Un estudio para personalizar los regímenes de tratamiento con ibrutinib para participantes con leucemia linfocítica crónica sin tratamiento previo (TAILOR)
Estudio de múltiples cohortes para personalizar los regímenes de tratamiento con ibrutinib para pacientes con leucemia linfocítica crónica sin tratamiento previo
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).
Descripción general del estudio
Estado
Intervención / Tratamiento
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 2
Contactos y Ubicaciones
Ubicaciones de estudio
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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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Brno-Bohunice, Chequia, 625 00
- Fakultni nemocnice Brno
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Hradec Králové, Chequia, 500 05
- Fakultni nemocnice Hradec Kralove
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Olomouc, Chequia, 779 00
- Fakultni nemocnice Olomouc
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Ostrava - Poruba, Chequia, 708 52
- Fakultni Nemocnice Ostrava
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Prague, Chequia, 100 34
- Fakultni nemocnice Kralovske Vinohrady
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Prague, Chequia, 128 00
- Ustav Hematologie A Krevni Transfuze
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Barcelona, España, 08035
- Hosp Univ Vall D Hebron
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Córdoba, España, 14004
- Hosp Reina Sofia
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Madrid, España, 28041
- Hosp. Univ. 12 de Octubre
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Madrid, España, 28034
- Hosp. Univ. Ramon Y Cajal
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Santander, España, 39008
- Hosp. Univ. Marques de Valdecilla
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Santiago de Compostela, España, 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, Francia, 63100
- CHU de Clermont Ferrand
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Nantes, Francia, 44000
- CHU Nantes
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Paris, Francia, 75651
- Hopital Pitie Salpetriere
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Pierre-Bénite, Francia, 69495
- CHU Lyon Sud
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Reims, Francia, 51100
- CHU de Reims
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Strasbourg, Francia, 67200
- Institut de Cancerologie Strasbourg Europe ICANS
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Budapest, Hungría, 1088
- Semmelweis Egyetem
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Győr, Hungría, 9024
- Gyor Moson Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz
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Nyíregyháza, Hungría, 4400
- Szabolcs Szatmar Bereg Varmegyei Oktatokorhaz
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Szeged, Hungría, 6725
- University of Szeged
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Bari, Italia, 70124
- U.O. Ematologia Istituto Tumori Giovanni Paolo II
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Ferrara, Italia, 44124
- Azienda Ospedaliero-Universitaria di Ferrara Arcispedale Sant Anna
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Florence, Italia, 50134
- Azienda Ospedaliero Universitaria Careggi
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Milan, Italia, 20132
- Ospedale San Raffaele
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Milan, Italia, 20162
- ASST Grande Ospedale Metropolitano Niguarda
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Novara, Italia, 28100
- Ospedale Maggiore della Carita
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Padova, Italia, 35129
- Universita degli Studi di Padova Azienda Ospedaliera di Pa
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Palermo, Italia, 90146
- Ospedale Villa Sofia-Cervello
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Perugia, Italia, 06132
- Azienda Ospedaliera di Perugia Ospedale S.Maria della Misericordia
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Roma, Italia, 00161
- Umberto I Policlinico di Roma
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Roma, Italia, 00136
- Ematologia Fondazione Univ. Policlinico Gemelli Università Cattolica del Sacro Cuore
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Biała Podlaska, Polonia, 21 500
- Wojewodzki Szpital Specjalistyczny
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Brzozów, Polonia, 36 200
- Szpital Specjalistyczny w Brzozowie
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Gdynia, Polonia, 81-519
- Szpitale Pomorskie Sp z o o
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Kielce, Polonia, 25 734
- Swietokrzyskie Centrum Onkologii SPZOZ w Kielcach
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Krakow, Polonia, 30 688
- Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki w Krakowie
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Lodz, Polonia, 93 513
- Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im M Kopernika w Lodzi
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Lublin, Polonia, 20 090
- Centrum Onkologii Ziemi Lubelskiej im sw Jana z Dukli
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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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.
Otros nombres:
Venetoclax tablets will be administered orally.
Otros nombres:
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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.
Otros nombres:
Venetoclax tablets will be administered orally.
Otros nombres:
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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.
Otros nombres:
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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.
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Best Overall Response Rate (ORR)
Periodo de tiempo: 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 resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Complete Response (CR) Rate
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: Up to 5 years
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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
Periodo de tiempo: Up to 5 years
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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
|
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Time to Worsening as Measured by Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Total Score
Periodo de tiempo: 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 FACIT-fatigue total score will be reported. |
Up to 5 years
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Director de estudio: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
- Procesos Patológicos
- Neoplasias
- Enfermedad crónica
- Atributos de la enfermedad
- Enfermedades del sistema inmunológico
- Neoplasias por tipo histológico
- Enfermedades hematológicas
- Enfermedades linfáticas
- Trastornos linfoproliferativos
- Trastornos inmunoproliferativos
- Leucemia de células B
- Leucemia Linfoide
- Leucemia
- Condiciones Patológicas, Signos y Síntomas
- Enfermedades hemic y linfáticas
- Leucemia Linfocítica Crónica De Células B
- venetoclax
- ibrutinib
Otros números de identificación del estudio
- 54179060CLL2032
- 54179060CLL2032 (Otro identificador: Janssen Research & Development, LLC)
- 2023-504044-34-00 (Identificador de registro: EUCT number)
- 2023 (Subvención/contrato del NIH de EE. UU.)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan 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
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .