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

November 10, 2023 updated by: AbbVie

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.

Study Overview

Status

Active, not recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

180

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Greece
      • Alexandroupolis, Greece, 68100
        • General University Hospital of Alexandroupolis /ID# 212927
      • Athens, Greece, 10676
        • General Hospital of Athens Evaggelismos and Ophthalmiatrio of Athens Polyclinic /ID# 212929
      • Chania, Greece, 73300
        • General Hospital of Chania "Agios Georgios" /ID# 241685
      • Ioannina, Greece, 45500
        • University General Hospital of Ioannina /ID# 212936
      • Larisa, Greece, 41110
        • Reg Gen Univ Hosp Larissa /ID# 213708
      • Patras, Greece, 26335
        • General Hospital of Patras Agios Andreas /ID# 213711
      • Patras, Greece, 26504
        • University Gen Hosp of Patra /ID# 212914
      • Piraeus, Greece, 18737
        • METAXA Cancer Hospital of Piraeus /ID# 212918
      • Thessaloniki, Greece, 54639
        • Theageneio Anticancer Hospital /ID# 212933
      • Thessaloniki, Greece, 57010
        • General Hospital of Thessaloniki George Papanikolaou /ID# 213709
    • Attiki
      • Athens, Attiki, Greece, 11526
        • Henry Dunnant Hospital Center /ID# 241682
      • Athens, Attiki, Greece, 11527
        • General Hospital of Athens Gennimatas /ID# 212917
      • Athens, Attiki, Greece, 11527
        • General Hospital of Athens Laiko /ID# 212902
      • Athens, Attiki, Greece, 11527
        • General Hospital of Athens Laiko /ID# 230222
      • Athens, Attiki, Greece, 12462
        • University General Hospital Attikon /ID# 212915
      • Cholargos, Attiki, Greece, 15562
        • Metropolitan General /ID# 212934
      • Marousi, Attiki, Greece, 15125
        • Iatriko Kentro Athinon /ID# 241689
      • Marousi, Attiki, Greece, 15125
        • Iatriko Kentro Athinon /ID# 241690
      • Piraeus, Attiki, Greece, 18547
        • Metropolitan Hospital /ID# 241687
    • Kriti
      • Heraklion, Kriti, Greece, 71500
        • University General Hospital of Heraklion PA.G.N.I /ID# 212916
    • Thessaloniki
      • Stavroupoli (Thessalonikis), Thessaloniki, Greece, 55536
        • Papageorgiou General Hospital Thessaloniki /ID# 213710

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Venetoclax Participants
Participants for whom the treating physician has decided to treat with venetoclax before enrollment in this study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Response Rate (ORR)
Time Frame: 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).
At Month 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Response Rate (ORR)
Time Frame: Up to Month 36
Defined by the International Workshop on Chronic Lymphocytic Leukemia (iwCLL) Guidelines.
Up to Month 36
Complete Response (CR)
Time Frame: Up to Month 36
Defined by the International Workshop on Chronic Lymphocytic Leukemia (iwCLL) Guidelines.
Up to Month 36
Complete Response with Incomplete Bone Marrow Recovery (CRi) Rate
Time Frame: Up to Month 36
Defined by the International Workshop on Chronic Lymphocytic Leukemia (iwCLL) Guidelines.
Up to Month 36
Nodule Partial Response (nPR) Rate
Time Frame: Up to Month 36
Defined by the International Workshop on Chronic Lymphocytic Leukemia (iwCLL) Guidelines.
Up to Month 36
Partial Response (PR) Rate
Time Frame: Up to Month 36
Defined by the International Workshop on Chronic Lymphocytic Leukemia (iwCLL).
Up to Month 36
Percentage of Participants With Disease Progression or Death
Time Frame: Up to Month 36
Disease progression as Assessed by the Investigator using International Workshop on Chronic Lymphocytic Leukemia (iwCLL) Guidelines.
Up to Month 36
Progression Free Survival (PFS)
Time Frame: 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).
Up to Month 36
Overall Survival (OS)
Time Frame: Up to Month 36
Defined as the time from first venetoclax intake to death from any cause.
Up to Month 36
Treatment Duration
Time Frame: Up to Month 36
Overall treatment duration of venetoclax.
Up to Month 36
Time to Progression (TTP)
Time Frame: 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).
Up to Month 36
Change in Patient Reported Outcomes
Time Frame: 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.
From Baseline (Week 0) Up to Month 36
Percentage of Participants with Undetectable Minimal Residual Disease (uMRD)
Time Frame: Up to Month 36
Determined by assessment of peripheral blood or bone marrow after treatment.
Up to Month 36
Percentage of Participants with Dose Modifications
Time Frame: Up to Month 36
Dose modifications include interruptions during ramp-up and maintenance phase.
Up to Month 36
Percentage of Participants with Adverse Drug Reactions (ADR)
Time Frame: 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.
Up to Month 36
Number of Lines of Prior Therapy in Participants with Relapse/Refractory Chronic Lymphocytic Leukemia
Time Frame: Up to Month 36
Number of lines of prior therapy per participant, in participants with Relapse/Refractory Chronic Lymphocytic Leukemia.
Up to Month 36

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AbbVie

Investigators

  • Study Director: ABBVIE INC., AbbVie

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 13, 2020

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

June 30, 2026

Study Registration Dates

First Submitted

November 8, 2019

First Submitted That Met QC Criteria

November 8, 2019

First Posted (Actual)

November 12, 2019

Study Record Updates

Last Update Posted (Estimated)

November 14, 2023

Last Update Submitted That Met QC Criteria

November 10, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P19-568

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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