A Study of Clinical Outcomes in Chronic Lymphocytic Leukemia (CLL) Patients Treated With Venetoclax in Greece

N/AActive Not RecruitingNCT04159779

AbbVie180 enrolled

Overview

This study is being done to evaluate the clinical outcomes of Chronic Lymphocytic Leukemia (CLL) participants treated with venetoclax as routine standard of care in Greece. The decision to treat with venetoclax is made by the participant's physician prior to being offered enrollment in this study. The objectives of this study include determining overall response rate, assessing safety information, analyzing patient profiles and disease characteristics and participant quality of life.

Study Type

OBSERVATIONAL

Enrollment

180

Conditions

Chronic Lymphocytic Leukemia

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Confirmed diagnosis of Chronic Lymphocytic Leukemia (CLL) according to the International Workshop on Chronic Lymphocytic Leukemia (iwCLL) criteria * Eligible to receive venetoclax as per local label * Physician has decided to initiate CLL treatment with venetoclax and the decision to treat is made by the physician in accordance with the local label prior to any decision to approach the participant about the study * Participant has been fully informed verbally and in writing about the study and does not object to their data being processed or subjected to data quality control Exclusion Criteria: * Prescribed or treated with venetoclax outside of marketing authorization * Currently participating in, or previously participated within 30 days prior to venetoclax start, in any other interventional clinical trial

Locations (21)

Henry Dunnant Hospital Center /ID# 241682

Athens, Attica, Greece

Outcomes

Primary Outcomes

Overall Response Rate (ORR)

Defined by the International Workshop on Chronic Lymphocytic Leukemia (iwCLL) Guidelines and includes partial response (PR), nodular partial response (nPR), complete response with incomplete bone marrow recovery (CRi), and complete response (CR).

Time frame: At Month 12

Secondary Outcomes

Overall Response Rate (ORR)

Defined by the International Workshop on Chronic Lymphocytic Leukemia (iwCLL) Guidelines.

Time frame: Up to Month 36

Complete Response (CR)

Defined by the International Workshop on Chronic Lymphocytic Leukemia (iwCLL) Guidelines.

Time frame: Up to Month 36

Complete Response with Incomplete Bone Marrow Recovery (CRi) Rate

Defined by the International Workshop on Chronic Lymphocytic Leukemia (iwCLL) Guidelines.

Time frame: Up to Month 36

Nodule Partial Response (nPR) Rate

Defined by the International Workshop on Chronic Lymphocytic Leukemia (iwCLL) Guidelines.

Time frame: Up to Month 36

Partial Response (PR) Rate

Defined by the International Workshop on Chronic Lymphocytic Leukemia (iwCLL).

Time frame: Up to Month 36

Percentage of Participants With Disease Progression or Death

Disease progression as Assessed by the Investigator using International Workshop on Chronic Lymphocytic Leukemia (iwCLL) Guidelines.

Time frame: Up to Month 36

Data from ClinicalTrials.gov

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General Hospital of Athens Gennimatas /ID# 212917

Athens, Attica, Greece

General Hospital of Athens Laiko /ID# 212902

Athens, Attica, Greece

General Hospital of Athens Laiko /ID# 230222

Athens, Attica, Greece

University General Hospital Attikon /ID# 212915

Athens, Attica, Greece

Metropolitan General /ID# 212934

Cholargós, Attica, Greece

Iatriko Kentro Athinon /ID# 241689

Marousi, Attica, Greece

Iatriko Kentro Athinon /ID# 241690

Marousi, Attica, Greece

Metropolitan Hospital /ID# 241687

Piraeus, Attica, Greece

General Hospital of Chania "Agios Georgios" /ID# 241685

Chania, Chania, Greece

...and 11 more locations

Progression Free Survival (PFS)

Defined as the time between the date of first venetoclax intake and the date of the first assessment documenting progression or death (from any cause).

Time frame: Up to Month 36

Overall Survival (OS)

Defined as the time from first venetoclax intake to death from any cause.

Time frame: Up to Month 36

Treatment Duration

Overall treatment duration of venetoclax.

Time frame: Up to Month 36

Time to Progression (TTP)

Defined as the period from first venetoclax intake until objective disease progression (until disease progression or death due to progression, whichever occurs first).

Time frame: Up to Month 36

Change in Patient Reported Outcomes

The 5-Level EuroQol Group Questionnaire (EQ-5D-5L) is a standardized instrument used to measure health-related quality of life that can be used in a wide range of health conditions and treatments.

Time frame: From Baseline (Week 0) Up to Month 36

Percentage of Participants with Undetectable Minimal Residual Disease (uMRD)

Determined by assessment of peripheral blood or bone marrow after treatment.

Time frame: Up to Month 36

Percentage of Participants with Dose Modifications

Dose modifications include interruptions during ramp-up and maintenance phase.

Time frame: Up to Month 36

Percentage of Participants with Adverse Drug Reactions (ADR)

ADR is defined as a response to a medicinal product that is noxious and unintended and that a causal relationship between a medicinal product and an adverse event is possible, probable or very likely as assessed by the investigator.

Time frame: Up to Month 36

Number of Lines of Prior Therapy in Participants with Relapse/Refractory Chronic Lymphocytic Leukemia

Number of lines of prior therapy per participant, in participants with Relapse/Refractory Chronic Lymphocytic Leukemia.

Time frame: Up to Month 36