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recidivante/resistente","language":7,"languageDescription":"Spanish"},{"id":10352799,"uuid":"4bab0e5a-6985-429b-be20-50c9100afe1e","attributeTranslation":"Étude multicentrique de phase 3, randomisée, en ouvert, évaluant le sonrotoclax en association avec des traitements par anticorps anti-CD20 par rapport au vénétoclax en association avec le rituximab chez des patients atteints de leucémie lymphoïde chronique/lymphome à petits lymphocytes en rechute/réfractaire","language":10,"languageDescription":"French"}],"publicTitle":"A Study to Investigate Progression-Free Survival With Sonrotoclax Plus Obinutuzumab Or Sonrotoclax Plus Rituximab Compared With Venetoclax Plus Rituximab Treatment In Patients With Relapsed and/or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma","publicTitleTranslations":[{"id":10352841,"uuid":"354e9961-4f29-4085-a891-d2fda432cbc6","attributeTranslation":"Badanie prowadzone w celu zbadania przeżycia bez progresji choroby po zastosowaniu leczenia skojarzonego sonrotoklaksem z obinutuzumabem lub sonrotoklaksem z rytuksymabem w porównaniu z leczeniem skojarzonym wenetoklaksem z rytuksymabem u pacjentów z nawrotową i/lub oporną przewlekłą białaczką limfocytową / chłoniakiem z małych limfocytów","language":19,"languageDescription":"Polish"},{"id":10352842,"uuid":"354e9961-4f29-4085-a891-d2fda432cbc6","attributeTranslation":"Étude visant à évaluer la survie sans progression avec le sonrotoclax associé à l’obinutuzumab ou le sonrotoclax associé au rituximab par rapport au vénétoclax associé au rituximab chez des patients atteints de leucémie lymphoïde chronique/lymphome à petits lymphocytes en rechute ou réfractaire","language":10,"languageDescription":"French"},{"id":10352844,"uuid":"354e9961-4f29-4085-a891-d2fda432cbc6","attributeTranslation":"Eine Studie zur Untersuchung des progressionsfreien Überlebens mit Sonrotoclax plus Obinutuzumab oder Sonrotoclax plus Rituximab gegenüber Venetoclax in Kombination mit Rituximab bei Patienten mit rezidivierender/refraktärer chronischer lymphatischer Leukämie/kleinzelligem lymphozytischem Lymphom","language":4,"languageDescription":"German"},{"id":10352840,"uuid":"354e9961-4f29-4085-a891-d2fda432cbc6","attributeTranslation":"Een onderzoek naar progressievrije overleving met Sonrotoclax Plus Obinutuzumab of Sonrotoclax Plus Rituximab vergeleken met behandeling met Venetoclax Plus Rituximab bij patiënten met recidief en/of refractaire chronische lymfatische leukemie/kleincellig lymfocytair lymfoom","language":18,"languageDescription":"Dutch"},{"id":10352843,"uuid":"354e9961-4f29-4085-a891-d2fda432cbc6","attributeTranslation":"Estudio para investigar la supervivencia sin progresión con sonrotoclax más obinutuzumab o sonrotoclax más rituximab frente al tratamiento con venetoclax más rituximab en pacientes con leucemia linfocítica crónica/linfoma linfocítico pequeño recidivante o resistente","language":7,"languageDescription":"Spanish"}],"shortTitle":"BGB-11417-303CLL-RR1","secondaryIdentifyingNumbers":{"nctNumber":{"id":511874,"number":"NCT06943872"},"additionalRegistries":[]}},"trialInformation":{"trialCategory":{"isLowIntervention":false,"trialPhase":"5","trialCategory":"2","justificationForTrialCategory":"This is a phase 3 trial","trialCategoryId":114771},"medicalCondition":{"partIMedicalConditions":[{"id":130251,"medicalCondition":"Relapsed/Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma","medicalConditionTranslations":[{"id":10352716,"uuid":"f8e304a8-5bb6-486f-8e79-d726dd7b901e","attributeTranslation":"Leucemia linfocítica crónica/linfoma linfocítico pequeño recidivante/resistente","language":7,"languageDescription":"Spanish"},{"id":10352715,"uuid":"f8e304a8-5bb6-486f-8e79-d726dd7b901e","attributeTranslation":"Leucémie lymphoïde chronique/lymphome à petits lymphocytes en rechute ou réfractaire","language":10,"languageDescription":"French"},{"id":10352717,"uuid":"f8e304a8-5bb6-486f-8e79-d726dd7b901e","attributeTranslation":"Recidief/refractaire chronische lymfatische leukemie/kleincellig lymfocytair lymfoom","language":18,"languageDescription":"Dutch"},{"id":10352718,"uuid":"f8e304a8-5bb6-486f-8e79-d726dd7b901e","attributeTranslation":"Nawrotowa/oporna przewlekła białaczka limfocytowa chłoniak z małych limfocytów","language":19,"languageDescription":"Polish"}],"isConditionRareDisease":false}],"meddraConditionTerms":[{"termId":100000059758,"version":"28.0","level":"LLT","termName":"B-Lymphocytic CLL (Kiel Classification) recurrent","classificationCode":"10003947","organClass":10029104,"active":false},{"termId":100000059769,"version":"28.0","level":"LLT","termName":"B-Lymphocytic CLL (Kiel Classification) refractory","classificationCode":"10003948","organClass":10029104,"active":false}]},"trialObjective":{"trialScopes":[{"code":"5","trialScopeId":378682},{"code":"4","trialScopeId":378683}],"mainObjective":"The primary objective of this study is to compare the efficacy of sonrotoclax plus\nobinutuzumab versus venetoclax plus rituximab in patients with relapsed and/or\nrefractory (R/R) chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL).","mainObjectiveTranslations":[{"id":10352839,"uuid":"4f287989-fbef-4750-be04-4681139b9dbf","attributeTranslation":"El objetivo principal de este estudio es comparar la eficacia de sonrotoclax más obinutuzumab frente a venetoclax más rituximab en pacientes con leucemia linfocítica crónica/linfoma linfocítico pequeño (LLC/LLP) recidivante o resistente (R/R).","language":7,"languageDescription":"Spanish"},{"id":10352836,"uuid":"4f287989-fbef-4750-be04-4681139b9dbf","attributeTranslation":"De primaire doelstelling van dit onderzoek is het vergelijken van de werkzaamheid van sonrotoclax plus obinutuzumab versus venetoclax plus rituximab bij patiënten met recidief en/of refractaire (R/R) chronische lymfocytaire leukemie/kleincellig lymfocytair lymfoom (CLL/SLL).","language":18,"languageDescription":"Dutch"},{"id":10352838,"uuid":"4f287989-fbef-4750-be04-4681139b9dbf","attributeTranslation":"L’objectif principal de cette étude est de comparer l’efficacité du sonrotoclax associé à l’obinutuzumab par rapport au vénétoclax associé au rituximab chez des patients atteints de leucémie lymphoïde chronique/lymphome à petits lymphocytes (LLC/LPL) en rechute ou réfractaire (R/R).","language":10,"languageDescription":"French"},{"id":10352837,"uuid":"4f287989-fbef-4750-be04-4681139b9dbf","attributeTranslation":"Głównym celem tego badania jest porównanie skuteczności skojarzenia sonrotoklaksu z obinutuzumabem i skojarzenia wenetoklaksu z rytuksymabem u pacjentów z nawrotową i/lub oporną na leczenie (R/R) przewlekłą białaczką limfocytową / chłoniakiem z małych limfocytów (CLL/SLL).","language":19,"languageDescription":"Polish"}],"secondaryObjectives":[{"id":441468,"number":1,"secondaryObjective":"To compare the efficacy between Arm B (sonrotoclax plus rituximab) versus Arm D (venetoclax plus rituximab) as measured by PFS.","secondaryObjectiveTranslations":[{"id":10352848,"uuid":"0689283e-b809-4c35-a15b-c07075f601b3","attributeTranslation":"Comparer l’efficacité entre le groupe B (sonrotoclax plus rituximab) et le groupe D (vénétoclax plus rituximab), telle que mesurée par la SSP.","language":10,"languageDescription":"French"},{"id":10352847,"uuid":"0689283e-b809-4c35-a15b-c07075f601b3","attributeTranslation":"Comparar la eficacia entre el grupo B (sonrotoclax más rituximab) y el grupo D (venetoclax más rituximab) según la SSP.","language":7,"languageDescription":"Spanish"},{"id":10352846,"uuid":"0689283e-b809-4c35-a15b-c07075f601b3","attributeTranslation":"Porównanie skuteczności leczenia pomiędzy grupą B (sonrotoklaks i rytuksymab) a grupą D (wenetoklaks i rytuksymab) na podstawie PFS.","language":19,"languageDescription":"Polish"},{"id":10352845,"uuid":"0689283e-b809-4c35-a15b-c07075f601b3","attributeTranslation":"Vergelijken van de werkzaamheid tussen Arm B (sonrotoclax plus rituximab) versus Arm D (venetoclax plus rituximab) zoals gemeten aan de hand van PFS.","language":18,"languageDescription":"Dutch"}]},{"id":441469,"number":2,"secondaryObjective":"To compare the efficacy between Arm A (sonrotoclax plus obinutuzumab) versus Arm D (venetoclax plus rituximab) as measured by the uMRD rate at C14D1, complete response/complete response with incomplete hematopoietic recovery (CR/CRi), and overall survival (OS).","secondaryObjectiveTranslations":[{"id":10352850,"uuid":"e9c694a1-fbe4-4ed8-97d8-e62ee4d7e34b","attributeTranslation":"Comparar la eficacia entre el grupo A (sonrotoclax más obinutuzumab) y el grupo D (venetoclax más rituximab) medida mediante la tasa de EMR indetectable (EMRi) en C14D1, respuesta completa/respuesta completa con recuperación hematopoyética incompleta (RC/RCi), y supervivencia global (SG).","language":7,"languageDescription":"Spanish"},{"id":10352852,"uuid":"e9c694a1-fbe4-4ed8-97d8-e62ee4d7e34b","attributeTranslation":"Vergelijken van de werkzaamheid tussen Arm A (sonrotoclax plus obinutuzumab) versus Arm D (venetoclax plus rituximab) zoals gemeten aan de hand van de uMRD-percentage bij C14D1, complete respons/complete respons met onvolledig hematopoëtisch herstel (CR/CRi) en algehele overleving (OS).","language":18,"languageDescription":"Dutch"},{"id":10352849,"uuid":"e9c694a1-fbe4-4ed8-97d8-e62ee4d7e34b","attributeTranslation":"Porównanie skuteczności pomiędzy grupą A (sonrotoklaks i obinutuzumab) a grupą D (wenetoklaks i rytuksymab) na podstawie wskaźnika uMRD w dniu 1. cyklu 14., całkowitej odpowiedzi / całkowitej odpowiedzi z niepełną regeneracją komórek krwi (ang. complete response / complete response with incomplete hematopoietic recovery, CR/CRi) i całkowitego przeżycia (ang. overall survival, OS).","language":19,"languageDescription":"Polish"},{"id":10352851,"uuid":"e9c694a1-fbe4-4ed8-97d8-e62ee4d7e34b","attributeTranslation":"Comparer l’efficacité entre le groupe A (sonrotoclax plus obinutuzumab) et le groupe D (vénétoclax plus rituximab), telle que mesurée par le taux d’uMRD au jour 1 du cycle 14, le taux de réponse complète/réponse complète avec récupération hématopoïétique incomplète (RC/RCi) et le taux de survie globale (SG).","language":10,"languageDescription":"French"}]},{"id":441470,"number":3,"secondaryObjective":"To compare the efficacy of Arm B (sonrotoclax plus rituximab) versus Arm D (venetoclax plus rituximab).","secondaryObjectiveTranslations":[{"id":10352853,"uuid":"37437f2c-5275-44d5-aa8b-0875dd5d97eb","attributeTranslation":"Comparar la eficacia entre el grupo B (sonrotoclax más rituximab) y el grupo D (venetoclax más rituximab).","language":7,"languageDescription":"Spanish"},{"id":10352855,"uuid":"37437f2c-5275-44d5-aa8b-0875dd5d97eb","attributeTranslation":"Vergelijken van de werkzaamheid van Arm B (sonrotoclax plus rituximab) versus Arm D (venetoclax plus rituximab).","language":18,"languageDescription":"Dutch"},{"id":10352856,"uuid":"37437f2c-5275-44d5-aa8b-0875dd5d97eb","attributeTranslation":"Porównanie skuteczności leczenia pomiędzy grupą B (sonrotoklaks i rytuksymab) a grupą D (wenetoklaks i rytuksymab).","language":19,"languageDescription":"Polish"},{"id":10352854,"uuid":"37437f2c-5275-44d5-aa8b-0875dd5d97eb","attributeTranslation":"Comparer l’efficacité du groupe B (sonrotoclax plus rituximab) par rapport au groupe D (vénétoclax plus rituximab).","language":10,"languageDescription":"French"}]},{"id":441471,"number":4,"secondaryObjective":"To evaluate the efficacy between Arm A (sonrotoclax plus obinutuzumab) versus Arm B (sonrotoclax plus rituximab).","secondaryObjectiveTranslations":[{"id":10352858,"uuid":"2bb84e33-f27f-44d4-8d7f-af6937fefea1","attributeTranslation":"Comparer l’efficacité entre le groupe A (sonrotoclax plus obinutuzumab) et le groupe B (sonrotoclax plus rituximab).","language":10,"languageDescription":"French"},{"id":10352860,"uuid":"2bb84e33-f27f-44d4-8d7f-af6937fefea1","attributeTranslation":"Evaluar la eficacia entre el grupo A (sonrotoclax más obinutuzumab) y el grupo B (sonrotoclax más rituximab).","language":7,"languageDescription":"Spanish"},{"id":10352857,"uuid":"2bb84e33-f27f-44d4-8d7f-af6937fefea1","attributeTranslation":"Ocena skuteczności leczenia pomiędzy grupą A (sonrotoklaks i obinutuzumab) a grupą B (sonrotoklaks i rytuksymab).","language":19,"languageDescription":"Polish"},{"id":10352859,"uuid":"2bb84e33-f27f-44d4-8d7f-af6937fefea1","attributeTranslation":"Het evalueren van de werkzaamheid tussen Arm A (sonrotoclax plus obinutuzumab) versus Arm B (sonrotoclax plus rituximab).","language":18,"languageDescription":"Dutch"}]},{"id":441472,"number":5,"secondaryObjective":"To evaluate the efficacy between Arm A (sonrotoclax plus obinutuzumab) versus Arm D (venetoclax plus rituximab).","secondaryObjectiveTranslations":[{"id":10352861,"uuid":"2848daa9-b112-43f4-aa92-768360998df3","attributeTranslation":"Comparer l’efficacité entre le groupe A (sonrotoclax plus obinutuzumab) et le groupe D (vénétoclax plus rituximab).","language":10,"languageDescription":"French"},{"id":10352863,"uuid":"2848daa9-b112-43f4-aa92-768360998df3","attributeTranslation":"Ocena skuteczności leczenia pomiędzy grupą A (sonrotoklaks i obinutuzumab) a grupą D (wenetoklaks i rytuksymab).","language":19,"languageDescription":"Polish"},{"id":10352864,"uuid":"2848daa9-b112-43f4-aa92-768360998df3","attributeTranslation":"Evaluar la eficacia entre el grupo A (sonrotoclax más obinutuzumab) y el grupo D (venetoclax más rituximab).","language":7,"languageDescription":"Spanish"},{"id":10352862,"uuid":"2848daa9-b112-43f4-aa92-768360998df3","attributeTranslation":"Het evalueren van de werkzaamheid tussen Arm A (sonrotoclax plus obinutuzumab) versus Arm D (venetoclax plus rituximab).","language":18,"languageDescription":"Dutch"}]},{"id":441473,"number":6,"secondaryObjective":"To evaluate the efficacy between Arm C (sonrotoclax plus obinutuzumab MRD-guided) versus Arm D (venetoclax plus rituximab).","secondaryObjectiveTranslations":[{"id":10352868,"uuid":"49b7b97a-b55d-4609-8236-2e1137be9787","attributeTranslation":"Het evalueren van de werkzaamheid tussen Arm C (sonrotoclax plus obinutuzumab MRD-geleid) versus Arm D (venetoclax plus rituximab).","language":18,"languageDescription":"Dutch"},{"id":10352866,"uuid":"49b7b97a-b55d-4609-8236-2e1137be9787","attributeTranslation":"Comparer l’efficacité entre le groupe C (traitement par sonrotoclax plus obinutuzumab guidé par la MRD) et le groupe D (vénétoclax plus rituximab).","language":10,"languageDescription":"French"},{"id":10352867,"uuid":"49b7b97a-b55d-4609-8236-2e1137be9787","attributeTranslation":"Evaluar la eficacia entre el grupo C (sonrotoclax más obinutuzumab guiado por EMR) y el grupo D (venetoclax más rituximab).","language":7,"languageDescription":"Spanish"},{"id":10352865,"uuid":"49b7b97a-b55d-4609-8236-2e1137be9787","attributeTranslation":"Ocena skuteczności leczenia pomiędzy grupą C (sonrotoklaks i obinutuzumab w zależności od MRD) a grupą D (wenetoklaks i rytuksymab).","language":19,"languageDescription":"Polish"}]},{"id":441474,"number":7,"secondaryObjective":"To evaluate the efficacy of combination treatments in all arms in terms of overall response rate (ORR), duration of response (DOR), and time to response (TTR), time to next anti-CLL/SLL treatment (TTNT)","secondaryObjectiveTranslations":[{"id":10352872,"uuid":"4bad9c29-9c40-4c52-bf41-327245a1dd58","attributeTranslation":"Évaluer l’efficacité des traitements d’association dans tous les groupes en ce qui concerne le taux de réponse globale (TRG), la durée de réponse (DDR), le délai de réponse (TTR) et le délai avant le prochain traitement anti-LLC/LPL (TTNT).","language":10,"languageDescription":"French"},{"id":10352871,"uuid":"4bad9c29-9c40-4c52-bf41-327245a1dd58","attributeTranslation":"Ocena skuteczności leczenia skojarzonego we wszystkich grupach pod względem wskaźnika odpowiedzi całkowitej (ang. overall response rate, ORR), czasu utrzymywania się odpowiedzi (ang. duration of response, DOR), czasu do wystąpienia odpowiedzi (ang. time to response, TTR) i czasu do następnego leczenia (ang. time to next treatment, TTNT) przeciw CLL/SLL.","language":19,"languageDescription":"Polish"},{"id":10352869,"uuid":"4bad9c29-9c40-4c52-bf41-327245a1dd58","attributeTranslation":"Het evalueren van de werkzaamheid van combinatiebehandelingen in alle armen in termen van algemeen responspercentage (ORR), duur van respons (DOR) en tijd tot respons (TTR), tijd tot volgende anti-CLL/SLL-behandeling (TTNT)","language":18,"languageDescription":"Dutch"},{"id":10352870,"uuid":"4bad9c29-9c40-4c52-bf41-327245a1dd58","attributeTranslation":"Evaluar la eficacia de los tratamientos combinados en todos los grupos en términos de: tasa de respuesta global (TRG), duración de la respuesta (DR), tiempo hasta la respuesta (TR) y tiempo hasta el siguiente tratamiento contra la LLC/LLP (TST).","language":7,"languageDescription":"Spanish"}]},{"id":441475,"number":8,"secondaryObjective":"To evaluate the rate of uMRD at various timepoints in all arms","secondaryObjectiveTranslations":[{"id":10352873,"uuid":"0d3a0f60-94c9-47bf-9244-2f3318db56e3","attributeTranslation":"Het evalueren van het percentage van uMRD op verschillende tijdstippen in alle armen","language":18,"languageDescription":"Dutch"},{"id":10352875,"uuid":"0d3a0f60-94c9-47bf-9244-2f3318db56e3","attributeTranslation":"Evaluar la tasa de EMRi en diferentes momentos de evaluación en todos los grupos.","language":7,"languageDescription":"Spanish"},{"id":10352874,"uuid":"0d3a0f60-94c9-47bf-9244-2f3318db56e3","attributeTranslation":"Évaluer le taux de uMRD à différents temps de mesure dans tous les groupes.","language":10,"languageDescription":"French"},{"id":10352876,"uuid":"0d3a0f60-94c9-47bf-9244-2f3318db56e3","attributeTranslation":"Ocena częstości uMRD w różnych punktach czasowych we wszystkich grupach","language":19,"languageDescription":"Polish"}]},{"id":441476,"number":9,"secondaryObjective":"To measure changes in the patient-reported disease- and treatment-specific symptoms and function and to compare the differences between Arm A (sonrotoclax plus obinutuzumab) versus Arm D (venetoclax plus rituximab), between Arm B (sonrotoclax plus rituximab) versus Arm D (venetoclax plus rituximab), between Arm C (sonrotoclax plus obinutuzumab MRD-guided) versus Arm D (venetoclax plus rituximab), between Arm A (sonrotoclax plus obinutuzumab) versus Arm B (sonrotoclax plus rituximab)","secondaryObjectiveTranslations":[{"id":10352879,"uuid":"1e3df876-ebb2-4612-8d76-ae3b39566940","attributeTranslation":"Om wijzigingen te meten in de door de patiënt gerapporteerde ziekte- en behandelspecifieke symptomen en functie en voor het vergelijken van de verschillen tussen Arm A (sonrotoclax plus obinutuzumab) versus Arm D (venetoclax plus rituximab), tussen Arm B (sonrotoclax plus rituximab) versus arm D (venetoclax plus rituximab), tussen Arm C (sonrotoclax plus obinutuzumab MRD-geleid) versus arm D (venetoclax plus rituximab), tussen Arm A (sonrotoclax plus obinutuzumab) versus Arm B (sonrotoclax plus rituximab)","language":18,"languageDescription":"Dutch"},{"id":10352880,"uuid":"1e3df876-ebb2-4612-8d76-ae3b39566940","attributeTranslation":"Pomiar zmian w zgłaszanych przez pacjentów objawach i funkcjach specyficznych dla choroby i leczenia oraz porównanie różnic między grupą A (sonrotoklaks i obinutuzumab) a grupą D (wenetoklaks i rytuksymab), między grupą B (sonrotoklaks i rytuksymab) a grupą D (wenetoklaks i rytuksymab), między grupą C (sonrotoklaks i obinutuzumab w zależności od MRD) a grupą D (wenetoklaks i rytuksymab) oraz między grupą A (sonrotoklaks i obinutuzumab) a grupą B (sonrotoklaks plus rytuksymab)","language":19,"languageDescription":"Polish"},{"id":10352878,"uuid":"1e3df876-ebb2-4612-8d76-ae3b39566940","attributeTranslation":"Medir los cambios en la función y los síntomas específicos del tratamiento y la enfermedad notificados por el paciente, y comparar las diferencias entre el grupo A (sonrotoclax más obinutuzumab) y el grupo D (venetoclax más rituximab), entre el grupo B (sonrotoclax más rituximab) y el grupo D (venetoclax más rituximab), entre el grupo C (sonrotoclax más obinutuzumab guiado por EMR) y el grupo D (venetoclax más rituximab), y entre el grupo A (sonrotoclax más obinutuzumab) y el grupo B (sonrotoclax más rituximab).","language":7,"languageDescription":"Spanish"},{"id":10352877,"uuid":"1e3df876-ebb2-4612-8d76-ae3b39566940","attributeTranslation":"Mesurer les changements rapportés par le patient concernant les symptômes spécifiques à la maladie et au traitement et la condition physique, et comparer les différences entre le groupe A (sonrotoclax plus obinutuzumab) et le groupe D (vénétoclax plus rituximab), entre le groupe B (sonrotoclax plus rituximab) et le groupe D (vénétoclax plus rituximab), entre le groupe C (traitement par sonrotoclax plus obinutuzumab guidé par la MRD) et le groupe D (vénétoclax plus rituximab), entre le groupe A (sonrotoclax plus obinutuzumab) et le groupe B (sonrotoclax plus rituximab).","language":10,"languageDescription":"French"}]},{"id":441477,"number":10,"secondaryObjective":"To evaluate the safety and tolerability of treatment in all arms","secondaryObjectiveTranslations":[{"id":10352883,"uuid":"af6b7be3-fdce-476d-a8ea-7eb41999a1bf","attributeTranslation":"Het evalueren van de veiligheid en verdraagbaarheid van de behandeling in alle armen","language":18,"languageDescription":"Dutch"},{"id":10352882,"uuid":"af6b7be3-fdce-476d-a8ea-7eb41999a1bf","attributeTranslation":"Evaluar la seguridad y la tolerabilidad del tratamiento en todos los grupos.","language":7,"languageDescription":"Spanish"},{"id":10352884,"uuid":"af6b7be3-fdce-476d-a8ea-7eb41999a1bf","attributeTranslation":"Évaluer l’innocuité et la tolérabilité du traitement dans tous les","language":10,"languageDescription":"French"},{"id":10352881,"uuid":"af6b7be3-fdce-476d-a8ea-7eb41999a1bf","attributeTranslation":"Ocena bezpieczeństwa i tolerancji leczenia we wszystkich grupach","language":19,"languageDescription":"Polish"}]}]},"eligibilityCriteria":{"principalInclusionCriteria":[{"id":843354,"number":1,"principalInclusionCriteria":"Patients aged ≥ 18 years with a confirmed diagnosis of CLL/SLL, per the iwCLL 2018 criteria (Hallek et al 2018).","principalInclusionCriteriaTranslations":[{"id":10352800,"uuid":"9c86a67c-2e45-4318-9043-195750a9b411","attributeTranslation":"Pacjenci w wieku ≥ 18 lat z potwierdzonym rozpoznaniem CLL/SLL zgodnie z kryteriami iwCLL 2018 (Hallek i in. 2018).","language":19,"languageDescription":"Polish"},{"id":10352801,"uuid":"9c86a67c-2e45-4318-9043-195750a9b411","attributeTranslation":"Patients âgés de ≥ 18 ans ayant reçu un diagnostic confirmé de LLC/LPL, selon les critères de l’iwCLL 2018 (Hallek et al. 2018).","language":10,"languageDescription":"French"},{"id":10352803,"uuid":"9c86a67c-2e45-4318-9043-195750a9b411","attributeTranslation":"Patiënten van ≥ 18 jaar met een bevestigde diagnose van CLL/SLL, volgens de iwCLL 2018-criteria (Hallek et al 2018).","language":18,"languageDescription":"Dutch"},{"id":10352802,"uuid":"9c86a67c-2e45-4318-9043-195750a9b411","attributeTranslation":"Pacientes de ≥18 años de edad o más con diagnóstico confirmado de LLC/LLP, según los criterios de iwCLL 2018 (Hallek et al. 2018).","language":7,"languageDescription":"Spanish"}]},{"id":843355,"number":2,"principalInclusionCriteria":"Patients must have ≥ 1 prior therapy for CLL/SLL. For each line of therapy, patients must receive at least 2 cycles of this therapy.","principalInclusionCriteriaTranslations":[{"id":10352806,"uuid":"b821c124-8adb-4909-8495-f9a07f200ca5","attributeTranslation":"Patiënten moeten ≥ 1 eerdere behandeling krijgen voor CLL/SLL. Voor elke behandelingslijn moeten patiënten ten minste 2 cycli van deze therapie krijgen.","language":18,"languageDescription":"Dutch"},{"id":10352805,"uuid":"b821c124-8adb-4909-8495-f9a07f200ca5","attributeTranslation":"Les patients doivent avoir reçu ≥ 1 traitement antérieur pour la LLC/le LPL. Pour chaque ligne de traitement, les patients doivent avoir reçu au moins 2 cycles de ce traitement.","language":10,"languageDescription":"French"},{"id":10352807,"uuid":"b821c124-8adb-4909-8495-f9a07f200ca5","attributeTranslation":"Pacjenci muszą być po ≥ 1 wcześniejszym leczeniu CLL/SLL. W przypadku każdej linii terapii pacjenci muszą otrzymać co najmniej 2 cykle tej terapii.","language":19,"languageDescription":"Polish"},{"id":10352804,"uuid":"b821c124-8adb-4909-8495-f9a07f200ca5","attributeTranslation":"Los pacientes deben haber recibido al menos un tratamiento previo para la LLC/LLP. Los pacientes deben recibir al menos 2 ciclos de cada línea de tratamiento.","language":7,"languageDescription":"Spanish"}]},{"id":843356,"number":3,"principalInclusionCriteria":"For patients who received a BCL2i, only those with CLL/SLL who received BCL2i in the first line setting with fixed duration therapy, have a remission for ≥ 3 years, and have a time interval of ≥ 2 years from the last dose of BCL2i to screening, are eligible. Patients should be informed about their options to choose other approved CLL/SLL therapies in this setting.","principalInclusionCriteriaTranslations":[{"id":10352809,"uuid":"eda36b72-ddf1-4b16-b2fb-d0ced55a6967","attributeTranslation":"W przypadku pacjentów, którym podano BCL2i, kwalifikują się wyłącznie chorzy z CLL/SLL, którzy otrzymali BCL2i w ramach leczenia pierwszej linii o ustalonym czasie trwania, mają remisję trwającą ≥ 3 lata oraz w przypadku których upłynęło ≥ 2 lata od ostatniej dawki BCL2i do badania przesiewowego.  Pacjentów należy poinformować o możliwości wyboru innych zarejestrowanych metod leczenia CLL/SLL w tym przypadku.","language":19,"languageDescription":"Polish"},{"id":10352808,"uuid":"eda36b72-ddf1-4b16-b2fb-d0ced55a6967","attributeTranslation":"Voor patiënten die een BCL2i kregen, komen alleen degenen met CLL/SLL die BCL2i kregen in de eerstelijnssetting met vaste behandelingsduur, een remissie gedurende ≥ 3 jaar en een tijdsinterval van ≥ 2 jaar vanaf de laatste\ndosis BCL2i voor screening hebben komen in aanmerking. Patiënten moeten worden geïnformeerd over hun opties om andere goedgekeurde CLL/SLL-therapieën te kiezen in deze instelling.","language":18,"languageDescription":"Dutch"},{"id":10352810,"uuid":"eda36b72-ddf1-4b16-b2fb-d0ced55a6967","attributeTranslation":"En el caso de los pacientes que recibieron un BCL2i, solo son aptos aquellos con LLC/LLP que: recibieron BCL2i en primera línea con tratamiento de duración fija; tienen remisión durante ≥3 años, y tienen un intervalo ≥2 años desde la última dosis de BCL2i hasta la selección. Se debe informar a los pacientes de sus opciones para elegir otros tratamientos para la LLC/LLP aprobados en este contexto.","language":7,"languageDescription":"Spanish"},{"id":10352811,"uuid":"eda36b72-ddf1-4b16-b2fb-d0ced55a6967","attributeTranslation":"Pour les patients ayant reçu un BCL2i, seuls ceux atteints de LLC/LPL ayant reçu un traitement de première intention à durée fixe par un BCL2i, étant en rémission depuis ≥ 3 ans et présentant un intervalle de temps de ≥ 2 ans entre la dernière dose de BCL2i et la sélection sont admissibles. Les patients doivent être informés de la possibilité de choisir d’autres traitements approuvés pour la LLC/le LPL dans ce contexte.","language":10,"languageDescription":"French"}]},{"id":843357,"number":4,"principalInclusionCriteria":"Indications for CLL/SLL therapy are met by one of the criteria per the iwCLL 2018 criteria, with minor modification as discussed in the main protocol.","principalInclusionCriteriaTranslations":[{"id":10352812,"uuid":"70263dba-6fc4-4366-b3d2-649e47f4add7","attributeTranslation":"Aan de indicaties voor CLL/SLL-therapie wordt voldaan aan een van de criteria volgens de iwCLL 2018-criteria, met\nkleine wijziging zoals besproken in het hoofdprotocol.","language":18,"languageDescription":"Dutch"},{"id":10352814,"uuid":"70263dba-6fc4-4366-b3d2-649e47f4add7","attributeTranslation":"Wskazania do leczenia CLL/SLL spełniają jedno z kryteriów zgodnie z kryteriami iwCLL 2018, z niewielkimi modyfikacjami omówionymi w protokole głównym.","language":19,"languageDescription":"Polish"},{"id":10352815,"uuid":"70263dba-6fc4-4366-b3d2-649e47f4add7","attributeTranslation":"Les indications pour le traitement de la LLC/du LPL doivent correspondre à l’un des critères définis par les critères de l’iwCLL 2018, avec une modification mineure comme indiqué dans le protocole principal.","language":10,"languageDescription":"French"},{"id":10352813,"uuid":"70263dba-6fc4-4366-b3d2-649e47f4add7","attributeTranslation":"Las indicaciones para el tratamiento para la LLC/LLP se cumplen según uno de los criterios de iwCLL 2018, con modificaciones menores, tal como se detalla en el protocolo principal.","language":7,"languageDescription":"Spanish"}]},{"id":843358,"number":5,"principalInclusionCriteria":"Eastern Cooperative Oncology Group (ECOG) Performance status 0, 1, or 2.","principalInclusionCriteriaTranslations":[{"id":10352818,"uuid":"fcdd1dd2-cbda-49b9-a404-cea62d59ff0e","attributeTranslation":"Escala de valoración del Grupo Oncológico Cooperativo de la costa Este (ECOG) de 0, 1 o 2.","language":7,"languageDescription":"Spanish"},{"id":10352817,"uuid":"fcdd1dd2-cbda-49b9-a404-cea62d59ff0e","attributeTranslation":"Indice de performance ECOG (Eastern Cooperative Oncology Group) de 0, 1 ou 2.","language":10,"languageDescription":"French"},{"id":10352819,"uuid":"fcdd1dd2-cbda-49b9-a404-cea62d59ff0e","attributeTranslation":"Eastern Cooperative Oncology Group (ECOG) prestatiestatus 0, 1 of 2.","language":18,"languageDescription":"Dutch"},{"id":10352816,"uuid":"fcdd1dd2-cbda-49b9-a404-cea62d59ff0e","attributeTranslation":"Stopień sprawności według Wschodniej Grupy Współpracy Onkologicznej (ang. Eastern Cooperative Oncology Group, ECOG): 0, 1 lub 2.","language":19,"languageDescription":"Polish"}]},{"id":843359,"number":6,"principalInclusionCriteria":"Adequate marrow function as defined by: – Absolute neutrophil count ≥ 1.0 x 109 cells/L with an exception for patients with bone marrow involvement, in which case the absolute neutrophil count must be ≥ 0.75 x 109 cells/L (without growth factor support within the past 7 days). – Platelet counts ≥ 75 x 109 cells/L; in cases of thrombocytopenia clearly due to marrow involvement of CLL (per the discretion of the investigator), the platelet count should be ≥ 30 x 109 cells/L (without growth factor support or transfusion within the past 7 days). – Hemoglobin > 75 g/L (may be posttransfusion).","principalInclusionCriteriaTranslations":[{"id":10352822,"uuid":"e41fe490-ddee-4fe7-a55d-f1b6ceff0696","attributeTranslation":"Odpowiednia czynność szpiku kostnego określona na podstawie następujących wartości: \n- Bezwzględna liczba neutrofili ≥ 1,0 × 109 komórek/l, z wyjątkiem pacjentów z zajęciem szpiku kostnego, w przypadku których bezwzględna liczba neutrofili musi wynosić ≥ 0,75 × 109 komórek/l (bez wspomagania czynnikami wzrostu w ciągu ostatnich 7 dni). \n- Liczba płytek krwi ≥ 75 × 109 komórek/l; w przypadku trombocytopenii jednoznacznie spowodowanej zajęciem szpiku kostnego przez CLL (według uznania badacza) liczba płytek krwi powinna wynosić ≥ 30 × 109 komórek/l (bez wspomagania czynnikami wzrostu lub przetoczeń w ciągu ostatnich 7 dni).\n- Hemoglobina > 75 g/l (może być po przetoczeniu).","language":19,"languageDescription":"Polish"},{"id":10352823,"uuid":"e41fe490-ddee-4fe7-a55d-f1b6ceff0696","attributeTranslation":"Adequate beenmergfunctie zoals gedefinieerd door:\n- Absolute neutrofielentelling ≥ 1.0 x 109 cellen/l, met uitzondering van patiënten met beenmergfunctie, in welk geval de absolute neutrofielentelling ≥ 0.75 x 109 cellen/l moet zijn (zonder groeifactor ondersteuning in de afgelopen 7 dagen).\n- Aantal bloedplaatjes ≥ 75 x 109 cellen/l; in gevallen van trombocytopenie is dit duidelijk als gevolg van mergbetrokkenheid van CLL (naar goeddunken van de onderzoeker), moet het aantal bloedplaatjes ≥ 30 x 109 cellen/l zijn (zonder ondersteuning van groeifactoren of transfusie in de afgelopen 7 dagen). \n- Hemoglobine > 75 g/l (kan posttransfusie zijn).","language":18,"languageDescription":"Dutch"},{"id":10352820,"uuid":"e41fe490-ddee-4fe7-a55d-f1b6ceff0696","attributeTranslation":"Función medular adecuada definida por:\n– Recuento absoluto de neutrófilos ≥1,0 x 109 células/l, excepto en\npacientes con afectación medular, en cuyo caso debe ser ≥0,75 x 109 células/l (sin apoyo del factor de crecimiento en los últimos 7 días).\n– Recuentos de plaquetas ≥75 x 109 células/l; en casos de trombocitopenia claramente atribuible a afectación medular por LLC (según el criterio del investigador), el recuento de plaquetas debe ser ≥30 x 109 células/l (sin apoyo del factor de crecimiento ni transfusión en los últimos 7 días).\n– Hemoglobina >75 g/l (puede ser postransfusión).","language":7,"languageDescription":"Spanish"},{"id":10352821,"uuid":"e41fe490-ddee-4fe7-a55d-f1b6ceff0696","attributeTranslation":"Fonction médullaire adéquate définie par :\n– Numération absolue des neutrophiles ≥ 1,0 x 109 cellules/l, à l’exception des patients présentant une atteinte de la moelle osseuse, auquel cas la numération absolue des neutrophiles doit être ≥ 0,75 x 109 cellules/l (sans soutien par facteur de croissance au cours des 7 derniers jours).\n– Numération plaquettaire ≥ 75 x 109 cellules/l ; en cas de thrombopénie clairement due à une atteinte médullaire liée à la LLC (selon le jugement de l’investigateur), la numération plaquettaire doit être ≥ 30 x 109 cellules/l (sans soutien par facteur de croissance ou transfusion au cours des 7 derniers jours).\n– Hémoglobine > 75 g/l (peut être post-transfusion).","language":10,"languageDescription":"French"}]},{"id":843360,"number":7,"principalInclusionCriteria":"Adequate liver function as indicated by aspartate aminotransferase and alanine aminotransferase ≤ 2.5 x upper limits of normal (ULNs) value; serum total bilirubin ≤ 1.5 x ULNs (unless documented Gilbert syndrome where total bilirubin ≤ 3 x ULNs).","principalInclusionCriteriaTranslations":[{"id":10352824,"uuid":"d19e2294-2596-47a8-b11c-089bc0fd5849","attributeTranslation":"Fonction hépatique adéquate telle qu’indiquée par des taux d’aspartate aminotransférase et d’alanine aminotransférase ≤ 2,5 x limites supérieures de la normale (LSN) ; bilirubine sérique totale ≤ 1,5 x LSN (bilirubine totale ≤ 3 x LSN en cas de syndrome de Gilbert documenté).","language":10,"languageDescription":"French"},{"id":10352827,"uuid":"d19e2294-2596-47a8-b11c-089bc0fd5849","attributeTranslation":"Función hepática adecuada indicada por: aspartato aminotransferasa y alanina aminotransferasa ≤2,5 veces el valor de los límites superiores de la normalidad (LSN);\nbilirrubina total sérica ≤1,5 veces los LSN (excepto con síndrome de Gilbert documentado, donde la bilirrubina total debe ser ≤3 x LSN).","language":7,"languageDescription":"Spanish"},{"id":10352826,"uuid":"d19e2294-2596-47a8-b11c-089bc0fd5849","attributeTranslation":"Prawidłowa czynność wątroby potwierdzona aktywnością aminotransferazy asparaginianowej i aminotransferazy alaninowej ≤ 2,5 × górna granica normy (GGN);\nstężeniem bilirubiny całkowitej w surowicy ≤ 1,5 × GGN (chyba że udokumentowano zespół Gilberta, w przypadku którego stężenie bilirubiny całkowitej wynosi ≤ 3 × GGN).","language":19,"languageDescription":"Polish"},{"id":10352825,"uuid":"d19e2294-2596-47a8-b11c-089bc0fd5849","attributeTranslation":"Adequate leverfunctie, zoals aangegeven door aspartaataminotransferase en alanine-aminotransferase ≤ 2.5 x bovengrens van normale waarde (ULN's);\nTotaal bilirubine in serum ≤ 1.5 x ULN's (tenzij gedocumenteerd syndroom van Gilbert waarbij totaal bilirubine ≤ 3 x ULN's).","language":18,"languageDescription":"Dutch"}]},{"id":843361,"number":8,"principalInclusionCriteria":"Adequate renal function, defined by a value ≥ 30 mL/min, determined either by creatinine clearance directly measured with a 24-hour urine collection or via estimated glomerular filtration rate calculated according to the Chronic Kidney Disease Epidemiology Collaboration equation.","principalInclusionCriteriaTranslations":[{"id":10352828,"uuid":"b8923d73-b305-4b10-86ba-c669d39eccfa","attributeTranslation":"Fonction rénale adéquate, définie par une valeur ≥ 30 ml/min, déterminée soit par la clairance de la créatinine mesurée directement avec un recueil des urines sur 24 heures, soit par le débit de filtration glomérulaire estimé, calculé selon l’équation CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration).","language":10,"languageDescription":"French"},{"id":10352829,"uuid":"b8923d73-b305-4b10-86ba-c669d39eccfa","attributeTranslation":"Función renal adecuada, definida por un valor ≥30 ml/min, determinada por: depuración de creatinina medido directamente con una muestra de orina de 24 horas o mediante la tasa de filtración glomerular estimada, calculada de acuerdo con la ecuación de Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI).","language":7,"languageDescription":"Spanish"},{"id":10352831,"uuid":"b8923d73-b305-4b10-86ba-c669d39eccfa","attributeTranslation":"Adequate nierfunctie, gedefinieerd door een waarde ≥ 30 ml/min, bepaald ofwel door creatinineklaring, rechtstreeks gemeten met een 24-uurs urine verzameling of via geschatte glomerulaire filtratiesnelheid berekend volgens de vergelijking Chronic Kidney Disease Epidemiology Collaboration.","language":18,"languageDescription":"Dutch"},{"id":10352830,"uuid":"b8923d73-b305-4b10-86ba-c669d39eccfa","attributeTranslation":"Prawidłowa czynność nerek zdefiniowana jako wartość ≥ 30 ml/min, określana albo na podstawie bezpośredniego pomiaru klirensu kreatyniny w dobowej zbiórce moczu, albo na podstawie szacowanego wskaźnika filtracji kłębuszkowej obliczonego zgodnie z równaniem Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI).","language":19,"languageDescription":"Polish"}]},{"id":843362,"number":9,"principalInclusionCriteria":"Life expectancy > 6 months.","principalInclusionCriteriaTranslations":[{"id":10352832,"uuid":"bd7891c8-3538-48c8-97ea-ced9ecdd41c3","attributeTranslation":"Przewidywana długość życia > 6 miesięcy.","language":19,"languageDescription":"Polish"},{"id":10352834,"uuid":"bd7891c8-3538-48c8-97ea-ced9ecdd41c3","attributeTranslation":"Levensverwachting > 6 maanden.","language":18,"languageDescription":"Dutch"},{"id":10352835,"uuid":"bd7891c8-3538-48c8-97ea-ced9ecdd41c3","attributeTranslation":"Esperanza de vida >6 meses.","language":7,"languageDescription":"Spanish"},{"id":10352833,"uuid":"bd7891c8-3538-48c8-97ea-ced9ecdd41c3","attributeTranslation":"Espérance de vie > 6 mois.","language":10,"languageDescription":"French"}]}],"principalExclusionCriteria":[{"id":1442258,"number":1,"principalExclusionCriteria":"No active infection including hepatitis B or C virus or HIV at the time of study treatment initiation.","principalExclusionCriteriaTranslations":[{"id":10352768,"uuid":"c10a3b6a-6165-4dca-b297-aeabdd094552","attributeTranslation":"Ninguna infección activa, inclusive virus de la hepatitis B o C o el VIH, en el momento del inicio del tratamiento del estudio.","language":7,"languageDescription":"Spanish"},{"id":10352767,"uuid":"c10a3b6a-6165-4dca-b297-aeabdd094552","attributeTranslation":"Brak aktywnego zakażenia, w tym wirusem zapalenia wątroby typu B lub C bądź wirusem HIV w momencie rozpoczęcia leczenia w ramach badania.","language":19,"languageDescription":"Polish"},{"id":10352770,"uuid":"c10a3b6a-6165-4dca-b297-aeabdd094552","attributeTranslation":"Geen actieve infectie waaronder hepatitis B- of C-virus of HIV ten tijde van de start van de onderzoeksbehandeling.","language":18,"languageDescription":"Dutch"},{"id":10352769,"uuid":"c10a3b6a-6165-4dca-b297-aeabdd094552","attributeTranslation":"Absence d’infection active, y compris par le virus de l’hépatite B ou C ou le VIH, lors de l’instauration du traitement de l’étude.","language":10,"languageDescription":"French"}]},{"id":1442259,"number":2,"principalExclusionCriteria":"No active prolymphocytic leukemia or currently suspected Richter’s transformation at the time of consideration for study.","principalExclusionCriteriaTranslations":[{"id":10352773,"uuid":"730bedd8-648b-49ea-bca9-a55ec3c87680","attributeTranslation":"Brak aktywnej białaczki prolimfocytowej i podejrzewanej transformacji Richtera w momencie oceny spełnienia kryteriów kwalifikacji do udziału w badaniu.","language":19,"languageDescription":"Polish"},{"id":10352772,"uuid":"730bedd8-648b-49ea-bca9-a55ec3c87680","attributeTranslation":"Geen actieve prelymfocytaire leukemie of momenteel vermoede Richter's transformatie ten tijde van de overweging voor het onderzoek.","language":18,"languageDescription":"Dutch"},{"id":10352774,"uuid":"730bedd8-648b-49ea-bca9-a55ec3c87680","attributeTranslation":"Absence de leucémie à prolymphocytes active ou de suspicion de syndrome de Richter lors de l’examen du/de la patient(e) pour l’étude.","language":10,"languageDescription":"French"},{"id":10352771,"uuid":"730bedd8-648b-49ea-bca9-a55ec3c87680","attributeTranslation":"No hay leucemia prolinfocítica activa ni se sospecha actualmente de transformación de Richter en el momento de la consideración para el estudio.","language":7,"languageDescription":"Spanish"}]},{"id":1442260,"number":3,"principalExclusionCriteria":"No ongoing clinically significant cardiovascular or pulmonary disease that prevents participation.","principalExclusionCriteriaTranslations":[{"id":10352778,"uuid":"90af5c56-eec2-48ba-897c-a667e993c2c5","attributeTranslation":"Absence de maladie cardiovasculaire ou pulmonaire cliniquement significative qui constituerait une contre-indication à la