Chronic Lymphocytic Leukemia
Conditions
Keywords
Chronic Lymphocytic Leukemia Venetoclax Relapsed/Refractory
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.
Interventions
None listed
Sponsors
AbbVie
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Response Rate (ORR) | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Complete Response (CR) | Up to Month 36 | Defined by the International Workshop on Chronic Lymphocytic Leukemia (iwCLL) Guidelines. |
| Complete Response with Incomplete Bone Marrow Recovery (CRi) Rate | Up to Month 36 | Defined by the International Workshop on Chronic Lymphocytic Leukemia (iwCLL) Guidelines. |
| Nodule Partial Response (nPR) Rate | Up to Month 36 | Defined by the International Workshop on Chronic Lymphocytic Leukemia (iwCLL) Guidelines. |
| Partial Response (PR) Rate | Up to Month 36 | Defined by the International Workshop on Chronic Lymphocytic Leukemia (iwCLL). |
| Percentage of Participants With Disease Progression or Death | Up to Month 36 | Disease progression as Assessed by the Investigator using International Workshop on Chronic Lymphocytic Leukemia (iwCLL) Guidelines. |
| Progression Free Survival (PFS) | 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). |
| Overall Survival (OS) | Up to Month 36 | Defined as the time from first venetoclax intake to death from any cause. |
| Overall Response Rate (ORR) | Up to Month 36 | Defined by the International Workshop on Chronic Lymphocytic Leukemia (iwCLL) Guidelines. |
| Time to Progression (TTP) | 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). |
| Change in Patient Reported Outcomes | 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. |
| Percentage of Participants with Undetectable Minimal Residual Disease (uMRD) | Up to Month 36 | Determined by assessment of peripheral blood or bone marrow after treatment. |
| Percentage of Participants with Dose Modifications | Up to Month 36 | Dose modifications include interruptions during ramp-up and maintenance phase. |
| Percentage of Participants with Adverse Drug Reactions (ADR) | 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. |
| Number of Lines of Prior Therapy in Participants with Relapse/Refractory Chronic Lymphocytic Leukemia | Up to Month 36 | Number of lines of prior therapy per participant, in participants with Relapse/Refractory Chronic Lymphocytic Leukemia. |
| Treatment Duration | Up to Month 36 | Overall treatment duration of venetoclax. |
Countries
Greece
Outcome results
None listed