":"0b2aa7cb-97fb-49a5-aaa7-c9a248fa615c","attributeTranslation":"Utilisation d'agents expérimentaux susceptibles d'interférer avec le médicament à l'étude dans les 28 jours précédant le screening dans l’étude","language":10,"languageDescription":"French"},{"id":12310673,"uuid":"0b2aa7cb-97fb-49a5-aaa7-c9a248fa615c","attributeTranslation":"Stosowanie w ciągu 28 dni przed rejestracją innych badanych substancji, które mogą oddziaływać na badany lek.","language":19,"languageDescription":"Polish"},{"id":12310670,"uuid":"0b2aa7cb-97fb-49a5-aaa7-c9a248fa615c","attributeTranslation":"Uso de agentes en investigación que puedan interferir con el fármaco del estudio en los 28 días previos al registro","language":7,"languageDescription":"Spanish"},{"id":12310672,"uuid":"0b2aa7cb-97fb-49a5-aaa7-c9a248fa615c","attributeTranslation":"Gebruik van experimentele middelen met een kans op interactie met het onderzoeksmiddel ≤ 28 dagen vóór registratie.","language":18,"languageDescription":"Dutch"}]},{"id":1685711,"number":13,"principalExclusionCriteria":"Legal incapacity","principalExclusionCriteriaTranslations":[{"id":12310675,"uuid":"55bcd57e-7285-4152-a209-5517c958ee2e","attributeTranslation":"Incapacidad legal","language":7,"languageDescription":"Spanish"},{"id":12310677,"uuid":"55bcd57e-7285-4152-a209-5517c958ee2e","attributeTranslation":"Wettelijke onbekwaamheid.","language":18,"languageDescription":"Dutch"},{"id":12310674,"uuid":"55bcd57e-7285-4152-a209-5517c958ee2e","attributeTranslation":"Incapacité légale","language":10,"languageDescription":"French"},{"id":12310676,"uuid":"55bcd57e-7285-4152-a209-5517c958ee2e","attributeTranslation":"Niezdolność prawna.","language":19,"languageDescription":"Polish"}]},{"id":1685712,"number":14,"principalExclusionCriteria":"Prisoners or subjects who are institutionalized by regulatory or court order","principalExclusionCriteriaTranslations":[{"id":12310681,"uuid":"6cc28a3b-78e9-40be-bf33-060a1069eabf","attributeTranslation":"Presos o sujetos institucionalizados por orden reglamentaria o judicial","language":7,"languageDescription":"Spanish"},{"id":12310678,"uuid":"6cc28a3b-78e9-40be-bf33-060a1069eabf","attributeTranslation":"Więźniowie lub osoby umieszczone w zakładach zamkniętych na mocy nakazu regulacyjnego lub sądowego","language":19,"languageDescription":"Polish"},{"id":12310680,"uuid":"6cc28a3b-78e9-40be-bf33-060a1069eabf","attributeTranslation":"Gedetineerden of personen die zijn geïnstitutionaliseerd op grond van regelgeving of een gerechtelijk bevel.","language":18,"languageDescription":"Dutch"},{"id":12310679,"uuid":"6cc28a3b-78e9-40be-bf33-060a1069eabf","attributeTranslation":"Détenus ou sujet placée en institution par une décision judiciaire ou administrative","language":10,"languageDescription":"French"}]},{"id":1685713,"number":15,"principalExclusionCriteria":"Persons who are in dependence to the sponsor or an investigator","principalExclusionCriteriaTranslations":[{"id":12310684,"uuid":"d06c76e2-7761-4542-8d59-383eefe28a7a","attributeTranslation":"Personas dependientes del promotor o de un investigador","language":7,"languageDescription":"Spanish"},{"id":12310683,"uuid":"d06c76e2-7761-4542-8d59-383eefe28a7a","attributeTranslation":"Les personnes qui ont une dépendance à l’égard du promoteur ou d'un investigateur","language":10,"languageDescription":"French"},{"id":12310685,"uuid":"d06c76e2-7761-4542-8d59-383eefe28a7a","attributeTranslation":"Osoby będące w zależności ze sponsorem lub badaczem.","language":19,"languageDescription":"Polish"},{"id":12310682,"uuid":"d06c76e2-7761-4542-8d59-383eefe28a7a","attributeTranslation":"Personen die afhankelijk zijn van de sponsor of een onderzoeker.","language":18,"languageDescription":"Dutch"}]},{"id":1685714,"number":2,"principalExclusionCriteria":"Decompensated auto-immune cytopenia (defined as ongoing drop in hemoglobin (AIHA) or in platelets (ITP) in spite of prednisolone and/or intravenous immunoglobulins treatment).","principalExclusionCriteriaTranslations":[{"id":12310689,"uuid":"b5df13e7-ede4-4672-aa3c-8e1f079b48d1","attributeTranslation":"Niewyrównana cytopenia autoimmunologiczna (definiowana jako ciągły spadek stężenia hemoglobiny [AIHA] lub płytek krwi [ITP] pomimo leczenia prednizolonem i/lub dożylnymi immunoglobulinami).","language":19,"languageDescription":"Polish"},{"id":12310687,"uuid":"b5df13e7-ede4-4672-aa3c-8e1f079b48d1","attributeTranslation":"Citopenia autoinmune descompensada (definida como descenso continuado de la hemoglobina [AHAI] o de las plaquetas [PTI] a pesar del tratamiento con prednisolona y/o inmunoglobulinas intravenosas).","language":7,"languageDescription":"Spanish"},{"id":12310688,"uuid":"b5df13e7-ede4-4672-aa3c-8e1f079b48d1","attributeTranslation":"Cytopénie auto-immune décompensée (définie par une baisse continue de l'hémoglobine [AIHA] ou des plaquettes [ITP] malgré un traitement à base de prednisolone et/ou d'immunoglobulines intraveineuses).","language":10,"languageDescription":"French"},{"id":12310686,"uuid":"b5df13e7-ede4-4672-aa3c-8e1f079b48d1","attributeTranslation":"Gedecompenseerde auto-immuuncytopenie (gedefinieerd als een aanhoudende daling in hemoglobine [AIHA] of trombocyten [ITP], ondanks behandeling met prednisolon en/of intraveneuze immunoglobulinen).","language":18,"languageDescription":"Dutch"}]},{"id":1685715,"number":3,"principalExclusionCriteria":"(Suspicion of) transformation of CLL/SLL (i.e. Richter`s transformation) or central nervous system (CNS) involvement.","principalExclusionCriteriaTranslations":[{"id":12310690,"uuid":"f4dacee8-c4b1-4523-bbcf-4bfbb95c7ad6","attributeTranslation":"(Podejrzenie) transformacji CLL/SLL (tj. transformacji Richtera) lub zajęcia ośrodkowego układu nerwowego (OUN).","language":19,"languageDescription":"Polish"},{"id":12310693,"uuid":"f4dacee8-c4b1-4523-bbcf-4bfbb95c7ad6","attributeTranslation":"(Verdenking op) transformatie van CLL/SLL (bv. Richter-transformatie) of betrokkenheid van het centrale zenuwstelsel (CZS).","language":18,"languageDescription":"Dutch"},{"id":12310692,"uuid":"f4dacee8-c4b1-4523-bbcf-4bfbb95c7ad6","attributeTranslation":"(Suspicion de) transformation de la LLC/LL (c'est-à-dire transformation de Richter) ou d’atteinte du système nerveux central (SNC).","language":10,"languageDescription":"French"},{"id":12310691,"uuid":"f4dacee8-c4b1-4523-bbcf-4bfbb95c7ad6","attributeTranslation":"(Sospecha de) transformación de LLC/LSL (es decir, transformación de Richter) o afectación del sistema nervioso central (SNC).","language":7,"languageDescription":"Spanish"}]},{"id":1685716,"number":4,"principalExclusionCriteria":"(Suspicion of) progressive multifocal leukoencephalopathy (PML).","principalExclusionCriteriaTranslations":[{"id":12310697,"uuid":"20289a37-f51f-41f2-b632-27ab4b12668d","attributeTranslation":"(Podejrzenie) postępującej wieloogniskowej leukoencefalopatii (PML).","language":19,"languageDescription":"Polish"},{"id":12310694,"uuid":"20289a37-f51f-41f2-b632-27ab4b12668d","attributeTranslation":"(Suspicion de) leucoencéphalopathie multifocale progressive (LEMP).","language":10,"languageDescription":"French"},{"id":12310696,"uuid":"20289a37-f51f-41f2-b632-27ab4b12668d","attributeTranslation":"(Sospecha de) leucoencefalopatía multifocal progresiva (LMP).","language":7,"languageDescription":"Spanish"},{"id":12310695,"uuid":"20289a37-f51f-41f2-b632-27ab4b12668d","attributeTranslation":"(Verdenking op) progressieve multifocale leuko-encefalopathie (PML).","language":18,"languageDescription":"Dutch"}]},{"id":1685717,"number":5,"principalExclusionCriteria":"Malignant neoplasm other than CLL/SLL unless in remission and unlikely to adversely impact on patient´s life expectancy, defined as curatively treated non-melanoma skin cancer or other neoplasias treated curatively ≥1 year ago, without signs of progression and not currently requiring systemic therapies (with the exception of ongoing anti-hormonal therapy).","principalExclusionCriteriaTranslations":[{"id":12310699,"uuid":"def8383a-b7c3-42e6-b002-f8e8df3e89a9","attributeTranslation":"Maligne neoplasma anders dan CLL/SLL, tenzij het in remissie is en waarschijnlijk geen invloed heeft op de levensverwachting van de patiënt, gedefinieerd als curatief behandelde non-melanoma huidkanker of andere neoplasmen die ≥ 1 jaar geleden curatief behandeld zijn, geen tekenen van progressie vertonen en momenteel geen systemische behandeling behoeven (met uitzondering van lopende antihormonale therapie).","language":18,"languageDescription":"Dutch"},{"id":12310700,"uuid":"def8383a-b7c3-42e6-b002-f8e8df3e89a9","attributeTranslation":"Tumeur maligne autre que la LLC/LL, sauf si le patient est en rémission et qu'il est peu probable que cela impacte défavorablement son espérance de vie, tel qu’un cancer de la peau non-mélanome traité de manière curative ou d’autres néoplasies traitées de manière curative il y a ≥1 an, sans signe de progression et ne nécessitant actuellement pas de traitement systémique (à l'exception d'une thérapie anti-hormonale en cours).","language":10,"languageDescription":"French"},{"id":12310701,"uuid":"def8383a-b7c3-42e6-b002-f8e8df3e89a9","attributeTranslation":"Neoplasia maligna distinta de la LLC/LSL, a menos que esté en remisión y sea improbable que repercuta negativamente en la esperanza de vida del paciente, definida como cáncer de piel no melanoma tratado curativamente u otras neoplasias tratadas curativamente hace ≥1 año, sin signos de progresión y que no requieran actualmente terapias sistémicas (a excepción de la terapia antihormonal en curso).","language":7,"languageDescription":"Spanish"},{"id":12310698,"uuid":"def8383a-b7c3-42e6-b002-f8e8df3e89a9","attributeTranslation":"Nowotwór złośliwy inny niż przewlekła białaczka limfocytowa (CLL) / chłoniak z małych limfocytów (SLL), chyba że jest w remisji i mało prawdopodobne, aby miał negatywny wpływ na oczekiwaną długość życia pacjenta, zdefiniowany jako leczony radykalnie rak skóry inny niż czerniak lub inne nowotwory leczone radykalnie ≥1 rok temu, bez oznak progresji i obecnie niewymagające terapii ogólnoustrojowej (z wyjątkiem trwającej terapii antyhormonalnej).","language":19,"languageDescription":"Polish"}]},{"id":1685718,"number":6,"principalExclusionCriteria":"Active infection requiring systemic treatment, including HIV, HBV and HCV","principalExclusionCriteriaTranslations":[{"id":12310702,"uuid":"6b4dbab1-11a5-4b7d-aae3-cf3dab821a6f","attributeTranslation":"Infección activa que requiera tratamiento sistémico, incluyendo el VIH, el VHB y el VHC.","language":7,"languageDescription":"Spanish"},{"id":12310705,"uuid":"6b4dbab1-11a5-4b7d-aae3-cf3dab821a6f","attributeTranslation":"Actieve infectie waarvoor systemische behandeling nodig is, inclusief HIV, HBV en HCV.","language":18,"languageDescription":"Dutch"},{"id":12310703,"uuid":"6b4dbab1-11a5-4b7d-aae3-cf3dab821a6f","attributeTranslation":"Aktywne zakażenie wymagające leczenia ogólnoustrojowego, w tym HIV, HBV i HCV","language":19,"languageDescription":"Polish"},{"id":12310704,"uuid":"6b4dbab1-11a5-4b7d-aae3-cf3dab821a6f","attributeTranslation":"Infection active nécessitant un traitement systémique, y compris le VIH, le VHB et le VHC.","language":10,"languageDescription":"French"}]},{"id":1685719,"number":7,"principalExclusionCriteria":"Increased risk of bleeding, e.g. due to: - known bleeding disorder  - anticoagulant therapy with phenprocoumon or other vitamin K antagonists (anticoagulation with a direct oral Xa or thrombin inhibitor (DOAC) or heparin) is permitted) - major surgery ≤4 weeks prior to randomization - stroke or intracranial hemorrhage ≤ 6 months of randomization","principalExclusionCriteriaTranslations":[{"id":12310707,"uuid":"64890d09-3bde-44fb-adb0-e233c9dd620f","attributeTranslation":"Riesgo aumentado de hemorragia, por ejemplo, debido a:\n-\ttrastorno hemorrágico conocido\n-\ttratamiento anticoagulante con fenprocumón u otros antagonistas de la vitamina K (se permite la anticoagulación con un inhibidor oral directo [ACOD] del factor Xa o de la trombina [IDT] o heparina) \n-\tcirugía mayor ≤4 semanas antes de la randomización\n-\taccidente cerebrovascular o hemorragia intracraneal ≤ 6 meses de la randomización","language":7,"languageDescription":"Spanish"},{"id":12310709,"uuid":"64890d09-3bde-44fb-adb0-e233c9dd620f","attributeTranslation":"Verhoogd risico op bloeding, bv. als gevolg van:\n-\tbekende stollingsstoornis, \n-\tantistollingstherapie met fenprocoumon of een andere vitamine K-antagonist (antistolling met een directe orale Xa- of trombineremmer [DOAC] of heparine is toegestaan),\n-\tgrote operatie ≤ 4 weken vóór randomisatie,\n-\tCVA of intracraniële bloeding ≤ 6 maanden vóór randomisatie.","language":18,"languageDescription":"Dutch"},{"id":12310708,"uuid":"64890d09-3bde-44fb-adb0-e233c9dd620f","attributeTranslation":"Risque accru de saignement, par exemple en raison de:\n-\ttrouble de la coagulation connu \n-\ttraitement anticoagulant par phenprocoumone ou d'autres antagonistes de la vitamine K (l'anticoagulation par un inhibiteur direct de la Xa ou de la thrombine par voie orale [AOD] ou par l'héparine est autorisée)\n-\tchirurgie majeure ≤4 semaines avant la randomisation\n-\taccident vasculaire cérébral ou hémorragie intracrânienne ≤ 6 mois de randomisation","language":10,"languageDescription":"French"},{"id":12310706,"uuid":"64890d09-3bde-44fb-adb0-e233c9dd620f","attributeTranslation":"Podwyższone ryzyko wystąpienia krwawienia na przykład z powodu:\n-\tznanych zaburzeń krzepnięcia krwi \n-\tleczenia przeciwzakrzepowego fenprokumonem lub innymi antagonistami witaminy K (dozwolone jest leczenie przeciwzakrzepowe bezpośrednim doustnym inhibitorem Xa lub trombiny [DOAC] lub heparyną)\n-\tpoważnego zabiegu chirurgicznego w ciągu ≤4 tygodni przed randomizacją\n-\tudaru mózgu lub krwotoku śródczaszkowego w ciągu ≤ 6 miesięcy przed randomizacją","language":19,"languageDescription":"Polish"}]},{"id":1685720,"number":8,"principalExclusionCriteria":"Any comorbidity or organ system impairment rated with a CIRS (cumulative illness rating scale) score of 4 or any other life-threatening illness, medical condition or organ system dysfunction that – in the investigator´s opinion - could compromise the patient`s safety  or interfere with the absorption or metabolism of the study drugs (e.g, inability to swallow tab-lets or impaired resorption in the gastrointestinal tract)","principalExclusionCriteriaTranslations":[{"id":12310713,"uuid":"8a4afcd0-cb77-4ac0-8b4a-c2f273ae3012","attributeTranslation":"Cualquier comorbilidad o deterioro del sistema orgánico con una puntuación a través de la escala CIRS (cumulative illness rating scale) de 4 o cualquier otra enfermedad potencialmente mortal, afección médica o disfunción del sistema orgánico que -en opinión del investigador- pudiera comprometer la seguridad del paciente o interferir con la absorción o el metabolismo de los fármacos del estudio (por ejemplo, incapacidad para tragar comprimidos o alteración de la reabsorción en el tracto gastrointestinal).","language":7,"languageDescription":"Spanish"},{"id":12310710,"uuid":"8a4afcd0-cb77-4ac0-8b4a-c2f273ae3012","attributeTranslation":"Jakiekolwiek współistniejące schorzenie lub upośledzenie układu narządów ocenione na 4 w skali CIRS (kumulatywnej skali oceny chorób) lub jakakolwiek inna zagrażająca życiu choroba, stan chorobowy lub dysfunkcja układu narządów, która – zdaniem badacza – mogłaby zagrozić bezpieczeństwu pacjenta lub zakłócić wchłanianie lub metabolizm leków badanych (np. niezdolność do połykania tabletek lub upośledzone wchłanianie w przewodzie pokarmowym).","language":19,"languageDescription":"Polish"},{"id":12310712,"uuid":"8a4afcd0-cb77-4ac0-8b4a-c2f273ae3012","attributeTranslation":"Toute comorbidité ou défaillance d’organe(s) noté 4 sur l’échelle CIRS (cumulative illness rating scale - échelle d'évaluation cumulative des maladies) ou toute autre maladie menaçant le pronostic vital, condition médicale ou dysfonctionnement d’organes qui - de l'avis de l'investigateur - pourrait compromettre la sécurité du patient  ou interférer avec l'absorption ou le métabolisme des médicaments de l'étude (par exemple, incapacité d'avaler des comprimés ou altération des capacités de résorption du tractus gastro-intestinal).","language":10,"languageDescription":"French"},{"id":12310711,"uuid":"8a4afcd0-cb77-4ac0-8b4a-c2f273ae3012","attributeTranslation":"Comorbiditeit of stoornis van het orgaansysteem met een CIRS-score (Cumulative Illness Rating Scale) van 4, of een andere levensbedreigende ziekte, medische aandoening of orgaansysteemdisfunctie die – naar mening van de onderzoeker – de veiligheid van de patiënt in gevaar kan brengen  of de absorptie of het metabolisme van de onderzoeksmedicatie kan verstoren (bv. onvermogen om tabletten te slikken of verstoorde gastro-intestinale opname).","language":18,"languageDescription":"Dutch"}]},{"id":1685721,"number":9,"principalExclusionCriteria":"Pregnant women and nursing mothers (a negative pregnancy test is required for all women of childbearing potential within 7 days before start of treatment)","principalExclusionCriteriaTranslations":[{"id":12310717,"uuid":"04c24697-13db-4cee-8e76-4f97591224a2","attributeTranslation":"Femmes enceintes ou mères allaitantes (un test de grossesse négatif est requis pour toutes les femmes en âge de procréer dans les 7 jours précédant le début du traitement).","language":10,"languageDescription":"French"},{"id":12310715,"uuid":"04c24697-13db-4cee-8e76-4f97591224a2","attributeTranslation":"Zwangere vrouwen en vrouwen die borstvoeding geven (alle vrouwen die zwanger kunnen worden moeten maximaal 7 dagen vóór start van de behandeling een zwangerschapstest doen).","language":18,"languageDescription":"Dutch"},{"id":12310714,"uuid":"04c24697-13db-4cee-8e76-4f97591224a2","attributeTranslation":"Kobiety w ciąży i matki karmiące piersią (w przypadku wszystkich kobiet w wieku rozrodczym wymagane jest uzyskanie negatywnego wyniku testu ciążowego w ciągu 7 dni przed rozpoczęciem leczenia).","language":19,"languageDescription":"Polish"},{"id":12310716,"uuid":"04c24697-13db-4cee-8e76-4f97591224a2","attributeTranslation":"Embarazadas y madres lactantes (se requiere una prueba de embarazo negativa para todas las mujeres en edad fértil en los 7 días anteriores al inicio del tratamiento).","language":7,"languageDescription":"Spanish"}]}]},"endPoint":{"primaryEndPoints":[{"id":1154563,"number":1,"endPoint":"Progression-free survival (PFS)","isPrimary":true,"endPointTranslations":[{"id":12310624,"uuid":"bc13ff39-7157-46f1-b6a8-08f7acf6ab2d","attributeTranslation":"Supervivencia libre de progresión (PFS)","language":7,"languageDescription":"Spanish"},{"id":12310622,"uuid":"bc13ff39-7157-46f1-b6a8-08f7acf6ab2d","attributeTranslation":"Survie sans progression (SSP)","language":10,"languageDescription":"French"},{"id":12310625,"uuid":"bc13ff39-7157-46f1-b6a8-08f7acf6ab2d","attributeTranslation":"Przeżycie bez progresji choroby (PFS)","language":19,"languageDescription":"Polish"},{"id":12310623,"uuid":"bc13ff39-7157-46f1-b6a8-08f7acf6ab2d","attributeTranslation":"Progressievrije overleving (PFS)","language":18,"languageDescription":"Dutch"}]}],"secondaryEndPoints":[{"id":1154564,"number":1,"endPoint":"Measurable residual disease (MRD) levels by different types of measurement from different materials at final restaging (performed 3 months after end of treatment in all patients - except for patients that show progression of CLL disease or Richter transformation before this point of time - which differs depending on the duration of treatment) and selected other time points during and after treatment","isPrimary":false,"endPointTranslations":[{"id":12310626,"uuid":"ad8802c2-f16d-498e-9b34-d2d0a6c3aec9","attributeTranslation":"Niveau van minimale restziekte (MRD) middels verschillende typen metingen in verschillende materialen \n- bij de laatste herbeoordeling (uitgevoerd bij alle patiënten 3 maanden na het eind van de behandeling - behalve bij patiënten die progressie van CLL of de transformatie van Richter vertonen vóór dit tijdstip - en dit verschilt dus afhankelijk van de duur van de behandeling), en\n- op andere geselecteerde tijdstippen tijdens en na de behandeling","language":18,"languageDescription":"Dutch"},{"id":12310628,"uuid":"ad8802c2-f16d-498e-9b34-d2d0a6c3aec9","attributeTranslation":"Niveaux de maladie résiduelle mesurable (MRD) par différentes techniques de mesures à partir d’échantillons divers lors de\n- l’évaluation finale (réalisée 3 mois après la fin de traitement pour tous les patients - sauf pour ceux qui présentent une progression de la maladie LLC ou une transformation de Richter avant cette date - qui diffère selon la durée du traitement) et\n- d’autres temps de prélèvement sélectionnés pendant et après le traitement","language":10,"languageDescription":"French"},{"id":12310627,"uuid":"ad8802c2-f16d-498e-9b34-d2d0a6c3aec9","attributeTranslation":"Poziom mierzalnej choroby resztkowej (MRD) za pomocą różnych typów pomiarów z różnych materiałów podczas \n- ostatecznej ponownej oceny (wykonywana 3 miesiące po zakończeniu leczenia u wszystkich pacjentów – z wyjątkiem pacjentów z progresją CLL lub transformacją Richtera przed tym punktem czasowym – przy czym termin ten będzie różnił się w zależności od czasu trwania leczenia) oraz\n- w wybranych innych punktach czasowych w trakcie leczenia i po jego zakończeniu","language":19,"languageDescription":"Polish"},{"id":12310629,"uuid":"ad8802c2-f16d-498e-9b34-d2d0a6c3aec9","attributeTranslation":"Niveles de enfermedad residual mínima (EMR) mediante diferentes tipos de mediciones de diferentes materiales en \n- reestadificación final (realizada 3 meses después de finalizar el tratamiento en todos los pacientes, excepto en los pacientes que muestran progresión de la enfermedad de LLC o transformación de Richter antes de este momento, que difiere según la duración del tratamiento) y \n- otros momentos seleccionados durante y después del tratamiento","language":7,"languageDescription":"Spanish"}]},{"id":1154565,"number":2,"endPoint":"Overall response rate (ORR) and complete response (CR) rate at the final restaging and selected other time points","isPrimary":false,"endPointTranslations":[{"id":12310631,"uuid":"a0d5bd0e-798d-459c-97b7-62208af4aab5","attributeTranslation":"Taux de réponse globale (ORR) et taux de réponse complète (CR) à l’évaluation finale et à d’autres moments sélectionnés","language":10,"languageDescription":"French"},{"id":12310630,"uuid":"a0d5bd0e-798d-459c-97b7-62208af4aab5","attributeTranslation":"Tasa de respuesta general (ORR) y tasa de respuesta completa (CR) al final de la reestadificación y en otros momentos seleccionados","language":7,"languageDescription":"Spanish"},{"id":12310633,"uuid":"a0d5bd0e-798d-459c-97b7-62208af4aab5","attributeTranslation":"Totale responspercentage (ORR) en percentage complete respons (CR) bij de laatste herbeoordeling en de geselecteerde andere tijdstippen","language":18,"languageDescription":"Dutch"},{"id":12310632,"uuid":"a0d5bd0e-798d-459c-97b7-62208af4aab5","attributeTranslation":"Odsetek odpowiedzi ogółem (ORR) i odsetek odpowiedzi całkowitych (CR) podczas końcowej ponownej oceny stopnia zaawansowania choroby oraz w wybranych innych punktach czasowych","language":19,"languageDescription":"Polish"}]},{"id":1154566,"number":3,"endPoint":"Duration of response (DOR)","isPrimary":false,"endPointTranslations":[{"id":12310637,"uuid":"c0285b3d-3ade-47a8-9f69-e617bb22089e","attributeTranslation":"Durée de la réponse (DoR)","language":10,"languageDescription":"French"},{"id":12310634,"uuid":"c0285b3d-3ade-47a8-9f69-e617bb22089e","attributeTranslation":"Duración de la respuesta (DOR)","language":7,"languageDescription":"Spanish"},{"id":12310635,"uuid":"c0285b3d-3ade-47a8-9f69-e617bb22089e","attributeTranslation":"Duur van respons (DOR)","language":18,"languageDescription":"Dutch"},{"id":12310636,"uuid":"c0285b3d-3ade-47a8-9f69-e617bb22089e","attributeTranslation":"Czas trwania odpowiedzi (DOR)","language":19,"languageDescription":"Polish"}]},{"id":1154567,"number":4,"endPoint":"Time to next treatment (TTNT)","isPrimary":false,"endPointTranslations":[{"id":12310641,"uuid":"992bfde6-a83c-47b0-81e9-310c46ac782e","attributeTranslation":"Tijd tot volgende behandeling (TTNT)","language":18,"languageDescription":"Dutch"},{"id":12310640,"uuid":"992bfde6-a83c-47b0-81e9-310c46ac782e","attributeTranslation":"Czas do następnego leczenia (TTNT)","language":19,"languageDescription":"Polish"},{"id":12310638,"uuid":"992bfde6-a83c-47b0-81e9-310c46ac782e","attributeTranslation":"Tiempo hasta el siguiente tratamiento (TTNT)","language":7,"languageDescription":"Spanish"},{"id":12310639,"uuid":"992bfde6-a83c-47b0-81e9-310c46ac782e","attributeTranslation":"Délai avant le prochain traitement anti-lymphomateux (TTNT)","language":10,"languageDescription":"French"}]},{"id":1154568,"number":5,"endPoint":"Treatment-free survival (TFS)","isPrimary":false,"endPointTranslations":[{"id":12310643,"uuid":"7ab84b8f-1596-437e-8a69-fd69a9bd1aae","attributeTranslation":"Survie sans traitement (TFS)","language":10,"languageDescription":"French"},{"id":12310645,"uuid":"7ab84b8f-1596-437e-8a69-fd69a9bd1aae","attributeTranslation":"Czas przeżycia bez leczenia (TFS)","language":19,"languageDescription":"Polish"},{"id":12310644,"uuid":"7ab84b8f-1596-437e-8a69-fd69a9bd1aae","attributeTranslation":"Supervivencia libre de tratamiento (TFS)","language":7,"languageDescription":"Spanish"},{"id":12310642,"uuid":"7ab84b8f-1596-437e-8a69-fd69a9bd1aae","attributeTranslation":"Behandelingsvrije overleving (TFS)","language":18,"languageDescription":"Dutch"}]},{"id":1154569,"number":6,"endPoint":"Overall survival (OS)","isPrimary":false,"endPointTranslations":[{"id":12310648,"uuid":"1c9db4e7-c8c9-4f16-ae97-170cb30f0141","attributeTranslation":"Survie globale (OS)","language":10,"languageDescription":"French"},{"id":12310647,"uuid":"1c9db4e7-c8c9-4f16-ae97-170cb30f0141","attributeTranslation":"Totale overleving (OS)","language":18,"languageDescription":"Dutch"},{"id":12310649,"uuid":"1c9db4e7-c8c9-4f16-ae97-170cb30f0141","attributeTranslation":"Supervivencia en general (OS)","language":7,"languageDescription":"Spanish"},{"id":12310646,"uuid":"1c9db4e7-c8c9-4f16-ae97-170cb30f0141","attributeTranslation":"Całkowity czas przeżycia (OS)","language":19,"languageDescription":"Polish"}]},{"id":1154570,"number":7,"endPoint":"Safety parameters: Type, frequency and severity of  - adverse events (AEs) -\tadverse events of particular interest (AEPI)","isPrimary":false,"endPointTranslations":[{"id":12310652,"uuid":"4e056454-4709-43e3-a504-c30cc4c3bcae","attributeTranslation":"Paramètres de tolérance : Type, fréquence et gravité des: \n-\tÉvènements indésirables (AE)\n-\tÉvènements indésirables d’intérêt particulier (AEPI)","language":10,"languageDescription":"French"},{"id":12310651,"uuid":"4e056454-4709-43e3-a504-c30cc4c3bcae","attributeTranslation":"Parametry bezpieczeństwa: rodzaj, częstość występowania oraz nasilenie: \n- zdarzeń niepożądanych (AE)\n- zdarzeń niepożądanych o szczególnym znaczeniu (AEPI)","language":19,"languageDescription":"Polish"},{"id":12310653,"uuid":"4e056454-4709-43e3-a504-c30cc4c3bcae","attributeTranslation":"Parámetros de seguridad: tipo, frecuencia y severidad de \n- eventos adversos (AEs) \n- eventos adversos de interés particular (AEPI)","language":7,"languageDescription":"Spanish"},{"id":12310650,"uuid":"4e056454-4709-43e3-a504-c30cc4c3bcae","attributeTranslation":"Veiligheidsparameters: type, frequentie en ernst van de \n-\tbijwerkingen (AE)\n-\tbijwerkingen van bijzonder belang (AEPI)","language":18,"languageDescription":"Dutch"}]},{"id":1154571,"number":8,"endPoint":"Best response assessed until 1 year after end of treatment","isPrimary":false,"endPointTranslations":[{"id":12310654,"uuid":"5ab46c59-4081-4e87-b7b5-a2d75e5dd8df","attributeTranslation":"Najlepsza odpowiedź oceniana do 1 roku po zakończeniu leczenia","language":19,"languageDescription":"Polish"},{"id":12310655,"uuid":"5ab46c59-4081-4e87-b7b5-a2d75e5dd8df","attributeTranslation":"Mejor respuesta obtenida hasta un año después del fin del tratamiento","language":7,"languageDescription":"Spanish"},{"id":12310656,"uuid":"5ab46c59-4081-4e87-b7b5-a2d75e5dd8df","attributeTranslation":"Beste respons bepaling tot 1 jaar na einde behandeling","language":18,"languageDescription":"Dutch"},{"id":12310657,"uuid":"5ab46c59-4081-4e87-b7b5-a2d75e5dd8df","attributeTranslation":"Meilleure réponse possible évaluée jusqu'à 1 an après la fin du traitement","language":10,"languageDescription":"French"}]}]},"trialDuration":{"estimatedGlobalEndDate":"2031-06-02","estimatedEndDate":"2031-06-01","estimatedRecruitmentStartDate":"2025-06-01"},"sourceOfMonetarySupport":[{"id":106747,"organisationName":"AbbVie Inc."},{"id":106748,"organisationName":"Eli Lilly & Co."},{"id":106746,"organisationName":"F. Hoffmann-La Roche Ltd."}],"populationOfTrialSubjects":{"ageRanges":[{"id":398070,"ageRangeCategoryCode":"4","ageRangeCategory":"4"},{"id":398071,"ageRangeCategoryCode":"3","ageRangeCategory":"3"}],"ageRangeSecondaryIds":[],"clinicalTrialGroups":[{"code":"2","name":"Patients"}],"isFemaleSubjects":true,"isMaleSubjects":true,"isVulnerablePopulationSelected":false},"individualParticipantData":{"planToShareIPD":"1","planDescription":"IPD will be made available to investigators and researches conducting analyses as part of the accompanying scientific program as defined in the study protocol or upon positive decision of the study’s scientific committee (consists of GPI, Head of GCLLSG and national PIs from best-recruiting countries). Beside this, the GCLLSG will consider data sharing requests on a case-by-case basis. Requests for de-identified patient data and with a pre-determined research purpose can be submitted to the principal investigator PD Dr. med. Paula Cramer and the head of the GCLLSG Prof. Dr. med. Barbara Eichhorst.\nFollowing supportive information will be shared: Study Protocol, Statistical Analysis Plan, Informed Consent Form and Clinical Study Report.\nIt is intended that the data can be shared after the publication of the primary endpoint analysis and the final study analysis, respectively until 10 years after end of study.\nThe mechanism for making the data available has not yet been specified."}},"protocolInformation":{"studyDesign":{"periodDetails":[{"id":205936,"businessKey":"1","title":"Screening and Randomization","description":"Patients considered eligible based on the results of the screening examinations will be randomised via the clinical database (TrialMaster) in a 1:1:1 fashion to one of the three treatment arms (A: fixed-duration Ven/Obi, B: fixed-duration Ven/Pirto and C: MRD-guided Ven/Pirto). Stratification parameters are TP53 deletion and/or mutation (present vs absent), IGHV mutational status (unmutated vs. mutat-ed), type of lymphoma (CLL vs. SLL), and age (≤ vs. > 65 years).","blindingMethodCode":"3","blindedRoles":[],"armDetails":[],"allocationMethod":"1"},{"id":205937,"businessKey":"2","title":"Treatment","description":"Patient’s trial participation will include a screening phase, a treatment phase and a follow-up phase. The screening will take approximately 2 to 4 weeks, once all results of the screening examinations are available and the patient is randomised, treatment has to be started within 4 weeks. The duration of therapy is 12 and 15 cycles, respectively in the fixed duration arms A (Ven-Obi) and B (Ven-Pirto) and 15 to up to 36 cycles in the MRD-guided arm C (Ven-Pirto). Each cycle has a duration of 28 calendar days, thus the duration of treatment is 12x 28 days (336 days, approximately 11 months), 15x 28 days (420 days, approximately 14 months) and 15 to 36x 28 days (420 to 1008 days, approximately 14 to 33 months), respectively. However, in certain cases, missed treatment days may be made up at the end of the predefined treatment duration after consultation with the sponsor.","blindingMethodCode":"3","blindedRoles":[],"armDetails":[{"description":"Treatment in the standard arm will be the approved combination of venetoclax/obinutuzumab (Ven-Obi). According to the established treatment schema, Ven-Obi treatment consists of 12 cycles, each with a duration of 28 days resulting in a treatment duration of approximately 12 months. \nObinutuzumab is administered intravenously on days 1 (and 2), 8 and 15 of cycle 1, and day 1 of cycles 2-6. The continuous daily administration of venetoclax starts on day 22 of the first cycle with a weekly dose ramp-up from 20mg to 400mg over five weeks with the necessary safety measures needed for mitigation and early detection of a tumour-lysis syndrome.","title":"Ven-Obi fixed duration over 12 cycles (arm A, standard arm)","id":114215},{"description":"Arm B evaluates the combination of pirtobrutinib and venetoclax (Ven-Pirto) in a fixed duration schema over 15 cycles. The duration of each cycle is 28 days. Treatment starts with pirtobrutinib on day 1 of the first cycle and will be continued daily. The daily administration of venetoclax starts on day 1 of the fourth cycle with a weekly dose ramp-up from 20mg to 400mg over five weeks with the necessary safety measures needed for mitigation and early detection of a tumor-lysis syndrome.","title":"Ven-Pirto fixed duration over 15 cycles (arm B)","id":114216},{"description":"Arm C evaluates the combination of pirtobrutinib and venetoclax (Ven-Pirto) with an individualized, MRD-guided treatment duration of 15 to a maximum of 36 cycles. The duration of each cycle is 28 days. Treatment starts with pirtobrutinib on day 1 of the first cycle and will be continued daily. The daily administration of venetoclax starts on day 1 of the fourth cycle with a weekly dose ramp-up from 20mg to 400mg over five weeks with the necessary safety measures needed for mitigation and early detection of a tumor-lysis syndrome.","title":"Ven-Pirto