Leukemia, Lymphocytic, Chronic, B-CellEVIdeNCENCT03720561
A Study to Evaluate Ibrutinib Retention in Chronic Lymphocytic Leukemia Participants Treated in a Real World Setting
An observational study of Leukemia, Lymphocytic, Chronic, B-Cell, run by Janssen-Cilag S.p.A. at 39 sites in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Leukemia, Lymphocytic, Chronic, B-Cell
- What is being tested?
- Ibrutinib
- How many people
- 312 participants
- Where
- 39 sitesItaly
- Study dates
- 30 Oct 2018to 12 Nov 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
39 sites in 1 country.
39 sites in 1 country
Italy39 sites
Ospedali Riuniti Di Ancona
Ancona, 60126
U.O.C. Ematologia e Terapia Cellulare Ospedale C e G Mazzoni
Ascoli Piceno, 63100
U.O. Ematologia con Trapianto- AOU Policlinico di Bari
Bari, 70124
U.O. Ematologia Istituto Tumori Giovanni Paolo II
Bari, 70124
S.C. Ematologia e CTMO P.O. Businco A.O. Brotzu
Cagliari, 09121
AORN Sant'anna e San Sebastiano
Caserta, 81100
Div.Clinicizzata EmatologiaconTrapiantodi MidolloOsseo P.O.Rodoligo AOUPoliclinico-Vittorio Emanuele
Catania, 95124
S.O.C. Ematologia P.O. Ciaccio A.O. Pugliese-Ciaccio
Catanzaro, 88100
Azienda Ospedaliero Universitaria di Ferrara
Cona, 44124
S.C. Ematologia Azienda Ospedaliera S. Croce e Carle
Cuneo, 12100
Unità Funzionale di Ematologia Azienda ospedaliero-universitaria Careggi
Florence, 50134
S.C. Ematologia A.O.U. Ospedali Riuniti
Foggia, 71100
Ematologia Ospedale San Martino
Genova, 16132
U.O.C. Ematologia Ospedale V. Fazzi
Lecce, 73100
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
Meldola, 47014
U.O.C. Ematologia Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milan, 20122
Programma di ricerca strategica sulla LLC Ospedale San Raffaele
Milan, 20132
Divisione ematologia Grande Ospedale Metropolitano Niguarda
Milan, 20133
Division of Hematology, Cardarelli Hospital
Naples, 80131
U.O.C. Ematologia e Trapianti di midollo A.O.U. Federico II
Naples, 80131
Ospedale San Francesco
Nuoro, 08100
U.O.C. Ematologia e Immunologia Clinica Azienda Ospedaliera Padova
Padova, 35128
U.O. Ematologia ed Oncologia Ospedale A. Tortora
Pagani, 84016
Ospedale 'Villa Sofia-Cervello
Palermo, 90146
Fondazione IRCCS Policlinico San Matteo
Pavia, 27100
S.C. Ematologia A.O.U. Santa Maria della Misericordia
Perugia, 06132
UOSD Centro diagnosi e terapia dei linfomi Ospedale Santo Spirito
Pescara, 65124
U.O.C. Ematologia Ospedale S. Maria delle Croci
Ravenna, 48121
Arcispedale Santa Maria Nuova - IRCCS
Reggio Emilia, 42123
DH Oncoematologia Policlinico Tor Vergata
Roma, 00133
Università di Roma 'La Sapienza' - Ospedale Umberto 1°
Roma, 00161
Ematologia Fondazione Univ. Policlinico Gemelli Università Cattolica del Sacro Cuore
Roma, 00168
Azienda Ospedaliera Sant Andrea
Roma, 189
UO Oncologia ed Ematologia Istituto Clinico Humanitas
Rozzano, 20089
U.O.C. Ematologia e Trapianti Cellule Staminali Emopoietiche AOU S.Giovanni di Dio e Ruggi D'Aragona
Salerno, 84131
Ospedale 'Casa Sollievo della Sofferenza' - U.O. Ematologia-
San Giovanni Rotondo, 71013
Azienda Ospedaliera 'Santa Maria'
Terni
S.C. Ematologia U A.O.U. Citta della Salute e della Scienza P.O.Molinette
Torino, 10126
U.O. Ematologia Ospedale San Bortolo
Vicenza, 36100
About this study
Official title: EValuate Ibrutinib Retention iN Chronic Lymphocytic Leukemia Patients Treated in a rEal World Setting - EVIdeNCE
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.
- Conditions
- Leukemia, Lymphocytic, Chronic, B-Cell
- Being tested
- Ibrutinib
- Medical subject headings
- Leukemia, Lymphocytic, Chronic, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IbrutinibDrug
Participants in this observational study with confirmed diagnosis of CLL receiving ibrutinib in routine clinical practice settings will be observed approximately for 3 years.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Ibrutinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Approximately up to 2 years
Secondary outcomes (20)
Number of Participants Requiring Dose Modifications
Number of CLL participants with at least one ibrutinib treatment dose modification (that is, increase/decrease) will be reported.
