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

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 or obinutuzumab as prescribed at the discretion of the physician and in accordance with local clinical practice and label.

Study Overview

• Status: Active, not recruiting
• Conditions: Chronic Lymphocytic Leukemia (CLL)

• Study Type: Observational
• Enrollment (Estimated): 350

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
    • Landeskrankenhaus Salzburg-Universitätsklinikum der PMU (LKH) /ID# 221153
  • Wien, Austria, 1140
    • Hanusch Krankenhaus /ID# 221151
  • Niederoesterreich
    • Sankt Poelten, Niederoesterreich, Austria, 3100
      • Universitaetsklinikum St. Poelten /ID# 221152
  • Steiermark
    • Graz, Steiermark, Austria, 8010
      • Medizinische Universitaet Graz /ID# 221155
• Germany
  • Bad Mergentheim, Germany, 97980
    • Caritas-Krankenhaus gGmbH /ID# 243212
  • Bad Reichenhall, Germany, 83435
    • Drs. Tanzer, Chirca, Stoeberl /ID# 202613
  • Baden-Baden, Germany, 76532
    • MVZ Klinikum Mittelbaden GmbH /ID# 206207
  • Berlin, Germany, 10117
    • Praxis für Hämatologie und Onkologie /ID# 241763
  • Berlin, Germany, 10707
    • Onkologische Schwerpunktpraxis /ID# 200953
  • Berlin, Germany, 10715
    • Praxis am Volkspark /ID# 243195
  • Bremerhaven, Germany, 27576
    • Ambulantes Tumorzentrum Bremerhaven /ID# 224353
  • Cologne, Germany, 50674
    • Pioh Dres. Draube & Partner /ID# 239507
  • Dresden, Germany, 01307
    • Praxis Dres. Prange-Krex/Mohm /ID# 210049
  • Eisenach, Germany, 99817
    • St. Georg Klinikum Eisenach gemeinnützige GmbH (GKE) /ID# 250200
  • Erlangen, Germany, 91052
    • Internistische Schwerpunktpraxen, Erlangen /ID# 200949
  • Frankfurt, Germany, 65929
    • Klinikum Frankfurt Hoechst /ID# 210048
  • Freiburg im Breisgau, Germany, 79110
    • Praxis fuer interdisziplinaere Onkolologie und Haematologie /ID# 206999
  • Hagen, Germany, 58095
    • MVZ Onkologie GmbH /ID# 212376
  • Halle (Saale), Germany, 06110
    • Onkomedic GbR /ID# 218354
  • Hamburg, Germany, 22081
    • OncoResearch Lerchenfeld GmbH /ID# 205237
  • Hamburg, Germany, 22767
    • Onkologische Gemeinschaftspraxis /ID# 205239
  • Hamm, Germany, 59063
    • Evangelisches Krankenhaus Hamm /ID# 206703
  • Hanover, Germany, 30625
    • Studienbüro Kamal und Dorn GBR /ID# 234105
  • Hanover, Germany, 30161
    • Studienzentrum am Raschplatz /ID# 250180
  • Idar-Oberstein, Germany, 55743
    • Klinikum Idar-Oberstein GmbH /ID# 210046
  • Langen (Hessen), Germany, 63225
    • Praxis Fuchs/Koehler /ID# 243215
  • Luebeck, Germany, 23562
    • Luebecker Oncology Practice /ID# 200952
  • Neunkirchen, Germany, 66538
    • Praxis Dr. Klaproth/Cura /ID# 216413
  • Paderborn, Germany, 33098
    • Bruederkrankenhaus St. Josef Paderborn /ID# 202600
  • Porta Westfalica, Germany, 32457
    • Onkologische Praxis GbR /ID# 206705
  • Rostock, Germany, 18057
    • Praxis Dres. Decker/Lakner/Leithäuser /ID# 206208
  • Schwaebisch Hall, Germany, 74523
    • Diakonieklinikum Schwaebisch Hall /ID# 206205
  • Schwetzingen, Germany, 68723
    • MVZ am Schlossgarten GmbH /ID# 210043
  • Baden-Wuerttemberg
    • Mutlangen, Baden-Wuerttemberg, Germany, 73557
      • Stauferklinikum Schwaebisch Gmuend /ID# 201518
    • Stuttgart, Baden-Wuerttemberg, Germany, 70174
      • Onkologische Praxis /ID# 201545
    • Villingen-Schwenningen, Baden-Wuerttemberg, Germany, 78052
      • Schwarzwald-Baar-Klinikum /ID# 208176
  • Bayern
    • Aschaffenburg, Bayern, Germany, 63739
      • MVZ am Klinikum Aschaffenburg Onkologie /ID# 201548
    • Aschaffenburg, Bayern, Germany, 63739
      • Studienzentrum Aschaffenburg /ID# 204125
    • Augsburg, Bayern, Germany, 86150
      • Haematologisch-Onkologische Praxis im Zentrum Augsburg /ID# 200950
    • Berlin, Bayern, Germany, 12487
      • Onkologie am Segelfliegerdamm /ID# 202603
    • Hof, Bayern, Germany, 95028
      • Onkologie Hof /ID# 201531
    • Kronach, Bayern, Germany, 96317
      • Praxis Dr. Stauch /ID# 202611
    • Landshut, Bayern, Germany, 84036
      • VK&K Studien GbR /ID# 202614
    • Muenchen, Bayern, Germany, 81241
      • Haemato-Onkologie /ID# 205236
  • Berlin
    • Regensburg, Berlin, Germany, 93053
      • Praxis Dres. Krober/Stosiek /ID# 206729
  • Brandenburg
    • Bad Liebenwerda, Brandenburg, Germany, 04924
      • Praxis Dr. Kreher /ID# 202604
    • Frankfurt (Oder), Brandenburg, Germany, 15236
      • Praxis Dres. Kiehl/Stein /ID# 210052
    • Potsdam, Brandenburg, Germany, 14467
      • MVZ f. Blut- u.Krebserkrankungen /ID# 206704
  • Hessen
    • Frankfurt am Main, Hessen, Germany, 60389
      • Centrum für Haematologie /ID# 206701
    • Frankfurt am Main, Hessen, Germany, 60596
      • MVZ Dres. Cordes & Partner /ID# 202598
    • Kassel, Hessen, Germany, 34125
      • Praxis Dres. Tebbe/Mayer /ID# 206730
  • Niedersachsen
    • Goslar, Niedersachsen, Germany, 38642
      • Onkologische Kooperation Harz /ID# 201550
    • Hannover, Niedersachsen, Germany, 30171
      • OAZ Hannover /ID# 201538
    • Oldenburg, Niedersachsen, Germany, 26121
      • Onkolologische Praxis Oldenburg /ID# 202607
    • Osnabrück, Niedersachsen, Germany, 49076
      • MVZ der Paracelsus-Klinik /ID# 201541
    • Westerstede, Niedersachsen, Germany, 26655
      • Med. Studiengesellschaft Nord West GmbH /ID# 201535
  • Nordrhein-Westfalen
    • Neuss, Nordrhein-Westfalen, Germany, 41462
      • Praxis Dres. Plewe/Losem /ID# 202606
  • Rheinland-Pfalz
    • Kaiserslautern, Rheinland-Pfalz, Germany, 67655
      • Hämatologie und Onkologie /ID# 205247
  • Sachsen
    • Dresden, Sachsen, Germany, 01127
      • Onkozentrum Dresden /ID# 202599
    • Dresden, Sachsen, Germany, 01307
      • BAG Freiberg-Richter, Jacobasch, Illmer, Wolf /ID# 201532
  • Schleswig-Holstein
    • Neumuenster, Schleswig-Holstein, Germany, 24534
      • Friedrich-Ebert-Krankenhaus GmbH /ID# 206206
• Switzerland
  • Bern, Switzerland, 3010
    • Inselspital, Universitätsspital Bern /ID# 210031
  • Aargau
    • Aarau, Aargau, Switzerland, 5001
      • Kantonsspital Aarau AG /ID# 210034
  • Bern
    • Thun, Bern, Switzerland, 3600
      • Spital Thun /ID# 233714
  • Luzern
    • Luzern 16, Luzern, Switzerland, 6000
      • Luzerner Kantonsspital /ID# 210029
  • Neuchatel
    • Neuchâtel, Neuchatel, Switzerland, 2000
      • Réseau Hospitalier Neuchâtelois /ID# 227865
  • Sankt Gallen
    • St. Gallen, Sankt Gallen, Switzerland, 9007
      • Kantonsspital St. Gallen /ID# 223037
  • Thurgau
    • Münsterlingen, Thurgau, Switzerland, 8596
      • Kantonsspital Münsterlingen /ID# 210035
  • Ticino
    • Bellinzona, Ticino, Switzerland, 6500
      • EOC Ospedale Regionale di Bellinzona e Valli /ID# 208782
  • Zuerich
    • Winterthur, Zuerich, Switzerland, 8400
      • KSW Kantonsspital Winterthur /ID# 211068

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) administering venetoclax and who meets the following conditions as specified in the label for venetoclax:
• Venetoclax monotherapy for the treatment of CLL in the presence of deletion chromosome 17 (del[17p]) or tumor protein p53 (TP53) mutation in adult participants, who are unsuitable for or have failed to a B-cell receptor pathway inhibitor.
• Venetoclax monotherapy for the treatment of CLL in the absence of del(17p) or TP53 mutation in adult participants, who have failed both chemoimmunotherapy and a B-cell receptor pathway inhibitor.
• Venetoclax in combination with rituximab for the treatment of adult participants with CLL who have received at least one prior therapy.
• Venetoclax in combination with obinutuzumab for previously untreated adult participants with CLL.

Exclusion Criteria:

- None

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

3

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.

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

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): December 4, 2017
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2025

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): September 21, 2023
• Last Update Submitted That Met QC Criteria: September 20, 2023
• Last Verified: September 1, 2023

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; Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Disease Attributes; Leukemia, B-Cell; Chronic Disease; Leukemia; Leukemia, Lymphocytic, Chronic, B-Cell; Leukemia, Lymphoid
• 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