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

Observational Study of the Use of Venetoclax in Patients With Chronic Lymphocytic Leukemia (CLL) Under Real-Life Setting in Austria, Germany and Switzerland

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.

Study Overview

• Status: Recruiting
• Conditions: Chronic Lymphocytic Leukemia (CLL)

• Study Type: Observational
• Enrollment (Estimated): 500

Contacts and Locations

• Study Contact: Name: Johannes Huelsenbeck; Phone Number: +49 611-1720-3036; Email: johannes.huelsenbeck@abbvie.com
• Study Contact Backup: Name: Stefan Lorenz; Email: stefan.lorenz@abbvie.com

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

5

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Still on Venetoclax Monotherapy	Percentage of participants still on venetoclax monotherapy throughout the study.	Up to 24 months
Percentage of Participants Still on Venetoclax in Combination with Rituximab	Percentage of participants still on venetoclax in combination with rituximab throughout the study.	Up to 24 months
Percentage of Participants Receiving Venetoclax Monotherapy with Disease Progression	Disease progression as defined in the study protocol in participants receiving venetoclax monotherapy.	Up to 24 months
Percentage of Participants Receiving Venetoclax in Combination with Obinutuzumab with Disease Progression	Disease progression as defined in the study protocol in participants receiving venetoclax in combination with obinutuzumab.	Up to 24 months
Percentage of Participants Receiving Venetoclax in Combination with Rituximab with Disease Progression	Disease progression as defined in the study protocol in participants receiving venetoclax in combination with rituximab.	Up to 36 months
Overall Survival (OS) Rate in Participants Receiving Venetoclax Monotherapy	Percentage of participants with OS where OS is defined as the number of days from the date of entry in the study to the date of death.	Up to 24 months
Overall Survival (OS) Rate in Participants Receiving Venetoclax in Combination with Obinutuzumab	Percentage of participants with OS where OS is defined as the number of days from the date of entry in the study to the date of death.	Up to 24 months
Overall Survival (OS) Rate in Participants Receiving Venetoclax in Combination with Rituximab	Percentage of participants with OS where OS is defined as the number of days from the date of entry in the study to the date of death.	Up to 36 months
Progression-Free Survival (PFS) Rate in Participants Receiving Venetoclax Monotherapy	Percentage of participants with PFS where PFS is defined as the number of days from the date of entry in the study to the date of the first documented disease progression, start of a subsequent treatment regimen, or death due to any cause, whichever occurs first.	Up to 24 months
Progression-Free Survival (PFS) Rate in Participants Receiving Venetoclax in Combination with Obinutuzumab	Percentage of participants with PFS where PFS is defined as the number of days from the date of entry in the study to the date of the first documented disease progression, start of a subsequent treatment regimen, or death due to any cause, whichever occurs first.	Up to 24 months
Progression-Free Survival (PFS) Rate in Participants Receiving Venetoclax in Combination with Rituximab	Percentage of participants with PFS where PFS is defined as the number of days from the date of entry in the study to the date of the first documented disease progression, start of a subsequent treatment regimen, or death due to any cause, whichever occurs first.	Up to 36 months
Minimal Residual Disease (MRD) measurement on plasma circulating tumor Deoxyribo nucleic acid (DNA) (Switzerland Only)	MRD is defined as less than 1 clonal lymphocyte per 10000 leukocytes in peripheral blood or bone marrow.	Up to 24 months
Percentage of Participants Receiving Venetoclax Monotherapy and Achieving Complete Response (CR)	Complete Response as defined in the study protocol.	Up to 24 months
Percentage of Participants Receiving Venetoclax in Combination with Obinutuzumab and Achieving Complete Response (CR)	Complete Response as defined in the study protocol.	Up to 24 months
Percentage of Participants Receiving Venetoclax in Combination with Rituximab and Achieving Complete Response (CR)	Complete Response as defined in the study protocol.	Up to 36 months
Percentage of Participants Receiving Venetoclax Monotherapy and Achieving Complete Response with Incomplete Regeneration of Bone Marrow (CRi)	Incomplete regeneration of bone marrow (CRi) as defined in the study protocol.	Up 24 months
Percentage of Participants Receiving Venetoclax Combination with Obinutuzumab and Achieving Complete Response with Incomplete Regeneration of Bone Marrow (CRi)	Incomplete regeneration of bone marrow (CRi) as defined in the study protocol.	Up 24 months
Percentage of Participants Receiving Venetoclax Combination with Rituximab and Achieving Complete Response with Incomplete Regeneration of Bone Marrow (CRi)	Incomplete regeneration of bone marrow (CRi) as defined in the study protocol.	Up 36 months
Percentage of Participants Receiving Venetoclax Monotherapy and Achieving Partial Response (PR)	Partial response as defined in the study protocol.	Up to 24 months
Percentage of Participants Receiving Venetoclax Combination with Obinutuzumab and Achieving Partial Response (PR)	Partial response as defined in the study protocol.	Up to 24 months
Percentage of Participants Receiving Venetoclax Combination with Rituximab and Achieving Partial Response (PR)	Partial response as defined in the study protocol.	Up to 36 months
Percentage of Participants Receiving Venetoclax Monotherapy with Progressive Disease	Progressive disease as defined in the study protocol.	Up to 24 months
Percentage of Participants Receiving Venetoclax Combination with Obinutuzumab with Progressive Disease	Progressive disease as defined in the study protocol.	Up to 24 months
Percentage of Participants Receiving Venetoclax Combination with Rituximab with Progressive Disease	Progressive disease as defined in the study protocol.	Up to 36 months
Percentage of Participants Receiving Venetoclax Monotherapy with Stable Disease (SD)	SD is defined as percentage of all participants not having PD, but who do not meet the criteria for PR or CR.	Up to 24 months
Percentage of Participants Receiving Venetoclax Combination with Obinutuzumab with Stable Disease (SD)	SD is defined as percentage of all participants not having PD, but who do not meet the criteria for PR or CR.	Up to 24 months
Percentage of Participants Receiving Venetoclax Combination with Rituximab with Stable Disease (SD)	SD is defined as percentage of all participants not having PD, but who do not meet the criteria for PR or CR.	Up to 36 months
Quality of Life using EORTC QLQ-C30 Scores	European Organization for Research and Treatment of Cancer (EORTC) Quality of Life questionnaire (QLQ) developed to assess the quality of life of cancer patients. and is based on multi-item and single-item scales. The core questionnaire contains 5 functional scales, 3 symptom scales, 1 global health status scale, as well as 6 single-item measures.	Up to 104 weeks
QLQ-CLL 16/17 Scores	Quality of Life Questionnaire - Chronic Lymphocytic Leukemia (QLQ-CLL)16/17 is designed for participants with stage 0 to stage 4 chronic lymphocytic leukemia. It is used to assess 5 domains of health-related quality of life important in CLL: fatigue, side effects and symptoms of disease, infection and social activities or future illness-related concerns.	Up to 104 weeks
European Quality of Life 5 Dimensions (EQ-5D-5L) including visual analogue scale (VAS)	The EQ-5D-5L is a standardized non-disease specific instrument for describing and valuing health-related quality of life. EQ-5D-5L questionnaire consists of 2 pages: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The EQ-5D-5L questionnaire plus a VAS will be used to assess general health in 5 dimensions (mobility, self-care, usual activities, pain/discomfort anxiety/depression).	Up 24 months
Management of Venetoclax Therapy	Management of venetoclax therapy includes time from blood sampling to laboratory result availability, changes in laboratory values, occurence of tumor lysis syndrome and possible interventions, length and reason for hospitalizations, duration of IV hydration, therapy modifications, supportive therapies other criteria described in the protocol.	Up to 24 Months
Health Resource Utilization (HRU) per year	Health Resource Utilization (HRU) per year will be assessed.	Up to 24 Months
Clonal evolution and eradication of Tumor Protein p53 (TP53) mutated clones associated with treatment in relation to MRD negativity (Switzerland Only)	Clonal evolution and eradication of TP53 mutated clones associated with treatment in relation to MRD negativity is evaluated	Up to 24 months
Value of MRD Assessment	Value of MRD assessment by flow cytometry compared to comprehensive MRD assessment including flow cytometry plus NGS in peripheral blood as described in Annex II (Switzerland only).	Up to 24 Months

Collaborators and Investigators

• Sponsor: AbbVie
• Investigators: Study Director: ABBVIE INC., AbbVie

Publications and helpful links

General 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.

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): December 4, 2017
• Primary Completion (Estimated): December 1, 2030
• Study Completion (Estimated): December 1, 2030

Study Registration Dates

• First Submitted: November 10, 2017
• First Submitted That Met QC Criteria: November 10, 2017
• First Posted (Actual): November 14, 2017

Study Record Updates

• Last Update Posted (Actual): December 8, 2025
• Last Update Submitted That Met QC Criteria: December 2, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Cancer; rituximab; Leukemia; Chronic Lymphocytic Leukemia (CLL); ABT-199; venetoclax; obinutuzumab; venclexta; venclyxto
• Additional Relevant MeSH Terms: Pathologic Processes; Chronic Disease; Disease Attributes; Immune System Diseases; Neoplasms by Histologic Type; Hematologic Diseases; Lymphatic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Leukemia, B-Cell; Leukemia, Lymphoid; Pathological Conditions, Signs and Symptoms; Hemic and Lymphatic Diseases; Neoplasms; Leukemia; Leukemia, Lymphocytic, Chronic, B-Cell
• Other Study ID Numbers: P17-132

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No