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Cancer - Chronic Lymphocytic LeukemiaVERONENCT03415035

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

An observational study of Cancer - Chronic Lymphocytic Leukemia, run by AbbVie at 60 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 18 years and older
Conditions the study is for
Cancer - Chronic Lymphocytic Leukemia
How many people
269 participants
Where
60 sitesFrance
Study dates
9 Mar 2018to 17 Jun 2026
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Adult patients starting venetoclax treatment for CLL.

Who may be able to join

  • 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.

Who cannot join

  • Participating in a clinical trial with an investigative drug for CLL within 30 days prior to treatment initiation.

Trial locations and contacts

60 sites in 1 country.

60 sites in 1 country

France60 sites

  • Ch Agen /Id# 170742

    Agen, 47923

  • CHU Amiens-Picardie Site Sud /ID# 170724

    Amiens, Somme, 80054

  • CH Victor Dupouy /ID# 169946

    Argenteuil, 95100

  • Centre Hospitalier de la Cote Basque /ID# 170735

    Bayonne, Pyrenees-Atlantiques, 64100

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

    Besançon, Doubs, 25000

  • Ch Blois /Id# 170727

    Blois, 41016

  • Hopital Avicenne - APHP /ID# 169940

    Bobigny, Île-de-France Region, 93000

  • Institut Bergonie /ID# 170746

    Bordeaux, Gironde, 33000

  • CHRU de Brest - Hopital Morvan /ID# 169457

    Brest, 29200

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

    Caen, Calvados, 14033

  • CH Cannes - les Broussailles /ID# 201108

    Cannes, Alpes-Maritimes, 06414

  • CH CARCASSONNE - Antoine Gayraud /ID# 202530

    Carcassonne, Aude, 11000

  • Hopital Prive Sevigne /Id# 170718

    Cesson-Sévigné, 35510

  • Medipole de Savoie /ID# 169454

    Challes-les-Eaux, 73190

  • CH William Morey /ID# 169939

    Chalon-sur-Saône, 71321

  • Centre Hospitalier de CHOLET /ID# 171215

    Cholet, 49300

  • Hopital d'Instruction des Armées PERCY /ID# 170740

    Clamart, 92141

  • CHU Clermont-Ferrand /ID# 170736

    Clermont, Auvergne-Rhône-Alpes, 63100

  • Clinique Pole santé République /ID# 204658

    Clermont-Ferrand, Auvergne, 63050

  • Centre Joseph BELOT /ID# 170853

    Désertines, 03030

  • CH Annecy Genevois - Site Annecy /ID# 200826

    Epagny Metz Tessy, 74370

  • CHU Grenoble - Hopital Michallon /ID# 170741

    La Tronche, Isere, 38700

  • Centre Hospitalier de Versailles André Mignot /ID# 169950

    Le Chesnay, 78150

  • AP-HP - Hopital Bicetre /ID# 170747

    Le Kremlin-Bicêtre, Paris, 94270

  • Clinique Victor Hugo /ID# 169973

    Le Mans, Sarthe, 72000

  • Centre Hospitalier du Mans /ID# 169451

    Le Mans, Sarthe, 72037

  • CH Libourne - Hopital Robert Boulin /ID# 170739

    Libourne, 33500

  • Hopital Saint Vincent de Paul /ID# 169956

    Lille, 59020

  • CHU Limoges - Dupuytren 1 /ID# 200193

    Limoges, Franche-Comte, 87042

  • Centre Leon Berard /ID# 170018

    Lyon, Rhone, 69373

  • Clinique de la Sauvegarde /ID# 169904

    Lyon, 69009

  • Hopital de la Conception /ID# 201981

    Marseille, Provence-Alpes-Côte d'Azur Region, 13005

  • Hopital de Melun /ID# 202569

    Melun, Seine-et-Marne, 77011

  • CH Princesse Grace /ID# 200196

    Monaco, 98000

  • CH Mont de MARSAN /ID# 169955

    Mont-de-Marsan, 40024

  • CHU Montpellier - Hopital Saint Eloi /ID# 200192

    Montpellier, Herault, 34295

  • Ch Mulhouse /Id# 170726

    Mulhouse, 68100

  • Polyclinique le LANGUEDOC /ID# 169925

    Narbonne, 11100

  • Centre Hospitalier Régional d'Orléans - Hôpital de la Source /ID# 169453

    Orléans, 45067

  • Hopital Saint-Louis /ID# 170856

    Paris, 75010

  • Hopital Pitie Salpetriere /ID# 169974

    Paris, Île-de-France Region, 75013

  • CH Périgueux /ID# 169458

    Périgueux, 24019

  • Centre Hospitalier de Perpignan /ID# 170743

    Perpignan, 66000

  • CHU Poitiers - La miletrie /ID# 169470

    Poitiers, Vienne, 86000

  • Centre Hospitalier de Cornouaille /ID# 169937

    Quimper, Finistere, 29000

  • CHU Reims - Hôpital Robert Debre /ID# 170917

    Reims, Marne, 51092

  • CHU de RENNES /ID# 169944

    Rennes, Brittany Region, 35033

  • CH Roubaix - Hopital Victor Provo /ID# 170909

    Roubaix, Hauts-de-France, 59100

  • Centre De Lutte Contre Le Cancer - Centre Henri Becquerel Normandie Rouen /ID# 169948

    Rouen, Seine-Maritime, 76038

  • CH Saint-Brieuc /ID# 171076

    Saint-Brieuc, 22000

  • CHI POISSY - Saint-Germain-en-Laye /ID# 169966

    Saint-Germain-en-Laye, Yvelines, 78100

  • CH de Saint-Malo - Hôpital Broussais /ID# 169935

    St-Malo, Ille-et-Vilaine, 35400

  • CHR Metz-Thionville - Hopital Bel-Air /ID# 170722

    Thionville, Moselle, 57100

  • IUCT Oncopole /ID# 170749

    Toulouse, Occitanie, 31059

  • CHRU Tours - Hopital Bretonneau /ID# 169469

    Tours, Indre-et-Loire, 37044

  • Hopital Nord Franche Comté /ID# 170744

    Trévenans, 90400

  • Centre Hospitalier Regional Universitaire de Nancy - Hopitaux de Brabois /ID# 170855

    Vandœuvre-lès-Nancy, Meurthe-et-Moselle, 54511

  • CH Bretagne Atlantique /ID# 200191

    Vannes, Morbihan, 56017

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

    Vesoul, Bourgogne-Franche-Comté, 70014

  • Institut Gustave Roussy /ID# 202436

    Villejuif, Val-de-Marne, 94805

Other trials in France

About this study

Official title: 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).

Keywords
Venetoclax, Venclyxto, Cancer, Chronic Lynmphocytic Leukemia (CLL)
Medical subject headings
Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT03415035
Study groupRoleWhat they receive
Patients with Chronic Lymphocytic Leukemia (CLL)Patients with diagnosed CLL and eligible to venetoclax as per label

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: Up to approximately 12 months

Secondary outcomes (12)

  1. 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.

    Measured: Up to approximately 48 months

  2. 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.

    Measured: Up to approximately 24 months

  3. 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).

    Measured: Up to approximately 24 months

  4. 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.

    Measured: Up to approximately 24 months

  5. 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.

    Measured: Up to approximately 24 months

  6. 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.

    Measured: Up to approximately 24 months

  7. 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.

    Measured: Up to approximately 48 months

  8. 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.

    Measured: Up to approximately 48 months

  9. Overall survival (OS)

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

    Measured: Up to approximately 48 months

  10. 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.

    Measured: Up to approximately 48 months

  11. 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.

    Measured: Up to approximately 48 months

  12. 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.

    Measured: Up to approximately 48 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jan 2018
  2. Study start9 Mar 2018
  3. Primary completion17 Jun 2026
  4. Study completion17 Jun 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
269 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03415035
Sponsor's protocol ID
P16-913
Acronym
VERONE
Status last verified
Jul 2026
First submitted
24 Jan 2018
Last updated
23 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Cancer - Chronic Lymphocytic Leukemia, run by AbbVie at 60 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 60 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Best Response of Venetoclax in Participants with Chronic Lymphocytic Leukemia (CLL) up to 12 Months (time frame: Up to approximately 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03415035.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2026.

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