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Bovendien moeten eerdere behandelingsgerelateerde bijwerkingen hersteld zijn tot graad ≤ 1, met uitzondering van alopecia. • Gerichte werkzame stoffen, onderzoeksgeneesmiddelen, therapeutische monoklonale antilichamen of cytotoxische chemotherapie: 5 halfwaardetijden of 2 weken, afhankelijk van welke periode korter is • Brede bestraling (≥ 30% van het beenmerg of bestraling van de gehele hersenen) moet 14 dagen vóór deelname aan het onderzoek zijn voltooid • Palliatieve beperkte bestraling moet 7 dagen vóór deelname aan het onderzoek zijn voltooid.","language":37,"languageDescription":"Dutch (Netherlands)"}]},{"id":819999,"number":5,"principalInclusionCriteria":"Creatinine clearance ≥40ml/min calculated according to the modified formula of Cockcroft and Gault or directly measured with 24hr urine collection or an equivalent method.","principalInclusionCriteriaTranslations":[{"id":10054769,"uuid":"e21bc162-8f34-41c7-8c48-8441de89cf44","attributeTranslation":"Creatinineklaring ≥ 40 ml/min, berekend volgens de aangepaste formule van Cockcroft en Gault of direct gemeten met 24-uurs urineverzameling of een vergelijkbare methode","language":37,"languageDescription":"Dutch (Netherlands)"}]},{"id":820000,"number":6,"principalInclusionCriteria":"Adequate liver function as indicated by a total bilirubin ≤ 1.5 x, AST/ALT ≤ 3.0 x the institu-tional ULN value, unless directly attributable to the patient’s CLL/RT or to Gilbert’s Syn-drome, in which case a max. total bilirubin ≤ 3 x and AST/ALT ≤ 5 x the institutional ULN value are required.","principalInclusionCriteriaTranslations":[{"id":10054770,"uuid":"4e5f3cc6-9507-46b6-81ee-c85941cf7c7d","attributeTranslation":"Adequate leverfunctie, zoals aangegeven door een totaal bilirubine ≤ 1,5 x, AST/ALT ≤ 3,0 x de institutionele ULN-waarde, tenzij dit direct toe te schrijven is aan de CLL/RT van de patiënt of aan het syndroom van Gilbert, in welk geval een maximaal totaal bilirubine ≤ 3 x en AST/ALT ≤ 5 x de institutionele ULN-waarde vereist zijn.","language":37,"languageDescription":"Dutch (Netherlands)"}]},{"id":820001,"number":7,"principalInclusionCriteria":"Neutrophil count ≥ 1.0 G/l (G-CSF administration allowed), Hb ≥ 8 g/dl/ 4.96mmol/L (except for patients with bone marrow involvement due to CLL or RT in which the Hb must be ≥ 6.0G/dl/ 3.72 mmol/L), platelet count ≥ 50 G/l (except for patients with bone marrow involve-ment in which the platelet count must be ≥ 30,000).","principalInclusionCriteriaTranslations":[{"id":10054771,"uuid":"bc6b4854-4c7a-4111-93e8-d6fccb282694","attributeTranslation":"Neutrofielenaantal ≥ 1,0 G/l (toediening van G-CSF toegestaan), Hb ≥ 8 g/dl/ 4,96 mmol/l (behalve bij patiënten met beenmergaantasting als gevolg van CLL of RT, waarbij het Hb ≥ 6,0 G/dl/ 3,72 mmol/l), aantal bloedplaatjes ≥ 50 G/l (behalve voor patiënten met beenmergaantasting, waarbij het aantal bloedplaatjes ≥ 30.000 moet zijn).","language":37,"languageDescription":"Dutch (Netherlands)"}]},{"id":820002,"number":8,"principalInclusionCriteria":"Adequate coagulation, defined as activated partial thromboplastin time (aPTT) or partial thromboplastintime (PTT) and prothrombin (PT) or (international normalized ratio (INR) not greater than 1.5 x ULN.","principalInclusionCriteriaTranslations":[{"id":10054772,"uuid":"c29aedf3-950b-40f6-a7e6-8ce83b05691b","attributeTranslation":"Adequate coagulatie, gedefinieerd als geactiveerde partiële tromboplastinetijd (aPTT) of partiële tromboplastinetijd (PTT) en protrombine (PT) of (internationale genormaliseerde ratio (INR) niet groter dan 1,5 x ULN.","language":37,"languageDescription":"Dutch (Netherlands)"}]},{"id":820003,"number":9,"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, treated with appro-priate antiviral therapy and HBV-DNA PCR is performed every month/every three months if persistently negative until 12 months after last study treatment), negative testing for hepa-titis-C RNA and negative HIV test within 6 weeks prior to registration.","principalInclusionCriteriaTranslations":[{"id":10054773,"uuid":"eb016778-0571-4798-803d-93a2a409ef62","attributeTranslation":"Negatieve serologische test voor hepatitis B (HBsAg-negatief en anti-HBc-negatief; patiënten die positief zijn voor anti-HBc kunnen worden opgenomen als de PCR voor HBV-DNA negatief is, behandeld met een geschikte antivirale therapie en HBV-DNA-PCR elke maand/elke drie maanden wordt uitgevoerd als deze aanhoudend negatief is tot 12 maanden na de laatste studiebehandeling), negatieve test voor hepatitis-C-RNA en negatieve HIV-test binnen 6 weken voorafgaand aan de registratie.","language":37,"languageDescription":"Dutch (Netherlands)"}]}],"principalExclusionCriteria":[{"id":1403227,"number":1,"principalExclusionCriteria":"Patients with prior RT-directed therapy, including corticosteroids given for > 10 days with a daily dose above 50mg prednisolone or equivalent for more than 10 days.","principalExclusionCriteriaTranslations":[{"id":10054732,"uuid":"77871b0e-367c-4d5d-8068-9c9d9a3b484a","attributeTranslation":"Patiënten die eerder een RT-gerichte behandeling hebben ondergaan, waaronder corticosteroïden die gedurende meer dan 10 dagen zijn toegediend met een dagelijkse dosis van meer dan 50 mg prednisolon of een equivalent daarvan gedurende meer dan 10 dagen","language":37,"languageDescription":"Dutch (Netherlands)"}]},{"id":1403228,"number":10,"principalExclusionCriteria":"Significant cardiovascular disease defined as: • unstable angina or acute coronary syndrome within the past 2 months prior to randomization • history of myocardial infarction within 3 months prior to randomization or • documented LVEF by any method of ≤ 40% in the 12 months prior to randomization • ≥ Grade 3 NYHA functional classification system of heart failure • Uncontrolled or symptomatic arrhythmias • Prolongation of the QT interval corrected for heart rate (QTcF) > 470 msec. QTcF is calcu-lated using Fridericia’s Formula (QTcF): QTcF = QT/(RR0.33). • Correction of suspected drug-induced QTcF prolongation can be attempted at the investi-gator’s discretion and only if clinically safe to do so with either discontinuation of the offend-ing drug or switch to another drug not known to be associated with QTcF prolongation. • Correction for underlying bundle branch block (BBB) allowed.","principalExclusionCriteriaTranslations":[{"id":10054733,"uuid":"6824a601-e1e3-4b96-a5a2-4b42b8730f28","attributeTranslation":"Significante hart- en vaatziekten gedefinieerd als: • instabiele angina of acuut coronair syndroom in de afgelopen 2 maanden voorafgaand aan randomisatie • voorgeschiedenis van myocardinfarct in de 3 maanden voorafgaand aan randomisatie of • gedocumenteerde LVEF door middel van een willekeurige methode van ≤ 40% in de 12 maanden voorafgaand aan randomisatie • ≥ graad 3 NYHA functioneel classificatiesysteem voor hartfalen • Ongecontroleerde of symptomatische aritmieën • Verlenging van het voor hartslag gecorrigeerde QT-interval (QTcF) > 470 msec. QTcF wordt berekend met behulp van de formule van Fridericia (QTcF): QTcF = QT/(RR0,33). • Correctie van vermoedelijke door geneesmiddelen veroorzaakte