A Study of Clinical Outcomes in Chronic Lymphocytic Leukemia (CLL) Patients Treated With Venetoclax in Greece
- Conditions
- Chronic Lymphocytic Leukemia
- Registration Number
- NCT04159779
- Lead Sponsor
- AbbVie
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 180
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Overall Response Rate (ORR) At Month 12 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).
- Secondary Outcome Measures
Name Time Method Complete Response (CR) Up to Month 36 Defined by the International Workshop on Chronic Lymphocytic Leukemia (iwCLL) Guidelines.
Time to Progression (TTP) Up to Month 36 Defined as the period from first venetoclax intake until objective disease progression (until disease progression or death due to progression, whichever occurs first).
Overall Response Rate (ORR) Up to Month 36 Defined by the International Workshop on Chronic Lymphocytic Leukemia (iwCLL) Guidelines.
Nodule Partial Response (nPR) Rate Up to Month 36 Defined by the International Workshop on Chronic Lymphocytic Leukemia (iwCLL) Guidelines.
Number of Lines of Prior Therapy in Participants with Relapse/Refractory Chronic Lymphocytic Leukemia Up to Month 36 Number of lines of prior therapy per participant, in participants with Relapse/Refractory Chronic Lymphocytic Leukemia.
Treatment Duration Up to Month 36 Overall treatment duration of venetoclax.
Change in Patient Reported Outcomes From Baseline (Week 0) Up to Month 36 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.
Percentage of Participants with Undetectable Minimal Residual Disease (uMRD) Up to Month 36 Determined by assessment of peripheral blood or bone marrow after treatment.
Percentage of Participants with Dose Modifications Up to Month 36 Dose modifications include interruptions during ramp-up and maintenance phase.
Complete Response with Incomplete Bone Marrow Recovery (CRi) Rate Up to Month 36 Defined by the International Workshop on Chronic Lymphocytic Leukemia (iwCLL) Guidelines.
Partial Response (PR) Rate Up to Month 36 Defined by the International Workshop on Chronic Lymphocytic Leukemia (iwCLL).
Percentage of Participants With Disease Progression or Death Up to Month 36 Disease progression as Assessed by the Investigator using International Workshop on Chronic Lymphocytic Leukemia (iwCLL) Guidelines.
Progression Free Survival (PFS) Up to Month 36 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).
Overall Survival (OS) Up to Month 36 Defined as the time from first venetoclax intake to death from any cause.
Percentage of Participants with Adverse Drug Reactions (ADR) Up to Month 36 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.
Trial Locations
- Locations (21)
University Gen Hosp of Patra /ID# 212914
🇬🇷Patras, Greece
General Hospital of Chania "Agios Georgios" /ID# 241685
🇬🇷Chania, Greece
Papageorgiou General Hospital /ID# 213710
🇬🇷Thessaloniki, Greece
Henry Dunnant Hospital Center /ID# 241682
🇬🇷Athens, Attiki, Greece
General Hospital of Athens Gennimatas /ID# 212917
🇬🇷Athens, Attiki, Greece
General Hospital of Athens Laiko /ID# 230222
🇬🇷Athens, Attiki, Greece
General Hospital of Patras Agios Andreas /ID# 213711
🇬🇷Patras, Greece
Metropolitan Hospital /ID# 241687
🇬🇷Piraeus, Attiki, Greece
General Hospital of Athens Evaggelismos and Ophthalmiatrio of Athens Polyclinic /ID# 212929
🇬🇷Athens, Greece
METAXA Cancer Hospital of Piraeus /ID# 212918
🇬🇷Piraeus, Greece
General Hospital of Thessaloniki George Papanikolaou /ID# 213709
🇬🇷Thessaloniki, Greece
General University Hospital of Alexandroupolis /ID# 212927
🇬🇷Alexandroupolis, Greece
Theageneio Anticancer Hospital /ID# 212933
🇬🇷Thessaloniki, Greece
General Hospital of Athens Laiko /ID# 212902
🇬🇷Athens, Attiki, Greece
University General Hospital Attikon /ID# 212915
🇬🇷Athens, Attiki, Greece
Metropolitan General /ID# 212934
🇬🇷Cholargos, Attiki, Greece
Iatriko Kentro Athinon /ID# 241689
🇬🇷Maroussi, Attiki, Greece
Iatriko Kentro Athinon /ID# 241690
🇬🇷Maroussi, Attiki, Greece
University General Hospital of Ioannina /ID# 212936
🇬🇷Ioannina, Greece
University General Hospital of Heraklion PA.G.N.I /ID# 212916
🇬🇷Heraklion, Kriti, Greece
Reg Gen Univ Hosp Larissa /ID# 213708
🇬🇷Larisa, Greece