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A randomized study with extensive immune phenotyping.","fullTitleTranslations":[{"id":5468089,"uuid":"f7b073d0-0e2f-44ec-af61-b09a5a012a17","attributeTranslation":"Een onderzoek naar de kortdurende behandeling met acalabrutinib gecombineerd met venetoclax bij nieuw gediagnosticeerde patiënten met chronische lymfatische leukemie (CLL) met een hoog risico op het krijgen van een infectie en/of op vroege behandeling, die niet voldoen aan de behandelingscriteria van de International Workshop on CLL (IWCLL) voor behandeling. Een gerandomiseerd onderzoek met uitgebreide immunofenotypering (PreVent-ACaLL).","language":37,"languageDescription":"Dutch (Netherlands)"},{"id":5468087,"uuid":"f7b073d0-0e2f-44ec-af61-b09a5a012a17","attributeTranslation":"Korttids kombinationsbehandling med acalabrutinib og venetoclax for nydiagnosticerede patienter med CLL i høj risiko for infektioner og/eller tidlig behandling, der ikke opfylder IWCLL behandlingskriterierne for behandling. 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This is a non-inferiority analysis as detailed in the\nstatistical analysis plan to assure safety of the combination treatment in\nthis preemptive trial population.\nPrimary Objective optional phase 3 part:\nGrade ≥3-infection free and CLL-treatment-free survival 2 years after\nenrollment","mainObjectiveTranslations":[{"id":5468104,"uuid":"9b9d80fa-ae5d-4080-a345-621cabe37719","attributeTranslation":"Primaire doelstelling fase 2-gedeelte:\nGraad ≥3-Infectievrije overleving in de behandelingsarm in vergelijking met de observatiearm 12 weken na beëindiging van de behandeling (24 weken na de start van de behandeling). 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opgenomen als de PCR-test voor HBV DNA negatief is en er elke maand een HBV-DNA PCR-test wordt uitgevoerd tot 12 maanden na de laatste behandelingscyclus), negatief testen op hepatitis C-RNA binnen 6 weken voorafgaand aan de registratie (ondertekeningsdatum op de geïnformeerde toestemming).","language":37,"languageDescription":"Dutch (Netherlands)"}]},{"id":480489,"number":11,"principalInclusionCriteria":"Eastern Cooperative Oncology Group Performance Status (ECOG) performance status 0-2.","principalInclusionCriteriaTranslations":[{"id":5468092,"uuid":"35ec1069-c6e3-4f1c-ae87-cbecad6decb9","attributeTranslation":"Prestatiestatus van de Eastern Cooperative Oncology Group Performance Status (ECOG) 0-2.","language":37,"languageDescription":"Dutch (Netherlands)"}]},{"id":480490,"number":12,"principalInclusionCriteria":"Woman of childbearing potential (WOCBP) who are sexually active must use highly effective methods of contraception during treatment and for 30 days after the last dose of investigational drugs.","principalInclusionCriteriaTranslations":[{"id":5468093,"uuid":"1dbebf50-533c-40f1-89f4-643cc1fad626","attributeTranslation":"Vrouw op vruchtbare leeftijd (WOCBP) die seksueel actief is, moet tijdens de behandeling en gedurende 30 dagen na de laatste dosis van de studiemedicatie zeer effectieve anticonceptiemethoden gebruiken.","language":37,"languageDescription":"Dutch (Netherlands)"}]},{"id":480491,"number":13,"principalInclusionCriteria":"Willing and able to participate in all required evaluations and procedures in this study protocol including swallowing capsules without difficulty.","principalInclusionCriteriaTranslations":[{"id":5468094,"uuid":"3a4869eb-649b-4112-921e-18cd5342a697","attributeTranslation":"Bereid en in staat zijn om deel te nemen aan alle vereiste evaluaties en procedures in dit studieprotocol, inclusief het slikken van capsules zonder problemen.","language":37,"languageDescription":"Dutch (Netherlands)"}]},{"id":480492,"number":14,"principalInclusionCriteria":"Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information.","principalInclusionCriteriaTranslations":[{"id":5468095,"uuid":"05cb7b97-de84-499d-86f7-fe1d2e329cb5","attributeTranslation":"Vermogen om het doel en de risico's van de studie te begrijpen en ondertekende en gedateerde geïnformeerde toestemming en machtiging geven voor het gebruik van beschermde gezondheidsinformatie.","language":37,"languageDescription":"Dutch (Netherlands)"}]},{"id":480493,"number":2,"principalInclusionCriteria":"High risk of infection and/or progressive treatment within 2 years according to CLL-TIM","principalInclusionCriteriaTranslations":[{"id":5468096,"uuid":"a336d0d0-dd3d-4e5d-b200-c72007ab5f15","attributeTranslation":"Hoog risico op infectie en/of progressieve behandeling binnen 2 jaar volgens CLL-TIM","language":37,"languageDescription":"Dutch (Netherlands)"}]},{"id":480494,"number":3,"principalInclusionCriteria":"IWCLL treatment indication not fulfilled","principalInclusionCriteriaTranslations":[{"id":5468097,"uuid":"22763564-7b23-41d8-bcb9-123cc13aad25","attributeTranslation":"IWCLL-behandelingsindicatie is niet vervuld","language":37,"languageDescription":"Dutch (Netherlands)"}]},{"id":480495,"number":4,"principalInclusionCriteria":"Life expectancy > 2 years","principalInclusionCriteriaTranslations":[{"id":5468098,"uuid":"be564381-9912-4abc-bb33-51c9c0cc418a","attributeTranslation":"Levensverwachting > 2 jaar","language":37,"languageDescription":"Dutch (Netherlands)"}]},{"id":480496,"number":5,"principalInclusionCriteria":"Age at least 18 years","principalInclusionCriteriaTranslations":[{"id":5468099,"uuid":"88dbe342-0a23-4975-98a2-c054f69fb01e","attributeTranslation":"Leeftijd is minimaal 18 jaar","language":37,"languageDescription":"Dutch (Netherlands)"}]},{"id":480497,"number":6,"principalInclusionCriteria":"Ability and willingness to provide written informed consent and adhere to study procedures and treatment","principalInclusionCriteriaTranslations":[{"id":5468100,"uuid":"68409de1-9a82-4be9-9596-ef6d731187e3","attributeTranslation":"Vermogen en bereidheid om schriftelijke geïnformeerde toestemming te geven en zich te houden aan studieprocedures en behandeling","language":37,"languageDescription":"Dutch (Netherlands)"}]},{"id":480498,"number":7,"principalInclusionCriteria":"Adequate bone marrow function as indicated by platelets above 100 x 10E9, hemoglobin above 10 g/dL and neutrophils above 1 x 10E9","principalInclusionCriteriaTranslations":[{"id":5468101,"uuid":"2d8818ce-766e-468a-826d-33f0c8f33620","attributeTranslation":"Adequate beenmergfunctie zoals aangegeven door bloedplaatjes boven 100 x 10E9, hemoglobine boven 10 g/dl en neutrofielen boven 1 x 10E9","language":37,"languageDescription":"Dutch (Netherlands)"}]},{"id":480499,"number":8,"principalInclusionCriteria":"Creatinine clearance above 30 mL/min directly measured with 24hr urine collection or calculated according to the modified formula of Cockcroft and Gault","principalInclusionCriteriaTranslations":[{"id":5468102,"uuid":"f39f4e40-4f00-4865-b1e3-8560f96480c4","attributeTranslation":"Creatinineklaring boven 30 ml/min rechtstreeks gemeten met 24 uur urineverzameling of berekend volgens de gewijzigde formule van Cockcroft en Gault","language":37,"languageDescription":"Dutch (Netherlands)"}]},{"id":480500,"number":9,"principalInclusionCriteria":"Adequate liver function as indicated by a total bilirubin≤ 2 x, AST or ALT ≤ 2.5 x the institutional ULN value, unless directly attributable to the patient’s CLL or to Gilbert’s