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Wcześniejsze stosowanie kortykosteroidów z przyczyn innych niż powikłania autoimmunologiczne CLL jest dozwolone.","language":19,"languageDescription":"Polish"}]},{"id":372120,"number":13,"principalInclusionCriteria":"No major surgery within 4 weeks (28 days) of first dose of study drug or minor surgery within 3 days of first dose of study drug","principalInclusionCriteriaTranslations":[{"id":4137999,"uuid":"85923d1a-fcb7-41bb-8325-7ec0179adba6","attributeTranslation":"Brak poważnych zabiegów operacyjnych w ciągu 4 tygodni (28 dni) przed pierwszym podaniem leku badanego lub mniejszych zabiegów w ciągu 3 dni przed pierwszym podaniem leku badanego.","language":19,"languageDescription":"Polish"}]},{"id":372121,"number":14,"principalInclusionCriteria":"No radiation therapy ≤ 4 weeks prior to study treatment initiation","principalInclusionCriteriaTranslations":[{"id":4138000,"uuid":"0acbfe8b-15d6-4f6b-b662-55b14b54f1f6","attributeTranslation":"Brak radioterapii w czasie ≤ 4 tygodni przed rozpoczęciem leczenia w badaniu.","language":19,"languageDescription":"Polish"}]},{"id":372122,"number":15,"principalInclusionCriteria":"Patient must be able to receive xanthine oxidase inhibitor or rasburicase for tumor lysis syndrome (TLS) prophylaxis","principalInclusionCriteriaTranslations":[{"id":4138001,"uuid":"e7d66939-3adf-4576-b373-8bbb0448c7a3","attributeTranslation":"Pacjent bez istniejących przeciwwskazań do otrzymania inhibitora oksydazy ksantynowej lub rasburykazy jako profilaktyki zespołu rozpadu guza (TLS).","language":19,"languageDescription":"Polish"}]},{"id":372123,"number":16,"principalInclusionCriteria":"Negative pregnancy test (serum βHCG) for women of childbearing potential (including pre-menopausal women who have had a tubal ligation) and for all women not meeting the definition of postmenopausal (≥ 24 months of amenorrhea), and who have not undergone surgical sterilization with a hysterectomy and/or bilateral oophorectomy. For all other women, documentation must be present in medical history confirming that the patient is not of childbearing potential. o Female patients who are not surgically sterile or postmenopausal must agree to use 2 reliable forms of contraception simultaneously or to practice complete abstinence from heterosexual intercourse during the study. o Male subjects must agree to use a latex condom during sexual contact with females of childbearing potential while participating in the study and for at least 28 days following discontinuation from the study even if he has undergone a successful vasectomy","principalInclusionCriteriaTranslations":[{"id":4138002,"uuid":"21713f8a-93ef-4074-b04a-e33badab01f7","attributeTranslation":"Negatywny wynik testu ciążowego (βHCG w surowicy) u kobiet w wieku rozrodczym (w tym kobiet przed menopauzą, które miały zabieg podwiązania jajowodów) oraz dla wszystkich kobiet niespełniających definicji braku miesiączki po menopauzie (24 miesiące bez miesiączki), które nie przeszły sterylizacji chirurgicznej z histerektomią i/lub obustronnym usunięciem jajników. W przypadku wszystkich pozostałych kobiet w wywiadzie musi znajdować się dokumentacja potwierdzająca, że pacjentka nie jest w wieku rozrodczym.\n▪ pacjentki, które nie przeszły chirurgicznej sterylizacji lub nie są w okresie postmenopauzalnym, muszą zgodzić się na jednoczesne stosowanie dwóch niezawodnych form antykoncepcji lub na praktykę całkowitej abstynencji seksualnej przez cały czas trwania badania,\n▪ mężczyźni muszą wyrazić zgodę, aby w czasie trwania badania i przez co najmniej 28 dni po zakończeniu leczenia, używać prezerwatywy lateksowej podczas kontaktów seksualnych z kobietami w wieku rozrodczym, nawet jeśli przeszli udany zabieg wazektomii.","language":19,"languageDescription":"Polish"}]},{"id":372124,"number":2,"principalInclusionCriteria":"Ability and willingness to comply with the requirements of the study protocol","principalInclusionCriteriaTranslations":[{"id":4138003,"uuid":"e6d81f8a-82d6-4902-b578-4f8042ddd486","attributeTranslation":"Zdolność i gotowość do stosowania się do wymagań protokołu badania.","language":19,"languageDescription":"Polish"}]},{"id":372125,"number":3,"principalInclusionCriteria":"Patient must have diagnosis of CLL or SLL that meets published 2018 IWCLL NCI-WG criteria","principalInclusionCriteriaTranslations":[{"id":4138004,"uuid":"a1d1a027-e311-4e5f-be3a-3e9751ebcbbe","attributeTranslation":"Pacjent z rozpoznaniem CLL lub SLL spełniającym kryteria 2018 IWCLL NCI-WG.","language":19,"languageDescription":"Polish"}]},{"id":372126,"number":4,"principalInclusionCriteria":"No prior treatment for CLL or SLL including chemotherapy, BTK inhibitor therapy, venetoclax, small molecule signaling inhibitor, or monoclonal antibody therapy","principalInclusionCriteriaTranslations":[{"id":4138005,"uuid":"48b79b23-39d6-48fe-b3ee-cd78cb8f8701","attributeTranslation":"Brak wcześniejszych terapii przeciwko CLL lub SLL, w tym chemioterapii, terapii inhibitorami BTK, wenetoklaksem, drobnocząsteczkowym inhibitorem sygnalizacji lub terapii przeciwciałem monoklonalnym.","language":19,"languageDescription":"Polish"}]},{"id":372127,"number":5,"principalInclusionCriteria":"Patient must have an indication for treatment according to published 2018 IWCLL NCI-WG criteria","principalInclusionCriteriaTranslations":[{"id":4138006,"uuid":"85d8cc8a-91a5-41b9-b404-523c89469f3f","attributeTranslation":"Pacjent ze wskazaniem do leczenia zgodnie z kryteriami 2018 IWCLL NCI-WG.","language":19,"languageDescription":"Polish"}]},{"id":372128,"number":6,"principalInclusionCriteria":"Patient must have an Eastern Cooperative Oncology Group (ECOG) performance score of ≤ 2","principalInclusionCriteriaTranslations":[{"id":4138007,"uuid":"8cdf51b3-e8dd-4d34-9c67-5d0d3f6885e6","attributeTranslation":"Pacjent z wynikiem oceny sprawności wg Eastern Cooperative Oncology Group (ECOG) ≤ 2.","language":19,"languageDescription":"Polish"}]},{"id":372129,"number":7,"principalInclusionCriteria":"Adequate hematologic function independent of growth factor or transfusion support, per local laboratory reference range at screening (unless caused by underlying disease, as established by extensive bone marrow involvement or as a result of hypersplenism secondary to the involvement of the spleen by lymphoma per the investigator) defined as follows: o Hemoglobin ≥ 9 g/dL; o  Absolute neutrophil count ≥ 1.0 × 109/L; o Platelet count ≥ 50 × 109/L","principalInclusionCriteriaTranslations":[{"id":4138008,"uuid":"3f322df2-16ef-41ab-b7f6-1154ff3a0918","attributeTranslation":"Odpowiednie parametry hematologiczne w fazie przesiewowej, niezależne od czynnika wzrostu lub wsparcia transfuzyjnego, zgodnie z zakresem wartości referencyjnych laboratorium lokalnego (chyba, że spowodowane chorobą podstawową i w ocenie badacza ustanowione przez rozległe zajęcie szpiku lub jest wynikiem wtórnego hipersplenizmu w związku z zajęciem śledziony przez chłoniaka) zdefiniowane jak poniżej:\n▪ hemoglobina ≥ 9 g/dL,\n▪ bezwzględna liczba neutrofili ≥ 1.0 x 109/L,\n▪ płytki krwi ≥ 50 x 109/L.","language":19,"languageDescription":"Polish"}]},{"id":372130,"number":8,"principalInclusionCriteria":"Adequate renal function, per local laboratory reference range at screening, as indicated by: o Calculated creatinine clearance ≥ 30 mL/min using 24-hour Creatinine Clearance or modified Cockcroft-Gault equation (eCCR; with the use of ideal body mass [IBM] instead of mass)","principalInclusionCriteriaTranslations":[{"id":4138009,"uuid":"dfa13998-c77c-440d-9974-f3ae979ed0fe","attributeTranslation":"Odpowiednia czynność nerek, zgodnie z zakresem referencyjnym lokalnego laboratorium podczas badania przesiewowego:\n▪ obliczony klirens kreatyniny ≥ 30 mL/min przy użyciu 24-godzinnego klirensu kreatyniny lub zmodyfikowanego równania Cockrofta-Gaulta (eCCR; z użyciem idealnej masy ciała [IBM] zamiast masy ciała).","language":19,"languageDescription":"Polish"}]},{"id":372131,"number":9,"principalInclusionCriteria":"Adequate liver function, per local laboratory reference range at screening, as indicated by: o AST and ALT ≤ 2.5 × ULN o Total bilirubin ≤ 1.5 × ULN (or ≤ 3 × ULN for patients with documented Gilbert syndrome)","principalInclusionCriteriaTranslations":[{"id":4138010,"uuid":"d95a52f9-c0d2-45a3-974e-f3808a82dd25","attributeTranslation":"Odpowiednia czynność wątroby, zgodnie z zakresem referencyjnym laboratorium lokalnego podczas badań przesiewowych, wskazana przez:\n▪ AST i ALT ≤ 2.5 x ULN (górna granica normy),\n▪ bilirubina całkowita ≤ 1.5 x ULN (lub ≤ 3 x ULN dla pacjentów z udokumentowanym syndromem Gilberta).","language":19,"languageDescription":"Polish"}]}],"principalExclusionCriteria":[{"id":641955,"number":1,"principalExclusionCriteria":"Richter's transformation confirmed by biopsy","principalExclusionCriteriaTranslations":[{"id":4137981,"uuid":"4e00f363-dd68-4303-814d-79235a2d2c4d","attributeTranslation":"Potwierdzona biopsją transformacja Richtera.","language":19,"languageDescription":"Polish"}]},{"id":641956,"number":10,"principalExclusionCriteria":"Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that in the opinion of the investigator may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and/or would make the patient inappropriate for enrollment into this study","principalExclusionCriteriaTranslations":[{"id":4137982,"uuid":"0e17ab69-148a-4913-97ed-8a56bfba30d2","attributeTranslation":"Inne ciężkie ostre lub przewlekłe stany medyczne lub psychiatryczne, nieprawidłowości laboratoryjne, które w opinii badacza mogą zwiększać ryzyko związane z uczestnictwem w badaniu lub podawaniem badanego produktu lub mogą uniemożliwiać włączenie do tego badania.","language":19,"languageDescription":"Polish"}]},{"id":641957,"number":11,"principalExclusionCriteria":"Patients who have received strong and moderate CYP3A inhibitors and/or CYP3A inducers within 7 days prior to the first dose of venetoclax, patients who consumed grapefruit, grapefruit products, Seville oranges (including marmalade containing Seville oranges), or star fruit within 3 days prior to the first dose of venetoclax","principalExclusionCriteriaTranslations":[{"id":4137983,"uuid":"fadac620-a90e-4e5d-a381-0f129534663e","attributeTranslation":"Pacjenci, którzy otrzymali silne lub umiarkowane inhibitory CYP3A i/lub induktory CYP3A w ciągu 7 dni przed pierwszą dawką wenetoklaksu, pacjenci, którzy