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

NCT03342144 | Recruiting

• 1 other identifier: P17-132
• Study Type: observational
• Target: 500
• Locations: 3 countries
• Sites: 70

Brief 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.

Conditions

Chronic Lymphocytic Leukemia (CLL)

Keywords

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

Outcome Measures

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.

  Up to 12 months

Study Arms (5)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• \- 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.

You may not qualify if:

• \- None

Sponsors & Collaborators

• AbbVie: lead

Study Sites (70)

Universitaetsklinikum St. Poelten /ID# 221152

Sankt Pölten, Lower Austria, 3100, Austria

RECRUITING

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

ACTIVE NOT RECRUITING

MVZ am Klinikum Aschaffenburg Onkologie /ID# 201548

Aschaffenburg, Bavaria, 63739, Germany

ACTIVE NOT RECRUITING

Studienzentrum Aschaffenburg /ID# 204125

Aschaffenburg, Bavaria, 63739, Germany

ACTIVE NOT RECRUITING

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

ACTIVE NOT RECRUITING

VK&K Studien GbR /ID# 202614

Landshut, Bavaria, 84036, Germany

ACTIVE NOT RECRUITING

Haemato-Onkologie /ID# 205236

Munich, Bavaria, 81241, Germany

ACTIVE NOT RECRUITING

Praxis Dr. Kreher /ID# 202604

Bad Liebenwerda, Brandenburg, 04924, Germany

ACTIVE NOT RECRUITING

Praxis Dres. Kiehl/Stein /ID# 210052

Frankfurt (Oder), Brandenburg, 15236, Germany

COMPLETED

MVZ f. Blut- u.Krebserkrankungen /ID# 206704

Potsdam, Brandenburg, 14467, Germany

ACTIVE NOT RECRUITING

Ambulantes Tumorzentrum Bremerhaven /ID# 224353

Bremerhaven, City state Bremen, 27576, Germany

COMPLETED

Centrum fuer Haematologie und Onkologie Bethanien /ID# 206701

Frankfurt am Main, Hesse, 60389, Germany

ACTIVE NOT RECRUITING

MVZ Dres. Cordes & Partner /ID# 202598

Frankfurt am Main, Hesse, 60596, Germany

ACTIVE NOT RECRUITING

Klinikum Frankfurt Hoechst /ID# 210048

Frankfurt am Main, Hesse, 65929, Germany

COMPLETED

Praxis Dres. Tebbe/Mayer /ID# 206730

Kassel, Hesse, 34125, Germany

ACTIVE NOT RECRUITING

Onkologische Kooperation Harz /ID# 201550

Goslar, Lower Saxony, 38642, Germany

ACTIVE NOT RECRUITING

OAZ Hannover /ID# 201538

Hanover, Lower Saxony, 30171, Germany

ACTIVE NOT RECRUITING

Onkolologische Praxis Oldenburg /ID# 202607

Oldenburg, Lower Saxony, 26121, Germany

ACTIVE NOT RECRUITING

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

ACTIVE NOT RECRUITING

Hämatologie und Onkologie /ID# 205247

Kaiserslautern, Rhineland-Palatinate, 67655, Germany

ACTIVE NOT RECRUITING

Praxis Dr. Klaproth/Cura /ID# 216413

Neunkirchen, Saarland, 66538, Germany

COMPLETED

Onkozentrum Dresden /ID# 202599

Dresden, Saxony, 01127, Germany

ACTIVE NOT RECRUITING

BAG Freiberg-Richter, Jacobasch, Illmer, Wolf /ID# 201532

Dresden, Saxony, 01307, Germany

COMPLETED

Luebecker Oncology Practice /ID# 200952

Lübeck, Schleswig-Holstein, 23562, Germany

COMPLETED

Friedrich-Ebert-Krankenhaus GmbH /ID# 206206

Neumünster, Schleswig-Holstein, 24534, Germany

ACTIVE NOT RECRUITING

Praxis Dres. Krober/Stosiek /ID# 206729

Regensburg, State of Berlin, 93053, Germany

ACTIVE NOT RECRUITING

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

ACTIVE NOT RECRUITING

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

ACTIVE NOT RECRUITING

MVZ Onkologie GmbH /ID# 212376

Hagen, 58095, Germany

COMPLETED

onkomedic GbR /ID# 218354

Halle, 06110, Germany

COMPLETED

OncoResearch Lerchenfeld GmbH /ID# 205237

Hamburg, 22081, Germany

ACTIVE NOT RECRUITING

Onkologische Gemeinschaftspraxis /ID# 205239

Hamburg, 22767, Germany

ACTIVE NOT RECRUITING

Evangelisches Krankenhaus Hamm /ID# 206703

Hamm, 59063, Germany

ACTIVE NOT RECRUITING

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

ACTIVE NOT RECRUITING

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

ACTIVE NOT RECRUITING

Praxis Dres. Decker/Lakner/Leithäuser /ID# 206208

Rostock, 18057, Germany

ACTIVE NOT RECRUITING

Diakonieklinikum Schwaebisch Hall /ID# 206205

Schwäbisch Hall, 74523, Germany

ACTIVE NOT RECRUITING

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

Related Publications (1)

• 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.

  PMID: 38421404 DERIVED

Related Links

• Related Info

MeSH Terms

Conditions

Leukemia, Lymphocytic, Chronic, B-Cell; Neoplasms; Leukemia

Condition Hierarchy (Ancestors)

Leukemia, B-Cell; Leukemia, Lymphoid; Neoplasms by Histologic Type; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Central Study Contacts

Johannes Huelsenbeck

CONTACT

+49 611-1720-3036; johannes.huelsenbeck@abbvie.com

Stefan Lorenz

CONTACT

stefan.lorenz@abbvie.com

Study Design

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

Study Record Dates

• First Submitted: November 10, 2017
• First Posted: November 14, 2017
• Study Start: December 4, 2017
• Primary Completion (Estimated): December 1, 2030
• Study Completion (Estimated): December 1, 2030
• Last Updated: December 8, 2025

Record last verified: 2025-12

Locations

CH (9); AU (4); DE (57)