Clinical trial NCT03720561: A Study to Evaluate Ibrutinib Retention in Chronic Lymphocytic Leukemia Participants Treated in a Real World Setting
Official title: EValuate Ibrutinib Retention iN Chronic Lymphocytic Leukemia Patients Treated in a rEal World Setting - EVIdeNCE
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Leukemia, Lymphocytic, Chronic, B-Cell
Lead sponsor: Janssen-Cilag S.p.A.
Sponsor class: INDUSTRY
First posted: 2018-10-25
Enrollment: 312
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study includes participants who already started ibrutinib treatment within 3 months before enrollment visit or was prescribed ibrutinib before or on the enrollment day as per routine clinical practice - within the 30 days after enrollment visit. Along with alive participants, also deceased or untraceable participants who are eligible based on the selection criteria, their data will be collected for the evaluation of primary objective of the study.

Brief summary: The purpose of this study is to describe the 2-year retention rate of ibrutinib treatment for chronic lymphocytic leukemia (CLL) in Italian routine clinical practice.


Eligibility criteria: Inclusion Criteria:

* Must have a confirmed diagnosis of Chronic Lymphocytic Leukemia (CLL) requiring treatment (iwCLL \[International Workshop on Chronic Lymphocytic Leukemia\] 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 any interventional clinical trial
* 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

