NCT03415035

Brief Summary

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

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
269

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2018

Longer than P75 for all trials

Geographic Reach
1 country

60 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 24, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 30, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

March 9, 2018

Completed
8.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Completed
Last Updated

July 16, 2025

Status Verified

July 1, 2025

Enrollment Period

8.2 years

First QC Date

January 24, 2018

Last Update Submit

July 14, 2025

Conditions

Keywords

VenetoclaxVenclyxtoCancerChronic Lynmphocytic Leukemia (CLL)

Outcome Measures

Primary Outcomes (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).

    Up to approximately 12 months

Secondary Outcomes (12)

  • Time To Next Treatment

    Up to approximately 48 months

  • Time to First Response to Treatment (TTR)

    Up to approximately 24 months

  • Minimal Residual Disease

    Up to approximately 24 months

  • Overall Response Rate (ORR)

    Up to approximately 24 months

  • Change in Score of EuroQol 5 Dimensions (EQ-5D-5L)

    Up to approximately 24 months

  • +7 more secondary outcomes

Study Arms (1)

Patients with Chronic Lymphocytic Leukemia (CLL)

Patients with diagnosed CLL and eligible to venetoclax as per label

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients starting venetoclax treatment for CLL.

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (60)

CH Cannes - les Broussailles /ID# 201108

Cannes, Alpes-Maritimes, 06414, France

Location

CH CARCASSONNE - Antoine Gayraud /ID# 202530

Carcassonne, Aude, 11000, France

Location

CHU Clermont-Ferrand /ID# 170736

Clermont, Auvergne-Rhône-Alpes, 63100, France

Location

Clinique Pole santé République /ID# 204658

Clermont-Ferrand, Auvergne, 63050, France

Location

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

Vesoul, Bourgogne-Franche-Comté, 70014, France

Location

CHU de RENNES /ID# 169944

Rennes, Brittany Region, 35033, France

Location

CHU de Besancon - Jean Minjoz /ID# 170721

Besançon, Doubs, 25030, France

Location

Centre Hospitalier de Cornouaille /ID# 169937

Quimper, Finistere, 29000, France

Location

CHU Limoges - Dupuytren 1 /ID# 200193

Limoges, Franche-Comte, 87042, France

Location

Institut Bergonie /ID# 170746

Bordeaux, Gironde, 33000, France

Location

CH Roubaix - Hopital Victor Provo /ID# 170909

Roubaix, Hauts-de-France, 59100, France

Location

CHU Montpellier - Hopital Saint Eloi /ID# 200192

Montpellier, Herault, 34295, France

Location

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

St-Malo, Ille-et-Vilaine, 35400, France

Location

CHRU Tours - Hopital Bretonneau /ID# 169469

Tours, Indre-et-Loire, 37044, France

Location

CHU Grenoble - Hopital Michallon /ID# 170741

La Tronche, Isere, 38700, France

Location

CHU Reims - Hôpital Robert Debre /ID# 170917

Reims, Marne, 51092, France

Location

CHRU Nancy - Hopitaux de Brabois /ID# 170855

Vandœuvre-lès-Nancy, Meurthe-et-Moselle, 54500, France

Location

CH Bretagne Atlantique /ID# 200191

Vannes, Morbihan, 56017, France

Location

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

Thionville, Moselle, 57100, France

Location

IUCT Oncopole /ID# 170749

Toulouse, Occitanie, 31059, France

Location

AP-HP - Hopital Bicetre /ID# 170747

Le Kremlin-Bicêtre, Paris, 94270, France

Location

Hopital de la Conception /ID# 201981

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

Location

Centre Hospitalier de la Cote Basque /ID# 170735

Bayonne, Pyrenees-Atlantiques, 64100, France

Location

Centre Leon Berard /ID# 170018

Lyon, Rhone, 69373, France

Location

Clinique Victor Hugo /ID# 169973

Le Mans, Sarthe, 72000, France

Location

Centre Hospitalier du Mans /ID# 169451

Le Mans, Sarthe, 72037, France

Location

Hopital de Melun /ID# 202569

Melun, Seine-et-Marne, 77011, France

Location

Centre Henri Becquerel /ID# 169948

Rouen, Seine-Maritime, 76038, France

Location

CHU Amiens-Picardie Site Sud /ID# 170724

Amiens, Somme, 80054, France

Location

Institut Gustave Roussy /ID# 202436

Villejuif, Val-de-Marne, 94805, France

Location

CHU Poitiers - La miletrie /ID# 169470

Poitiers, Vienne, 86000, France

Location

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

Saint-Germain-en-Laye, Yvelines, 78100, France

Location

Ch Agen /Id# 170742

Agen, 47923, France

Location

CH Victor Dupouy /ID# 169946

Argenteuil, 95100, France

Location

Ch Blois /Id# 170727

Blois, 41016, France

Location

CHRU de Brest - Hopital Morvan /ID# 169457

Brest, 29200, France

Location

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

Caen, 14033, France

Location

Hopital Prive Sevigne /Id# 170718

Cesson-Sévigné, 35510, France

Location

Medipole de Savoie /ID# 169454

Challes-les-Eaux, 73190, France

Location

CH William Morey /ID# 169939

Chalon-sur-Saône, 71321, France

Location

Centre Hospitalier de CHOLET /ID# 171215

Cholet, 49300, France

Location

Hopital d'Instruction des Armées PERCY /ID# 170740

Clamart, 92141, France

Location

Centre Joseph BELOT /ID# 170853

Désertines, 03030, France

Location

CH Annecy Genevois - Site Annecy /ID# 200826

Epagny Metz Tessy, 74370, France

Location

Centre Hospitalier de Versailles André Mignot /ID# 169950

Le Chesnay, 78150, France

Location

CH Libourne - Hopital Robert Boulin /ID# 170739

Libourne, 33500, France

Location

Hopital Saint Vincent de Paul /ID# 169956

Lille, 59020, France

Location

Clinique de la Sauvegarde /ID# 169904

Lyon, 69009, France

Location

CH Princesse Grace /ID# 200196

Monaco, 98000, France

Location

CH Mont de MARSAN /ID# 169955

Mont-de-Marsan, 40024, France

Location

Ch Mulhouse /Id# 170726

Mulhouse, 68100, France

Location

Polyclinique le LANGUEDOC /ID# 169925

Narbonne, 11100, France

Location

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

Orléans, 45067, France

Location

Hôpital Saint-Louis /ID# 170856

Paris, 75010, France

Location

Centre Hospitalier de Perpignan /ID# 170743

Perpignan, 66000, France

Location

CH Périgueux /ID# 169458

Périgueux, 24019, France

Location

CH Saint-Brieuc /ID# 171076

Saint-Brieuc, 22000, France

Location

Hopital Nord Franche Comté /ID# 170744

Trévenans, 90400, France

Location

Hopital Avicenne - APHP /ID# 169940

Bobigny, Île-de-France Region, 93000, France

Location

Hopital Pitie Salpetriere /ID# 169974

Paris, Île-de-France Region, 75013, France

Location

Related Links

MeSH Terms

Conditions

Neoplasms

Study Officials

  • ABBVIE INC.

    AbbVie

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 24, 2018

First Posted

January 30, 2018

Study Start

March 9, 2018

Primary Completion

June 1, 2026

Study Completion

June 1, 2026

Last Updated

July 16, 2025

Record last verified: 2025-07

Locations