QTcF-verlenging kan naar beoordeling van de onderzoeker worden geprobeerd en alleen als dit klinisch veilig is door het betreffende geneesmiddel te staken of over te stappen op een ander geneesmiddel waarvan niet bekend is dat het QTcF-verlenging veroorzaakt. • Correctie voor onderliggende bundeltakblok (BBB) is toegestaan","language":37,"languageDescription":"Dutch (Netherlands)"}]},{"id":1403229,"number":11,"principalExclusionCriteria":"Unable to swallow capsules or disease significantly affecting gastrointestinal function such as malabsorption syndrome, resection of the stomach or small bowel, bariatric surgery procedures, symptomatic inflammatory bowel disease, or partial or complete bowel obstruction","principalExclusionCriteriaTranslations":[{"id":10054734,"uuid":"b7059f9f-50a2-4652-9f84-6d6dfdbaf01a","attributeTranslation":"Niet in staat zijn om capsules door te slikken of een ziekte hebben die de maag-darmfunctie aanzienlijk beïnvloedt, zoals malabsorptiesyndroom, resectie van de maag of dunne darm, bariatrische chirurgie, symptomatische inflammatoire darmziekte of gedeeltelijke of volledige darmobstructie.","language":37,"languageDescription":"Dutch (Netherlands)"}]},{"id":1403230,"number":12,"principalExclusionCriteria":"Non-curatively treated malignancies other than the disease under the study (unless the malig-nant disease is in a stable remission [e.g. prostate cancer with SD under antihormonal therapy] and life expectancy > 2 years)","principalExclusionCriteriaTranslations":[{"id":10054735,"uuid":"dec2e41e-b3ba-4587-b581-c75ee68b17a1","attributeTranslation":"Niet-curatief behandelde maligniteiten anders dan de ziekte die wordt onderzocht (tenzij de maligne ziekte zich in een stabiele remissie bevindt [bijv. prostaatkanker met SD onder antihormonale therapie] en de levensverwachting > 2 jaar is).","language":37,"languageDescription":"Dutch (Netherlands)"}]},{"id":1403231,"number":13,"principalExclusionCriteria":"Active infection (e.g. persiting fever related to infection and not RT or persisting positive blood cultures) currently requiring systemic treatment","principalExclusionCriteriaTranslations":[{"id":10054736,"uuid":"d6614071-76fb-44cf-a27c-47a9ff77443a","attributeTranslation":"Actieve infectie (bijv. aanhoudende koorts die verband houdt met een infectie en niet met RT of aanhoudende positieve bloedkweken) waarvoor momenteel systemische behandeling nodig is.","language":37,"languageDescription":"Dutch (Netherlands)"}]},{"id":1403232,"number":14,"principalExclusionCriteria":"In case of suspicion for CMV infection, CMV testing (CMV PCR in Serum) should be done. Patients with unknown or negative status are eligible.","principalExclusionCriteriaTranslations":[{"id":10054737,"uuid":"c5d6d61a-df83-4b1d-9ee3-0ecd8bbc06f8","attributeTranslation":"Bij vermoeden van CMV-infectie moet een CMV-test (CMV-PCR in serum) worden uitgevoerd. Patiënten met een onbekende of negatieve status komen in aanmerking.","language":37,"languageDescription":"Dutch (Netherlands)"}]},{"id":1403233,"number":15,"principalExclusionCriteria":"Any comorbidity or organ system impairment rated with a CIRS (cumulative illness rating scale) score of 4, excluding the eyes/ears/nose/throat/larynx organ system1, or any other life-threaten-ing illness, medical condition or organ system dysfunction that – in the investigator´s opinion could comprise the patients` safety or interfere with the absorption or metabolism of the study drugs (i.e. swallow study drug). This includes also patients with autoimmune condition other than autoimmune cytopenias requiring