En undersøgelse for at tilpasse Ibrutinib-behandlingsregimer til deltagere med tidligere ubehandlet kronisk lymfatisk leukæmi (TAILOR)
Multikohorteundersøgelse for at tilpasse Ibrutinib-behandlingsregimer til patienter med tidligere ubehandlet kronisk lymfatisk leukæmi
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).
Studieoversigt
Status
Intervention / Behandling
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 2
Kontakter og lokationer
Studiesteder
-
-
Nova Scotia
-
Halifax, Nova Scotia, Canada, B3H 1V7
- QEII Health Sciences Centre
-
-
Ontario
-
St. Catharines, Ontario, Canada, L2S 0A9
- Niagara Health System
-
-
-
-
California
-
Cerritos, California, Forenede Stater, 90703
- The Oncology Institute Clinical Research
-
Los Alamitos, California, Forenede Stater, 90720
- Cancer and Blood Specialty Clinic
-
San Luis Obispo, California, Forenede Stater, 93401
- SLO Oncology and Hematology Health Center
-
Santa Rosa, California, Forenede Stater, 95403
- Providence Medical Foundation
-
Whittier, California, Forenede Stater, 90602
- PIH Health Hospital
-
-
Colorado
-
Grand Junction, Colorado, Forenede Stater, 81505
- Grand Valley Oncology
-
-
Florida
-
Miami Beach, Florida, Forenede Stater, 33140-2948
- Mount Sinai Medical Center Campus
-
North Miami Beach, Florida, Forenede Stater, 33169
- The Oncology Institute
-
Orange, Florida, Forenede Stater, 32763
- Mid Florida Hematology Oncology
-
-
Idaho
-
Boise, Idaho, Forenede Stater, 83702
- Boise VA Medical Center
-
-
Illinois
-
Hinsdale, Illinois, Forenede Stater, 60521
- Hope and Healing Cancer Services
-
Springfield, Illinois, Forenede Stater, 62702
- Springfield Clinic
-
-
Iowa
-
Iowa City, Iowa, Forenede Stater, 52246
- Iowa City VA Health Care System
-
-
Minnesota
-
Minneapolis, Minnesota, Forenede Stater, 55404
- Minnesota Oncology Hematology P A
-
-
Missouri
-
Kansas City, Missouri, Forenede Stater, 64132
- Research Medical Center
-
-
New Jersey
-
Flemington, New Jersey, Forenede Stater, 08822
- Hunterdon Hematology Oncology
-
Florham Park, New Jersey, Forenede Stater, 07932
- Summit Medical Group
-
-
New York
-
Nyack, New York, Forenede Stater, 10960
- Hematology Oncology Associates of Rockland
-
-
North Carolina
-
Goldsboro, North Carolina, Forenede Stater, 27534
- Southeastern Medical Oncology Center
-
-
Ohio
-
Cincinnati, Ohio, Forenede Stater, 45242
- Oncology Hematology Care
-
-
Oregon
-
Eugene, Oregon, Forenede Stater, 97401
- Willamette Valley Cancer Institute and Research Center
-
Portland, Oregon, Forenede Stater, 97239
- OHSU Knight Cancer Institute
-
-
Texas
-
El Paso, Texas, Forenede Stater, 79915
- Renovatio Clinical
-
Fort Worth, Texas, Forenede Stater, 76104
- Texas Oncology-Fort Worth Cancer Center
-
Houston, Texas, Forenede Stater, 77030
- The University of Texas MD Anderson Cancer Center
-
The Woodlands, Texas, Forenede Stater, 77380
- Renovatio Clinical 1
-
The Woodlands, Texas, Forenede Stater, 77380
- Texas Oncology-Gulf Coast
-
-
Utah
-
Ogden, Utah, Forenede Stater, 84405
- Community Cancer Trials of Utah
-
-
Virginia
-
Manassas, Virginia, Forenede Stater, 20110
- Virginia Cancer Specialists
-
Virginia Beach, Virginia, Forenede Stater, 23456
- Virginia Oncology Associates
-
-
Washington
-
Seattle, Washington, Forenede Stater, 98108
- VA Puget Sound Healthcare System
-
Vancouver, Washington, Forenede Stater, 98684
- Northwest Cancer Specialists PC
-
-
-
-
-
Clermont-Ferrand, Frankrig, 63100
- CHU de Clermont Ferrand
-
Nantes, Frankrig, 44000
- CHU Nantes
-
Paris, Frankrig, 75651
- Hopital Pitie Salpetriere
-
Pierre-Bénite, Frankrig, 69495
- CHU Lyon Sud
-
Reims, Frankrig, 51100
- CHU de Reims
-
Strasbourg, Frankrig, 67200
- Institut de Cancerologie Strasbourg Europe ICANS
-
-
-
-
-
Bari, Italien, 70124
- U.O. Ematologia Istituto Tumori Giovanni Paolo II
-
Ferrara, Italien, 44124
- Azienda Ospedaliero-Universitaria di Ferrara Arcispedale Sant Anna
-
Florence, Italien, 50134
- Azienda Ospedaliero Universitaria Careggi
-
Milan, Italien, 20132
- Ospedale San Raffaele
-
Milan, Italien, 20162
- ASST Grande Ospedale Metropolitano Niguarda
-
Novara, Italien, 28100
- Ospedale Maggiore della Carita
-
Padova, Italien, 35129
- Universita degli Studi di Padova Azienda Ospedaliera di Pa
-
Palermo, Italien, 90146
- Ospedale Villa Sofia-Cervello
-
Perugia, Italien, 06132
- Azienda Ospedaliera di Perugia Ospedale S.Maria della Misericordia
-
Roma, Italien, 00161
- Umberto I Policlinico di Roma
-
Roma, Italien, 00136
- Ematologia Fondazione Univ. Policlinico Gemelli Università Cattolica del Sacro Cuore
-
-
-
-
-
Biała Podlaska, Polen, 21 500
- Wojewodzki Szpital Specjalistyczny
-
Brzozów, Polen, 36 200
- Szpital Specjalistyczny w Brzozowie
-
Gdynia, Polen, 81-519