participation.","language":10,"languageDescription":"French"},{"id":10352777,"uuid":"90af5c56-eec2-48ba-897c-a667e993c2c5","attributeTranslation":"Geen aanhoudende klinisch significante cardiovasculaire of longziekte die deelname verhindert.","language":18,"languageDescription":"Dutch"},{"id":10352776,"uuid":"90af5c56-eec2-48ba-897c-a667e993c2c5","attributeTranslation":"Brak trwających, istotnych klinicznie chorób układu sercowo-naczyniowego lub płuc, które uniemożliwiłyby udział w badaniu.","language":19,"languageDescription":"Polish"},{"id":10352775,"uuid":"90af5c56-eec2-48ba-897c-a667e993c2c5","attributeTranslation":"No hay ninguna enfermedad cardiovascular o pulmonar clínicamente significativa que impida la participación.","language":7,"languageDescription":"Spanish"}]},{"id":1442261,"number":4,"principalExclusionCriteria":"No central nervous system involvement by CLL/SLL.","principalExclusionCriteriaTranslations":[{"id":10352781,"uuid":"459410bd-33a9-4678-87c6-2bec5eb105dc","attributeTranslation":"Geen betrokkenheid van het centrale zenuwstelsel door CLL/SLL.","language":18,"languageDescription":"Dutch"},{"id":10352782,"uuid":"459410bd-33a9-4678-87c6-2bec5eb105dc","attributeTranslation":"Absence d’atteinte du système nerveux central par la LLC/le LPL.","language":10,"languageDescription":"French"},{"id":10352779,"uuid":"459410bd-33a9-4678-87c6-2bec5eb105dc","attributeTranslation":"Brak zajęcia ośrodkowego układu nerwowego przez CLL/SLL.","language":19,"languageDescription":"Polish"},{"id":10352780,"uuid":"459410bd-33a9-4678-87c6-2bec5eb105dc","attributeTranslation":"No hay afectación del sistema nervioso central por la LLC/LLP.","language":7,"languageDescription":"Spanish"}]},{"id":1442262,"number":5,"principalExclusionCriteria":"No history of prior or active malignancy within 18 months, except for conditions as listed below and as long as patients have recovered from the acute side effects incurred because of previous therapy:  – Adequately treated nonmelanoma skin cancer or lentigo maligna without evidence of disease. – Adequately treated cervical carcinoma in situ without evidence of disease. – Localized prostate cancer with Gleason score ≤ 6 or controlled prostate cancer with androgen deprivation treatment. – Treated early-stage breast cancer with or without hormonal therapy.","principalExclusionCriteriaTranslations":[{"id":10352784,"uuid":"8ce66fd0-ef0b-4b50-b9b0-6832488ea269","attributeTranslation":"Geen voorgeschiedenis van eerdere of actieve maligniteit binnen 18 maanden, behalve aandoeningen zoals hieronder vermeld en zolang patiënten zijn hersteld van de acute bijwerkingen veroorzaakt door eerdere therapie:\n- Adequaat behandeld niet-melanome huidkanker of lentigo maligne zonder bewijs van ziekte.\n- Adequaat behandeld cervicaal carcinoom in situ zonder bewijs van ziekte.\n- Gelokaliseerde prostaatkanker met Gleason-score ≤ 6 of gecontroleerde prostaat kanker met androgeendeprivatiebehandeling.\n- Behandeling van borstkanker in een vroeg stadium met of zonder hormonale therapie.","language":18,"languageDescription":"Dutch"},{"id":10352783,"uuid":"8ce66fd0-ef0b-4b50-b9b0-6832488ea269","attributeTranslation":"Brak wcześniejszej lub aktywnej choroby nowotworowej w ciągu 18 miesięcy, z wyjątkiem chorób wskazanych poniżej, pod warunkiem że pacjenci powrócili do zdrowia po wystąpieniu ostrych zdarzeń niepożądanych spowodowanych wcześniejszą terapią:\n- Odpowiednio leczony rak skóry inny niż czerniak lub czerniak wywodzący się ze złośliwej plamy soczewicowatej bez objawów choroby.\n- Odpowiednio leczony rak szyjki macicy in situ bez objawów choroby.\n- Zlokalizowany rak gruczołu krokowego z wynikiem w skali Gleasona ≤ 6 lub kontrolowany rak gruczołu krokowego leczony poprzez deprywację androgenów.\n- Leczone wczesne stadium raka piersi z terapią hormonalną lub bez niej.","language":19,"languageDescription":"Polish"},{"id":10352785,"uuid":"8ce66fd0-ef0b-4b50-b9b0-6832488ea269","attributeTranslation":"Absence de tumeur maligne antérieure ou active au cours des 18 derniers mois, sauf pour les pathologies répertoriées ci-dessous et à condition que les patients se soient rétablis des effets secondaires aigus présentés en raison d’un traitement précédent : \n– Cancer de la peau non-mélanome ou lentigo malin adéquatement traité sans preuve de maladie.\n– Carcinome du col de l’utérus in situ adéquatement traité sans preuve de maladie.\n– Cancer de la prostate localisé avec score de Gleason ≤ 6 ou cancer de la prostate contrôlé par un traitement par privation androgénique.\n– Cancer du sein à un stade précoce traité avec ou sans hormonothérapie.","language":10,"languageDescription":"French"},{"id":10352786,"uuid":"8ce66fd0-ef0b-4b50-b9b0-6832488ea269","attributeTranslation":"No hay antecedentes de neoplasia maligna previa o activa en los últimos 18 meses, excepto en las afecciones que se enumeran a continuación y siempre que los pacientes se hayan recuperado de los efectos secundarios agudos producidos por el tratamiento previo:\n– Cáncer de piel distinto del melanoma tratado adecuadamente o lentigo maligno sin evidencia de enfermedad.\n– Carcinoma de cuello uterino in situ tratado adecuadamente sin evidencia de enfermedad.\n– Cáncer de próstata localizado con puntuación de Gleason ≤6 o cáncer de próstata controlado con tratamiento de privación androgénica.\n– Tratamiento del cáncer de mama en su fase inicial con o sin terapia hormonal.","language":7,"languageDescription":"Spanish"}]},{"id":1442263,"number":6,"principalExclusionCriteria":"No other active antineoplastic treatment.","principalExclusionCriteriaTranslations":[{"id":10352789,"uuid":"97413241-90ca-49dd-b538-2a18c1e1968b","attributeTranslation":"Ningún otro tratamiento antineoplásico activo.","language":7,"languageDescription":"Spanish"},{"id":10352790,"uuid":"97413241-90ca-49dd-b538-2a18c1e1968b","attributeTranslation":"Brak innego aktywnego leczenia przeciwnowotworowego.","language":19,"languageDescription":"Polish"},{"id":10352788,"uuid":"97413241-90ca-49dd-b538-2a18c1e1968b","attributeTranslation":"Aucun autre traitement antinéoplasique actif.","language":10,"languageDescription":"French"},{"id":10352787,"uuid":"97413241-90ca-49dd-b538-2a18c1e1968b","attributeTranslation":"Geen andere actieve antineoplastische behandeling.","language":18,"languageDescription":"Dutch"}]},{"id":1442264,"number":7,"principalExclusionCriteria":"No CYP3A4 moderate or strong inhibitors or CYP3A4 moderate or strong inducers.","principalExclusionCriteriaTranslations":[{"id":10352794,"uuid":"925b8d6e-0bdd-4b9e-a0a9-9fb7782820ad","attributeTranslation":"Pas d’inhibiteurs modérés ou puissants du CYP3A4 ni d’inducteurs modérés ou puissants du CYP3A4.","language":10,"languageDescription":"French"},{"id":10352793,"uuid":"925b8d6e-0bdd-4b9e-a0a9-9fb7782820ad","attributeTranslation":"Brak leczenia umiarkowanymi lub silnymi inhibitorami CYP3A4 bądź umiarkowanymi albo silnymi induktorami CYP3A4.","language":19,"languageDescription":"Polish"},{"id":10352791,"uuid":"925b8d6e-0bdd-4b9e-a0a9-9fb7782820ad","attributeTranslation":"Geen matige of sterke CYP3A4-remmers of matige of sterke CYP3A4-inductoren.","language":18,"languageDescription":"Dutch"},{"id":10352792,"uuid":"925b8d6e-0bdd-4b9e-a0a9-9fb7782820ad","attributeTranslation":"Ausencia de inhibidores fuertes o moderados de CYP3A4 o de inductores fuertes o moderados de CYP3A4.","language":7,"languageDescription":"Spanish"}]}]},"endPoint":{"primaryEndPoints":[{"id":987775,"number":1,"endPoint":"PFS, defined as the time from the date of randomization to the date of disease progression as determined by the blinded independent review committee (BIRC) or death, whichever occurs first.","isPrimary":true,"endPointTranslations":[{"id":10352721,"uuid":"6b82a7f2-3291-4cb2-906d-a35295843754","attributeTranslation":"PFS, gedefinieerd als de tijd vanaf de datum van randomisatie tot de datum van ziekteprogressie als bepaald door de geblindeerde onafhankelijke controle commissie (BIRC) of overlijden, afhankelijk van wat zich het eerst voordoet.","language":18,"languageDescription":"Dutch"},{"id":10352719,"uuid":"6b82a7f2-3291-4cb2-906d-a35295843754","attributeTranslation":"SSP, définie comme le temps écoulé entre la date de randomisation et la date de progression de la maladie telle que déterminée par le comité d’examen indépendant en aveugle (BIRC) ou le décès, selon la situation qui se présente en premier.","language":10,"languageDescription":"French"},{"id":10352720,"uuid":"6b82a7f2-3291-4cb2-906d-a35295843754","attributeTranslation":"La SSP, definida como el tiempo transcurrido desde la fecha de aleatorización hasta la fecha de progresión de la enfermedad, según lo que determine el comité de revisión central independiente ciego (BIRC, por sus siglas en inglés), o el fallecimiento, lo que ocurra primero.","language":7,"languageDescription":"Spanish"},{"id":10352722,"uuid":"6b82a7f2-3291-4cb2-906d-a35295843754","attributeTranslation":"PFS definiowane jako czas od daty randomizacji do daty stwierdzenia progresji choroby przez niezależną, nieposiadającą informacji o przydzielonym leczeniu komisję ds. przeglądu badania (ang. blinded independent review committee, BIRC) lub zgonu, w zależności od tego, co nastąpi wcześniej.","language":19,"languageDescription":"Polish"}]}],"secondaryEndPoints":[{"id":987776,"number":1,"endPoint":"PFS, defined as the time from the date of randomization to the date of disease progression as determined by the BIRC or death, whichever occurs first.","isPrimary":false,"endPointTranslations":[{"id":10352723,"uuid":"78ceda01-965a-4834-a541-ba3219d3d508","attributeTranslation":"SSP, définie comme le temps écoulé entre la date de randomisation et la date de progression de la maladie telle que déterminée par le BIRC ou le décès, selon la situation qui se présente en premier.","language":10,"languageDescription":"French"},{"id":10352726,"uuid":"78ceda01-965a-4834-a541-ba3219d3d508","attributeTranslation":"PFS definiowane jako czas od daty randomizacji do daty stwierdzenia progresji choroby przez BIRC lub zgonu, w zależności od tego, co nastąpi wcześniej.","language":19,"languageDescription":"Polish"},{"id":10352725,"uuid":"78ceda01-965a-4834-a541-ba3219d3d508","attributeTranslation":"PFS, gedefinieerd als de tijd vanaf de datum van randomisatie tot de datum van ziekteprogressie als bepaald door de BIRC of overlijden, afhankelijk van wat zich het eerst voordoet.","language":18,"languageDescription":"Dutch"},{"id":10352724,"uuid":"78ceda01-965a-4834-a541-ba3219d3d508","attributeTranslation":"La SSP, definida como el tiempo transcurrido desde la fecha de aleatorización hasta la fecha de progresión de la enfermedad, según lo determine el BIRC, o el fallecimiento, lo que ocurra primero.","language":7,"languageDescription":"Spanish"}]},{"id":987777,"number":2,"endPoint":"• Undetectable minimal residual disease at < 10-4 sensitivity (uMRD4) rate in peripheral blood at C14D1 Visit based on next-generation sequencing (NGS [clonoSEQ]). • Complete response rate (CRR), defined as the proportion of patients that achieve a best response of CR or CRi (CR/CRi), as determined by the BIRC. • OS, defined as the time from the date of randomization to the date of death.","isPrimary":false,"endPointTranslations":[{"id":10352728,"uuid":"12d18531-0477-46e2-a20d-61d782fa0b3c","attributeTranslation":"•\tNiewykrywalna minimalna choroba resztkowa przy wskaźniku czułości < 10–4 (uMRD4) we krwi obwodowej podczas wizyty w dniu 1. cyklu 14. na podstawie sekwencjonowania nowej generacji (NGS [clonoSEQ]).\n•\tWskaźnik odpowiedzi całkowitej (ang. complete response rate, CRR) zdefiniowany jako odsetek pacjentów, u których uzyskano najlepszą odpowiedź w postaci CR lub CRi (CR/CRi), zgodnie z ustaleniami BIRC. \n•\tOS, definiowany jako czas od daty randomizacji do daty zgonu.","language":19,"languageDescription":"Polish"},{"id":10352727,"uuid":"12d18531-0477-46e2-a20d-61d782fa0b3c","attributeTranslation":"• Maladie résiduelle minime indétectable à un taux de sensibilité < 10-4 (uMRD4) dans le sang périphérique au jour 1 du cycle 14 selon le séquençage de nouvelle génération (NGS [clonoSEQ]).\n• Taux de réponse complète (TRC), défini comme la proportion de patients dont la meilleure réponse est une RC ou une RCi (RC/RCi), selon l’évaluation du BIRC.\n• SG, définie comme le temps écoulé entre la date de randomisation et la date de décès.","language":10,"languageDescription":"French"},{"id":10352729,"uuid":"12d18531-0477-46e2-a20d-61d782fa0b3c","attributeTranslation":"• Niet-detecteerbare minimale residuele ziekte bij < 10-4 gevoeligheidspercentage (uMRD4) in perifeer bloed bij C14D1 Bezoek op basis van de next-generation sequencing (NGS [clonoSEQ]).\n• Complete responspercentage (CRR), gedefinieerd als het deel van de patiënten dat de beste respons bereikt van CR of CRi (CR/CRi), zoals bepaald door de BIRC.\n• OS, gedefinieerd als de tijd vanaf de datum van randomisatie tot de datum van overlijden.","language":18,"languageDescription":"Dutch"},{"id":10352730,"uuid":"12d18531-0477-46e2-a20d-61d782fa0b3c","attributeTranslation":"• La tasa de enfermedad residual mínima indetectable con una sensibilidad <10-4 (EMRi4) en sangre periférica en la visita de C14D1 en base a la secuenciación de nueva generación (NGS [clonoSEQ]).\n• La tasa de respuesta completa (TRC), definida como el porcentaje de pacientes que logran una mejor respuesta de RC o RCi (RC/RCi), según lo determinado por el BIRC.\n• La SG, definida como el tiempo transcurrido desde la fecha de aleatorización hasta la fecha del fallecimiento.","language":7,"languageDescription":"Spanish"}]},{"id":987778,"number":3,"endPoint":"• PFS per investigator assessment. • CRR per the BIRC and investigator assessment. • OS. • Rate of uMRD4 (C8D1, C11D1, C14D1, and Posttreatment follow-up [PTFU]1) based on NGS (clonoSEQ).","isPrimary":false,"endPointTranslations":[{"id":10352734,"uuid":"6bd9809e-17a2-4dbf-b58b-eb39684f33f5","attributeTranslation":"• La SSP según la evaluación del investigador.\n• La TRC según el BIRC y la evaluación del investigador.\n• La SG.\n• Tasa de EMRi4 (C8D1, C11D1, C14D1, y seguimiento posterior al tratamiento [PTFU]1) en base a NGS (clonoSEQ).","language":7,"languageDescription":"Spanish"},{"id":10352731,"uuid":"6bd9809e-17a2-4dbf-b58b-eb39684f33f5","attributeTranslation":"•\tPFS według oceny badacza.\n•\tCRR według BIRC i oceny badacza. \n•\tOS.\n•\tWskaźnik uMRD4 (dzień 1. cyklu 8., dzień 1. cyklu 11., dzień 1. cyklu 14. i obserwacja po leczeniu [ang. posttreatment follow-up, PTFU1]) na podstawie NGS (clonoSEQ).","language":19,"languageDescription":"Polish"},{"id":10352732,"uuid":"6bd9809e-17a2-4dbf-b58b-eb39684f33f5","attributeTranslation":"• SSP selon l’évaluation de l’investigateur.\n• TRC selon l’évaluation du BIRC et de l’investigateur.\n• SG.\n• Taux de uMRD4 (au jour 1 des cycles 8, 11 et 14 et lors de la première visite de suivi post-traitement [SPT]) selon le NGS (clonoSEQ).","language":10,"languageDescription":"French"},{"id":10352733,"uuid":"6bd9809e-17a2-4dbf-b58b-eb39684f33f5","attributeTranslation":"• PFS volgens beoordeling van de onderzoeker.\n• CRR volgens de BIRC en de beoordeling door de onderzoeker.\n• OS.\n• Percentage van uMRD4 (C8D1, C11D1, C14D1, en follow-up na de behandeling [PTFU]1) op basis van NGS (clonoSEQ).","language":18,"languageDescription":"Dutch"}]},{"id":987779,"number":4,"endPoint":"• PFS per BIRC and investigator assessment. • CRR per BIRC and investigator assessment. • OS. • Rate of uMRD4 (C8D1, C11D1, C14D1, and PTFU1) based on NGS (clonoSEQ).","isPrimary":false,"endPointTranslations":[{"id":10352736,"uuid":"ad360f50-926e-4008-bb8d-2ccc1bb21f05","attributeTranslation":"• PFS per BIRC en beoordeling door de onderzoeker.\n• CRR per BIRC en beoordeling door de onderzoeker.\n• OS.\n• Percentage van uMRD4 (C8D1, C11D1, C14D1, en PTFU1) op basis van NGS (clonoSEQ).","language":18,"languageDescription":"Dutch"},{"id":10352737,"uuid":"ad360f50-926e-4008-bb8d-2ccc1bb21f05","attributeTranslation":"• La SSP según el BIRC y la evaluación del investigador.\n• La TRC según el BIRC y la evaluación del investigador.\n• La SG.\n• Tasa de EMRi4 (C8D1, C11D1, C14D1, y PTFU1) en base a NGS (clonoSEQ).","language":7,"languageDescription":"Spanish"},{"id":10352738,"uuid":"ad360f50-926e-4008-bb8d-2ccc1bb21f05","attributeTranslation":"• SSP selon l’évaluation du BIRC et de l’investigateur.\n• TRC selon l’évaluation du BIRC et de l’investigateur.\n• SG.\n• Taux de uMRD4 (au jour 1 des cycles 8, 11 et 14 et lors de la première visite SPT) selon le NGS (clonoSEQ).","language":10,"languageDescription":"French"},{"id":10352735,"uuid":"ad360f50-926e-4008-bb8d-2ccc1bb21f05","attributeTranslation":"•\tPFS według BIRC i oceny badacza.\n•\tCRR według BIRC i oceny badacza.\n•\tOS.\n•\tWskaźnik uMRD4 (dzień 1. cyklu 8., dzień 1. cyklu 11., dzień 1. cyklu 14. i PTFU1) na podstawie NGS (clonoSEQ).","language":19,"languageDescription":"Polish"}]},{"id":987780,"number":5,"endPoint":"• Rate of uMRD4 (C8D1, C11D1 and PTFU1) based on NGS (clonoSEQ). • CRR per investigator assessment. • PFS per investigator assessment.","isPrimary":false,"endPointTranslations":[{"id":10352741,"uuid":"16ce3ed6-685d-4512-9d6a-544414f17805","attributeTranslation":"• Percentage van uMRD4 (C8D1, C11D1 en PTFU1) gebaseerd op NGS (clonoSEQ).\n• CRR volgens beoordeling van de onderzoeker.\n• PFS volgens beoordeling van de onderzoeker.","language":18,"languageDescription":"Dutch"},{"id":10352739,"uuid":"16ce3ed6-685d-4512-9d6a-544414f17805","attributeTranslation":"•\tWskaźnik uMRD4 (dzień 1. cyklu 8., dzień 1. cyklu 11. i obserwacja po leczeniu PTFU1) na podstawie NGS (clonoSEQ).\n•\tCRR według oceny badacza.\n•\tPFS według oceny badacza.","language":19,"languageDescription":"Polish"},{"id":10352742,"uuid":"16ce3ed6-685d-4512-9d6a-544414f17805","attributeTranslation":"• Taux de uMRD4 (au jour 1 des cycles 8 et 11 et lors de la première visite SPT) selon le NGS (clonoSEQ).\n• TRC selon l’évaluation de l’investigateur.\n• SSP selon l’évaluation de l’investigateur.","language":10,"languageDescription":"French"},{"id":10352740,"uuid":"16ce3ed6-685d-4512-9d6a-544414f17805","attributeTranslation":"• Tasa de EMRi4 (C8D1, C11D1 y PTFU1) en base a NGS (clonoSEQ).\n• La TRC según la evaluación del investigador.\n• La SSP según la evaluación del investigador.","language":7,"languageDescription":"Spanish"}]},{"id":987781,"number":6,"endPoint":"• PFS per investigator assessment. • CRR per investigator assessment. • OS. • Rate of uMRD4 (C8D1, C11D1, C14D1, and PTFU1) based on NGS (clonoSEQ).","isPrimary":false,"endPointTranslations":[{"id":10352745,"uuid":"5550d502-44c5-4c03-a153-a2da3d9a56aa","attributeTranslation":"• La SSP según la evaluación del investigador.\n• La TRC según la evaluación del investigador.\n• La SG.\n• Tasa de EMRi4 (C8D1, C11D1, C14D1, y PTFU1) en base a NGS (clonoSEQ).","language":7,"languageDescription":"Spanish"},{"id":10352746,"uuid":"5550d502-44c5-4c03-a153-a2da3d9a56aa","attributeTranslation":"• SSP selon l’évaluation de l’investigateur.\n• TRC selon l’évaluation de l’investigateur.\n• SG.\n• Taux de uMRD4 (au jour 1 des cycles 8, 11 et 14 et lors de la première visite SPT) selon le NGS (clonoSEQ).","language":10,"languageDescription":"French"},{"id":10352744,"uuid":"5550d502-44c5-4c03-a153-a2da3d9a56aa","attributeTranslation":"•\tPFS według oceny badacza.\n•\tCRR według oceny badacza.\n•\tOS.\n•\tWskaźnik uMRD4 (dzień 1. cyklu 8., dzień 1. cyklu 11., dzień 1. cyklu 14. i PTFU1) na podstawie NGS (clonoSEQ).","language":19,"languageDescription":"Polish"},{"id":10352743,"uuid":"5550d502-44c5-4c03-a153-a2da3d9a56aa","attributeTranslation":"• PFS volgens beoordeling van de onderzoeker.\n• CRR volgens beoordeling van de onderzoeker.\n• OS.\n• Percentage van uMRD4 (C8D1, C11D1, C14D1, en PTFU1) op basis van NGS (clonoSEQ).","language":18,"languageDescription":"Dutch"}]},{"id":987782,"number":7,"endPoint":"• ORR, defined as the proportion of patients that achieve a best response of partial response (PR) or better, as determined by the BIRC and investigator assessment. • DOR, defined as the time from the date that response criteria were first met to the date of first documentation of disease progression or death, whichever occurred first per the BIRC and investigator assessment.","isPrimary":false,"endPointTranslations":[{"id":10352750,"uuid":"8270c33f-d8f0-4bf4-9132-ed9525e8c013","attributeTranslation":"• ORR, gedefinieerd als het deel van de patiënten dat een beste respons van gedeeltelijke respons (PR) bereiken of beter, zoals bepaald door de BIRC en beoordeling van de onderzoeker.\n• DOR, gedefinieerd als de tijd vanaf de datum die waarop er voor het eerst werd voldaan aan de responscriteria tot de datum van de eerste documentatie van ziekteprogressie of overlijden, afhankelijk van wat zich het eerst heeft voorgedaan volgens de BIRC en beoordeling van de onderzoeker.","language":18,"languageDescription":"Dutch"},{"id":10352748,"uuid":"8270c33f-d8f0-4bf4-9132-ed9525e8c013","attributeTranslation":"• El TRG, definido como el porcentaje de pacientes que logran una mejor tasa de respuesta parcial (RP) o mejor, según lo determinado por el BIRC y la evaluación del investigador.\n• La DR, definida como el tiempo transcurrido desde la fecha en que se cumplieron por primera vez los criterios de respuesta hasta la fecha de la primera documentación de progresión de la enfermedad o el fallecimiento,\nlo que haya ocurrido primero, según el BIRC y la evaluación del investigador.","language":7,"languageDescription":"Spanish"},{"id":10352749,"uuid":"8270c33f-d8f0-4bf4-9132-ed9525e8c013","attributeTranslation":"•\tORR, zdefiniowany jako odsetek pacjentów, którzy osiągnęli najlepszą odpowiedź w postaci odpowiedzi częściowej (ang. partial response, PR) lub lepszej, według BIRC i oceny badacza.\n•\tDOR, zdefiniowany jako czas od daty pierwszego spełnienia kryteriów odpowiedzi do daty pierwszej udokumentowanej progresji choroby lub zgonu, w zależności od tego, co nastąpiło pierwsze według BIRC i oceny badacza.","language":19,"languageDescription":"Polish"},{"id":10352747,"uuid":"8270c33f-d8f0-4bf4-9132-ed9525e8c013","attributeTranslation":"• TRG, défini comme la proportion de patients dont la meilleure réponse est une réponse partielle (RP) ou meilleure, selon l’évaluation du BIRC et de l’investigateur.\n• DDR, définie comme le temps écoulé entre la date à laquelle les critères de réponse ont été remplis pour la première fois et la date de la première documentation de la progression de la maladie ou la date du décès, selon la situation qui s’est produite en premier, selon l’évaluation du BIRC et de l’investigateur.","language":10,"languageDescription":"French"}]},{"id":987783,"number":8,"endPoint":"• TTR, defined as the time from the date of randomization to the date response criteria were first met, per the BIRC and investigator assessment. • TTNT, defined as the time from the date of randomization to the date of next anti-CLL/SLL treatment. (The BIRC assessments are applicable for Arms A, B, and D only.)","isPrimary":false,"endPointTranslations":[{"id":10352754,"uuid":"28718e09-49d3-43f6-8d98-6ff82d6febf8","attributeTranslation":"• TTR, défini comme le temps écoulé entre la date de randomisation et la date à laquelle les critères de réponse ont été remplis pour la première fois, selon l’évaluation du BIRC et de l’investigateur.\n• TTNT, défini comme le temps écoulé entre la date de randomisation et la date du prochain traitement anti-LLC/LPL.\n(Les évaluations du BIRC s’appliquent uniquement aux groupes A, B et D.)","language":10,"languageDescription":"French"},{"id":10352751,"uuid":"28718e09-49d3-43f6-8d98-6ff82d6febf8","attributeTranslation":"•\tTTR, zdefiniowany jako czas od daty randomizacji do daty pierwszego spełnienia kryteriów odpowiedzi według BIRC i oceny badacza.\n•\tTTNT, zdefiniowany jako czas od daty randomizacji do daty następnego leczenia przeciw CLL/SLL.\n(Oceny BIRC dotyczą wyłącznie grup A, B i D).","language":19,"languageDescription":"Polish"},{"id":10352752,"uuid":"28718e09-49d3-43f6-8d98-6ff82d6febf8","attributeTranslation":"• TTR, gedefinieerd als de tijd vanaf de datum van randomisatie op de datum waarop voor het eerste aan de responscriteria werd voldaan, volgens de BIRC en de beoordeling van de onderzoeker.\n• TTNT, gedefinieerd als de tijd vanaf de datum van randomisatie tot de datum van de volgende anti-CLL/SLL behandeling.\n(De BIRC-beoordelingen zijn alleen van toepassing op Armen A, B en D.)","language":18,"languageDescription":"Dutch"},{"id":10352753,"uuid":"28718e09-49d3-43f6-8d98-6ff82d6febf8","attributeTranslation":"• El TR, definido como el tiempo transcurrido desde la fecha de aleatorización hasta la fecha en que se cumplieron los criterios de respuesta por primera vez, según la evaluación del BIRC y del investigador.\n• El TST, definido como el tiempo transcurrido desde la fecha de aleatorización hasta la fecha del siguiente tratamiento contra la LLC/LLP. 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