Tutkimus ibrutinibin hoito-ohjelmien mukauttamisesta potilaille, joilla on aiemmin hoitamaton krooninen lymfosyyttinen leukemia (TAILOR)
Monikohorttitutkimus ibrutinibin hoito-ohjelmien räätälöimiseksi potilaille, joilla on aiemmin hoitamaton krooninen lymfosyyttinen leukemia
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).
Tutkimuksen yleiskatsaus
Tila
Interventio / Hoito
Opintotyyppi
Ilmoittautuminen (Todellinen)
Vaihe
- Vaihe 2
Yhteystiedot ja paikat
Opiskelupaikat
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Barcelona, Espanja, 08035
- Hosp Univ Vall D Hebron
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Córdoba, Espanja, 14004
- Hosp Reina Sofia
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Madrid, Espanja, 28041
- Hosp. Univ. 12 de Octubre
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Madrid, Espanja, 28034
- Hosp. Univ. Ramon Y Cajal
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Santander, Espanja, 39008
- Hosp. Univ. Marques de Valdecilla
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Santiago de Compostela, Espanja, 15706
- Hosp. Clinico Univ. de Santiago
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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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Nova Scotia
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Halifax, Nova Scotia, Kanada, B3H 1V7
- QEII Health Sciences Centre
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Ontario
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St. Catharines, Ontario, Kanada, L2S 0A9
- Niagara Health System
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Biała Podlaska, Puola, 21 500
- Wojewodzki Szpital Specjalistyczny
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Brzozów, Puola, 36 200
- Szpital Specjalistyczny w Brzozowie
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Gdynia, Puola, 81-519
- Szpitale Pomorskie Sp z o o
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Kielce, Puola, 25 734
- Swietokrzyskie Centrum Onkologii SPZOZ w Kielcach
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Krakow, Puola, 30 688
- Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki w Krakowie
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Lodz, Puola, 93 513
- Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im M Kopernika w Lodzi
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Lublin, Puola, 20 090
- Centrum Onkologii Ziemi Lubelskiej im sw Jana z Dukli
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Clermont-Ferrand, Ranska, 63100
- CHU de Clermont Ferrand
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Nantes, Ranska, 44000
- CHU Nantes
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Paris, Ranska, 75651
- Hopital Pitie Salpetriere
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Pierre-Bénite, Ranska, 69495
- CHU Lyon Sud
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Reims, Ranska, 51100
- CHU de Reims
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Strasbourg, Ranska, 67200
- Institut de Cancerologie Strasbourg Europe ICANS
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Brno-Bohunice, Tšekki, 625 00
- Fakultni nemocnice Brno
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Hradec Králové, Tšekki, 500 05
- Fakultni nemocnice Hradec Kralove
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Olomouc, Tšekki, 779 00
- Fakultni nemocnice Olomouc
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Ostrava - Poruba, Tšekki, 708 52
- Fakultni Nemocnice Ostrava
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Prague, Tšekki, 100 34
- Fakultni nemocnice Kralovske Vinohrady
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Prague, Tšekki, 128 00
- Ustav Hematologie A Krevni Transfuze
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Budapest, Unkari, 1088
- Semmelweis Egyetem
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Győr, Unkari, 9024
- Gyor Moson Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz
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Nyíregyháza, Unkari, 4400
- Szabolcs Szatmar Bereg Varmegyei Oktatokorhaz
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Szeged, Unkari, 6725
- University of Szeged
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California
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Cerritos, California, Yhdysvallat, 90703
- The Oncology Institute Clinical Research
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Los Alamitos, California, Yhdysvallat, 90720
- Cancer and Blood Specialty Clinic
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San Luis Obispo, California, Yhdysvallat, 93401
- SLO Oncology and Hematology Health Center
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Santa Rosa, California, Yhdysvallat, 95403
- Providence Medical Foundation
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Whittier, California, Yhdysvallat, 90602
- PIH Health Hospital
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Colorado
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Grand Junction, Colorado, Yhdysvallat, 81505
- Grand Valley Oncology
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Florida
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Miami Beach, Florida, Yhdysvallat, 33140-2948
- Mount Sinai Medical Center Campus
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North Miami Beach, Florida, Yhdysvallat, 33169
- The Oncology Institute
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Orange, Florida, Yhdysvallat, 32763
- Mid Florida Hematology Oncology
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Idaho
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Boise, Idaho, Yhdysvallat, 83702
- Boise VA Medical Center
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Illinois
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Hinsdale, Illinois, Yhdysvallat, 60521
- Hope and Healing Cancer Services
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Springfield, Illinois, Yhdysvallat, 62702
- Springfield Clinic
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Iowa
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Iowa City, Iowa, Yhdysvallat, 52246
- Iowa City VA Health Care System
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Minnesota
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Minneapolis, Minnesota, Yhdysvallat, 55404
- Minnesota Oncology Hematology P A
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Missouri
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Kansas City, Missouri, Yhdysvallat, 64132
- Research Medical Center
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New Jersey
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Flemington, New Jersey, Yhdysvallat, 08822
- Hunterdon Hematology Oncology
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Florham Park, New Jersey, Yhdysvallat, 07932
- Summit Medical Group
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New York
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Nyack, New York, Yhdysvallat, 10960
- Hematology Oncology Associates of Rockland
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North Carolina
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Goldsboro, North Carolina, Yhdysvallat, 27534
- Southeastern Medical Oncology Center
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Ohio
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Cincinnati, Ohio, Yhdysvallat, 45242
- Oncology Hematology Care
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Oregon
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Eugene, Oregon, Yhdysvallat, 97401
- Willamette Valley Cancer Institute and Research Center
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Portland, Oregon, Yhdysvallat, 97239
- OHSU Knight Cancer Institute
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Texas
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El Paso, Texas, Yhdysvallat, 79915
- Renovatio Clinical
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Fort Worth, Texas, Yhdysvallat, 76104
- Texas Oncology-Fort Worth Cancer Center
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Houston, Texas, Yhdysvallat, 77030
- The University of Texas MD Anderson Cancer Center
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The Woodlands, Texas, Yhdysvallat, 77380
- Renovatio Clinical 1
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The Woodlands, Texas, Yhdysvallat, 77380
- Texas Oncology-Gulf Coast
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Utah
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Ogden, Utah, Yhdysvallat, 84405
- Community Cancer Trials of Utah
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Virginia
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Manassas, Virginia, Yhdysvallat, 20110
- Virginia Cancer Specialists
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Virginia Beach, Virginia, Yhdysvallat, 23456
- Virginia Oncology Associates
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Washington
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Seattle, Washington, Yhdysvallat, 98108
- VA Puget Sound Healthcare System
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Vancouver, Washington, Yhdysvallat, 98684
- Northwest Cancer Specialists PC
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Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
Hyväksyy terveitä vapaaehtoisia
Sukupuolet, jotka voivat opiskella
Kuvaus
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
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Hoito
- Jako: Satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Ei mitään (avoin tarra)
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
|---|---|
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Kokeellinen: 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.
Muut nimet:
Venetoclax tablets will be administered orally.
Muut nimet:
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|
Kokeellinen: 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.
Muut nimet:
Venetoclax tablets will be administered orally.
Muut nimet:
|
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Kokeellinen: 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.
Muut nimet:
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Kokeellinen: 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.
Muut nimet:
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Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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Best Overall Response Rate (ORR)
Aikaikkuna: 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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Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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Complete Response (CR) Rate
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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
Aikaikkuna: 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)
Aikaikkuna: 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
Aikaikkuna: Up to 5 years
|
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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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)
Aikaikkuna: 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
|
|
Time to Worsening as Measured by European Organization for Research and Treatment of Cancer-Quality of Life Questionnaire (EORTC QLQ)-C30)
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
|
Yhteistyökumppanit ja tutkijat
Sponsori
Yhteistyökumppanit
Tutkijat
- Opintojohtaja: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Todellinen)
Ensisijainen valmistuminen (Arvioitu)
Opintojen valmistuminen (Arvioitu)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Todellinen)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Muita asiaankuuluvia MeSH-ehtoja
- Patologiset prosessit
- Neoplasmat
- Krooninen sairaus
- Sairauden ominaisuudet
- Immuunijärjestelmän sairaudet
- Neoplasmat histologisen tyypin mukaan
- Hematologiset sairaudet
- Lymfaattiset sairaudet
- Lymfoproliferatiiviset häiriöt
- Immunoproliferatiiviset häiriöt
- Leukemia, B-solu
- Leukemia, imusolmukkeet
- Leukemia
- Patologiset tilat, merkit ja oireet
- Hemic- ja imusuutteet
- Leukemia, lymfosyyttinen, krooninen, B-solu
- Venetoclax
- Ibrutinib
Muut tutkimustunnusnumerot
- 54179060CLL2032
- 54179060CLL2032 (Muu tunniste: Janssen Research & Development, LLC)
- 2023-504044-34-00 (Rekisterin tunniste: EUCT number)
- 2023 (Yhdysvaltain NIH-apuraha/sopimus)
Yksittäisten osallistujien tietojen suunnitelma (IPD)
Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?
IPD-suunnitelman kuvaus
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
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