Clinical trial NCT03415035: Study Venetoclax Effectiveness and Real-Life Treatment Management in Participants With Chronic Lymphocytic Leukemia
Official title: Venetoclax in Chronic Lymphocytic Leukemia Effectiveness and Real-life Treatment Management
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Cancer - Chronic Lymphocytic Leukemia
Keywords: Venetoclax
Venclyxto
Cancer
Chronic Lynmphocytic Leukemia (CLL)
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2018-01-30
Enrollment: 269
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients starting venetoclax treatment for CLL.

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


Eligibility criteria: 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.

Primary outcomes:
measure: Best Response of Venetoclax in Participants with Chronic Lymphocytic Leukemia (CLL) up to 12 Months
timeFrame: Up to approximately 12 months
Secondary outcomes:
measure: Time To Next Treatment
timeFrame: Up to approximately 48 months
measure: Time to First Response to Treatment (TTR)
timeFrame: Up to approximately 24 months
measure: Minimal Residual Disease
timeFrame: Up to approximately 24 months
measure: Overall Response Rate (ORR)
timeFrame: Up to approximately 24 months
measure: Change in Score of EuroQol 5 Dimensions (EQ-5D-5L)
timeFrame: Up to approximately 24 months
measure: Time to Best Response to Treatment
timeFrame: Up to approximately 24 months
measure: Response Duration
timeFrame: Up to approximately 48 months
measure: PFS after Disease Progression Following Venetoclax Treatment
timeFrame: Up to approximately 48 months
measure: Overall survival (OS)
timeFrame: Up to approximately 48 months
measure: Best Response under Next CLL Treatment
timeFrame: Up to approximately 48 months
measure: Progression-Free Survival (PFS)
timeFrame: Up to approximately 48 months
measure: Time To Progression (TTP)
timeFrame: Up to approximately 48 months
Other outcomes:
Locations:
city: Cannes CEDEX
country: France
facility: CH Cannes - les Broussailles /ID# 201108
state: Alpes-Maritimes
city: Carcassonne
country: France
facility: CH CARCASSONNE - Antoine Gayraud /ID# 202530
state: Aude
city: Clermont
country: France
facility: CHU Clermont-Ferrand /ID# 170736
state: Auvergne-Rhone-Alpes
city: Clermont Ferrand
country: France
facility: Clinique Pole santé République /ID# 204658
state: Auvergne
city: Marseille
country: France
facility: Hopital de la Conception /ID# 201981
state: Bouches-du-Rhone
city: Vesoul CEDEX
country: France
facility: CH de la Haute-Saône - Vesoul /ID# 205150
state: Bourgogne-Franche-Comte
city: Rennes CEDEX 9
country: France
facility: CHU de RENNES /ID# 169944
state: Bretagne
city: Besancon
country: France
facility: CHU de Besancon - Jean Minjoz /ID# 170721
state: Doubs
city: Quimper
country: France
facility: CH Cornouailles - Site Quimper-Laennec /ID# 169937
state: Finistere
city: Limoges CEDEX 1
country: France
facility: CHU Limoges - Dupuytren 1 /ID# 200193
state: Franche-Comte
city: Bordeaux
country: France
facility: Institut Bergonie /ID# 170746
state: Gironde
city: Roubaix Cedex 1
country: France
facility: CH Roubaix - Hopital Victor Provo /ID# 170909
state: Hauts-de-France
city: Montpellier Cedex 5
country: France
facility: CHU Montpellier - Hopital Saint Eloi /ID# 200192
state: Herault
city: Bobigny
country: France
facility: Hopital Avicenne - APHP /ID# 169940
state: Ile-de-France
city: Saint-Malo
country: France
facility: CH de Saint-Malo - Hôpital Broussais /ID# 169935
state: Ille-et-Vilaine
city: Tours CEDEX 9
country: France
facility: CHRU Tours - Hopital Bretonneau /ID# 169469
state: Indre-et-Loire
city: La Tronche
country: France
facility: CHU Grenoble - Hopital Michallon /ID# 170741
state: Isere
city: Reims CEDEX
country: France
facility: CHU Reims - Hôpital Robert Debre /ID# 170917
state: Marne
city: Vandoeuvre-les-Nancy
country: France
facility: CHRU Nancy - Hopitaux de Brabois /ID# 170855
state: Meurthe-et-Moselle
city: Vannes CEDEX
country: France
facility: CH Bretagne Atlantique /ID# 200191
state: Morbihan
city: Bayonne
country: France
facility: Centre Hospitalier de la Cote Basque /ID# 170735
state: Pyrenees-Atlantiques
city: Lyon CEDEX 08
country: France
facility: Centre Leon Berard /ID# 170018
state: Rhone
city: Le Mans CEDEX 9
country: France
facility: Centre Hospitalier du Mans /ID# 169451
state: Sarthe
city: Melun CEDEX
country: France
facility: Hopital de Melun /ID# 202569
state: Seine-et-Marne
city: Amiens CEDEX 1
country: France
facility: CHU Amiens-Picardie Site Sud /ID# 170724
state: Somme
city: Villejuif Cedex
country: France
facility: Institut Gustave Roussy /ID# 202436
state: Val-de-Marne
city: Poitiers
country: France
facility: CHU Poitiers - La miletrie /ID# 169470
state: Vienne
city: St Germain en Laye
country: France
facility: CHI POISSY - Saint-Germain-en-Laye /ID# 169966
state: Yvelines
city: Agen Cedex 9
country: France
facility: Ch Agen /Id# 170742
city: Argenteuil
country: France
facility: CH Victor Dupouy /ID# 169946
city: Blois
country: France
facility: Ch Blois /Id# 170727
city: Brest
country: France
facility: CHRU de Brest - Hopital Morvan /ID# 169457
city: Caen
country: France
facility: CHU de CAEN - Hopital de la Cote de Nacre /ID# 169941
city: Cesson Sevigne
country: France
facility: Hopital Prive Sevigne /Id# 170718
city: Challes Les Eaux
country: France
facility: Medipole de Savoie /ID# 169454
city: Chalon Sur Saone
country: France
facility: CH William Morey /ID# 169939
city: Cholet
country: France
facility: Centre Hospitalier de CHOLET /ID# 171215
city: Clamart
country: France
facility: Hopital d'Instruction des Armées PERCY /ID# 170740
city: Desertines
country: France
facility: Centre Joseph BELOT /ID# 170853
city: Epagny Metz Tessy
country: France
facility: CH Annecy Genevois - Site Annecy /ID# 200826
city: Le Chesnay
country: France
facility: Centre Hospitalier de Versailles André Mignot /ID# 169950
city: Le Kremlin Bicetre
country: France
facility: AP-HP - Hôpital Bicêtre /ID# 170747
city: Le Mans
country: France
facility: Clinique Victor Hugo /ID# 169973
city: Libourne
country: France
facility: CH Libourne - Hopital Robert Boulin /ID# 170739
city: Lille Cedex
country: France
facility: Hopital Saint Vincent de Paul /ID# 169956
city: Lyon
country: France
facility: Clinique de la Sauvegarde /ID# 169904
city: Monaco
country: France
facility: CH Princesse Grace /ID# 200196
city: Mont de Marsan
country: France
facility: CH Mont de MARSAN /ID# 169955
city: Mulhouse
country: France
facility: Ch Mulhouse /Id# 170726
city: Narbonne
country: France
facility: Polyclinique le LANGUEDOC /ID# 169925
city: Orléans
country: France
facility: Centre Hospitalier Régional d'Orléans - Hôpital de la Source /ID# 169453
city: Paris
country: France
facility: AP-HP - Hopital Saint-Louis /ID# 170856
city: Paris
country: France
facility: Hopital Pitie Salpetriere /ID# 169974
city: Perigueux
country: France
facility: CH Périgueux /ID# 169458
city: Perpignan
country: France
facility: Centre Hospitalier de Perpignan /ID# 170743
city: Rouen
country: France
facility: Centre Henri Becquerel /ID# 169948
city: Saint-brieuc
country: France
facility: CH Saint-Brieuc /ID# 171076
city: Thionville
country: France
facility: CHR Metz-Thionville - Hopital Bel-Air /ID# 170722
city: Toulouse Cedex 9
country: France
facility: IUCT Oncopole /ID# 170749
city: Trevenans
country: France
facility: Hopital Nord Franche Comté /ID# 170744
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: