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Chronic Lymphocytic LeukemiaNCT04159779

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

An observational study of Chronic Lymphocytic Leukemia, run by AbbVie at 21 sites in Greece.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Chronic Lymphocytic Leukemia
How many people
180 participants
Where
21 sitesGreece
Study dates
13 Jan 2020to 30 Jun 2026
Phase
Observational
Are there results?
Not yet: the study is under way

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 will enroll adult participants (age >=18) with confirmed diagnosis of Relapse/Refractory Chronic Lymphocytic Leukemia being treated with venetoclax in Greece as part of routine standard of care.

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

21 sites in 1 country.

21 sites in 1 country

Greece21 sites

  • General University Hospital of Alexandroupolis /ID# 212927

    Alexandroupoli, 68100

  • Henry Dunnant Hospital Center /ID# 241682

    Athens, Attica, 11526

  • General Hospital of Athens Gennimatas /ID# 212917

    Athens, Attica, 11527

  • General Hospital of Athens Laiko /ID# 212902

    Athens, Attica, 11527

  • General Hospital of Athens Laiko /ID# 230222

    Athens, Attica, 11527

  • University General Hospital Attikon /ID# 212915

    Athens, Attica, 12462

  • General Hospital of Athens Evaggelismos and Ophthalmiatrio of Athens Polyclinic /ID# 212929

    Athens, 10676

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

    Chania, Chania, 73300

  • Metropolitan General /ID# 212934

    Cholargós, Attica, 15562

  • University General Hospital of Heraklion PA.G.N.I /ID# 212916

    Heraklion, Crete, 71500

  • University General Hospital of Ioannina /ID# 212936

    Ioannina, Ioannina, 45500

  • Reg Gen Univ Hosp Larissa /ID# 213708

    Larissa, Larisa, 41110

  • Iatriko Kentro Athinon /ID# 241689

    Marousi, Attica, 15125

  • Iatriko Kentro Athinon /ID# 241690

    Marousi, Attica, 15125

  • General Hospital of Patras Agios Andreas /ID# 213711

    Pátrai, 26335

  • University Gen Hosp of Patra /ID# 212914

    Pátrai, 26504

  • Metropolitan Hospital /ID# 241687

    Piraeus, Attica, 18547

  • METAXA Cancer Hospital of Piraeus /ID# 212918

    Piraeus, 18737

  • Theageneio Anticancer Hospital /ID# 212933

    Thessaloniki, Thessaloniki, 54639

  • General Hospital of Thessaloniki George Papanikolaou /ID# 213709

    Thessaloniki, Thessaloniki, 57010

  • Papageorgiou General Hospital /ID# 213710

    Thessaloniki, 56429

Other trials in Greece

About this study

Official title: Clinical Outcomes of Chronic Lymphocytic Leukemia (CLL) Patients Treated With Venetoclax in Routine Clinical Settings in Greece

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.

Keywords
Chronic Lymphocytic Leukemia Venetoclax Relapsed/Refractory
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.

Study groups in NCT04159779
Study groupRoleWhat they receive
Venetoclax ParticipantsParticipants for whom the treating physician has decided to treat with venetoclax before enrollment in this study.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: At Month 12

Secondary outcomes (15)

  1. Overall Response Rate (ORR)

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

    Measured: Up to Month 36

  2. Complete Response (CR)

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

    Measured: Up to Month 36

  3. Complete Response with Incomplete Bone Marrow Recovery (CRi) Rate

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

    Measured: Up to Month 36

  4. Nodule Partial Response (nPR) Rate

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

    Measured: Up to Month 36

  5. Partial Response (PR) Rate

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

    Measured: Up to Month 36

  6. Percentage of Participants With Disease Progression or Death

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

    Measured: Up to Month 36

  7. 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).

    Measured: Up to Month 36

  8. Overall Survival (OS)

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

    Measured: Up to Month 36

  9. Treatment Duration

    Overall treatment duration of venetoclax.

    Measured: Up to Month 36

  10. 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).

    Measured: Up to Month 36

  11. 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.

    Measured: From Baseline (Week 0) Up to Month 36

  12. Percentage of Participants with Undetectable Minimal Residual Disease (uMRD)

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

    Measured: Up to Month 36

  13. Percentage of Participants with Dose Modifications

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

    Measured: Up to Month 36

  14. 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.

    Measured: Up to Month 36

  15. 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.

    Measured: Up to Month 36

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Nov 2019
  2. Study start13 Jan 2020
  3. Primary completion30 Jun 2026 (estimated)
  4. Study completion30 Jun 2026 (estimated)

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
180 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04159779
Sponsor's protocol ID
P19-568
Status last verified
Jul 2025
First submitted
8 Nov 2019
Last updated
17 Jul 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Chronic Lymphocytic Leukemia, run by AbbVie at 21 sites in Greece.

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 2 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: under way, not looking for participants, as of the sponsor's last update on 17 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 21 sites in Greece. 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?

This study is still under way. Results are not available in the source record yet.

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?

Overall Response Rate (ORR) (time frame: At Month 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04159779.

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 17 Jul 2025.

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