MRD-guided duration of 15 to 36 cycles (arm C)","id":114217}],"allocationMethod":"1"},{"id":205938,"businessKey":"3","title":"Follow Up","description":"The follow-up will be approximately three to five years for patients in arms A (Ven-Obi) and B (Ven-Pirto) (depending on timepoint of recruitment), but can potentially as short as 16 months in patients in arm C (Ven -Pirto MRD guided) (if recruited at the end of the recruitment period and treated for the full 36 cycles).","blindingMethodCode":"3","blindedRoles":[],"armDetails":[],"allocationMethod":"1"}]}},"scientificAdviceAndPip":{"scientificAdvices":[],"paediatricInvestigationPlan":[]},"associatedClinicalTrials":[],"references":[],"pubmedCode":[],"pubmedUrl":[]},"assessmentOutcome":"acceptable","therapeuticAreas":[{"code":"4","name":"Diseases [C] - Neoplasms [C04]"}],"medicalConditions":[{"id":151847,"medicalCondition":"small lymphocytic lymphoma (SLL)","isConditionRareDisease":true},{"id":151848,"medicalCondition":"chronic lymphocytic leukemia (CLL)","isConditionRareDisease":true}],"sponsors":[{"id":165066,"primary":true,"publicContacts":[{"id":487468,"type":"Public","functionalName":"Paula Cramer","functionalEmailAddress":"cll-18@uk-koeln.de","telephone":"004922147888220","organisation":{"id":290451,"type":"Educational Institution","typeCode":"1","name":"University Of Cologne","commercial":true,"isBusinessKeyValidated":true,"businessKey":"ORG-100006227","organisationLocationStatus":"Active"}}],"scientificContacts":[{"id":487469,"type":"Scientific","functionalName":"Paula Cramer","functionalEmailAddress":"cll-18@uk-koeln.de","telephone":"004922147888220","organisation":{"id":290451,"type":"Educational Institution","typeCode":"1","name":"University Of Cologne","commercial":true,"isBusinessKeyValidated":true,"businessKey":"ORG-100006227","organisationLocationStatus":"Active"}}],"thirdParties":[{"id":758096,"organisationAddress":{"id":526098,"organisation":{"id":558659,"type":"Hospital/Clinic/Other health care facility","typeCode":"8","name":"HUS-Yhtymae","commercial":false,"isBusinessKeyValidated":true,"businessKey":"ORG-100022862","organisationLocationStatus":"Active"},"address":{"addressId":565641,"oneLine":"Haartmaninkatu 4","addressLine1":"Haartmaninkatu 4","addressLine2":"","addressLine3":"","addressLine4":"","city":"Helsinki","postcode":"00290","country":2011,"countryName":"Finland"},"phone":"00358504279011","email":"vesa.lindstrom@hus.fi","isBusinessKeyValidated":true,"businessKey":"ORG-100022862"},"sponsorDuties":[{"id":1173930,"code":"12"},{"id":1173931,"code":"2"},{"id":1173932,"code":"5"}],"phoneNumber":"00358504279011","email":"vesa.lindstrom@hus.fi"},{"id":758084,"organisationAddress":{"id":536111,"organisation":{"id":568705,"type":"Hospital/Clinic/Other health care facility","typeCode":"8","name":"Tampere University Hospital","commercial":false,"isBusinessKeyValidated":true,"businessKey":"ORG-100009144","organisationLocationStatus":"Active"},"address":{"addressId":576640,"oneLine":"Elamanaukio 2","addressLine1":"Elamanaukio 2","addressLine2":"","addressLine3":"","addressLine4":"","city":"Tampere","postcode":"33520","country":2011,"countryName":"Finland"},"phone":"00358405130063","email":"saara.ojala@pirha.fi","isBusinessKeyValidated":true,"businessKey":"ORG-100009144"},"sponsorDuties":[{"id":1173892,"code":"1"},{"id":1173893,"code":"12"},{"id":1173894,"code":"5"}],"phoneNumber":"00358405130063","email":"saara.ojala@pirha.fi"},{"id":758090,"organisationAddress":{"id":526049,"organisation":{"id":558610,"type":"Laboratory/Research/Testing facility","typeCode":"9","name":"LYSARC","commercial":true,"isBusinessKeyValidated":true,"businessKey":"ORG-100010583","organisationLocationStatus":"Active"},"address":{"addressId":565587,"oneLine":"2d Lyon Sud Batiment","addressLine1":"2d Lyon Sud Batiment","addressLine2":"","addressLine3":"","addressLine4":"","city":"Pierre Benite Cedex","postcode":"69495","country":2012,"countryName":"France"},"phone":"0033427012748","email":"affaires-reglementaires@lysarc.org","isBusinessKeyValidated":true,"businessKey":"ORG-100010583"},"sponsorDuties":[{"id":1173912,"code":"1"},{"id":1173913,"code":"12"},{"id":1173914,"code":"2"},{"id":1173915,"code":"5"}],"phoneNumber":"0033427012748","email":"affaires-reglementaires@lysarc.org"},{"id":758099,"organisationAddress":{"id":526092,"organisation":{"id":558653,"type":"Hospital/Clinic/Other health care facility","typeCode":"8","name":"Fakultni Nemocnice Kralovske Vinohrady","commercial":false,"isBusinessKeyValidated":true,"businessKey":"ORG-100029480","organisationLocationStatus":"Active"},"address":{"addressId":565634,"oneLine":"Srobarova 1150/50, Vinohrady","addressLine1":"Srobarova 1150/50","addressLine2":"Vinohrady","addressLine3":"","addressLine4":"","city":"Prague","postcode":"100 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