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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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

Other trials in Italy

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.

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 groups in NCT03720561
Study groupRoleWhat they receive
Group: Ibrutinib TreatmentParticipants 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.

  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.

    Measured: Approximately up to 2 years

Secondary outcomes (20)
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. Change from Baseline in Immunoglobulin levels

    Changes in the immunoglobulin levels from baseline will be reported.

    Measured: Baseline up to 2 years

  11. 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

  12. 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

  13. 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

  14. 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

  15. 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

  16. 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

  17. 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

  18. 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

  19. 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

  20. 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.

  1. First posted25 Oct 2018
  2. Study start30 Oct 2018
  3. Primary completion12 Nov 2021
  4. Study completion12 Nov 2021

Resources

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)
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

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.

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