A Study to Evaluate Ibrutinib Retention in Chronic Lymphocytic Leukemia Participants Treated in a Real World Setting
NCT ID: NCT03720561
Last Updated: 2022-01-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
312 participants
OBSERVATIONAL
2018-10-30
2021-11-12
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Group: Ibrutinib Treatment
Participants will not receive any intervention as a part of this study. This study will collect retrospective and prospective real-world data to describe retention rates for participants of chronic lymphocytic leukemia (CLL) receiving ibrutinib in routine Italian clinical practice over a 2-year follow-up period. Participants with CLL who have started ibrutinib treatment within 3 months before enrollment visit or in case ibrutinib was prescribed before or on the enrollment day as per routine clinical practice within the 30 days after enrollment visit will be included in the study. The primary data source for this observational study will be the medical records of each enrolled participant, as well as questionnaires concerning quality of life and treatment adherence. Data will be collected every 3 months for the first year and every 6 months for the second year during prospective period.
Ibrutinib
Participants in this observational study with confirmed diagnosis of CLL receiving ibrutinib in routine clinical practice settings will be observed approximately for 3 years.
Interventions
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Ibrutinib
Participants in this observational study with confirmed diagnosis of CLL receiving ibrutinib in routine clinical practice settings will be observed approximately for 3 years.
Eligibility Criteria
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Inclusion Criteria
* If alive, must sign an Informed Consent Form (ICF) allowing data collection and source data verification in accordance with Italian requirements
* Participants with one of the following characteristics: a) Participants starting ibrutinib treatment according to the summary of product characteristics (SmPC) at enrolment or within 30 days starting from informed consent signature, as per routine clinical practice and independently of this non-interventional study; OR b) Participants who have started ibrutinib within 3 months before enrollment, according to the SmPC, as per routine clinical practice and independently of this non- interventional study (including also participants who, by the time of enrollment, are not receiving ibrutinib)
* If alive, must be able to read and write in Italian and to understand and sign the ICF
Exclusion Criteria
* Currently enrolled in observational studies sponsored or managed by Janssen company
* Treated with any investigational compound or any invasive investigational medical device within 30 days before start of ibrutinib treatment
* Having contraindications to ibrutinib use as described in the SmPC
* Pregnant or breast-feeding
18 Years
ALL
No
Sponsors
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Janssen-Cilag S.p.A.
INDUSTRY
Responsible Party
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Principal Investigators
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Janssen-Cilag S.p.A., Italy Clinical Trial
Role: STUDY_DIRECTOR
Janssen-Cilag S.p.A.
Locations
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Ospedali Riuniti Di Ancona
Ancona, , Italy
U.O.C. Ematologia e Terapia Cellulare Ospedale C e G Mazzoni
Ascoli Piceno, , Italy
U.O. Ematologia con Trapianto- AOU Policlinico di Bari
Bari, , Italy
U.O. Ematologia Istituto Tumori Giovanni Paolo II
Bari, , Italy
S.C. Ematologia e CTMO P.O. Businco A.O. Brotzu
Cagliari, , Italy
AORN Sant'anna e San Sebastiano
Caserta, , Italy
Div.Clinicizzata EmatologiaconTrapiantodi MidolloOsseo P.O.Rodoligo AOUPoliclinico-Vittorio Emanuele
Catania, , Italy
S.O.C. Ematologia P.O. Ciaccio A.O. Pugliese-Ciaccio
Catanzaro, , Italy
Azienda Ospedaliero Universitaria di Ferrara
Cona, , Italy
S.C. Ematologia Azienda Ospedaliera S. Croce e Carle
Cuneo, , Italy
Unità Funzionale di Ematologia Azienda ospedaliero-universitaria Careggi
Florence, , Italy
S.C. Ematologia A.O.U. Ospedali Riuniti
Foggia, , Italy
Ematologia Ospedale San Martino
Genova, , Italy
U.O.C. Ematologia Ospedale V. Fazzi
Lecce, , Italy
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
Meldola, , Italy
U.O.C. Ematologia Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milan, , Italy
Programma di ricerca strategica sulla LLC Ospedale San Raffaele
Milan, , Italy
Divisione ematologia Grande Ospedale Metropolitano Niguarda
Milan, , Italy
Division of Hematology, Cardarelli Hospital
Napoli, , Italy
U.O.C. Ematologia e Trapianti di midollo A.O.U. Federico II
Napoli, , Italy
Ospedale San Francesco
Nuoro, , Italy
U.O.C. Ematologia e Immunologia Clinica Azienda Ospedaliera Padova
Padua, , Italy
U.O. Ematologia ed Oncologia Ospedale A. Tortora
Pagani, , Italy
Ospedale 'Villa Sofia-Cervello
Palermo, , Italy
Fondazione IRCCS Policlinico San Matteo
Pavia, , Italy
S.C. Ematologia A.O.U. Santa Maria della Misericordia
Perugia, , Italy
UOSD Centro diagnosi e terapia dei linfomi Ospedale Santo Spirito
Pescara, , Italy
U.O.C. Ematologia Ospedale S. Maria delle Croci
Ravenna, , Italy
Arcispedale Santa Maria Nuova - IRCCS
Reggio Emilia, , Italy
DH Oncoematologia Policlinico Tor Vergata
Roma, , Italy
Università di Roma 'La Sapienza' - Ospedale Umberto 1°
Roma, , Italy
Ematologia Fondazione Univ. Policlinico Gemelli Università Cattolica del Sacro Cuore
Roma, , Italy
Azienda Ospedaliera Sant Andrea
Roma, , Italy
UO Oncologia ed Ematologia Istituto Clinico Humanitas
Rozzano, , Italy
U.O.C. Ematologia e Trapianti Cellule Staminali Emopoietiche AOU S.Giovanni di Dio e Ruggi D'Aragona
Salerno, , Italy
Ospedale 'Casa Sollievo della Sofferenza' - U.O. Ematologia-
San Giovanni Rotondo, , Italy
Azienda Ospedaliera 'Santa Maria'
Terni, , Italy
S.C. Ematologia U A.O.U. Citta della Salute e della Scienza P.O.Molinette
Torino, , Italy
U.O. Ematologia Ospedale San Bortolo
Vicenza, , Italy
Countries
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Other Identifiers
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54179060CLL4013
Identifier Type: OTHER
Identifier Source: secondary_id
CR108517
Identifier Type: -
Identifier Source: org_study_id
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