Study Venetoclax Effectiveness and Real-Life Treatment Management in Participants With Chronic Lymphocytic Leukemia

AbbVie269 enrolled

Overview

This study will evaluate real-life effectiveness and use in participants starting venetoclax treatment for Chronic Lymphocytic Leukemia (CLL).

Study Type

OBSERVATIONAL

Enrollment

269

Conditions

Cancer - Chronic Lymphocytic Leukemia

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (60)

Outcomes

Primary Outcomes

Best Response of Venetoclax in Participants with Chronic Lymphocytic Leukemia (CLL) up to 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).

Time frame: Up to approximately 12 months

Secondary Outcomes

Time To Next Treatment

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 frame: Up to approximately 48 months

Time to First Response to Treatment (TTR)

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.

Time frame: Up to approximately 24 months

Minimal Residual Disease

The proportion of participants with assessment of the minimal residual disease under venetoclax treatment (assessed by flow cytometry or Polymerase Chain Reaction).

Time frame: Up to approximately 24 months

Overall Response Rate (ORR)

ORR is defined as the proportion of participants who reach either CR, CRi, nPR, or PR to treatment, according to physician's assessment.

Time frame: Up to approximately 24 months

Change in Score of EuroQol 5 Dimensions (EQ-5D-5L)

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.

Data from ClinicalTrials.gov

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CH Cannes - les Broussailles /ID# 201108

Cannes, Alpes-Maritimes, France

CH CARCASSONNE - Antoine Gayraud /ID# 202530

Carcassonne, Aude, France

CHU Clermont-Ferrand /ID# 170736

Clermont, Auvergne-Rhône-Alpes, France

Clinique Pole santé République /ID# 204658

Clermont-Ferrand, Auvergne, France

CH de la Haute-Saône - Vesoul /ID# 205150

Vesoul, Bourgogne-Franche-Comté, France

CHU de RENNES /ID# 169944

Rennes, Brittany Region, France

CHU de CAEN - Hopital de la Cote de Nacre /ID# 169941

Caen, Calvados, France

Centre Hospitalier Regional Universitaire de Besancon - Hopital Jean Minjoz /ID# 170721

Besançon, Doubs, France

Centre Hospitalier de Cornouaille /ID# 169937

Quimper, Finistere, France

CHU Limoges - Dupuytren 1 /ID# 200193

Limoges, Franche-Comte, France

...and 50 more locations

Time frame: Up to approximately 24 months

Time to Best Response to Treatment

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.

Time frame: Up to approximately 24 months

Response Duration

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.

Time frame: Up to approximately 48 months

PFS after Disease Progression Following Venetoclax Treatment

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.

Time frame: Up to approximately 48 months

Overall survival (OS)

OS is defined as the time from the date of first venetoclax intake to the date of death from any cause.

Time frame: Up to approximately 48 months

Best Response under Next CLL Treatment

The best response under next CLL treatment will be calculated in the sub-population of patients having a next CLL treatment after venetoclax discontinuation.

Time frame: Up to approximately 48 months

Progression-Free Survival (PFS)

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 frame: Up to approximately 48 months

Time To Progression (TTP)

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.

Time frame: Up to approximately 48 months