Um estudo para personalizar regimes de tratamento com Ibrutinibe para participantes com leucemia linfocítica crônica não tratada anteriormente (TAILOR)
Estudo multicoorte para personalizar regimes de tratamento com ibrutinibe para pacientes com leucemia linfocítica crônica não tratada anteriormente
The purpose of this study is to evaluate the efficacy and safety of ibrutinib + venetoclax (I+V) and ibrutinib monotherapy regimens in which dosing of ibrutinib is either proactively reduced or reactively modified in response to adverse events (AEs).
Visão geral do estudo
Status
Intervenção / Tratamento
Tipo de estudo
Inscrição (Real)
Estágio
- Fase 2
Contactos e Locais
Locais de estudo
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Nova Scotia
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Halifax, Nova Scotia, Canadá, B3H 1V7
- QEII Health Sciences Centre
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Ontario
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St. Catharines, Ontario, Canadá, L2S 0A9
- Niagara Health System
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Barcelona, Espanha, 08035
- Hosp Univ Vall D Hebron
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Córdoba, Espanha, 14004
- Hosp Reina Sofia
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Madrid, Espanha, 28041
- Hosp. Univ. 12 de Octubre
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Madrid, Espanha, 28034
- Hosp. Univ. Ramon Y Cajal
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Santander, Espanha, 39008
- Hosp. Univ. Marques de Valdecilla
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Santiago de Compostela, Espanha, 15706
- Hosp. Clinico Univ. de Santiago
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California
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Cerritos, California, Estados Unidos, 90703
- The Oncology Institute Clinical Research
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Los Alamitos, California, Estados Unidos, 90720
- Cancer and Blood Specialty Clinic
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San Luis Obispo, California, Estados Unidos, 93401
- SLO Oncology and Hematology Health Center
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Santa Rosa, California, Estados Unidos, 95403
- Providence Medical Foundation
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Whittier, California, Estados Unidos, 90602
- PIH Health Hospital
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Colorado
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Grand Junction, Colorado, Estados Unidos, 81505
- Grand Valley Oncology
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Florida
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Miami Beach, Florida, Estados Unidos, 33140-2948
- Mount Sinai Medical Center Campus
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North Miami Beach, Florida, Estados Unidos, 33169
- The Oncology Institute
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Orange, Florida, Estados Unidos, 32763
- Mid Florida Hematology Oncology
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Idaho
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Boise, Idaho, Estados Unidos, 83702
- Boise VA Medical Center
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Illinois
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Hinsdale, Illinois, Estados Unidos, 60521
- Hope and Healing Cancer Services
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Springfield, Illinois, Estados Unidos, 62702
- Springfield Clinic
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Iowa
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Iowa City, Iowa, Estados Unidos, 52246
- Iowa City VA Health Care System
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Minnesota
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Minneapolis, Minnesota, Estados Unidos, 55404
- Minnesota Oncology Hematology P A
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Missouri
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Kansas City, Missouri, Estados Unidos, 64132
- Research Medical Center
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New Jersey
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Flemington, New Jersey, Estados Unidos, 08822
- Hunterdon Hematology Oncology
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Florham Park, New Jersey, Estados Unidos, 07932
- Summit Medical Group
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New York
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Nyack, New York, Estados Unidos, 10960
- Hematology Oncology Associates of Rockland
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North Carolina
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Goldsboro, North Carolina, Estados Unidos, 27534
- Southeastern Medical Oncology Center
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Ohio
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Cincinnati, Ohio, Estados Unidos, 45242
- Oncology Hematology Care
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Oregon
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Eugene, Oregon, Estados Unidos, 97401
- Willamette Valley Cancer Institute and Research Center
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Portland, Oregon, Estados Unidos, 97239
- OHSU Knight Cancer Institute
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Texas
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El Paso, Texas, Estados Unidos, 79915
- Renovatio Clinical
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Fort Worth, Texas, Estados Unidos, 76104
- Texas Oncology-Fort Worth Cancer Center
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Houston, Texas, Estados Unidos, 77030
- The University of Texas MD Anderson Cancer Center
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The Woodlands, Texas, Estados Unidos, 77380
- Renovatio Clinical 1
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The Woodlands, Texas, Estados Unidos, 77380
- Texas Oncology-Gulf Coast
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Utah
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Ogden, Utah, Estados Unidos, 84405
- Community Cancer Trials of Utah
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Virginia
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Manassas, Virginia, Estados Unidos, 20110
- Virginia Cancer Specialists
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Virginia Beach, Virginia, Estados Unidos, 23456
- Virginia Oncology Associates
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Washington
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Seattle, Washington, Estados Unidos, 98108
- VA Puget Sound Healthcare System
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Vancouver, Washington, Estados Unidos, 98684
- Northwest Cancer Specialists PC
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Clermont-Ferrand, França, 63100
- CHU de Clermont Ferrand
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Nantes, França, 44000
- CHU Nantes
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Paris, França, 75651
- Hopital Pitie Salpetriere
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Pierre-Bénite, França, 69495
- CHU Lyon Sud
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Reims, França, 51100
- CHU de Reims
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Strasbourg, França, 67200
- Institut de Cancerologie Strasbourg Europe ICANS
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Budapest, Hungria, 1088
- Semmelweis Egyetem
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Győr, Hungria, 9024
- Gyor Moson Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz
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Nyíregyháza, Hungria, 4400
- Szabolcs Szatmar Bereg Varmegyei Oktatokorhaz
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Szeged, Hungria, 6725
- University of Szeged
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Bari, Itália, 70124
- U.O. Ematologia Istituto Tumori Giovanni Paolo II
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Ferrara, Itália, 44124
- Azienda Ospedaliero-Universitaria di Ferrara Arcispedale Sant Anna
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Florence, Itália, 50134
- Azienda Ospedaliero Universitaria Careggi
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Milan, Itália, 20132
- Ospedale San Raffaele
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Milan, Itália, 20162
- ASST Grande Ospedale Metropolitano Niguarda
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Novara, Itália, 28100
- Ospedale Maggiore della Carita
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Padova, Itália, 35129
- Universita degli Studi di Padova Azienda Ospedaliera di Pa
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Palermo, Itália, 90146
- Ospedale Villa Sofia-Cervello
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Perugia, Itália, 06132
- Azienda Ospedaliera di Perugia Ospedale S.Maria della Misericordia
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Roma, Itália, 00161
- Umberto I Policlinico di Roma
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Roma, Itália, 00136
- Ematologia Fondazione Univ. Policlinico Gemelli Università Cattolica del Sacro Cuore
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Biała Podlaska, Polônia, 21 500
- Wojewodzki Szpital Specjalistyczny
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Brzozów, Polônia, 36 200
- Szpital Specjalistyczny w Brzozowie
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Gdynia, Polônia, 81-519
- Szpitale Pomorskie Sp z o o
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Kielce, Polônia, 25 734