Measured: Approximately up to 2 years
Overall Response Rate (ORR)
The ORR will be calculated as the proportion of participants who achieve either complete response (CR), partial response (PR) or partial response with lymphocytosis, as assessed by the participating physician. The ORR in CLL participants as per International Workshop on Chronic Lymphocytic Leukemia (iwCLL) criteria is defined as normal circulating lymphocyte count during CR and decrease by greater than or equal to (>=) 50 percent (%) during PR.
Measured: Approximately up to 2 years
Time to Best Response
Time to best response is defined as the time from start of ibrutinib therapy until best objective response. Best response will be evaluated based on the following generally accepted algorithm: complete response greater than (>) partial response > partial response with lymphocytosis > stable disease > progressive disease.
Measured: Approximately up to 2 years
Time to Treatment Discontinuation(TTD)
Time to treatment discontinuation (TTD) will be calculated as the difference between ibrutinib initiation date and ibrutinib permanent discontinuation date.
Measured: Approximately up to 2 years
Time to Next Therapy (TTNT)
The TTNT will be calculated as the difference between ibrutinib initiation date and initiation date of the first next therapy for CLL.
Measured: Approximately up to 2 years
Progression Free Survival (PFS)
PFS is defined as the duration from date of ibrutinib initiation to date of disease progression (PD [according to the physician's evaluation]) or death from any cause. PD is defined as >= 50% increase in circulating lymphocyte count as per iwCLL criteria.
Measured: 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
Overall Survival (OS)
The OS in CLL participants will be measured and reported from start of ibrutinib therapy to the date of death (all-cause mortality); and from diagnosis to the date of death.
Measured: From the date of assignment until the date of death from any cause, whichever comes first, assessed up to 2 years
Number of Participants with Clinically Significant Change in Hematologic Parameters
Number of participants with change in hematologic parameters (complete blood count, hemoglobin, leukocyte count, lymphocyte count, neutrophil count, platelet count) will be determined.
Measured: Approximately up to 2 years
Number of Participants with Clinically Significant Change in Biochemistry Parameters
Number of participants with clinically significant change in biochemistry parameters (including lactate dehydrogenase [LDH] and creatinine clearance) will be determined.
Measured: Approximately up to 2 years
Change from Baseline in Immunoglobulin levels
Changes in the immunoglobulin levels from baseline will be reported.
Measured: Baseline up to 2 years
Number of Participants with at least one Clinical Significant Characteristics
Number of participants with at least one of the following conditions: lymphadenopathy, hepatosplenomegaly, bone marrow involvement, or B-symptoms as provided will be reported.
Measured: Approximately 2 years
Number of Participants with Each Grade of Eastern Cooperative Oncology Group (ECOG) Performance Status Score
ECOG performance status is a standard criterion for measuring how the disease impacts daily living abilities. It describes the level of functioning in terms of the ability to care for oneself, daily activity, and physical ability (walking, working, etc). ECOG performance status score ranges from Grade 0 to 5: 0) Fully active and performances without restriction, 1) Restricted in physically strenuous activity, 2) Ambulatory and capable of all self-care but unable to carry out any work activities, 3) Capable of only limited self-care and confined to bed or chair more than 50% of waking hours, 4) Completely disabled, and 5) Dead.
Measured: Approximately up to 2 years
Percentage of Participants with Adverse Events (AEs), Serious Adverse Events (SAEs) and Special Situations
An AE is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. An SAE is any AE that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life-threatening experience, is a congenital anomaly/birth defect and may jeopardize participant and/or may require medical or surgical intervention to prevent one of the outcomes listed above. Percentage of participants with AEs, all serious AEs, and all special situations (for example, medication error, overdosing, abuse, lack of effect, unexpected benefits following exposure to ibrutinib) will be reported.
Measured: Approximately up to 2 years
Health-Related Quality of Life as Measured by European Quality of Life-5 Dimensions; 5 Levels Questionnaire (EQ-5D-5L)
The EQ-5D questionnaire is a brief, generic health-related quality of life assessment (HRQOL) that can also be used to incorporate participant preferences into health economic evaluations. The EQ-5D-5L descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression and as overall health using a "thermometer" visual analog scale with response options ranging from 0 (worst imaginable health) to 100 (best imaginable health).
Measured: Approximately up to 2 years
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
EORTC QLQ-30 designed to measure cancer patients' physical, psychological and social functions. It is composed of multi-item scales (physical, role, social, emotional and cognitive functioning) and single items (pain, fatigue, financial impact, appetite loss, nausea/vomiting, diarrhea, constipation, sleep disturbance and quality of life); high scores on the global and functional scales but low scores on the symptom scales indicate good QOL. QLQ-C30 has four-point scales for the first five items. These are coded with the same response categories as items 6 to 28, namely "Not at all", "A little", "Quite a bit" and "Very much." For items 29 and 30, a seven-point scale (ranging from 1 = "Very Poor" to 7 = "Excellent") rates overall health and overall quality of life.