- Szpitale Pomorskie Sp z o o
-
Kielce, Polen, 25 734
- Swietokrzyskie Centrum Onkologii SPZOZ w Kielcach
-
Krakow, Polen, 30 688
- Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki w Krakowie
-
Lodz, Polen, 93 513
- Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im M Kopernika w Lodzi
-
Lublin, Polen, 20 090
- Centrum Onkologii Ziemi Lubelskiej im sw Jana z Dukli
-
-
-
-
-
Barcelona, Spanien, 08035
- Hosp Univ Vall D Hebron
-
Córdoba, Spanien, 14004
- Hosp Reina Sofia
-
Madrid, Spanien, 28041
- Hosp. Univ. 12 de Octubre
-
Madrid, Spanien, 28034
- Hosp. Univ. Ramon Y Cajal
-
Santander, Spanien, 39008
- Hosp. Univ. Marques de Valdecilla
-
Santiago de Compostela, Spanien, 15706
- Hosp. Clinico Univ. de Santiago
-
-
-
-
-
Brno-Bohunice, Tjekkiet, 625 00
- Fakultni nemocnice Brno
-
Hradec Králové, Tjekkiet, 500 05
- Fakultni nemocnice Hradec Kralove
-
Olomouc, Tjekkiet, 779 00
- Fakultni nemocnice Olomouc
-
Ostrava - Poruba, Tjekkiet, 708 52
- Fakultni Nemocnice Ostrava
-
Prague, Tjekkiet, 100 34
- Fakultni nemocnice Kralovske Vinohrady
-
Prague, Tjekkiet, 128 00
- Ustav Hematologie A Krevni Transfuze
-
-
-
-
-
Budapest, Ungarn, 1088
- Semmelweis Egyetem
-
Győr, Ungarn, 9024
- Gyor Moson Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz
-
Nyíregyháza, Ungarn, 4400
- Szabolcs Szatmar Bereg Varmegyei Oktatokorhaz
-
Szeged, Ungarn, 6725
- University of Szeged
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 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.
Andre navne:
Venetoclax tablets will be administered orally.
Andre navne:
|
|
Eksperimentel: 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.
Andre navne:
Venetoclax tablets will be administered orally.
Andre navne:
|
|
Eksperimentel: 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.
Andre navne:
|
|
Eksperimentel: 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.
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Best Overall Response Rate (ORR)
Tidsramme: Up to 5 years
|
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
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Complete Response (CR) Rate
Tidsramme: Up to 5 years
|
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
|
|
Duration of Response (DOR)
Tidsramme: Up to 5 years
|
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
|
|
Progression Free Survival (PFS)
Tidsramme: Up to 5 years
|
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
|
|
Overall Survival (OS)
Tidsramme: Up to 5 years
|
OS is defined as the time from date of randomization to date of death from any cause. |
Up to 5 years
|
|
Cohorts 1a and 1b: Minimal Residual Disease (MRD) Negative Rate
Tidsramme: Up to 5 years
|
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
|
|
Number of Participants with Adverse Events (AEs)
Tidsramme: Up to 5 years
|
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
|
|
Number of Participants with AEs by Severity
Tidsramme: 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
|
|
Percentage of Participants with Rate of Discontinuation due to AEs
Tidsramme: Up to 5 years
|
Percentage of participants with rate of discontinuation due to AEs will be reported. |
Up to 5 years
|
|
Percentage of Participants with Dose Reduction due AEs
Tidsramme: Up to 5 years
|
Percentage of participants with dose reduction due AEs will be reported. |
Up to 5 years
|
|
Adherence Rates
Tidsramme: Up to 5 years
|
The adherence rate is defined as the percentage of total dose taken over the total dose prescribed. |
Up to 5 years
|
|
Duration of Treatment
Tidsramme: Up to 5 years
|
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
|
|
Time to Worsening as Measured by EuroQol 5 Dimension 5 Level Questionnaire (EQ-5D-5L)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
|
Samarbejdspartnere og efterforskere
Samarbejdspartnere
Efterforskere
- Studieleder: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Patologiske processer
- Neoplasmer
- Kronisk sygdom
- Sygdomsegenskaber
- Sygdomme i immunsystemet
- Neoplasmer efter histologisk type
- Hæmatologiske sygdomme
- Lymfesygdomme
- Lymfoproliferative lidelser
- Immunproliferative lidelser
- Leukæmi, B-celle
- Leukæmi, lymfoid
- Leukæmi
- Patologiske tilstande, tegn og symptomer
- Hemiske og lymfatiske sygdomme
- Leukæmi, lymfatisk, kronisk, B-celle
- Venetoclax
- Ibrutinib
Andre undersøgelses-id-numre
- 54179060CLL2032
- 54179060CLL2032 (Anden identifikator: Janssen Research & Development, LLC)
- 2023-504044-34-00 (Registry Identifier: EUCT number)
- 2023 (U.S. NIH-bevilling/kontrakt)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
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
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .