Cancer - Chronic Lymphocytic Leukemia
Conditions
Keywords
Venetoclax, Venclyxto, Cancer, Chronic Lynmphocytic Leukemia (CLL)
Brief summary
This study will evaluate real-life effectiveness and use in participants starting venetoclax treatment for Chronic Lymphocytic Leukemia (CLL).
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
* Participants with diagnosed Chronic Lymphocytic Leukemia (CLL) and eligible for venetoclax as per label. * Participants for whom the physician has decided to initiate CLL treatment with venetoclax. * Participants the physician believes he can personally follow over all the study period. * Participants who have been informed verbally and in writing about this study, and who do not object to their data being electronically processed or subjected to data quality control.
Exclusion criteria
\- Participating in a clinical trial with an investigative drug for CLL within 30 days prior to treatment initiation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Best Response of Venetoclax in Participants with Chronic Lymphocytic Leukemia (CLL) up to 12 Months | Up to approximately 12 months | The best response is defined as the best response observed during the first year of study treatment among the possible responses to treatment: Complete Response (CR), CR with incomplete bone marrow recovery (CRi), nodular Partial Response (nPR), Partial Response (PR), Stable Disease (SD), or Disease Progression (DP). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time To Next Treatment | Up to approximately 48 months | The time to next treatment is defined as the time between the date of the first venetoclax intake and the date of the first next treatment intake after venetoclax discontinuation. |
| Time to First Response to Treatment (TTR) | Up to approximately 24 months | The time to response to treatment (TTR) is defined by the time between the date of the first venetoclax intake and the date of the first assessment having documented the response among CR, CRi, nPR, and PR. |
| Minimal Residual Disease | Up to approximately 24 months | The proportion of participants with assessment of the minimal residual disease under venetoclax treatment (assessed by flow cytometry or Polymerase Chain Reaction). |
| Overall Response Rate (ORR) | Up to approximately 24 months | ORR is defined as the proportion of participants who reach either CR, CRi, nPR, or PR to treatment, according to physician's assessment. |
| Change in Score of EuroQol 5 Dimensions (EQ-5D-5L) | Up to approximately 24 months | The EQ-5D-5L has five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. These dimensions are measured on a five-level scale: no problems, slight problems, moderate problems, severe problems, and extreme problems. The scores for the 5 dimensions are used to compute a single utility index score ranging from zero (0.0) to 1 (1.0) representing the general health status of the individual. The EQ-5D-5L also contains a visual analog scale (VAS) to assess the subject's overall health. |
| Time to Best Response to Treatment | Up to approximately 24 months | The time to best response to treatment is defined by the time between the date of the first venetoclax intake and the date of the assessment having documented the best response among CR, CRi, nPR, PR, SD, and DP. |
| Response Duration | Up to approximately 48 months | The response duration will be calculated in the sub-population of participants experiencing treatment response (CR, CRi, nPR, or PR) from the date when response is first met to the date of first following documented progression. |
| PFS after Disease Progression Following Venetoclax Treatment | Up to approximately 48 months | The PFS after disease progression following venetoclax treatment will be calculated in the sub-population of patients experiencing disease progression under venetoclax. The PFS following venetoclax treatment is defined as the time from the date of first next CLL treatment intake to the date of the following documented progression or death from any cause. |
| Overall survival (OS) | Up to approximately 48 months | OS is defined as the time from the date of first venetoclax intake to the date of death from any cause. |
| Best Response under Next CLL Treatment | Up to approximately 48 months | The best response under next CLL treatment will be calculated in the sub-population of patients having a next CLL treatment after venetoclax discontinuation. |
| Progression-Free Survival (PFS) | Up to approximately 48 months | PFS is defined as the time from the date of first venetoclax intake to the date of the first documented disease progression or death from any cause. |
| Time To Progression (TTP) | Up to approximately 48 months | The Time To Progression (TTP) is defined as the time from the date of first venetoclax intake to the date of the first documented disease progression. |
Countries
France
Contacts
STUDY_DIRECTORABBVIE INC.
AbbVie
Outcome results
None listed