spożyli grejpfruty (owoc lub produkt zawierający grejpfruty), pomarańcze sewilskie (w tym marmoladę zawierającą te pomarańcze) lub owoc gwiaździsty (karambola) w ciągu 3 dni przed pierwszą dawką wenetoklaksu.","language":19,"languageDescription":"Polish"}]},{"id":641958,"number":12,"principalExclusionCriteria":"Patients who require use of warfarin (due to potential drug-drug interactions that may potentially increase the exposure of warfarin). Patients may be eligible if able to be taken off warfarin and started on an alternative anticoagulant","principalExclusionCriteriaTranslations":[{"id":4137984,"uuid":"a7497688-f006-4067-a22a-eab635a79adc","attributeTranslation":"Pacjenci, którzy wymagają stosowania warfaryny (ze względu na potencjalne interakcje lekowe, które mogą potencjalnie zwiększać ekspozycję na warfarynę). Pacjenci mogą zostać włączeni do badania, jeśli będą mogli odstawić warfarynę i rozpocząć leczenie alternatywnym lekiem przeciwzakrzepowym.","language":19,"languageDescription":"Polish"}]},{"id":641959,"number":13,"principalExclusionCriteria":"Patients with evidence of any of the following conditions: o New York Heart Association Functional Classification III or IV congestive heart failure o History of myocardial infarction, unstable angina, or acute coronary syndrome within 6 months prior to registration o Recent infection requiring systemic treatment; need to have completed anti-biotic therapy > 14 days before the first dose of study drug o Cerebral vascular accident or intracranial bleed within the last 6 months o Known active chronic hepatitis C o Positive serology for hepatitis B defined as a positive test for hepatitis B surface antigen (HBsAg); in addition, if negative for HBsAg but hepatitis B core antibody (HBcAb) positive (regardless of hepatitis B surface antibody [HBsAb] status), a hepatitis B deoxyribonucleic acid (DNA) test will be performed and, if positive the subject will be ineligible; if the hepatitis B DNA test is negative (i.e. viral load undetectable) then the individual is eligible; if a patient who is HBsAg negative, HBcAb positive, and hepatitis B DNA negative is enrolled, they should be considered for either prophylactic anti-viral therapy or careful monitoring for HBV reactivation. Patients who have protective titers of HBsAb after vaccination or prior but cured hepatitis B are eligible.","principalExclusionCriteriaTranslations":[{"id":4137985,"uuid":"5c5a4fe6-9aa5-4c31-94b8-b45e263be675","attributeTranslation":"Pacjenci z dowodami na obecność któregokolwiek z poniższych stanów:\n▪ zastoinowa niewydolność serca klasy III lub IV według NYHA,\n▪ przebyty zawał mięśnia sercowego, niestabilna dławica piersiowa lub ostry zespół wieńcowy w ciągu 6 miesięcy przed rejestracją do badania,\n▪ niedawne zakażenie wymagające leczenia ogólnoustrojowego; konieczność zakończenia antybiotykoterapii > 14 dni przed pierwszą dawką leku badanego,\n▪ udar naczyniowy mózgu lub krwawienie śródczaszkowe w ciągu ostatnich 6 miesięcy,\n▪ rozpoznane aktywne przewlekłe zapalenie wątroby typu C,\n▪ dodatni wynik badania serologicznego w kierunku zapalenia wątroby typu B zdefiniowany jako dodatni wynik testu na obecność antygenu powierzchniowego (HBsAg); dodatkowo, jeśli wynik testu na obecność HBsAg jest negatywny, ale test na obecność przeciwciała przeciwko wirusowi zapalenia wątroby typu B (HBcAb) jest dodatni [niezależnie od statusu przeciwciała powierzchniowego wirusa zapalenia wątroby typu B (HBsAb)], zostanie przeprowadzony test na kwas dezoksyrybonukleinowy (DNA) wirusa zapalenia wątroby typu B, jeśli uzyskany wynik będzie dodatni pacjent nie będzie się kwalifikował; jeśli test DNA wirusa zapalenia wątroby typu B jest ujemny (tj. miano wirusa niewykrywalne), pacjent będzie kwalifikował się do badania; jeśli zakwalifikowany jest pacjent z ujemnym wynikiem oznaczenia HBsAg, dodatnim HBcAb i ujemnym DNA wirusa zapalenia wątroby typu B, należy rozważyć profilaktyczne leczenie przeciwwirusowe. Pacjenci z ochronnym mianem HBsAb po szczepieniu lub wcześniejszym, lecz wyleczonym zapaleniu wątroby kwalifikują się.","language":19,"languageDescription":"Polish"}]},{"id":641960,"number":2,"principalExclusionCriteria":"History of other malignancy that could affect compliance with the protocol or interpretation of results o Patients with a history of curatively treated basal or squamous cell carcinoma or Stage 1 melanoma of the skin or in situ carcinoma of the cervix are eligible. o Patients with a malignancy that has been treated with surgery alone with curative intent will be included. Individuals in documented remission without treatment for (> / =) 2 years prior to enrollment may be included at the discretion of the investigator.","principalExclusionCriteriaTranslations":[{"id":4137986,"uuid":"f5c7bfd0-b1bc-42dc-9baf-30122e421c48","attributeTranslation":"Historia innych nowotworów złośliwych, które mogą mieć wpływ na zgodność z protokołem lub interpretację wyników.\n▪ do badania kwalifikują się pacjenci z wyleczonym w wywiadzie rakiem podstawnokomórkowym lub płaskonabłonkowym, czerniakiem skóry w stadium 1 lub rakiem szyjki macicy in situ.\n▪ Pacjenci z nowotworem złośliwym, którzy byli leczeni wyłącznie chirurgicznie z zamiarem wyleczenia, mogą zostać zakwalifikowani do badania. Osoby z udokumentowaną remisją bez leczenia przez ≥ 2 lata przed włączeniem do badania mogą zostać zakwalifikowani do badania według uznania badacza.","language":19,"languageDescription":"Polish"}]},{"id":641961,"number":3,"principalExclusionCriteria":"Uncontrolled active systemic infection (viral, bacterial, and fungal)","principalExclusionCriteriaTranslations":[{"id":4137987,"uuid":"d94334ea-7ad6-4292-8439-ab4d26f614d2","attributeTranslation":"Niekontrolowane aktywne zakażenie ogólnoustrojowe (wirusowe, bakteryjne i grzybicze).","language":19,"languageDescription":"Polish"}]},{"id":641962,"number":4,"principalExclusionCriteria":"Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) infection confirmed by polymerase chain reaction (PCR) test from respiratory tract specimen (e.g. nasopharyngeal swab)","principalExclusionCriteriaTranslations":[{"id":4137988,"uuid":"cbc50f66-d7ec-4346-a687-f8a9b4830e3a","attributeTranslation":"Potwierdzone testem PCR zakażenie wirusem SARS-CoV-2 (test z próbki pobranej z dróg oddechowych np. wymaz z nosogardzieli).","language":19,"languageDescription":"Polish"}]},{"id":641963,"number":5,"principalExclusionCriteria":"Known positive serology for human immunodeficiency virus (HIV), due to potential drug-drug interactions between anti-retroviral medications and the study drugs","principalExclusionCriteriaTranslations":[{"id":4137989,"uuid":"f789b1e6-6a40-438a-8470-63df293d3d4d","attributeTranslation":"Dodatni wynik serologiczny dla ludzkiego wirusa niedoboru odporności (HIV), ze względu na potencjalne interakcje lekowe między lekami przeciwretrowirusowymi a badanymi lekami.","language":19,"languageDescription":"Polish"}]},{"id":641964,"number":6,"principalExclusionCriteria":"Active hepatitis C, defined by the detectable hepatitis C ribonucleic acid (RNA) in plasma by polymerase chain reaction (PCR)","principalExclusionCriteriaTranslations":[{"id":4137990,"uuid":"dd99b6c0-42aa-4fa6-845c-2bfab2370229","attributeTranslation":"Aktywne zapalenie wątroby typu C, definiowane przez wykrywalny kwas rybonukleinowy (RNA) wirusa zapalenia wątroby typu C w osoczu za pomocą reakcji łańcuchowej polimerazy (PCR).","language":19,"languageDescription":"Polish"}]},{"id":641965,"number":7,"principalExclusionCriteria":"Patient is pregnant or breast-feeding","principalExclusionCriteriaTranslations":[{"id":4137991,"uuid":"987f5a77-647e-474c-a0f2-ff646a348e2a","attributeTranslation":"Pacjentka w trakcie ciąży lub karmiąca piersią.","language":19,"languageDescription":"Polish"}]},{"id":641966,"number":8,"principalExclusionCriteria":"Malabsorption syndrome or other condition that precludes enteral route of administration","principalExclusionCriteriaTranslations":[{"id":4137992,"uuid":"e937f7a4-b9c9-4ed9-bc33-19556d5f4a68","attributeTranslation":"Zespół złego wchłaniania lub inny stan, który uniemożliwia dojelitową drogę podania leku.","language":19,"languageDescription":"Polish"}]},{"id":641967,"number":9,"principalExclusionCriteria":"An individual organ/system impairment score of 4 as assessed by the CIRS definition limiting the ability to receive the treatment regimen of this trial with the exception of eyes, ears, nose, throat organ system (note that symptoms related to CLL should not be included in the patient’s screening CIRS score). Investigators should consult the General Rules for Severity Rating as well as the Organ-Specific Categories when assigning scores for certain conditions (i.e., pulmonary embolism) and consider the level of morbidity associated with a patient’s condition","principalExclusionCriteriaTranslations":[{"id":4137993,"uuid":"60e1232d-4138-4273-826e-0267669bb100","attributeTranslation":"Osłabienie poszczególnych organów/narządów na 4 punkty w skali wg definicji CIRS, ograniczające możliwość otrzymania schematu leczenia w tym badaniu, z wyjątkiem takich narządów jak oczy, uszy, nos, gardło (objawów związanych z CLL nie należy uwzględniać w przesiewowym wyniku CIRS). Badacze powinni zapoznać się z Ogólnymi Zasadami Oceny Ciężkości, jak również z Kategorią Narządową podczas przypisywania punktów dla określonych stanów (np. zator płucny) i rozważyć poziom zachorowalności związany ze stanem pacjenta.","language":19,"languageDescription":"Polish"}]}]},"endPoint":{"primaryEndPoints":[{"id":430266,"number":1,"endPoint":"The proportion of patients who will achieve a CR or CRi with bone marrow MRD assessed by flow cytometry less than 10-4 at the end of treatment.","isPrimary":true,"endPointTranslations":[{"id":4137970,"uuid":"956c650c-f147-4b75-b017-70297f9ec36c","attributeTranslation":"Odsetek pacjentów, którzy osiągną CR lub CRi z MRD < 10-4 w szpiku kostnym ocenianego za pomocą cytometrii przepływowej pod koniec leczenia.","language":19,"languageDescription":"Polish"}]}],"secondaryEndPoints":[{"id":430267,"number":1,"endPoint":"Overall Response Rate (ORR) Percentage of Participants with Best Overall Response (ORR)(defined as complete response [CR], CR [CRi], nodular partial response [nPR], PR) as assessed by investigator determined using iwCLL guidelines","isPrimary":false,"endPointTranslations":[{"id":4137971,"uuid":"affe9b86-4f4a-4a4d-bf76-59f07de166f8","attributeTranslation":"Odsetek uczestników z najlepszą odpowiedzią ogólną (ORR) (zdefiniowany jako odpowiedź całkowita [CR], odpowiedź całkowita z niepełnym wyzdrowieniem hematologicznym [CRi], częściowa odpowiedź guzkowa [nPR], odpowiedź częściowa [PR]) oceniany przez badacza przy użyciu wytycznych iwCLL.","language":19,"languageDescription":"Polish"}]},{"id":430268,"number":2,"endPoint":"Percentage of participants with MRD less than 10-4 in peripheral blood at 12 months following end of treatment","isPrimary":false,"endPointTranslations":[{"id":4137972,"uuid":"bf843e00-e506-4946-a645-7f45210e548c","attributeTranslation":"Odsetek uczestników z MRD poniżej 10-4 we krwi obwodowej po 12 miesiącach od zakończenia leczenia.","language":19,"languageDescription":"Polish"}]},{"id":430269,"number":3,"endPoint":"Duration of Responses (DOR) [time frame: response up to disease progression or death, whichever occurs first (up to approximately 5 years)].","isPrimary":false,"endPointTranslations":[{"id":4137973,"uuid":"d3b7a0e4-56a6-4e61-9bc3-e9c99f29f399","attributeTranslation":"Czas trwania odpowiedzi (DOR) [ramy czasowe: odpowiedź do progresji choroby lub zgonu, w zależności od tego, co nastąpi wcześniej].","language":19,"languageDescription":"Polish"}]},{"id":430270,"number":4,"endPoint":"Progression-Free Survival (PFS) [ time frame: baseline up to disease progression or death, whichever occurs first (up to approximately 5 years)] Investigator-Assessed Progression-Free Survival (PFS) determined using standard International Workshop on Chronic Lymphocytic Leukemia (iwCLL) guidelines","isPrimary":false,"endPointTranslations":[{"id":4137974,"uuid":"63cf1321-38e4-4178-b6c6-292a882a7ffa","attributeTranslation":"Przeżycie wolne od progresji (PFS) [ramy czasowe: wartość wyjściowa do progresji choroby lub zgonu, w zależności od tego, co nastąpi wcześniej]\nOceniane przez badacza przeżycie wolne od progresji (PFS) określone przy użyciu standardowych wytycznych International Workshop on Chronic Lymphocytic Leukemia (iwCLL).","language":19,"languageDescription":"Polish"}]},{"id":430271,"number":5,"endPoint":"Overall Survival (OS) [time Frame: Baseline up to death (up to approximately 5 years)]","isPrimary":false,"endPointTranslations":[{"id":4137975,"uuid":"f35c398b-62a6-4485-b64e-4ca89dc67c2f","attributeTranslation":"Całkowite przeżycie (OS) [ramy czasowe: od momentu włączenia do badania do zgonu]","language":19,"languageDescription":"Polish"}]},{"id":430272,"number":6,"endPoint":"Time to Next Anti-CLL Treatment (TTNT) [time frame: baseline up to next treatment or death from any cause, whichever occurs first (up to approximately 5 years)]","isPrimary":false,"endPointTranslations":[{"id":4137976,"uuid":"e1507cae-147d-45af-a9e1-1f11126f692b","attributeTranslation":"Time to Next Anti-CLL Treatment (TTNT) [ramy czasowe: od momentu włączenia do badania do następnego leczenia lub zgonu z dowolnej przyczyny, w zależności od tego, co nastąpi wcześniej .","language":19,"languageDescription":"Polish"}]},{"id":430273,"number":7,"endPoint":"Quality of life (QOL) of subjects during therapy. Changes from baseline in QOL measures assessed using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30).","isPrimary":false,"endPointTranslations":[{"id":4137977,"uuid":"3685b19e-9986-4a48-94ed-b423e61c6864","attributeTranslation":"Ocena jakości życia (QOL) uczestników podczas terapii. 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