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

Chronic Lymphocytic Leukemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04159779
• Other study ID #: P19-568
• Status: Active, not recruiting
• Start date: January 13, 2020
• Est. completion date: June 30, 2026

Study information

• Verified date: June 2024
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

The objectives of this study include determining overall response rate, assessing safety information, analyzing patient profiles and disease characteristics and participant quality of life.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 180
• Est. completion date: June 30, 2026
• Est. primary completion date: June 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Lymphocytic Leukemia
• Leukemia
• Leukemia, Lymphocytic, Chronic, B-Cell
• Leukemia, Lymphoid

Locations

Country	Name	City	State
Greece	General University Hospital of Alexandroupolis /ID# 212927	Alexandroupolis
Greece	General Hospital of Athens Evaggelismos and Ophthalmiatrio of Athens Polyclinic /ID# 212929	Athens
Greece	General Hospital of Athens Gennimatas /ID# 212917	Athens	Attiki
Greece	General Hospital of Athens Laiko /ID# 212902	Athens	Attiki
Greece	General Hospital of Athens Laiko /ID# 230222	Athens	Attiki
Greece	Henry Dunnant Hospital Center /ID# 241682	Athens	Attiki
Greece	University General Hospital Attikon /ID# 212915	Athens	Attiki
Greece	General Hospital of Chania "Agios Georgios" /ID# 241685	Chania
Greece	Metropolitan General /ID# 212934	Cholargos	Attiki
Greece	University General Hospital of Heraklion PA.G.N.I /ID# 212916	Heraklion	Kriti
Greece	University General Hospital of Ioannina /ID# 212936	Ioannina
Greece	Reg Gen Univ Hosp Larissa /ID# 213708	Larisa
Greece	Iatriko Kentro Athinon /ID# 241689	Maroussi	Attiki
Greece	Iatriko Kentro Athinon /ID# 241690	Maroussi	Attiki
Greece	General Hospital of Patras Agios Andreas /ID# 213711	Patras
Greece	University Gen Hosp of Patra /ID# 212914	Patras
Greece	METAXA Cancer Hospital of Piraeus /ID# 212918	Piraeus
Greece	Metropolitan Hospital /ID# 241687	Piraeus	Attiki
Greece	General Hospital of Thessaloniki George Papanikolaou /ID# 213709	Thessaloniki
Greece	Papageorgiou General Hospital /ID# 213710	Thessaloniki
Greece	Theageneio Anticancer Hospital /ID# 212933	Thessaloniki

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Overall Response Rate (ORR)	Defined by the International Workshop on Chronic Lymphocytic Leukemia (iwCLL) Guidelines.	Up to Month 36
Secondary	Complete Response (CR)	Defined by the International Workshop on Chronic Lymphocytic Leukemia (iwCLL) Guidelines.	Up to Month 36
Secondary	Complete Response with Incomplete Bone Marrow Recovery (CRi) Rate	Defined by the International Workshop on Chronic Lymphocytic Leukemia (iwCLL) Guidelines.	Up to Month 36
Secondary	Nodule Partial Response (nPR) Rate	Defined by the International Workshop on Chronic Lymphocytic Leukemia (iwCLL) Guidelines.	Up to Month 36
Secondary	Partial Response (PR) Rate	Defined by the International Workshop on Chronic Lymphocytic Leukemia (iwCLL).	Up to Month 36
Secondary	Percentage of Participants With Disease Progression or Death	Disease progression as Assessed by the Investigator using International Workshop on Chronic Lymphocytic Leukemia (iwCLL) Guidelines.	Up to Month 36
Secondary	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).	Up to Month 36
Secondary	Overall Survival (OS)	Defined as the time from first venetoclax intake to death from any cause.	Up to Month 36
Secondary	Treatment Duration	Overall treatment duration of venetoclax.	Up to Month 36
Secondary	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).	Up to Month 36
Secondary	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.	From Baseline (Week 0) Up to Month 36
Secondary	Percentage of Participants with Undetectable Minimal Residual Disease (uMRD)	Determined by assessment of peripheral blood or bone marrow after treatment.	Up to Month 36
Secondary	Percentage of Participants with Dose Modifications	Dose modifications include interruptions during ramp-up and maintenance phase.	Up to Month 36
Secondary	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.	Up to Month 36
Secondary	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.	Up to Month 36

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