Measured: Approximately up to 2 years
Medical Resource Utilization
Number of medical care encounters and treatments (including physician or emergency room visits, tests and procedures, and medications, surgeries and other procedures [such as computerized tomography {CT}, x-ray]) will be reported.
Measured: Approximately up to 2 years
Duration of Hospitalization
Duration of hospitalization is defined as number of days from the day of admission to discharge (total days length of stay), including duration by wards (for example, intensive care unit).
Measured: Approximately up to 2 years
Duration of Medical Care Encounters
Duration of medical care encounters, including surgeries, and other selected procedures (inpatient and outpatient) will be reported.
Measured: Approximately up to 2 years
Number of Participants Requiring Blood and Platelets Transfusions
Number of participants requiring blood and platelets transfusions will be reported.
Measured: Approximately up to 2 years
Number of Participants Requiring Erythropoietin and Growth Factor Administrations
Number of participants requiring erythropoietin and growth factor administrations will be reported.
Measured: Approximately up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2018
- Study start30 Oct 2018
- Primary completion12 Nov 2021
- Study completion12 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Leukemia, Lymphocytic, Chronic, B-CellStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 312 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen-Cilag S.p.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen-Cilag S.p.A., Italy Clinical Trial, Study director, Janssen-Cilag S.p.A.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03720561
- Sponsor's protocol ID
- CR108517
- Other IDs
- 54179060CLL4013
- Acronym
- EVIdeNCE
- Status last verified
- Dec 2021
- First submitted
- 24 Oct 2018
- Last updated
- 3 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EValuate Ibrutinib Retention iN Chronic Lymphocytic Leukemia Patients Treated in a rEal World Setting - EVIdeNCE
- ClinicalTrials.gov ID
- NCT03720561
- Acronym / sponsor ID
- EVIdeNCE / CR108517
- Conditions
- Leukemia, Lymphocytic, Chronic, B-Cell
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 312 participants (actual)
- Lead sponsor
- Janssen-Cilag S.p.A.Industry (pharma, biotech, devices)
- Study start
- 30 Oct 2018 (actual)
- Primary completion
- 12 Nov 2021 (actual)
- Study completion
- 12 Nov 2021 (actual)
- First posted
- 25 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group: Ibrutinib Treatment | – | Drug: IbrutinibParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IbrutinibParticipants in this observational study with confirmed diagnosis of CLL receiving ibrutinib in routine clinical practice settings will be observed approximately for 3 years. | Drug | Group: Ibrutinib Treatment |
Primary outcome
Retention Rate of Ibrutinib
Time frame: Approximately up to 2 years
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.
20 secondary outcomes
Number of Participants Requiring Dose Modifications
Time frame: Approximately up to 2 years
Overall Response Rate (ORR)
Time frame: Approximately up to 2 years
Time to Best Response
Time frame: Approximately up to 2 years
Time to Treatment Discontinuation(TTD)
Time frame: Approximately up to 2 years
Time to Next Therapy (TTNT)
Time frame: Approximately up to 2 years
Progression Free Survival (PFS)
Time frame: 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
Overall Survival (OS)
Time frame: From the date of assignment until the date of death from any cause, whichever comes first, assessed up to 2 years
Number of Participants with Clinically Significant Change in Hematologic Parameters
Time frame: Approximately up to 2 years
Number of Participants with Clinically Significant Change in Biochemistry Parameters
Time frame: Approximately up to 2 years
Change from Baseline in Immunoglobulin levels
Time frame: Baseline up to 2 years
Number of Participants with at least one Clinical Significant Characteristics
Time frame: Approximately 2 years
Number of Participants with Each Grade of Eastern Cooperative Oncology Group (ECOG) Performance Status Score
Time frame: Approximately up to 2 years
Percentage of Participants with Adverse Events (AEs), Serious Adverse Events (SAEs) and Special Situations
Time frame: Approximately up to 2 years
Health-Related Quality of Life as Measured by European Quality of Life-5 Dimensions; 5 Levels Questionnaire (EQ-5D-5L)
Time frame: Approximately up to 2 years
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
Time frame: Approximately up to 2 years
Medical Resource Utilization
Time frame: Approximately up to 2 years
Duration of Hospitalization
Time frame: Approximately up to 2 years
Duration of Medical Care Encounters
Time frame: Approximately up to 2 years
Number of Participants Requiring Blood and Platelets Transfusions
Time frame: Approximately up to 2 years
Number of Participants Requiring Erythropoietin and Growth Factor Administrations
Time frame: Approximately up to 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janssen-Cilag S.p.A., Italy Clinical Trial study director
Janssen-Cilag S.p.A.
39 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Leukemia, Lymphocytic, Chronic, B-Cell, run by Janssen-Cilag S.p.A. at 39 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 39 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Retention Rate of Ibrutinib (time frame: Approximately up to 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2022.