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

Venetoclax in Chronic Lymphocytic Leukemia Effectiveness and Real-life Treatment Management

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

Study Overview

• Status: Active, not recruiting
• Conditions: Cancer - Chronic Lymphocytic Leukemia

• Study Type: Observational
• Enrollment (Actual): 269

Contacts and Locations

Study Locations

• France
  • Agen Cedex 9, France, 47923
    • Ch Agen /Id# 170742
  • Aix En Provence Cedex 1, France, 13616
    • CH du Pays d'AIX /ID# 169923
  • Argenteuil, France, 95100
    • CH Victor Dupouy /ID# 169946
  • Blois, France, 41016
    • Ch Blois /Id# 170727
  • Bourg En Bresse, France, 01012
    • CH de Bourg-en Bresse - Hopital Fleyriat /ID# 170017
  • Brest, France, 29200
    • CHRU de Brest - Hopital Morvan /ID# 169457
  • Caen, France, 14033
    • CHU de CAEN - Hopital de la Cote de Nacre /ID# 169941
  • Cesson Sevigne, France, 35510
    • Hopital Prive Sevigne /Id# 170718
  • Challes Les Eaux, France, 73190
    • Medipole de Savoie /ID# 169454
  • Chalon Sur Saone, France, 71321
    • CH William Morey /ID# 169939
  • Cholet, France, 49300
    • Centre Hospitalier de CHOLET /ID# 171215
  • Clamart, France, 92141
    • Hopital d'Instruction des Armées PERCY /ID# 170740
  • Creil, France, 60109
    • GHPSO CH Creil /ID# 212802
  • Desertines, France, 03030
    • Centre Joseph BELOT /ID# 170853
  • Epagny Metz Tessy, France, 74370
    • CH Annecy Genevois - Site Annecy /ID# 200826
  • La Tronche, France, 38700
    • CHU Grenoble - Hopital Michallon /ID# 170741
  • Le Chesnay, France, 78150
    • Centre Hospitalier de Versailles André Mignot /ID# 169950
  • Le Kremlin Bicetre, France, 94270
    • AP-HP - Hôpital Bicêtre /ID# 170747
  • Le Mans, France, 72000
    • Clinique Victor Hugo /ID# 169973
  • Libourne, France, 33500
    • CH Libourne - Hopital Robert Boulin /ID# 170739
  • Lille Cedex, France, 59020
    • Hopital Saint Vincent de Paul /ID# 169956
  • Lyon, France, 69009
    • Clinique de la Sauvegarde /ID# 169904
  • Marseille, France, 13005
    • AP-HM - Hopital de la Conception /ID# 201981
  • Monaco, France, 98000
    • CH Princesse Grace /ID# 200196
  • Mont de Marsan, France, 40024
    • CH Mont de MARSAN /ID# 169955
  • Mulhouse, France, 68100
    • Ch Mulhouse /Id# 170726
  • Narbonne, France, 11100
    • Polyclinique le LANGUEDOC /ID# 169925
  • Nimes Cedex 09, France, 30029
    • Institut de Cancérologie du Gard /ID# 169975
  • Nimes Cedex 09, France, 30029
    • Institut de Cancérologie du Gard /ID# 171207
  • Paris, France, 75010
    • AP-HP - Hopital Saint-Louis /ID# 170856
  • Paris, France, 75013
    • Hopital Pitie Salpetriere /ID# 169974
  • Perigueux, France, 24019
    • CH Périgueux /ID# 169458
  • Perpignan, France, 66000
    • Centre Hospitalier de Perpignan /ID# 170743
  • Quimper, France, 29000
    • CH Cornouailles - Site Quimper-Laennec /ID# 169937
  • Rouen, France, 76038
    • Centre Henri Becquerel /ID# 169948
  • Saint-brieuc, France, 22000
    • CH Saint-Brieuc /ID# 171076
  • Strasbourg cedex, France, 67091
    • CHU Strasbourg - Hopital Civil /ID# 200195
  • Thionville, France, 57100
    • CHR Metz-Thionville - Hopital Bel-Air /ID# 170722
  • Toulouse Cedex 9, France, 31059
    • IUCT Oncopole /ID# 170749
  • Trevenans, France, 90400
    • Hopital Nord Franche Comté /ID# 170744
  • Alpes-Maritimes
    • Cannes CEDEX, Alpes-Maritimes, France, 06414
      • CH Cannes - les Broussailles /ID# 201108
  • Aude
    • Carcassonne, Aude, France, 11000
      • CH CARCASSONNE - Antoine Gayraud /ID# 202530
  • Auvergne
    • Clermont Ferrand, Auvergne, France, 63050
      • Clinique Pole santé République /ID# 204658
  • Auvergne-Rhone-Alpes
    • Clermont, Auvergne-Rhone-Alpes, France, 63100
      • CHU Clermont-Ferrand /ID# 170736
  • Bourgogne-Franche-Comte
    • Vesoul CEDEX, Bourgogne-Franche-Comte, France, 70014
      • CH de la Haute-Saône - Vesoul /ID# 205150
  • Bretagne
    • Rennes CEDEX 9, Bretagne, France, 35033
      • CHU de RENNES /ID# 169944
    • Vannes CEDEX, Bretagne, France, 56017
      • CH Bretagne Atlantique /ID# 200191
  • Doubs
    • Besancon, Doubs, France, 25030
      • CHU de Besancon - Jean Minjoz /ID# 170721
