A Study to Evaluate Ibrutinib Retention in Chronic Lymphocytic Leukemia Participants Treated in a Real World Setting
EVIdeNCE
EValuate Ibrutinib Retention iN Chronic Lymphocytic Leukemia Patients Treated in a rEal World Setting - EVIdeNCE
2 other identifiers
observational
312
1 country
39
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2018
Typical duration for all trials
39 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 24, 2018
CompletedFirst Posted
Study publicly available on registry
October 25, 2018
CompletedStudy Start
First participant enrolled
October 30, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 12, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
November 12, 2021
CompletedJanuary 3, 2022
December 1, 2021
3 years
October 24, 2018
December 30, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Retention Rate of Ibrutinib
The retention rate is defined as the ratio of the number of participants taking ibrutinib over the number of participants at risk. The retention rate of ibrutinib treatment for (Chronic lymphocytic leukemia) CLL in Italian routine clinical practice will be measured.
Approximately up to 2 years
Secondary Outcomes (20)
Number of Participants Requiring Dose Modifications
Approximately up to 2 years
Overall Response Rate (ORR)
Approximately up to 2 years
Time to Best Response
Approximately up to 2 years
Time to Treatment Discontinuation(TTD)
Approximately up to 2 years
Time to Next Therapy (TTNT)
Approximately up to 2 years
- +15 more secondary outcomes
Study Arms (1)
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.
Interventions
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
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.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (39)
Ospedali Riuniti Di Ancona
Ancona, 60126, Italy
U.O.C. Ematologia e Terapia Cellulare Ospedale C e G Mazzoni
Ascoli Piceno, 63100, Italy
U.O. Ematologia con Trapianto- AOU Policlinico di Bari
Bari, 70124, Italy
U.O. Ematologia Istituto Tumori Giovanni Paolo II
Bari, 70124, Italy
S.C. Ematologia e CTMO P.O. Businco A.O. Brotzu
Cagliari, 09121, Italy
AORN Sant'anna e San Sebastiano
Caserta, 81100, Italy
Div.Clinicizzata EmatologiaconTrapiantodi MidolloOsseo P.O.Rodoligo AOUPoliclinico-Vittorio Emanuele
Catania, 95124, Italy
S.O.C. Ematologia P.O. Ciaccio A.O. Pugliese-Ciaccio
Catanzaro, 88100, Italy
Azienda Ospedaliero Universitaria di Ferrara
Cona, 44124, Italy
S.C. Ematologia Azienda Ospedaliera S. Croce e Carle
Cuneo, 12100, Italy
Unità Funzionale di Ematologia Azienda ospedaliero-universitaria Careggi
Florence, 50134, Italy
S.C. Ematologia A.O.U. Ospedali Riuniti
Foggia, 71100, Italy
Ematologia Ospedale San Martino
Genova, 16132, Italy
U.O.C. Ematologia Ospedale V. Fazzi
Lecce, 73100, Italy
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
Meldola, 47014, Italy
U.O.C. Ematologia Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milan, 20122, Italy
Programma di ricerca strategica sulla LLC Ospedale San Raffaele
Milan, 20132, Italy
Divisione ematologia Grande Ospedale Metropolitano Niguarda
Milan, 20133, Italy
Division of Hematology, Cardarelli Hospital
Napoli, 80131, Italy
U.O.C. Ematologia e Trapianti di midollo A.O.U. Federico II
Napoli, 80131, Italy
Ospedale San Francesco
Nuoro, 08100, Italy
U.O.C. Ematologia e Immunologia Clinica Azienda Ospedaliera Padova
Padua, 35128, Italy
U.O. Ematologia ed Oncologia Ospedale A. Tortora
Pagani, 84016, Italy
Ospedale 'Villa Sofia-Cervello
Palermo, 90146, Italy
Fondazione IRCCS Policlinico San Matteo
Pavia, 27100, Italy
S.C. Ematologia A.O.U. Santa Maria della Misericordia
Perugia, 06132, Italy
UOSD Centro diagnosi e terapia dei linfomi Ospedale Santo Spirito
Pescara, 65124, Italy
U.O.C. Ematologia Ospedale S. Maria delle Croci
Ravenna, 48121, Italy
Arcispedale Santa Maria Nuova - IRCCS
Reggio Emilia, 42123, Italy
DH Oncoematologia Policlinico Tor Vergata
Roma, 00133, Italy
Università di Roma 'La Sapienza' - Ospedale Umberto 1°
Roma, 00161, Italy
Ematologia Fondazione Univ. Policlinico Gemelli Università Cattolica del Sacro Cuore
Roma, 00168, Italy
Azienda Ospedaliera Sant Andrea
Roma, 189, Italy
UO Oncologia ed Ematologia Istituto Clinico Humanitas
Rozzano, 20089, Italy
U.O.C. Ematologia e Trapianti Cellule Staminali Emopoietiche AOU S.Giovanni di Dio e Ruggi D'Aragona
Salerno, 84131, Italy
Ospedale 'Casa Sollievo della Sofferenza' - U.O. Ematologia-
San Giovanni Rotondo, 71013, Italy
Azienda Ospedaliera 'Santa Maria'
Terni, Italy
S.C. Ematologia U A.O.U. Citta della Salute e della Scienza P.O.Molinette
Torino, 10126, Italy
U.O. Ematologia Ospedale San Bortolo
Vicenza, 36100, Italy
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Janssen-Cilag S.p.A., Italy Clinical Trial
Janssen-Cilag S.p.A.
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 24, 2018
First Posted
October 25, 2018
Study Start
October 30, 2018
Primary Completion
November 12, 2021
Study Completion
November 12, 2021
Last Updated
January 3, 2022
Record last verified: 2021-12