Clinical trial NCT04159779: A Study of Clinical Outcomes in Chronic Lymphocytic Leukemia (CLL) Patients Treated With Venetoclax in Greece
Official title: Clinical Outcomes of Chronic Lymphocytic Leukemia (CLL) Patients Treated With Venetoclax in Routine Clinical Settings in Greece
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Chronic Lymphocytic Leukemia
Keywords: Chronic Lymphocytic Leukemia Venetoclax Relapsed/Refractory
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2019-11-12
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Overall Response Rate (ORR)
timeFrame: At Month 12
Secondary outcomes:
measure: Overall Response Rate (ORR)
timeFrame: Up to Month 36
measure: Complete Response (CR)
timeFrame: Up to Month 36
measure: Complete Response with Incomplete Bone Marrow Recovery (CRi) Rate
timeFrame: Up to Month 36
measure: Nodule Partial Response (nPR) Rate
timeFrame: Up to Month 36
measure: Partial Response (PR) Rate
timeFrame: Up to Month 36
measure: Percentage of Participants With Disease Progression or Death
timeFrame: Up to Month 36
measure: Progression Free Survival (PFS)
timeFrame: Up to Month 36
measure: Overall Survival (OS)
timeFrame: Up to Month 36
measure: Treatment Duration
timeFrame: Up to Month 36
measure: Time to Progression (TTP)
timeFrame: Up to Month 36
measure: Change in Patient Reported Outcomes
timeFrame: From Baseline (Week 0) Up to Month 36
measure: Percentage of Participants with Undetectable Minimal Residual Disease (uMRD)
timeFrame: Up to Month 36
measure: Percentage of Participants with Dose Modifications
timeFrame: Up to Month 36
measure: Percentage of Participants with Adverse Drug Reactions (ADR)
timeFrame: Up to Month 36
measure: Number of Lines of Prior Therapy in Participants with Relapse/Refractory Chronic Lymphocytic Leukemia
timeFrame: Up to Month 36
Other outcomes:
Locations:
city: Athens
country: Greece
facility: Henry Dunnant Hospital Center /ID# 241682
state: Attiki
city: Athens
country: Greece
facility: General Hospital of Athens Gennimatas /ID# 212917
state: Attiki
city: Athens
country: Greece
facility: General Hospital of Athens Laiko /ID# 212902
state: Attiki
city: Athens
country: Greece
facility: General Hospital of Athens Laiko /ID# 230222
state: Attiki
city: Athens
country: Greece
facility: University General Hospital Attikon /ID# 212915
state: Attiki
city: Cholargos
country: Greece
facility: Metropolitan General /ID# 212934
state: Attiki
city: Maroussi
country: Greece
facility: Iatriko Kentro Athinon /ID# 241689
state: Attiki
city: Maroussi
country: Greece
facility: Iatriko Kentro Athinon /ID# 241690
state: Attiki
city: Piraeus
country: Greece
facility: Metropolitan Hospital /ID# 241687
state: Attiki
city: Heraklion
country: Greece
facility: University General Hospital of Heraklion PA.G.N.I /ID# 212916
state: Kriti
city: Alexandroupolis
country: Greece
facility: General University Hospital of Alexandroupolis /ID# 212927
city: Athens
country: Greece
facility: General Hospital of Athens Evaggelismos and Ophthalmiatrio of Athens Polyclinic /ID# 212929
city: Chania
country: Greece
facility: General Hospital of Chania "Agios Georgios" /ID# 241685
city: Ioannina
country: Greece
facility: University General Hospital of Ioannina /ID# 212936
city: Larisa
country: Greece
facility: Reg Gen Univ Hosp Larissa /ID# 213708
city: Patras
country: Greece
facility: General Hospital of Patras Agios Andreas /ID# 213711
city: Patras
country: Greece
facility: University Gen Hosp of Patra /ID# 212914
city: Piraeus
country: Greece
facility: METAXA Cancer Hospital of Piraeus /ID# 212918
city: Thessaloniki
country: Greece
facility: Theageneio Anticancer Hospital /ID# 212933
city: Thessaloniki
country: Greece
facility: Papageorgiou General Hospital /ID# 213710
city: Thessaloniki
country: Greece
facility: General Hospital of Thessaloniki George Papanikolaou /ID# 213709
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: