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
🇫🇷Agen Cedex 9, France
CH Victor Dupouy /ID# 169946
🇫🇷Argenteuil, France
CH Libourne - Hopital Robert Boulin /ID# 170739
🇫🇷Libourne, France
Clinique de la Sauvegarde /ID# 169904
🇫🇷Lyon, France
CHRU Nancy - Hopitaux de Brabois /ID# 170855
🇫🇷Vandoeuvre-les-Nancy, Meurthe-et-Moselle, France
CH Cannes - les Broussailles /ID# 201108
🇫🇷Cannes CEDEX, Alpes-Maritimes, France
CH Roubaix - Hopital Victor Provo /ID# 170909
🇫🇷Roubaix Cedex 1, Hauts-de-France, France
Centre Hospitalier du Mans /ID# 169451
🇫🇷Le Mans CEDEX 9, Sarthe, France
CHU Reims - Hôpital Robert Debre /ID# 170917
🇫🇷Reims CEDEX, Marne, France
CH Bretagne Atlantique /ID# 200191
🇫🇷Vannes CEDEX, Morbihan, France
Hopital de Melun /ID# 202569
🇫🇷Melun CEDEX, Seine-et-Marne, France
Institut Gustave Roussy /ID# 202436
🇫🇷Villejuif Cedex, Val-de-Marne, France
CH de Saint-Malo - Hôpital Broussais /ID# 169935
🇫🇷Saint-Malo, Ille-et-Vilaine, France
CHRU Tours - Hopital Bretonneau /ID# 169469
🇫🇷Tours CEDEX 9, Indre-et-Loire, France
CHU Poitiers - La miletrie /ID# 169470
🇫🇷Poitiers, Vienne, France
CHI POISSY - Saint-Germain-en-Laye /ID# 169966
🇫🇷St Germain en Laye, Yvelines, France
CHU Clermont-Ferrand /ID# 170736
🇫🇷Clermont, Auvergne-Rhone-Alpes, France
Clinique Pole santé République /ID# 204658
🇫🇷Clermont Ferrand, Auvergne, France
CH CARCASSONNE - Antoine Gayraud /ID# 202530
🇫🇷Carcassonne, Aude, France
Hopital de la Conception /ID# 201981
🇫🇷Marseille, Bouches-du-Rhone, France
CH de la Haute-Saône - Vesoul /ID# 205150
🇫🇷Vesoul CEDEX, Bourgogne-Franche-Comte, France
CHU de RENNES /ID# 169944
🇫🇷Rennes CEDEX 9, Bretagne, France
CHU de Besancon - Jean Minjoz /ID# 170721
🇫🇷Besancon, Doubs, France
CHU Limoges - Dupuytren 1 /ID# 200193
🇫🇷Limoges CEDEX 1, Franche-Comte, France
Institut Bergonie /ID# 170746
🇫🇷Bordeaux, Gironde, France
CH Cornouailles - Site Quimper-Laennec /ID# 169937
🇫🇷Quimper, Finistere, France
Hopital Avicenne - APHP /ID# 169940
🇫🇷Bobigny, Ile-de-France, France
CHU Montpellier - Hopital Saint Eloi /ID# 200192
🇫🇷Montpellier Cedex 5, Herault, France
CHU Grenoble - Hopital Michallon /ID# 170741
🇫🇷La Tronche, Isere, France
Centre Hospitalier de la Cote Basque /ID# 170735
🇫🇷Bayonne, Pyrenees-Atlantiques, France
Centre Leon Berard /ID# 170018
🇫🇷Lyon CEDEX 08, Rhone, France
CHU Amiens-Picardie Site Sud /ID# 170724
🇫🇷Amiens CEDEX 1, Somme, France
CHRU de Brest - Hopital Morvan /ID# 169457
🇫🇷Brest, France
Hopital Prive Sevigne /Id# 170718
🇫🇷Cesson Sevigne, France
Ch Blois /Id# 170727
🇫🇷Blois, France
CHU de CAEN - Hopital de la Cote de Nacre /ID# 169941
🇫🇷Caen, France
Medipole de Savoie /ID# 169454
🇫🇷Challes Les Eaux, France
CH William Morey /ID# 169939
🇫🇷Chalon Sur Saone, France
Centre Hospitalier de CHOLET /ID# 171215
🇫🇷Cholet, France
Hopital d'Instruction des Armées PERCY /ID# 170740
🇫🇷Clamart, France
CH Princesse Grace /ID# 200196
🇫🇷Monaco, France
Centre Joseph BELOT /ID# 170853
🇫🇷Desertines, France
CH Annecy Genevois - Site Annecy /ID# 200826
🇫🇷Epagny Metz Tessy, France
Centre Hospitalier de Versailles André Mignot /ID# 169950
🇫🇷Le Chesnay, France
AP-HP - Hôpital Bicêtre /ID# 170747
🇫🇷Le Kremlin Bicetre, France
Ch Mulhouse /Id# 170726
🇫🇷Mulhouse, France
Clinique Victor Hugo /ID# 169973
🇫🇷Le Mans, France
Hopital Saint Vincent de Paul /ID# 169956
🇫🇷Lille Cedex, France
CH Mont de MARSAN /ID# 169955
🇫🇷Mont de Marsan, France
Polyclinique le LANGUEDOC /ID# 169925
🇫🇷Narbonne, France
Centre Hospitalier Régional d'Orléans - Hôpital de la Source /ID# 169453
🇫🇷Orléans, France
AP-HP - Hopital Saint-Louis /ID# 170856
🇫🇷Paris, France
Centre Hospitalier de Perpignan /ID# 170743
🇫🇷Perpignan, France
Hopital Pitie Salpetriere /ID# 169974
🇫🇷Paris, France
CH Périgueux /ID# 169458
🇫🇷Perigueux, France
Centre Henri Becquerel /ID# 169948
🇫🇷Rouen, France
CHR Metz-Thionville - Hopital Bel-Air /ID# 170722
🇫🇷Thionville, France
CH Saint-Brieuc /ID# 171076
🇫🇷Saint-brieuc, France
IUCT Oncopole /ID# 170749
🇫🇷Toulouse Cedex 9, France
Hopital Nord Franche Comté /ID# 170744
🇫🇷Trevenans, France