Study Venetoclax Effectiveness and Real-Life Treatment Management in Participants With Chronic Lymphocytic Leukemia
- Conditions
- Cancer - Chronic Lymphocytic Leukemia
- Registration Number
- NCT03415035
- Lead Sponsor
- AbbVie
- Brief Summary
This study will evaluate real-life effectiveness and use in participants starting venetoclax treatment for Chronic Lymphocytic Leukemia (CLL).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 269
- 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.
- Participating in a clinical trial with an investigative drug for CLL within 30 days prior to treatment initiation.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.
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 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.
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.
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).
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.
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.
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.
Trial Locations
- Locations (60)
Ch Agen /Id# 170742
馃嚝馃嚪Agen Cedex 9, France
CH Victor Dupouy /ID# 169946
馃嚝馃嚪Argenteuil, France
CH Libourne - Hopital Robert Boulin /ID# 170739
馃嚝馃嚪Libourne, France
Clinique de la Sauvegarde /ID# 169904
馃嚝馃嚪Lyon, France
CHRU Nancy - Hopitaux de Brabois /ID# 170855
馃嚝馃嚪Vandoeuvre-les-Nancy, Meurthe-et-Moselle, France
CH Cannes - les Broussailles /ID# 201108
馃嚝馃嚪Cannes CEDEX, Alpes-Maritimes, France
CH Roubaix - Hopital Victor Provo /ID# 170909
馃嚝馃嚪Roubaix Cedex 1, Hauts-de-France, France
Centre Hospitalier du Mans /ID# 169451
馃嚝馃嚪Le Mans CEDEX 9, Sarthe, France
CHU Reims - H么pital Robert Debre /ID# 170917
馃嚝馃嚪Reims CEDEX, Marne, France
CH Bretagne Atlantique /ID# 200191
馃嚝馃嚪Vannes CEDEX, Morbihan, France
Hopital de Melun /ID# 202569
馃嚝馃嚪Melun CEDEX, Seine-et-Marne, France
Institut Gustave Roussy /ID# 202436
馃嚝馃嚪Villejuif Cedex, Val-de-Marne, France
CH de Saint-Malo - H么pital Broussais /ID# 169935
馃嚝馃嚪Saint-Malo, Ille-et-Vilaine, France
CHRU Tours - Hopital Bretonneau /ID# 169469
馃嚝馃嚪Tours CEDEX 9, Indre-et-Loire, France
CHU Poitiers - La miletrie /ID# 169470
馃嚝馃嚪Poitiers, Vienne, France
CHI POISSY - Saint-Germain-en-Laye /ID# 169966
馃嚝馃嚪St Germain en Laye, Yvelines, France
CHU Clermont-Ferrand /ID# 170736
馃嚝馃嚪Clermont, Auvergne-Rhone-Alpes, France
Clinique Pole sant茅 R茅publique /ID# 204658
馃嚝馃嚪Clermont Ferrand, Auvergne, France
CH CARCASSONNE - Antoine Gayraud /ID# 202530
馃嚝馃嚪Carcassonne, Aude, France
Hopital de la Conception /ID# 201981
馃嚝馃嚪Marseille, Bouches-du-Rhone, France
CH de la Haute-Sa么ne - Vesoul /ID# 205150
馃嚝馃嚪Vesoul CEDEX, Bourgogne-Franche-Comte, France
CHU de RENNES /ID# 169944
馃嚝馃嚪Rennes CEDEX 9, Bretagne, France
CHU de Besancon - Jean Minjoz /ID# 170721
馃嚝馃嚪Besancon, Doubs, France
CHU Limoges - Dupuytren 1 /ID# 200193
馃嚝馃嚪Limoges CEDEX 1, Franche-Comte, France
Institut Bergonie /ID# 170746
馃嚝馃嚪Bordeaux, Gironde, France
CH Cornouailles - Site Quimper-Laennec /ID# 169937
馃嚝馃嚪Quimper, Finistere, France
Hopital Avicenne - APHP /ID# 169940
馃嚝馃嚪Bobigny, Ile-de-France, France
CHU Montpellier - Hopital Saint Eloi /ID# 200192
馃嚝馃嚪Montpellier Cedex 5, Herault, France
CHU Grenoble - Hopital Michallon /ID# 170741
馃嚝馃嚪La Tronche, Isere, France
Centre Hospitalier de la Cote Basque /ID# 170735
馃嚝馃嚪Bayonne, Pyrenees-Atlantiques, France
Centre Leon Berard /ID# 170018
馃嚝馃嚪Lyon CEDEX 08, Rhone, France
CHU Amiens-Picardie Site Sud /ID# 170724
馃嚝馃嚪Amiens CEDEX 1, Somme, France
CHRU de Brest - Hopital Morvan /ID# 169457
馃嚝馃嚪Brest, France
Hopital Prive Sevigne /Id# 170718
馃嚝馃嚪Cesson Sevigne, France
Ch Blois /Id# 170727
馃嚝馃嚪Blois, France
CHU de CAEN - Hopital de la Cote de Nacre /ID# 169941
馃嚝馃嚪Caen, France
Medipole de Savoie /ID# 169454
馃嚝馃嚪Challes Les Eaux, France
CH William Morey /ID# 169939
馃嚝馃嚪Chalon Sur Saone, France
Centre Hospitalier de CHOLET /ID# 171215
馃嚝馃嚪Cholet, France
Hopital d'Instruction des Arm茅es PERCY /ID# 170740
馃嚝馃嚪Clamart, France
CH Princesse Grace /ID# 200196
馃嚝馃嚪Monaco, France
Centre Joseph BELOT /ID# 170853
馃嚝馃嚪Desertines, France
CH Annecy Genevois - Site Annecy /ID# 200826
馃嚝馃嚪Epagny Metz Tessy, France
Centre Hospitalier de Versailles Andr茅 Mignot /ID# 169950
馃嚝馃嚪Le Chesnay, France
AP-HP - H么pital Bic锚tre /ID# 170747
馃嚝馃嚪Le Kremlin Bicetre, France
Ch Mulhouse /Id# 170726
馃嚝馃嚪Mulhouse, France
Clinique Victor Hugo /ID# 169973
馃嚝馃嚪Le Mans, France
Hopital Saint Vincent de Paul /ID# 169956
馃嚝馃嚪Lille Cedex, France
CH Mont de MARSAN /ID# 169955
馃嚝馃嚪Mont de Marsan, France
Polyclinique le LANGUEDOC /ID# 169925
馃嚝馃嚪Narbonne, France
Centre Hospitalier R茅gional d'Orl茅ans - H么pital de la Source /ID# 169453
馃嚝馃嚪Orl茅ans, France
AP-HP - Hopital Saint-Louis /ID# 170856
馃嚝馃嚪Paris, France
Centre Hospitalier de Perpignan /ID# 170743
馃嚝馃嚪Perpignan, France
Hopital Pitie Salpetriere /ID# 169974
馃嚝馃嚪Paris, France
CH P茅rigueux /ID# 169458
馃嚝馃嚪Perigueux, France
Centre Henri Becquerel /ID# 169948
馃嚝馃嚪Rouen, France
CHR Metz-Thionville - Hopital Bel-Air /ID# 170722
馃嚝馃嚪Thionville, France
CH Saint-Brieuc /ID# 171076
馃嚝馃嚪Saint-brieuc, France
IUCT Oncopole /ID# 170749
馃嚝馃嚪Toulouse Cedex 9, France
Hopital Nord Franche Comt茅 /ID# 170744
馃嚝馃嚪Trevenans, France