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RecruitingNCT03342144VeRVeUpdated Sep 25, 2026

Study of the Use of Venetoclax in Participants With Chronic Lymphocytic Leukemia (CLL) Under Real-Life Setting

An observational study in Chronic Lymphocytic Leukemia (CLL), sponsored by AbbVie. Recruiting at 72 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-25.

Sponsored by AbbVie · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
500
Ages
18 Years and older
Sex
All
01

Study summary

An observational study to assess the effectiveness, health economic-relevant costs and participant reported outcomes in participants with Chronic lymphocytic leukemia (CLL) receiving venetoclax as a monotherapy or in combination with rituximab, obinutuzumab, ibrutinib, or acalabrutinib as prescribed at the discretion of the physician and in accordance with local clinical practice and label.

02

Conditions studied

  • Chronic Lymphocytic Leukemia (CLL)

Keywords

  • Chronic Lymphocytic Leukemia (CLL)
  • Cancer
  • Leukemia
  • venetoclax
  • rituximab
  • obinutuzumab
  • ABT-199
  • venclexta
  • venclyxto
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Participants with chronic lymphocytic leukemia (CLL) administering venetoclax per the local label.

Inclusion criteria

- Participant with chronic lymphocytic leukemia (CLL) who start venetoclax therapy can be included in the study if treated as specified in the local label for any specific line of treatment.

Exclusion criteria

Exclusion Criteria:

- None

04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
500 participants (estimated)

Groups and cohorts

  • Participants Receiving Venetoclax

    Participants with Chronic Lymphocytic Leukemia (CLL) receiving venetoclax.

  • Participants Receiving Venetoclax + Rituximab

    Participants with CLL receiving venetoclax in combination with rituximab.

  • Participants Receiving Venetoclax + Obinutuzumab

    Participants with CLL receiving venetoclax in combination with obinutuzumab.

  • Participants Receiving Venetoclax + Ibrutinib

    Participants with CLL receiving venetoclax in combination with ibrutinib.

  • Participants Receiving Venetoclax + Acalabrutinib

    Participants with CLL receiving venetoclax in combination with acalabrutinib.

05

What researchers measure

Primary outcomes

  1. Percentage of Participants Achieving Best Overall Response Rate (ORR)

    ORR is defined as the percentage of participants achieving partial response (PR) and complete response with incomplete regeneration of bone marrow (CRi) and complete response (CR) according to physician's assessment to therapy with venetoclax.

    Time frame: Up to 12 months

06

Study locations

3 of 72 sites recruiting
  • Universitaetsklinikum St. Poelten /ID# 221152
    Sankt Pölten, Lower Austria 3100, Austria
    Completed
  • Medizinische Universitaet Graz /ID# 221155
    Graz, Styria 8010, Austria
    Completed
  • Landeskrankenhaus Salzburg-Universitaetsklinikum der PMU (LKH) /ID# 221153
    Salzburg, 5020, Austria
    Active, not recruiting
  • Hanusch Krankenhaus /ID# 221151
    Vienna, 1140, Austria
    Completed
  • Stauferklinikum Schwaebisch Gmuend /ID# 201518
    Mutlangen, Baden-Wurttemberg 73557, Germany
    Completed
  • Onkologische Praxis /ID# 201545
    Stuttgart, Baden-Wurttemberg 70174, Germany
    Completed
  • Schwarzwald-Baar-Klinikum /ID# 208176
    Villingen-Schwenningen, Baden-Wurttemberg 78052, Germany
    Completed
  • MVZ am Klinikum Aschaffenburg Onkologie /ID# 201548
    Aschaffenburg, Bavaria 63739, Germany
    Completed
  • Studienzentrum Aschaffenburg /ID# 204125
    Aschaffenburg, Bavaria 63739, Germany
    Completed
  • Gemeinschaftspraxis Dr. Heinrich und Prof. Bangerter /ID# 200950
    Augsburg, Bavaria 86150, Germany
    Completed
  • Drs. Tanzer, Chirca, Stoeberl /ID# 202613
    Bad Reichenhall, Bavaria 83435, Germany
    Completed
  • Internistische Schwerpunktpraxen, Erlangen /ID# 200949
    Erlangen, Bavaria 91052, Germany
    Completed
  • Onkologie Hof /ID# 201531
    Hof, Bavaria 95028, Germany
    Completed
  • Praxis Dr. Stauch /ID# 202611
    Kronach, Bavaria 96317, Germany
    Completed
  • VK&K Studien GbR /ID# 202614
    Landshut, Bavaria 84036, Germany
    Completed
  • Haemato-Onkologie /ID# 205236
    Munich, Bavaria 81241, Germany
    Completed
  • Praxis Dr. Kreher /ID# 202604
    Bad Liebenwerda, Brandenburg 04924, Germany
    Completed
  • Praxis Dres. Kiehl/Stein /ID# 210052
    Frankfurt (Oder), Brandenburg 15236, Germany
    Completed
  • MVZ f. Blut- u.Krebserkrankungen /ID# 206704
    Potsdam, Brandenburg 14467, Germany
    Completed
  • Ambulantes Tumorzentrum Bremerhaven /ID# 224353
    Bremerhaven, Free Hanseatic City of Bremen 27576, Germany
    Completed
  • Centrum fuer Haematologie und Onkologie Bethanien /ID# 206701
    Frankfurt am Main, Hesse 60389, Germany
    Completed
  • MVZ Dres. Cordes & Partner /ID# 202598
    Frankfurt am Main, Hesse 60596, Germany
    Completed
  • Klinikum Frankfurt Hoechst /ID# 210048
    Frankfurt am Main, Hesse 65929, Germany
    Completed
  • Varisano Klinikum Frankfurt Hoechst /ID# 288028
    Frankfurt am Main, Hesse 65929, Germany
    Recruiting
  • Onkologische Schwerpunktpraxis Hanau /ID# 287948
    Hanau, Hesse 63450, Germany
    Recruiting
  • Praxis Dres. Tebbe/Mayer /ID# 206730
    Kassel, Hesse 34125, Germany
    Completed
  • Onkologische Kooperation Harz /ID# 201550
    Goslar, Lower Saxony 38642, Germany
    Completed
  • OAZ Hannover /ID# 201538
    Hanover, Lower Saxony 30171, Germany
    Completed
  • Onkolologische Praxis Oldenburg /ID# 202607
    Oldenburg, Lower Saxony 26121, Germany
    Completed
  • MVZ der Paracelsus-Klinik /ID# 201541
    Osnabrück, Lower Saxony 49076, Germany
    Completed
  • Med. Studiengesellschaft Nord West GmbH /ID# 201535
    Westerstede, Lower Saxony 26655, Germany
    Completed
  • Praxis Dres. Plewe/Losem /ID# 202606
    Neuss, North Rhine-Westphalia 41462, Germany
    Completed
  • Hämatologie und Onkologie /ID# 205247
    Kaiserslautern, Rhineland-Palatinate 67655, Germany
    Completed
  • Praxis Dr. Klaproth/Cura /ID# 216413
    Neunkirchen, Saarland 66538, Germany
    Completed
  • Onkozentrum Dresden /ID# 202599
    Dresden, Saxony 01127, Germany
    Completed
  • BAG Freiberg-Richter, Jacobasch, Illmer, Wolf /ID# 201532
    Dresden, Saxony 01307, Germany
    Completed
  • Evidia MVZ III Oncology Halle /ID# 218354
    Halle, Saxony-Anhalt 06110, Germany
    Completed
  • Luebecker Oncology Practice /ID# 200952
    Lübeck, Schleswig-Holstein 23562, Germany
    Completed
  • Friedrich-Ebert-Krankenhaus GmbH /ID# 206206
    Neumünster, Schleswig-Holstein 24534, Germany
    Completed
  • Praxis Dres. Krober/Stosiek /ID# 206729
    Regensburg, State of Berlin 93053, Germany
    Completed
  • Caritas-Krankenhaus gGmbH /ID# 243212
    Bad Mergentheim, 97980, Germany
    Completed
  • MVZ Klinikum Mittelbaden GmbH /ID# 206207
    Baden-Baden, 76532, Germany
    Completed
  • Praxis für Hämatologie und Onkologie /ID# 241763
    Berlin, 10117, Germany
    Completed
  • Onkologische Schwerpunktpraxis /ID# 200953
    Berlin, 10707, Germany
    Completed
  • Praxis am Volkspark /ID# 243195
    Berlin, 10715, Germany
    Completed
  • Onkologie am Segelfliegerdamm /ID# 202603
    Berlin, 12487, Germany
    Completed
  • Pioh Dres. Draube & Partner /ID# 239507
    Cologne, 50674, Germany
    Completed
  • Praxis Dres. Prange-Krex/Mohm /ID# 210049
    Dresden, 01307, Germany
    Completed
  • St. Georg Klinikum Eisenach gemeinnützige GmbH (GKE) /ID# 250200
    Eisenach, 99817, Germany
    Completed
  • Praxis fuer interdisziplinaere Onkolologie und Haematologie /ID# 206999
    Freiburg im Breisgau, 79110, Germany
    Completed
  • MVZ Onkologie GmbH /ID# 212376
    Hagen, 58095, Germany
    Completed
  • OncoResearch Lerchenfeld GmbH /ID# 205237
    Hamburg, 22081, Germany
    Completed
  • Onkologische Gemeinschaftspraxis /ID# 205239
    Hamburg, 22767, Germany
    Completed
  • Evangelisches Krankenhaus Hamm /ID# 206703
    Hamm, 59063, Germany
    Completed
  • Studienzentrum am Raschplatz /ID# 250180
    Hanover, 30161, Germany
    Completed
  • Studienbüro Kamal und Dorn GBR /ID# 234105
    Hanover, 30625, Germany
    Completed
  • Klinikum Idar-Oberstein GmbH /ID# 210046
    Idar-Oberstein, 55743, Germany
    Completed
  • Praxis Fuchs/Koehler /ID# 243215
    Langenhessen, 63225, Germany
    Completed
  • Bruederkrankenhaus St. Josef Paderborn /ID# 202600
    Paderborn, 33098, Germany
    Completed
  • Onkologische Praxis GbR /ID# 206705
    Porta Westfalica, 32457, Germany
    Completed
  • Praxis Dres. Decker/Lakner/Leithäuser /ID# 206208
    Rostock, 18057, Germany
    Completed
  • Diakonieklinikum Schwaebisch Hall /ID# 206205
    Schwäbisch Hall, 74523, Germany
    Completed
  • MVZ am Schlossgarten GmbH /ID# 210043
    Schwetzingen, 68723, Germany
    Completed
  • Kantonsspital Aarau AG /ID# 210034
    Aarau, Canton of Aargau 5001, Switzerland
    Completed
  • Spital Thun /ID# 233714
    Thun, Canton of Bern 3600, Switzerland
    Completed
  • Luzerner Kantonsspital /ID# 210029
    Lucerne, Canton of Lucerne 6000, Switzerland
    Completed
  • Réseau Hospitalier Neuchâtelois /ID# 227865
    Neuchâtel, Canton of Neuchâtel 2000, Switzerland
    Recruiting
  • Kantonsspital St. Gallen /ID# 223037
    Sankt Gallen, Canton of St. Gallen 9007, Switzerland
    Completed
  • KSW Kantonsspital Winterthur /ID# 211068
    Winterthur, Canton of Zurich 8400, Switzerland
    Completed
  • EOC Ospedale Regionale di Bellinzona e Valli /ID# 208782
    Bellinzona, Canton Ticino 6500, Switzerland
    Completed
  • Kantonsspital Münsterlingen /ID# 210035
    Münsterlingen, Thurgau 8596, Switzerland
    Completed
  • Inselspital, Universitaetsspital Bern /ID# 210031
    Bern, 3010, Switzerland
    Completed
07

References and documents

Publications

  • Schwaner I, Kuhn T, Losem C, Wolff T, Otremba B, Zaiss M, Hulsenbeck J, Famulla K, Nosslinger T, Rossi D. Low incidence of tumor lysis syndrome in elderly patients with chronic lymphocytic leukemia treated with venetoclax under real-world conditions: results from the prospective observational VeRVe study. Ann Hematol. 2024 Jun;103(6):2013-2020. doi: 10.1007/s00277-024-05638-7. Epub 2024 Feb 29. PubMed 38421404 ↗

Related links

Individual participant data

Plan to share: Undecided

08

Registry details

Key details

Study ID
NCT03342144
Lead sponsor
AbbVie
Responsible party
Sponsor
First posted
Nov 14, 2017
Start date
Dec 4, 2017
Primary completion
Dec 2030 (estimated)
Completion
Dec 2030 (estimated)
Last update
Sep 25, 2026

Study contacts

Johannes Huelsenbeck
Contact
johannes.huelsenbeck@abbvie.com
+49 611-1720-3036
Stefan Lorenz
Contact
stefan.lorenz@abbvie.com
ABBVIE INC.
study director · AbbVie

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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