immunosuppressive therapy.","principalExclusionCriteriaTranslations":[{"id":10054738,"uuid":"9d6bda2a-425b-4239-83ec-42b89831a11c","attributeTranslation":"Elke comorbiditeit of orgaanfunctiestoornis met een CIRS-score (cumulative illness rating scale) van 4, met uitzondering van het orgaanstelsel van ogen/oren/neus/keel/strottenhoofd1, of elke andere levensbedreigende ziekte, medische aandoening of orgaanfunctiestoornis die – naar het oordeel van de onderzoeker – de veiligheid van de patiënt in gevaar kan brengen of de absorptie of het metabolisme van de onderzoeksgeneesmiddelen (d.w.z. het onderzoeksgeneesmiddel dat wordt ingenomen) kan verstoren. Dit omvat ook patiënten met een andere auto-immuunziekte dan auto-immuuncytopenieën waarvoor immunosuppressieve therapie nodig is.","language":37,"languageDescription":"Dutch (Netherlands)"}]},{"id":1403234,"number":16,"principalExclusionCriteria":"Requirement for therapy with strong CYP3A4 inhibitors/inducers","principalExclusionCriteriaTranslations":[{"id":10054739,"uuid":"ff2b29a9-a212-4892-8bbc-e0d7477c5b8e","attributeTranslation":"Vereiste voor therapie met sterke CYP3A4-remmers/inductoren","language":37,"languageDescription":"Dutch (Netherlands)"}]},{"id":1403235,"number":17,"principalExclusionCriteria":"Known active infection with HIV, or serologic status reflecting active hepatitis B or C infection and not meeting the inclusion criterion 9, which says: 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, treated with appropriate antiviral therapy and HBV-DNA PCR is per-formed every two months until 12 months after last dose of study treatment), and for hepatitis C (anti-HCV-ab negative; in case of positive HCV anti-body test, negative HCV-PCR is re-quired).","principalExclusionCriteriaTranslations":[{"id":10054740,"uuid":"b7717e95-312b-4fc6-a807-29f86424fb29","attributeTranslation":"Bekende actieve infectie met hiv of serologische status die wijst op actieve hepatitis B- of C-infectie en niet voldoet aan inclusiecriterium 9, dat luidt: Negatieve serologische test voor hepatitis B (HbsAg-negatief en anti-HBc-negatief; patiënten die positief zijn voor anti-HBc kunnen worden opgenomen als de PCR voor HBV-DNA negatief is, behandeld met een geschikte antivirale therapie en als er elke twee maanden tot 12 maanden na de laatste dosis van de onderzoeksbehandeling een HBV-DNA-PCR wordt uitgevoerd), en voor hepatitis C (anti-HCV-ab negatief; in geval van een positieve HCV-antistoffentest is een negatieve HCV-PCR vereist).","language":37,"languageDescription":"Dutch (Netherlands)"}]},{"id":1403236,"number":18,"principalExclusionCriteria":"Major surgery within 4 weeks of the first dose of study drug.","principalExclusionCriteriaTranslations":[{"id":10054741,"uuid":"5e7f18b2-1818-440c-aff6-b6ce05ad9a31","attributeTranslation":"Ingrijpende operatie binnen 4 weken na de eerste dosis van het onderzoeksgeneesmiddel.","language":37,"languageDescription":"Dutch (Netherlands)"}]},{"id":1403237,"number":19,"principalExclusionCriteria":"Use of investigational agents, e.g. monoclonal antibodies or other experimental drugs within clinical trials, which might interfere with the study drug within 28 days (or 5 times half-life [t1/2] of the compound, whichever is shorter) prior to registration bridging for CLL, e.g. with covalent BTK inhibitors or Bcl2 inhibitors may be used, if the abovementioned criteria for a time interval of 5 times half-life before day 1 cycle1 within the study protocol is maintained; bridging for RT is recommended with steroids.","principalExclusionCriteriaTranslations":[{"id":10054742,"uuid":"deaf0d67-488f-4bb8-b945-2fd31fbb4472","attributeTranslation":"Gebruik van onderzoeksgeneesmiddelen, bijvoorbeeld monoklonale antilichamen of andere experimentele geneesmiddelen in klinische onderzoeken, die de werking van het onderzoeksgeneesmiddel kunnen verstoren binnen 28 dagen (of 5 keer de halfwaardetijd [t1/2] van de verbinding, indien deze korter is) voorafgaand aan de registratieoverbrugging voor CLL, bijv. met covalente BTK-remmers of Bcl2-remmers, mogen worden gebruikt als aan de bovengenoemde criteria voor een tijdsinterval van 5 keer de halfwaardetijd vóór dag 1 cyclus 1 binnen het studieprotocol wordt voldaan; overbrugging voor RT wordt aanbevolen met steroïden.","language":37,"languageDescription":"Dutch (Netherlands)"}]},{"id":1403238,"number":2,"principalExclusionCriteria":"Patients with previous progression on non-covalent BTK inhibitors or CD20 targeting T-cell en-gaging antibodies","principalExclusionCriteriaTranslations":[{"id":10054743,"uuid":"10db30ed-7a04-46f0-a400-2a8e38521269","attributeTranslation":"Patiënten bij wie eerder progressie is opgetreden bij behandeling met niet-covalente BTK-remmers of CD20-gerichte T-cel-engagerende antilichamen","language":37,"languageDescription":"Dutch (Netherlands)"}]},{"id":1403239,"number":20,"principalExclusionCriteria":"Known hypersensitivity to epcoritamab, pirtobrutinib or any of the ingredients","principalExclusionCriteriaTranslations":[{"id":10054744,"uuid":"49170ef5-06ed-4d75-b862-a236f01af257","attributeTranslation":"Bekende overgevoeligheid voor epcoritamab, pirtobrutinib of een van de ingrediënten daarvan","language":37,"languageDescription":"Dutch (Netherlands)"}]},{"id":1403240,"number":21,"principalExclusionCriteria":"Pregnant women and nursing mothers or planning to become pregnant during the study or within 1 months of the last dose of study treatment.","principalExclusionCriteriaTranslations":[{"id":10054745,"uuid":"b000d5cb-2ab9-4b79-af41-533595da58ec","attributeTranslation":"Zwangere vrouwen en vrouwen die borstvoeding geven of van plan zijn zwanger te worden tijdens het onderzoek of binnen 1 maand na de laatste dosis van de onderzoeksbehandeling","language":37,"languageDescription":"Dutch (Netherlands)"}]},{"id":1403241,"number":22,"principalExclusionCriteria":"Fertile men or women of childbearing potential unless: a. surgically sterile or ≥ 2 years after the onset of menopause, or b. willing to use two methods of reliable contraception including one highly effective con-traceptive method (Pearl Index <1) and one additional effective (barrier) method during study treatment and for 12 months after the end of study treatment.","principalExclusionCriteriaTranslations":[{"id":10054746,"uuid":"32881c7a-3ea6-4aa3-bcb3-eda7c51ae8d3","attributeTranslation":"Vruchtbare mannen of vrouwen in de vruchtbare leeftijd, tenzij: a. chirurgisch gesteriliseerd of ≥ 2 jaar na het begin van de menopauze, of b. bereid zijn om twee betrouwbare anticonceptiemethoden te gebruiken, waaronder één zeer effectieve anticonceptiemethode (Pearl Index <1) en één aanvullende effectieve (barrière)methode tijdens de studiebehandeling en gedurende 12 maanden na het einde van de studiebehandeling.","language":37,"languageDescription":"Dutch (Netherlands)"}]},{"id":1403242,"number":23,"principalExclusionCriteria":"Vaccination with a live vaccine <28 days prior to registration for study screening","principalExclusionCriteriaTranslations":[{"id":10054747,"uuid":"604a1d44-e1db-4022-afa8-ff9512738205","attributeTranslation":"Vaccinatie met een levend vaccin <28 dagen voorafgaand aan de registratie voor de screening voor het onderzoek","language":37,"languageDescription":"Dutch (Netherlands)"}]},{"id":1403243,"number":24,"principalExclusionCriteria":"Legal incapacity","principalExclusionCriteriaTranslations":[{"id":10054748,"uuid":"a59ed17b-8303-4276-a531-b30a18d97462","attributeTranslation":"Wettelijke handelingsonbekwaamheid","language":37,"languageDescription":"Dutch (Netherlands)"}]},{"id":1403244,"number":25,"principalExclusionCriteria":"Prisoners or subjects who are institutionalized by regulatory or court order","principalExclusionCriteriaTranslations":[{"id":10054749,"uuid":"e242dcce-3ac2-44a8-ad6e-168336c31cf0","attributeTranslation":"Gevangenen of proefpersonen die op grond van regelgeving of een gerechtelijk veroordeling in een instelling zijn opgenomen.","language":37,"languageDescription":"Dutch (Netherlands)"}]},{"id":1403245,"number":26,"principalExclusionCriteria":"Persons who are in dependence to the sponsor or an investigator","principalExclusionCriteriaTranslations":[{"id":10054750,"uuid":"84560d32-709a-47bc-9cb9-0bb5ef1d0e09","attributeTranslation":"Personen die afhankelijk zijn van de sponsor of een onderzoeker.","language":37,"languageDescription":"Dutch (Netherlands)"}]},{"id":1403246,"number":3,"principalExclusionCriteria":"Patients with Richter transformation to Hodgkin’s lymphoma or patients with other types of lmpyhoma.","principalExclusionCriteriaTranslations":[{"id":10054751,"uuid":"9551ca9e-5f87-4484-b0ca-bce8a9d8d707","attributeTranslation":"Patiënten met Richter-transformatie naar Hodgkin-lymfoom of patiënten met andere soorten lymfoom.","language":37,"languageDescription":"Dutch (Netherlands)"}]},{"id":1403247,"number":4,"principalExclusionCriteria":"Allogenic stem cell transplantation or CAR T-cell therapy within the last 100 days as well as o active graft versus host disease (GVHD); o cytopenia from incomplete blood cell count recovery post-transplant not matching inclusion criterion 7; 1 For patients who start study treatment with elevated liver enzymes due to CLL/RT or Gilbert’s syndrome, toxicity and AE reporting will follow CTCAE grading once these values further increase. E.g. if a patient starts with a bilirubin value of 2.0 m/dl, which rises to 3.0 mg/dl after one cycle, this should be reported as grade 2 bilirubinemia (see CTCAE v5) or need for anti-cytokine therapy for toxicity from CAR-T therapy; residual symptoms of neurotoxicity > Grade 1 from CAR-T therapy; o ongoing systemic immunosuppressive therapy or > 20 mg prednisone or equivalent daily.","principalExclusionCriteriaTranslations":[{"id":10054752,"uuid":"3e1d74fc-6429-4fb3-a9aa-d5d21e8037bd","attributeTranslation":"Allogene stamceltransplantatie of CAR-T-celtherapie in de afgelopen 100 dagen, evenals o actieve graft-versus-hostziekte (GVHD); o cytopenie door onvolledig herstel van de bloedwaarden na transplantatie dat niet voldoet aan inclusiecriterium 7; 1 Voor patiënten die met de studiebehandeling beginnen met verhoogde leverenzymen als gevolg van CLL/RT of het syndroom van Gilbert, zullen toxiciteit en AE-rapportage worden uitgevoerd volgens de CTCAE-classificatie zodra deze waarden verder stijgen. Als een patiënt bijvoorbeeld begint met een bilirubinewaarde van 2,0 m/dl, die na één cyclus stijgt tot 3,0 mg/dl, moet dit worden gerapporteerd als graad 2 bilirubinemie (zie CTCAE v5) of als noodzaak voor anti-cytokinetherapie voor toxiciteit door CAR-T-therapie; restverschijnselen van neurotoxiciteit > graad 1 door CAR-T-therapie; o doorlopende systemische immunosuppressieve therapie of > 20 mg prednison of equivalent per