  • Franche-Comte
    • Limoges CEDEX 1, Franche-Comte, France, 87042
      • CHU Limoges - Dupuytren 1 /ID# 200193
  • Gironde
    • Bordeaux, Gironde, France, 33000
      • Institut Bergonie /ID# 170746
  • Hauts-de-France
    • Roubaix Cedex 1, Hauts-de-France, France, 59100
      • CH Roubaix - Hopital Victor Provo /ID# 170909
  • Herault
    • Montpellier Cedex 5, Herault, France, 34295
      • CHU Montpellier - Hôpital Saint Eloi /ID# 200192
  • Ile-de-France
    • Bobigny, Ile-de-France, France, 93000
      • Hopital Avicenne - APHP /ID# 169940
  • Ille-et-Vilaine
    • Saint-Malo, Ille-et-Vilaine, France, 35400
      • CH de Saint-Malo - Hôpital Broussais /ID# 169935
  • Indre-et-Loire
    • Tours CEDEX 9, Indre-et-Loire, France, 37044
      • CHRU Tours - Hopital Bretonneau /ID# 169469
  • La Reunion
    • Saint-Pierre, La Reunion, France, 97448
      • CHU de La Réunion sites Sud - Saint-Pierre /ID# 204093
  • Loiret
    • Orleans CEDEX 2, Loiret, France, 45067
      • CHR Orleans - Hopital de la Source /ID# 169453
  • Marne
    • Reims CEDEX, Marne, France, 51092
      • CHU Reims - Hôpital Robert Debre /ID# 170917
  • Meurthe-et-Moselle
    • Vandoeuvre-les-Nancy, Meurthe-et-Moselle, France, 54500
      • CHRU Nancy - Hopitaux de Brabois /ID# 170855
  • Poitou-Charentes
    • Poitiers, Poitou-Charentes, France, 86000
      • CHU Poitiers - La milétrie /ID# 169470
  • Pyrenees-Atlantiques
    • Bayonne, Pyrenees-Atlantiques, France, 64100
      • Centre Hospitalier de la Cote Basque /ID# 170735
  • Rhone
    • Lyon CEDEX 08, Rhone, France, 69373
      • Centre Leon Berard /ID# 170018
  • Sarthe
    • Le Mans CEDEX 9, Sarthe, France, 72037
      • Centre Hospitalier du Mans /ID# 169451
  • Seine-et-Marne
    • Melun CEDEX, Seine-et-Marne, France, 77011
      • Hopital de Melun /ID# 202569
  • Somme
    • Amiens CEDEX 1, Somme, France, 80054
      • CHU Amiens-Picardie Site Sud /ID# 170724
  • Val-d Oise
    • Pontoise, Val-d Oise, France, 95300
      • CH Pontoise - Hopital René Dubos /ID# 170720
    • Pontoise, Val-d Oise, France, 95300
      • CH Pontoise - Hopital René Dubos /ID# 201329
  • Val-de-Marne
    • Villejuif Cedex, Val-de-Marne, France, 94805
      • Institut Gustave Roussy /ID# 202436
  • Yvelines
    • St Germain en Laye, Yvelines, France, 78100
      • CHI POISSY - Saint-Germain-en-Laye /ID# 169966

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adult patients starting venetoclax treatment for CLL.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Patients with Chronic Lymphocytic Leukemia (CLL); Patients with diagnosed CLL and eligible to venetoclax as per label

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	Up to approximately 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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).	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.	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.	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.	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.	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.	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.	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.	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.	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.	Up to approximately 48 months

Collaborators and Investigators

• Sponsor: AbbVie

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): March 9, 2018
• Primary Completion (Anticipated): June 30, 2026
• Study Completion (Anticipated): June 30, 2026

Study Registration Dates

• First Submitted: January 24, 2018
• First Submitted That Met QC Criteria: January 24, 2018
• First Posted (Actual): January 30, 2018

Study Record Updates

• Last Update Posted (Actual): January 26, 2023
• Last Update Submitted That Met QC Criteria: January 25, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: Cancer; Venetoclax; Venclyxto; Chronic Lynmphocytic Leukemia (CLL)
• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Leukemia, B-Cell; Leukemia; Leukemia, Lymphocytic, Chronic, B-Cell; Leukemia, Lymphoid
• Other Study ID Numbers: P16-913

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No