Primary outcomes:
measure: Retention Rate of Ibrutinib
timeFrame: Approximately up to 2 years
Secondary outcomes:
measure: Number of Participants Requiring Dose Modifications
timeFrame: Approximately up to 2 years
measure: Overall Response Rate (ORR)
timeFrame: Approximately up to 2 years
measure: Time to Best Response
timeFrame: Approximately up to 2 years
measure: Time to Treatment Discontinuation(TTD)
timeFrame: Approximately up to 2 years
measure: Time to Next Therapy (TTNT)
timeFrame: Approximately up to 2 years
measure: Progression Free Survival (PFS)
timeFrame: From the date of assignment until the date of first documented progression or date of death from any cause, whichever comes first, assessed up to 2 years
measure: Overall Survival (OS)
timeFrame: From the date of assignment until the date of death from any cause, whichever comes first, assessed up to 2 years
measure: Number of Participants with Clinically Significant Change in Hematologic Parameters
timeFrame: Approximately up to 2 years
measure: Number of Participants with Clinically Significant Change in Biochemistry Parameters
timeFrame: Approximately up to 2 years
measure: Change from Baseline in Immunoglobulin levels
timeFrame: Baseline up to 2 years
measure: Number of Participants with at least one Clinical Significant Characteristics
timeFrame: Approximately 2 years
measure: Number of Participants with Each Grade of Eastern Cooperative Oncology Group (ECOG) Performance Status Score
timeFrame: Approximately up to 2 years
measure: Percentage of Participants with Adverse Events (AEs), Serious Adverse Events (SAEs) and Special Situations
timeFrame: Approximately up to 2 years
measure: Health-Related Quality of Life as Measured by European Quality of Life-5 Dimensions; 5 Levels Questionnaire (EQ-5D-5L)
timeFrame: Approximately up to 2 years
measure: Health-Related Quality of Life as Measured by European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life Questionnaire (QLQ-C30) Scores
timeFrame: Approximately up to 2 years
measure: Medical Resource Utilization
timeFrame: Approximately up to 2 years
measure: Duration of Hospitalization
timeFrame: Approximately up to 2 years
measure: Duration of Medical Care Encounters
timeFrame: Approximately up to 2 years
measure: Number of Participants Requiring Blood and Platelets Transfusions
timeFrame: Approximately up to 2 years
measure: Number of Participants Requiring Erythropoietin and Growth Factor Administrations
timeFrame: Approximately up to 2 years
Other outcomes:
Locations:
city: Ancona
country: Italy
facility: Ospedali Riuniti Di Ancona
city: Ascoli Piceno
country: Italy
facility: U.O.C. Ematologia e Terapia Cellulare Ospedale C e G Mazzoni
city: Bari
country: Italy
facility: U.O. Ematologia con Trapianto- AOU Policlinico di Bari
city: Bari
country: Italy
facility: U.O. Ematologia Istituto Tumori Giovanni Paolo II
city: Cagliari
country: Italy
facility: S.C. Ematologia e CTMO P.O. Businco A.O. Brotzu
city: Caserta
country: Italy
facility: AORN Sant'anna e San Sebastiano
city: Catania
country: Italy
facility: Div.Clinicizzata EmatologiaconTrapiantodi MidolloOsseo P.O.Rodoligo AOUPoliclinico-Vittorio Emanuele
city: Catanzaro
country: Italy
facility: S.O.C. Ematologia P.O. Ciaccio A.O. Pugliese-Ciaccio
city: Cona
country: Italy
facility: Azienda Ospedaliero Universitaria di Ferrara
city: Cuneo
country: Italy
facility: S.C. Ematologia Azienda Ospedaliera S. Croce e Carle
city: Firenze
country: Italy
facility: Unità Funzionale di Ematologia Azienda ospedaliero-universitaria Careggi
city: Foggia
country: Italy
facility: S.C. Ematologia A.O.U. Ospedali Riuniti
city: Genova
country: Italy
facility: Ematologia Ospedale San Martino
city: Lecce
country: Italy
facility: U.O.C. Ematologia Ospedale V. Fazzi
city: Meldola
country: Italy
facility: Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
city: Milano
country: Italy
facility: U.O.C. Ematologia Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
city: Milano
country: Italy
facility: Programma di ricerca strategica sulla LLC Ospedale San Raffaele
city: Milano
country: Italy
facility: Divisione ematologia Grande Ospedale Metropolitano Niguarda
city: Napoli
country: Italy
facility: Division of Hematology, Cardarelli Hospital
city: Napoli
country: Italy
facility: U.O.C. Ematologia e Trapianti di midollo A.O.U. Federico II
city: Nuoro
country: Italy
facility: Ospedale San Francesco
city: Padova
country: Italy
facility: U.O.C. Ematologia e Immunologia Clinica Azienda Ospedaliera Padova
city: Pagani
country: Italy
facility: U.O. Ematologia ed Oncologia Ospedale A. Tortora
city: Palermo
country: Italy
facility: Ospedale 'Villa Sofia-Cervello
city: Pavia
country: Italy
facility: Fondazione IRCCS Policlinico San Matteo
city: Perugia
country: Italy
facility: S.C. Ematologia A.O.U. Santa Maria della Misericordia
city: Pescara
country: Italy
facility: UOSD Centro diagnosi e terapia dei linfomi Ospedale Santo Spirito
city: Ravenna
country: Italy
facility: U.O.C. Ematologia Ospedale S. Maria delle Croci
city: Reggio Emilia
country: Italy
facility: Arcispedale Santa Maria Nuova - IRCCS
city: Roma
country: Italy
facility: DH Oncoematologia Policlinico Tor Vergata
city: Roma
country: Italy
facility: Università di Roma 'La Sapienza' - Ospedale Umberto 1°
city: Roma
country: Italy
facility: Ematologia Fondazione Univ. Policlinico Gemelli Università Cattolica del Sacro Cuore
city: Roma
country: Italy
facility: Azienda Ospedaliera Sant Andrea
city: Rozzano
country: Italy
facility: UO Oncologia ed Ematologia Istituto Clinico Humanitas
city: Salerno
country: Italy
facility: U.O.C. Ematologia e Trapianti Cellule Staminali Emopoietiche AOU S.Giovanni di Dio e Ruggi D'Aragona
city: San Giovanni Rotondo
country: Italy
facility: Ospedale 'Casa Sollievo della Sofferenza' - U.O. Ematologia-
city: Terni
country: Italy
facility: Azienda Ospedaliera 'Santa Maria'
city: Torino
country: Italy
facility: S.C. Ematologia U A.O.U. Citta della Salute e della Scienza P.O.Molinette
city: Vicenza
country: Italy
facility: U.O. Ematologia Ospedale San Bortolo
Study officials:
affiliation: Janssen-Cilag S.p.A.
name: Janssen-Cilag S.p.A., Italy Clinical Trial
role: STUDY_DIRECTOR
References: