NCT04159779

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
180

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2020

Longer than P75 for all trials

Geographic Reach
1 country

21 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 8, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 12, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

January 13, 2020

Completed
6.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2026

Completed
Last Updated

July 17, 2025

Status Verified

July 1, 2025

Enrollment Period

6.5 years

First QC Date

November 8, 2019

Last Update Submit

July 15, 2025

Conditions

Keywords

Chronic Lymphocytic Leukemia Venetoclax Relapsed/Refractory

Outcome Measures

Primary Outcomes (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).

    At Month 12

Secondary Outcomes (15)

  • Overall Response Rate (ORR)

    Up to Month 36

  • Complete Response (CR)

    Up to Month 36

  • Complete Response with Incomplete Bone Marrow Recovery (CRi) Rate

    Up to Month 36

  • Nodule Partial Response (nPR) Rate

    Up to Month 36

  • Partial Response (PR) Rate

    Up to Month 36

  • +10 more secondary outcomes

Study Arms (1)

Venetoclax Participants

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (21)

Henry Dunnant Hospital Center /ID# 241682

Athens, Attica, 11526, Greece

Location

General Hospital of Athens Gennimatas /ID# 212917

Athens, Attica, 11527, Greece

Location

General Hospital of Athens Laiko /ID# 212902

Athens, Attica, 11527, Greece

Location

General Hospital of Athens Laiko /ID# 230222

Athens, Attica, 11527, Greece

Location

University General Hospital Attikon /ID# 212915

Athens, Attica, 12462, Greece

Location

Metropolitan General /ID# 212934

Cholargós, Attica, 15562, Greece

Location

Iatriko Kentro Athinon /ID# 241689

Marousi, Attica, 15125, Greece

Location

Iatriko Kentro Athinon /ID# 241690

Marousi, Attica, 15125, Greece

Location

Metropolitan Hospital /ID# 241687

Piraeus, Attica, 18547, Greece

Location

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

Chania, Chania, 73300, Greece

Location

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

Heraklion, Crete, 71500, Greece

Location

University General Hospital of Ioannina /ID# 212936

Ioannina, Ioannina, 45500, Greece

Location

Reg Gen Univ Hosp Larissa /ID# 213708

Larissa, Larisa, 41110, Greece

Location

Theageneio Anticancer Hospital /ID# 212933

Thessaloniki, Thessaloniki, 54639, Greece

Location

General Hospital of Thessaloniki George Papanikolaou /ID# 213709

Thessaloniki, Thessaloniki, 57010, Greece

Location

General University Hospital of Alexandroupolis /ID# 212927

Alexandroupoli, 68100, Greece

Location

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

Athens, 10676, Greece

Location

General Hospital of Patras Agios Andreas /ID# 213711

Pátrai, 26335, Greece

Location

University Gen Hosp of Patra /ID# 212914

Pátrai, 26504, Greece

Location

METAXA Cancer Hospital of Piraeus /ID# 212918

Piraeus, 18737, Greece

Location

Papageorgiou General Hospital /ID# 213710

Thessaloniki, 56429, Greece

Location

Related Links

MeSH Terms

Conditions

Leukemia, Lymphocytic, Chronic, B-Cell

Condition Hierarchy (Ancestors)

Leukemia, B-CellLeukemia, LymphoidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • ABBVIE INC.

    AbbVie

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 8, 2019

First Posted

November 12, 2019

Study Start

January 13, 2020

Primary Completion

June 30, 2026

Study Completion

June 30, 2026

Last Updated

July 17, 2025

Record last verified: 2025-07

Locations