Syndrome.","principalInclusionCriteriaTranslations":[{"id":5468103,"uuid":"9126c0b0-50c0-4a8e-baa3-cb5e71a953a4","attributeTranslation":"Adequate leverfunctie zoals aangegeven door een totaal bilirubine ≤ 2 x, AST of ALT ≤ 2,5 x de bovengrens van de normale institutionele ULN-waarden, tenzij rechtstreeks toe te schrijven aan de CLL van de patiënt of aan het syndroom van Gilbert.","language":37,"languageDescription":"Dutch (Netherlands)"}]}],"principalExclusionCriteria":[{"id":827954,"number":1,"principalExclusionCriteria":"Prior CLL treatment (including monoclonal antibodies, chemotherapy, small molecules, including CD20 antibodies, BTK inhibitors and bcl-2 inhibitors for any indication)","principalExclusionCriteriaTranslations":[{"id":5468064,"uuid":"d2b68ee1-50d7-44eb-ab48-15c1accb2da0","attributeTranslation":"Voorafgaande CLL-behandeling (inclusief monoklonale antilichamen, chemotherapie, kleine moleculen, inclusief CD20-antilichamen, BTK-remmers en Bcl-2-remmers voor om het even welke indicatie)","language":37,"languageDescription":"Dutch (Netherlands)"}]},{"id":827955,"number":10,"principalExclusionCriteria":"History of clinically significant cardiovascular disease such as arrhythmias, congestive heart failure, or myocardial infarction within 6 months of screening (counting from signature date on informed consent), or any Class 3 or 4 cardiac disease as defined by the New York Heart Association Functional Classification, or corrected QT interval (QTc) > 480 msec at screening.","principalExclusionCriteriaTranslations":[{"id":5468065,"uuid":"04608dd7-cd19-4a29-bda9-7bf2e520ae0d","attributeTranslation":"Geschiedenis van klinisch significante hart- en vaatziekten zoals aritmieën, congestief hartfalen of een hartinfarct binnen 6 maanden na de screening (gerekend vanaf de ondertekeningsdatum van de geïnformeerde toestemming), of een hartziekte van klasse 3 of 4 zoals gedefinieerd door de Functionele classificatie van de New York Heart Association, of een gecorrigeerd QT-interval (QTc)> 480 msec bij de screening.","language":37,"languageDescription":"Dutch (Netherlands)"}]},{"id":827956,"number":11,"principalExclusionCriteria":"History of stroke or intracranial hemorrhage within 6 months prior to (signature date on informed consent).","principalExclusionCriteriaTranslations":[{"id":5468066,"uuid":"ad235a2b-bcbd-49e0-83f8-60ba30650b29","attributeTranslation":"Geschiedenis van een beroerte of intracraniële bloeding binnen 6 maanden voorafgaand aan de registratie (ondertekeningsdatum op de geïnformeerde toestemming).","language":37,"languageDescription":"Dutch (Netherlands)"}]},{"id":827957,"number":12,"principalExclusionCriteria":"Use of investigational agents which might interfere with the study drug within 28 days prior to first day of treatment/C1D1.","principalExclusionCriteriaTranslations":[{"id":5468067,"uuid":"83331558-e3fa-4d68-ab25-18b0a9195c12","attributeTranslation":"Gebruik van studiemiddelen die de studiemedicatie kunnen verstoren binnen 28 dagen voorafgaand aan de eerste dag van de behandeling/C1D1.","language":37,"languageDescription":"Dutch (Netherlands)"}]},{"id":827958,"number":13,"principalExclusionCriteria":"Vaccination with live vaccines within 28 days prior to first day of treatment/C1D1.","principalExclusionCriteriaTranslations":[{"id":5468068,"uuid":"0467faae-4b06-4dfa-b2df-943c63bc49d1","attributeTranslation":"Vaccinatie met levende vaccins binnen 28 dagen voorafgaand aan de eerste dag van de behandeling/C1D1.","language":37,"languageDescription":"Dutch (Netherlands)"}]},{"id":827959,"number":14,"principalExclusionCriteria":"Major surgery less than 30 days before start of treatment. 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