Uno studio per personalizzare i regimi di trattamento con ibrutinib per i partecipanti con leucemia linfocitica cronica non trattata in precedenza (TAILOR)
Studio multicoorte per personalizzare i regimi terapeutici con ibrutinib per i pazienti con leucemia linfocitica cronica non trattata in precedenza
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).
Panoramica dello studio
Stato
Intervento / Trattamento
Tipo di studio
Iscrizione (Effettivo)
Fase
- Fase 2
Contatti e Sedi
Luoghi di studio
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Nova Scotia
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Halifax, Nova Scotia, Canada, B3H 1V7
- QEII Health Sciences Centre
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Ontario
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St. Catharines, Ontario, Canada, L2S 0A9
- Niagara Health System
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Brno-Bohunice, Cechia, 625 00
- Fakultni nemocnice Brno
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Hradec Králové, Cechia, 500 05
- Fakultni nemocnice Hradec Kralove
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Olomouc, Cechia, 779 00
- Fakultni nemocnice Olomouc
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Ostrava - Poruba, Cechia, 708 52
- Fakultni Nemocnice Ostrava
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Prague, Cechia, 100 34
- Fakultni nemocnice Kralovske Vinohrady
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Prague, Cechia, 128 00
- Ustav Hematologie A Krevni Transfuze
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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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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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Barcelona, Spagna, 08035
- Hosp Univ Vall D Hebron
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Córdoba, Spagna, 14004
- Hosp Reina Sofia
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Madrid, Spagna, 28041
- Hosp. Univ. 12 de Octubre
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Madrid, Spagna, 28034
- Hosp. Univ. Ramon Y Cajal
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Santander, Spagna, 39008
- Hosp. Univ. Marques de Valdecilla
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Santiago de Compostela, Spagna, 15706
- Hosp. Clinico Univ. de Santiago
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California
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Cerritos, California, Stati Uniti, 90703
- The Oncology Institute Clinical Research
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Los Alamitos, California, Stati Uniti, 90720
- Cancer and Blood Specialty Clinic
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San Luis Obispo, California, Stati Uniti, 93401
- SLO Oncology and Hematology Health Center
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Santa Rosa, California, Stati Uniti, 95403
- Providence Medical Foundation
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Whittier, California, Stati Uniti, 90602
- PIH Health Hospital
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Colorado
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Grand Junction, Colorado, Stati Uniti, 81505
- Grand Valley Oncology
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Florida
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Miami Beach, Florida, Stati Uniti, 33140-2948
- Mount Sinai Medical Center Campus
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North Miami Beach, Florida, Stati Uniti, 33169
- The Oncology Institute
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Orange, Florida, Stati Uniti, 32763
- Mid Florida Hematology Oncology
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Idaho
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Boise, Idaho, Stati Uniti, 83702
- Boise VA Medical Center
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Illinois
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Hinsdale, Illinois, Stati Uniti, 60521
- Hope and Healing Cancer Services
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Springfield, Illinois, Stati Uniti, 62702
- Springfield Clinic
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Iowa
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Iowa City, Iowa, Stati Uniti, 52246
- Iowa City VA Health Care System
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Minnesota
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Minneapolis, Minnesota, Stati Uniti, 55404
- Minnesota Oncology Hematology P A
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Missouri
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Kansas City, Missouri, Stati Uniti, 64132
- Research Medical Center
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New Jersey
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Flemington, New Jersey, Stati Uniti, 08822
- Hunterdon Hematology Oncology
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Florham Park, New Jersey, Stati Uniti, 07932
- Summit Medical Group
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New York
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Nyack, New York, Stati Uniti, 10960
- Hematology Oncology Associates of Rockland
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North Carolina
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Goldsboro, North Carolina, Stati Uniti, 27534
- Southeastern Medical Oncology Center
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Ohio
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Cincinnati, Ohio, Stati Uniti, 45242
- Oncology Hematology Care
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Oregon
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Eugene, Oregon, Stati Uniti, 97401
- Willamette Valley Cancer Institute and Research Center
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Portland, Oregon, Stati Uniti, 97239
- OHSU Knight Cancer Institute
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Texas
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El Paso, Texas, Stati Uniti, 79915
- Renovatio Clinical
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Fort Worth, Texas, Stati Uniti, 76104
- Texas Oncology-Fort Worth Cancer Center
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Houston, Texas, Stati Uniti, 77030
- The University of Texas MD Anderson Cancer Center
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The Woodlands, Texas, Stati Uniti, 77380
- Renovatio Clinical 1
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The Woodlands, Texas, Stati Uniti, 77380
- Texas Oncology-Gulf Coast
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Utah
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Ogden, Utah, Stati Uniti, 84405
- Community Cancer Trials of Utah
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Virginia
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Manassas, Virginia, Stati Uniti, 20110
- Virginia Cancer Specialists
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Virginia Beach, Virginia, Stati Uniti, 23456
- Virginia Oncology Associates
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Washington
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Seattle, Washington, Stati Uniti, 98108
- VA Puget Sound Healthcare System
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Vancouver, Washington, Stati Uniti, 98684
- Northwest Cancer Specialists PC
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Budapest, Ungheria, 1088
- Semmelweis Egyetem
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Győr, Ungheria, 9024
- Gyor Moson Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz
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Nyíregyháza, Ungheria, 4400
- Szabolcs Szatmar Bereg Varmegyei Oktatokorhaz
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Szeged, Ungheria, 6725
- University of Szeged
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Sperimentale: 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.
Altri nomi:
Venetoclax tablets will be administered orally.
Altri nomi:
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Sperimentale: 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.
Altri nomi:
Venetoclax tablets will be administered orally.
Altri nomi:
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Sperimentale: 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.
Altri nomi:
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Sperimentale: 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.
Altri nomi:
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Best Overall Response Rate (ORR)
Lasso di tempo: 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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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Complete Response (CR) Rate
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: Up to 5 years
|
Percentage of participants with dose reduction due AEs will be reported. |
Up to 5 years
|
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Adherence Rates
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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 EQ-5D-5L will be reported. |
Up to 5 years
|
|
Time to Worsening as Measured by European Organization for Research and Treatment of Cancer-Quality of Life Questionnaire (EORTC QLQ)-C30)
Lasso di tempo: 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
|
|
Time to Worsening as Measured by EORTC QLQ-CLL17
Lasso di tempo: 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
Lasso di tempo: 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
|
Collaboratori e investigatori
Collaboratori
Investigatori
- Direttore dello studio: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
- Processi patologici
- Neoplasie
- Malattia cronica
- Attributi della malattia
- Malattie del sistema immunitario
- Neoplasie per tipo istologico
- Malattie ematologiche
- Malattie linfatiche
- Malattie linfoproliferative
- Disturbi immunoproliferativi
- Leucemia, cellule B
- Leucemia, linfoide
- Leucemia
- Condizioni patologiche, segni e sintomi
- Malattie emiche e linfatiche
- Leucemia, linfocitica, cronica, cellule B
- Venetoclax
- Ibrutinib
Altri numeri di identificazione dello studio
- 54179060CLL2032
- 54179060CLL2032 (Altro identificatore: Janssen Research & Development, LLC)
- 2023-504044-34-00 (Identificatore di registro: EUCT number)
- 2023 (Sovvenzione/contratto NIH degli Stati Uniti)
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Descrizione del piano 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
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .