A Study to Evaluate Ibrutinib Retention in Chronic Lymphocytic Leukemia Participants Treated in a Real World Setting

N/ACompletedNCT03720561

Janssen-Cilag S.p.A.312 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

312

Conditions

Leukemia, Lymphocytic, Chronic, B-Cell

Interventions

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (39)

Outcomes

Primary Outcomes

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.

Time frame: Approximately up to 2 years

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: Approximately up to 2 years

Data from ClinicalTrials.gov

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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

...and 29 more locations

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.

Time frame: 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.

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)

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.

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

Number of participants with change in hematologic parameters (complete blood count, hemoglobin, leukocyte count, lymphocyte count, neutrophil count, platelet count) will be determined.

Time frame: 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.

Time frame: Approximately up to 2 years

Change from Baseline in Immunoglobulin levels

Changes in the immunoglobulin levels from baseline will be reported.

Time frame: 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.

Time frame: 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.

Time frame: 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.

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)

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).

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

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.

Time frame: 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.

Time frame: 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).

Time frame: 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.

Time frame: Approximately up to 2 years

Number of Participants Requiring Blood and Platelets Transfusions

Number of participants requiring blood and platelets transfusions will be reported.

Time frame: 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.

Time frame: Approximately up to 2 years