Venetoclax for chronic lymphocytic leukemia in real-world care
Observational Study of the Use of Venetoclax in Patients With Chronic Lymphocytic Leukemia (CLL) Under Real-Life Setting in Austria, Germany and Switzerland
This study will see how well venetoclax works and how patients do when it is used alone or with other common CLL drugs in routine clinical care.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 500 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | AbbVie Industry-sponsored |
| Drugs / interventions | rituximab, obinutuzumab, ibrutinib, acalabrutinib |
| Locations | 70 sites (Sankt Pölten, Lower Austria and 69 other locations) |
| Trial ID | NCT03342144 on ClinicalTrials.gov |
What this trial studies
This observational study enrolls patients with CLL who begin venetoclax as prescribed in routine clinical practice and collects clinical outcomes, healthcare resource use, and patient-reported outcomes. Patients may receive venetoclax alone or in combination with rituximab, obinutuzumab, ibrutinib, or acalabrutinib according to their physician's discretion. Data are collected at participating centers in Austria and follow participants over time to capture treatment effectiveness, adverse events, and cost-related information. No experimental treatments are assigned by the study and all medical decisions follow local labels and standard care.
Who should consider this trial
Good fit: Adults with chronic lymphocytic leukemia who are starting venetoclax treatment (alone or with approved combination agents) according to local labeling and treated at a participating center are eligible.
Not a fit: Patients who are not treated with venetoclax, who require investigational therapies outside local labels, or who cannot attend a participating site are unlikely to gain direct benefit from participating.
Why it matters
Potential benefit: If successful, the study could provide real-world evidence to help doctors and health systems choose and fund venetoclax-based options for people with CLL.
How similar studies have performed: Randomized clinical trials have shown venetoclax is effective in CLL and other observational series have reported comparable real-world outcomes, so this study builds on existing evidence.
Eligibility criteria
Show full inclusion / exclusion criteria
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: \- None
Where this trial is running
Sankt Pölten, Lower Austria and 69 other locations
- Universitaetsklinikum St. Poelten /ID# 221152 — Sankt Pölten, Lower Austria, Austria (Recruiting)
- Medizinische Universitaet Graz /ID# 221155 — Graz, Styria, Austria (Completed)
- Landeskrankenhaus Salzburg-Universitaetsklinikum der PMU (LKH) /ID# 221153 — Salzburg, Austria (Active_not_recruiting)
- Hanusch Krankenhaus /ID# 221151 — Vienna, Austria (Completed)
- Stauferklinikum Schwaebisch Gmuend /ID# 201518 — Mutlangen, Baden-Wurttemberg, Germany (Completed)
- Onkologische Praxis /ID# 201545 — Stuttgart, Baden-Wurttemberg, Germany (Completed)
- Schwarzwald-Baar-Klinikum /ID# 208176 — Villingen-Schwenningen, Baden-Wurttemberg, Germany (Active_not_recruiting)
- MVZ am Klinikum Aschaffenburg Onkologie /ID# 201548 — Aschaffenburg, Bavaria, Germany (Active_not_recruiting)
- Studienzentrum Aschaffenburg /ID# 204125 — Aschaffenburg, Bavaria, Germany (Active_not_recruiting)
- Gemeinschaftspraxis Dr. Heinrich und Prof. Bangerter /ID# 200950 — Augsburg, Bavaria, Germany (Completed)
- Drs. Tanzer, Chirca, Stoeberl /ID# 202613 — Bad Reichenhall, Bavaria, Germany (Completed)
- Internistische Schwerpunktpraxen, Erlangen /ID# 200949 — Erlangen, Bavaria, Germany (Completed)
- Onkologie Hof /ID# 201531 — Hof, Bavaria, Germany (Completed)
- Praxis Dr. Stauch /ID# 202611 — Kronach, Bavaria, Germany (Active_not_recruiting)
- VK&K Studien GbR /ID# 202614 — Landshut, Bavaria, Germany (Active_not_recruiting)
- Haemato-Onkologie /ID# 205236 — Munich, Bavaria, Germany (Active_not_recruiting)
- Praxis Dr. Kreher /ID# 202604 — Bad Liebenwerda, Brandenburg, Germany (Active_not_recruiting)
- Praxis Dres. Kiehl/Stein /ID# 210052 — Frankfurt (Oder), Brandenburg, Germany (Completed)
- MVZ f. Blut- u.Krebserkrankungen /ID# 206704 — Potsdam, Brandenburg, Germany (Active_not_recruiting)
- Ambulantes Tumorzentrum Bremerhaven /ID# 224353 — Bremerhaven, Free Hanseatic City of Bremen, Germany (Completed)
- Centrum fuer Haematologie und Onkologie Bethanien /ID# 206701 — Frankfurt am Main, Hesse, Germany (Active_not_recruiting)
- MVZ Dres. Cordes & Partner /ID# 202598 — Frankfurt am Main, Hesse, Germany (Active_not_recruiting)
- Klinikum Frankfurt Hoechst /ID# 210048 — Frankfurt am Main, Hesse, Germany (Completed)
- Praxis Dres. Tebbe/Mayer /ID# 206730 — Kassel, Hesse, Germany (Active_not_recruiting)
- Onkologische Kooperation Harz /ID# 201550 — Goslar, Lower Saxony, Germany (Active_not_recruiting)
- OAZ Hannover /ID# 201538 — Hanover, Lower Saxony, Germany (Active_not_recruiting)
- Onkolologische Praxis Oldenburg /ID# 202607 — Oldenburg, Lower Saxony, Germany (Active_not_recruiting)
- MVZ der Paracelsus-Klinik /ID# 201541 — Osnabrück, Lower Saxony, Germany (Completed)
- Med. Studiengesellschaft Nord West GmbH /ID# 201535 — Westerstede, Lower Saxony, Germany (Completed)
- Praxis Dres. Plewe/Losem /ID# 202606 — Neuss, North Rhine-Westphalia, Germany (Active_not_recruiting)
- Hämatologie und Onkologie /ID# 205247 — Kaiserslautern, Rhineland-Palatinate, Germany (Active_not_recruiting)
- Praxis Dr. Klaproth/Cura /ID# 216413 — Neunkirchen, Saarland, Germany (Completed)
- Onkozentrum Dresden /ID# 202599 — Dresden, Saxony, Germany (Active_not_recruiting)
- BAG Freiberg-Richter, Jacobasch, Illmer, Wolf /ID# 201532 — Dresden, Saxony, Germany (Completed)
- Luebecker Oncology Practice /ID# 200952 — Lübeck, Schleswig-Holstein, Germany (Completed)
- Friedrich-Ebert-Krankenhaus GmbH /ID# 206206 — Neumünster, Schleswig-Holstein, Germany (Active_not_recruiting)
- Praxis Dres. Krober/Stosiek /ID# 206729 — Regensburg, State of Berlin, Germany (Active_not_recruiting)
- Caritas-Krankenhaus gGmbH /ID# 243212 — Bad Mergentheim, Germany (Completed)
- MVZ Klinikum Mittelbaden GmbH /ID# 206207 — Baden-Baden, Germany (Completed)
- Praxis für Hämatologie und Onkologie /ID# 241763 — Berlin, Germany (Completed)
- Onkologische Schwerpunktpraxis /ID# 200953 — Berlin, Germany (Completed)
- Praxis am Volkspark /ID# 243195 — Berlin, Germany (Completed)
- Onkologie am Segelfliegerdamm /ID# 202603 — Berlin, Germany (Completed)
- Pioh Dres. Draube & Partner /ID# 239507 — Cologne, Germany (Completed)
- Praxis Dres. Prange-Krex/Mohm /ID# 210049 — Dresden, Germany (Active_not_recruiting)
- St. Georg Klinikum Eisenach gemeinnützige GmbH (GKE) /ID# 250200 — Eisenach, Germany (Completed)
- Praxis fuer interdisziplinaere Onkolologie und Haematologie /ID# 206999 — Freiburg im Breisgau, Germany (Active_not_recruiting)
- MVZ Onkologie GmbH /ID# 212376 — Hagen, Germany (Completed)
- onkomedic GbR /ID# 218354 — Halle, Germany (Completed)
- OncoResearch Lerchenfeld GmbH /ID# 205237 — Hamburg, Germany (Active_not_recruiting)
+20 more sites — see ClinicalTrials.gov for the full list.
Study contacts
- Study coordinator: Johannes Huelsenbeck
- Email: johannes.huelsenbeck@abbvie.com
- Phone: +49 611-1720-3036
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.