dag.","language":37,"languageDescription":"Dutch (Netherlands)"}]},{"id":1403248,"number":5,"principalExclusionCriteria":"Patients with known CNS involvement of RT","principalExclusionCriteriaTranslations":[{"id":10054753,"uuid":"3bdf4dd5-a706-465b-845c-9ca0565d3772","attributeTranslation":"Patiënten met bekende RT betrokkenheid van het centrale zenuwstelsel.","language":37,"languageDescription":"Dutch (Netherlands)"}]},{"id":1403249,"number":6,"principalExclusionCriteria":"Patients with confirmed PML","principalExclusionCriteriaTranslations":[{"id":10054754,"uuid":"32c1533b-a116-417f-8f6b-506edb92f75a","attributeTranslation":"Patiënten met bevestigde PML","language":37,"languageDescription":"Dutch (Netherlands)"}]},{"id":1403250,"number":7,"principalExclusionCriteria":"Decompensated auto-immune cytopenia (defined as ongoing drop in haemoglobin [AIHA] or in platelets [ITP] in spite of prednisolone and/or intravenous immunoglobulins treatment)","principalExclusionCriteriaTranslations":[{"id":10054755,"uuid":"88f9faf4-efd7-4b87-a46b-c3ec072cab02","attributeTranslation":"Gedecompenseerde auto-immune cytopenie (gedefinieerd als een voortdurende daling van het hemoglobinegehalte [AIHA] of het aantal bloedplaatjes [ITP] ondanks behandeling met prednisolon en/of intraveneuze immunoglobulinen)","language":37,"languageDescription":"Dutch (Netherlands)"}]},{"id":1403251,"number":8,"principalExclusionCriteria":"Increased risk of bleeding, e.g. due to: o History of severe bleeding disorder such as hemophilia A, hemophilia B, von Willebrand disease, or history of spontaneous bleeding requiring blood transfusion or other medical intervention o Anticoagulant therapy with warfarin or other vitamin K antagonists (anticoagulation with a direct oral Xa or thrombin inhibitor (DOAC) or heparin is permitted) o History of major stroke or intracranial hemorrhage within 6 months before first dose of study drug","principalExclusionCriteriaTranslations":[{"id":10054756,"uuid":"fe164f07-5dbe-40f8-af5c-6a0d26eb6a4a","attributeTranslation":"Verhoogd risico op bloedingen, bijvoorbeeld als gevolg van: o Een voorgeschiedenis van ernstige bloedingsstoornissen zoals hemofilie A, hemofilie B, de ziekte van von Willebrand, of een voorgeschiedenis van spontane bloedingen waarvoor een bloedtransfusie of andere medische interventie nodig was o Anticoagulantia-behandeling met warfarine of andere vitamine K-antagonisten (anticoagulatie met een directe orale Xa- of trombineremmer (DOAC) of heparine is toegestaan) o Voorgeschiedenis van ernstige beroerte of intracraniële bloeding binnen 6 maanden vóór de eerste dosis van het onderzoeksgeneesmiddel","language":37,"languageDescription":"Dutch (Netherlands)"}]},{"id":1403252,"number":9,"principalExclusionCriteria":"Requiring supplemental oxygen.","principalExclusionCriteriaTranslations":[{"id":10054757,"uuid":"b60600a3-03ba-45bf-bbf1-11d95b97f857","attributeTranslation":"Aanvullende zuurstof nodig hebben.","language":37,"languageDescription":"Dutch (Netherlands)"}]}]},"endPoint":{"primaryEndPoints":[{"id":960934,"number":1,"endPoint":"Investigator-assessed progression-free survival (PFS) according to Lugano criteria","isPrimary":true,"endPointTranslations":[{"id":10054722,"uuid":"a1663ce6-b223-48f2-8b80-d2075ab1a2cc","attributeTranslation":"Door de onderzoeker-beoordeelde progressievrije overleven (PFS) volgens de Lugano-criteria","language":37,"languageDescription":"Dutch (Netherlands)"}]}],"secondaryEndPoints":[{"id":960935,"number":1,"endPoint":"Overall response rate (ORR; 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