- Swietokrzyskie Centrum Onkologii SPZOZ w Kielcach
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Krakow, Polônia, 30 688
- Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki w Krakowie
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Lodz, Polônia, 93 513
- Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im M Kopernika w Lodzi
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Lublin, Polônia, 20 090
- Centrum Onkologii Ziemi Lubelskiej im sw Jana z Dukli
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Brno-Bohunice, Tcheca, 625 00
- Fakultni nemocnice Brno
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Hradec Králové, Tcheca, 500 05
- Fakultni nemocnice Hradec Kralove
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Olomouc, Tcheca, 779 00
- Fakultni nemocnice Olomouc
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Ostrava - Poruba, Tcheca, 708 52
- Fakultni Nemocnice Ostrava
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Prague, Tcheca, 100 34
- Fakultni nemocnice Kralovske Vinohrady
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Prague, Tcheca, 128 00
- Ustav Hematologie A Krevni Transfuze
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- Diagnosis of chronic lymphocytic leukemia/ small lymphocytic lymphoma (CLL/SLL) as per International Workshop on Chronic Lymphocytic Leukemia (iwCLL) 2018 diagnostic criteria
- For ibruinib + venetocIax (I+V) cohorts: eastern cooperative oncology group (ECOG) performance status of 0-1. For ibrutinib monotherapy cohorts: ECOG performance status of 0-2
- Measurable nodal disease by computed tomography (CT), defined as at least 1 lymph node greater than and equal to (>=) 1.5 centimeters (cm) in longest diameter
- A participant using oral contraceptives must use an additional contraceptive method
- A participant must agree not to be pregnant, breastfeeding, or planning to become pregnant while enrolled in this study or until 1 month after last dose or per local label if more conservative (for example, 3 months in European Union or Canada and 1 month in United States)
Exclusion Criteria:
- Uncontrolled autoimmune hemolytic anemia or idiopathic thrombocytopenia purpura, such as those participants with a declining hemoglobin level or platelet count secondary to autoimmune destruction within the 4 weeks prior to first dose of study treatment, or the need for prednisone greater than (>) 20 milligrams (mg) daily (or corticosteroid equivalent) to treat or control the autoimmune disease
- Known bleeding disorders (example, von Willebrand's disease or hemophilia)
- Stroke or intracranial hemorrhage within 6 months prior to enrollment
- Known or suspected Richter's transformation or central nervous system (CNS) involvement
- Currently active, clinically significant cardiovascular disease, such as uncontrolled arrhythmia or Class II, III, or IV congestive heart failure as defined by the New York Heart Association Functional Classification
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: Cohort 1a: Ibrutinib Lead-in+Fixed Duration Ibrutinib+Venetoclax
Participants will receive ibrutinib 420 milligrams (mg) capsule every day (QD) for a lead-in of 3 cycles (1 cycle = 28 days). From Cycle 4, venetoclax 400 mg tablet dose ramp-up (from 20 to 400 mg over 5 weeks) will begin, and venetoclax 400 mg QD will be administered with ibrutinib 420 mg QD, orally for 12 cycles through Cycle 15. |
Ibrutinib capsules will be administered orally.
Outros nomes:
Venetoclax tablets will be administered orally.
Outros nomes:
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Experimental: Cohort 1b: Ibrutinib Lead-in+Fixed Duration Ibrutinib+Venetoclax
Participants will receive ibrutinib 420 mg capsule QD for a lead-in of 3 cycles (1 cycle = 28 days). From Cycle 4, venetoclax 400 mg tablet dose ramp-up (from 20 to 400 mg over 5 weeks) will begin and ibrutinib dose will be reduced to 280 mg and will be administered QD, venetoclax 400 mg tablets QD will be administered with ibrutinib 280 mg for 12 cycles through Cycle 15. |
Ibrutinib capsules will be administered orally.
Outros nomes:
Venetoclax tablets will be administered orally.
Outros nomes:
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Experimental: Cohort 2a: Continuous Ibrutinib Monotherapy
Participants will receive ibrutinib 420 mg QD (or last tolerated dose) until disease progression (PD) or unacceptable toxicity. |
Ibrutinib capsules will be administered orally.
Outros nomes:
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Experimental: Cohort 2b: Continuous Ibrutinib Monotherapy
Participants will receive ibrutinib 420 mg QD for 1 cycle (1 cycle = 28 days) followed by Ibrutinib 280 mg QD (or last tolerated dose) and continue until disease progression or unacceptable toxicity. |
Ibrutinib capsules will be administered orally.
Outros nomes:
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Best Overall Response Rate (ORR)
Prazo: Up to 5 years
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Best ORR is defined as the percentage of participants who achieve complete remission (CR), complete remission with an incomplete marrow recovery (CRi), nodular partial remission (nPR), or partial remission (PR) per International Workshop on Chronic Lymphocytic Leukemia (iwCLL) 2018 criteria as assessed by investigator. |
Up to 5 years
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Complete Response (CR) Rate
Prazo: Up to 5 years
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CR rate is defined as the percentage of participants achieving a best overall response of CR or CRi per iwCLL 2018 criteria as assessed by investigator. |
Up to 5 years
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Duration of Response (DOR)
Prazo: Up to 5 years
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DOR is defined as the duration in days from the date of initial documentation of PR or better to the date of first documented evidence of PD or death. |
Up to 5 years
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Progression Free Survival (PFS)
Prazo: Up to 5 years
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PFS by investigator assessment is defined as the duration from date of randomization to date of PD or death due to any cause, whichever occurs first. |
Up to 5 years
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Overall Survival (OS)
Prazo: Up to 5 years
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OS is defined as the time from date of randomization to date of death from any cause. |
Up to 5 years
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Cohorts 1a and 1b: Minimal Residual Disease (MRD) Negative Rate
Prazo: Up to 5 years
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MRD-negative rate is defined as the percentage of participants who reach MRD-negative status (that is, less than [<] 1 chronic lymphocytic leukemia (CLL) cell per 10,000 leukocytes or <0.01 percentage [%]) in the peripheral blood. |
Up to 5 years
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Number of Participants with Adverse Events (AEs)
Prazo: Up to 5 years
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An adverse event (AE) is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. |
Up to 5 years
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Number of Participants with AEs by Severity
Prazo: Up to 5 years
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An AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. Severity scale ranges from Grade 1 (Mild) to Grade 5 (Death). Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Life-threatening and Grade 5= Death related to adverse event. |
Up to 5 years
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Percentage of Participants with Rate of Discontinuation due to AEs
Prazo: Up to 5 years
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Percentage of participants with rate of discontinuation due to AEs will be reported. |
Up to 5 years
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Percentage of Participants with Dose Reduction due AEs
Prazo: Up to 5 years
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Percentage of participants with dose reduction due AEs will be reported. |
Up to 5 years
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Adherence Rates
Prazo: Up to 5 years
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The adherence rate is defined as the percentage of total dose taken over the total dose prescribed. |
Up to 5 years
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Duration of Treatment
Prazo: Up to 5 years
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Duration of treatment is defined as the time period in days between the date of first study treatment administration and date of last administration. |
Up to 5 years
|
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Time to Worsening as Measured by EuroQol 5 Dimension 5 Level Questionnaire (EQ-5D-5L)
Prazo: Up to 5 years
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Time to worsening is defined as time interval (months) from randomization to first observation of deterioration. Time to worsening as measured by EQ-5D-5L will be reported. |
Up to 5 years
|
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Time to Worsening as Measured by European Organization for Research and Treatment of Cancer-Quality of Life Questionnaire (EORTC QLQ)-C30)
Prazo: Up to 5 years
|
Time to worsening is defined as time interval from randomization to first observation of deterioration. Time to worsening as measured by EORTC QLQ-C30 will be reported. |
Up to 5 years
|
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Time to Worsening as Measured by EORTC QLQ-CLL17
Prazo: Up to 5 years
|
Time to worsening is defined as time interval from randomization to first observation of deterioration. Time to worsening as measured by EORTC QLQ-CLL17 will be reported. |
Up to 5 years
|
|
Time to Worsening as Measured by Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Total Score
Prazo: Up to 5 years
|
Time to Worsening is defined as time interval (months) from randomization to first observation of deterioration. Time to worsening as measured by FACIT-fatigue total score will be reported. |
Up to 5 years
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Diretor de estudo: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
- Processos Patológicos
- Neoplasias
- Doença crônica
- Atributos da doença
- Doenças do sistema imunológico
- Neoplasias por Tipo Histológico
- Doenças Hematológicas
- Doenças Linfáticas
- Distúrbios Linfoproliferativos
- Distúrbios imunoproliferativos
- Leucemia de Células B
- Leucemia Linfóide
- Leucemia
- Condições Patológicas, Sinais e Sintomas
- Doenças hemic e linfáticas
- Leucemia Linfocítica Crônica de Células B
- Venetoclax
- ibrutinibe
Outros números de identificação do estudo
- 54179060CLL2032
- 54179060CLL2032 (Outro identificador: Janssen Research & Development, LLC)
- 2023-504044-34-00 (Identificador de registro: EUCT number)
- 2023 (Concessão/Contrato do NIH dos EUA)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
Informações sobre medicamentos e dispositivos, documentos de estudo
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