Clinical trial NCT03342144: Study of the Use of Venetoclax in Participants With Chronic Lymphocytic Leukemia (CLL) Under Real-Life Setting
Official title: Observational Study of the Use of Venetoclax in Patients With Chronic Lymphocytic Leukemia (CLL) Under Real-Life Setting in Austria, Germany and Switzerland
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Chronic Lymphocytic Leukemia (CLL)
Keywords: Chronic Lymphocytic Leukemia (CLL)
Cancer
Leukemia
venetoclax
rituximab
obinutuzumab
ABT-199
venclexta
venclyxto
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2017-11-14
Enrollment: 350
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants with chronic lymphocytic leukemia (CLL) administering venetoclax per the local label.

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


Eligibility criteria: 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

Primary outcomes:
measure: Percentage of Participants Achieving Best Overall Response Rate (ORR)
timeFrame: Up to 12 months
Secondary outcomes:
measure: Percentage of Participants Still on Venetoclax Monotherapy
timeFrame: Up to 24 months
measure: Percentage of Participants Still on Venetoclax in Combination with Rituximab
timeFrame: Up to 24 months
measure: Percentage of Participants Receiving Venetoclax Monotherapy with Disease Progression
timeFrame: Up to 24 months
measure: Percentage of Participants Receiving Venetoclax in Combination with Obinutuzumab with Disease Progression
timeFrame: Up to 24 months
measure: Percentage of Participants Receiving Venetoclax in Combination with Rituximab with Disease Progression
timeFrame: Up to 36 months
measure: Overall Survival (OS) Rate in Participants Receiving Venetoclax Monotherapy
timeFrame: Up to 24 months
measure: Overall Survival (OS) Rate in Participants Receiving Venetoclax in Combination with Obinutuzumab
timeFrame: Up to 24 months
measure: Overall Survival (OS) Rate in Participants Receiving Venetoclax in Combination with Rituximab
timeFrame: Up to 36 months
measure: Progression-Free Survival (PFS) Rate in Participants Receiving Venetoclax Monotherapy
timeFrame: Up to 24 months
measure: Progression-Free Survival (PFS) Rate in Participants Receiving Venetoclax in Combination with Obinutuzumab
timeFrame: Up to 24 months
measure: Progression-Free Survival (PFS) Rate in Participants Receiving Venetoclax in Combination with Rituximab
timeFrame: Up to 36 months
measure: Minimal Residual Disease (MRD) measurement on plasma circulating tumor Deoxyribo nucleic acid (DNA) (Switzerland Only)
timeFrame: Up to 24 months
measure: Percentage of Participants Receiving Venetoclax Monotherapy and Achieving Complete Response (CR)
timeFrame: Up to 24 months
measure: Percentage of Participants Receiving Venetoclax in Combination with Obinutuzumab and Achieving Complete Response (CR)
timeFrame: Up to 24 months
measure: Percentage of Participants Receiving Venetoclax in Combination with Rituximab and Achieving Complete Response (CR)
timeFrame: Up to 36 months
measure: Percentage of Participants Receiving Venetoclax Monotherapy and Achieving Complete Response with Incomplete Regeneration of Bone Marrow (CRi)
timeFrame: Up 24 months
measure: Percentage of Participants Receiving Venetoclax Combination with Obinutuzumab and Achieving Complete Response with Incomplete Regeneration of Bone Marrow (CRi)
timeFrame: Up 24 months
measure: Percentage of Participants Receiving Venetoclax Combination with Rituximab and Achieving Complete Response with Incomplete Regeneration of Bone Marrow (CRi)
timeFrame: Up 36 months
measure: Percentage of Participants Receiving Venetoclax Monotherapy and Achieving Partial Response (PR)
timeFrame: Up to 24 months
measure: Percentage of Participants Receiving Venetoclax Combination with Obinutuzumab and Achieving Partial Response (PR)
timeFrame: Up to 24 months
measure: Percentage of Participants Receiving Venetoclax Combination with Rituximab and Achieving Partial Response (PR)
timeFrame: Up to 36 months
measure: Percentage of Participants Receiving Venetoclax Monotherapy with Progressive Disease
timeFrame: Up to 24 months
measure: Percentage of Participants Receiving Venetoclax Combination with Obinutuzumab with Progressive Disease
timeFrame: Up to 24 months
measure: Percentage of Participants Receiving Venetoclax Combination with Rituximab with Progressive Disease
timeFrame: Up to 36 months
measure: Percentage of Participants Receiving Venetoclax Monotherapy with Stable Disease (SD)
timeFrame: Up to 24 months
measure: Percentage of Participants Receiving Venetoclax Combination with Obinutuzumab with Stable Disease (SD)
timeFrame: Up to 24 months
measure: Percentage of Participants Receiving Venetoclax Combination with Rituximab with Stable Disease (SD)
timeFrame: Up to 36 months
measure: Quality of Life using EORTC QLQ-C30 Scores
timeFrame: Up to 104 weeks
measure: QLQ-CLL 16/17 Scores
timeFrame: Up to 104 weeks
measure: European Quality of Life 5 Dimensions (EQ-5D-5L) including visual analogue scale (VAS)
timeFrame: Up 24 months
measure: Management of Venetoclax Therapy
timeFrame: Up to 24 Months
measure: Health Resource Utilization (HRU) per year
timeFrame: Up to 24 Months
measure: Clonal evolution and eradication of Tumor Protein p53 (TP53) mutated clones associated with treatment in relation to MRD negativity (Switzerland Only)
timeFrame: Up to 24 months
measure: Value of MRD Assessment
timeFrame: Up to 24 Months
Other outcomes:
Locations:
city: Sankt Poelten
country: Austria
facility: Universitaetsklinikum St. Poelten /ID# 221152
state: Niederoesterreich
city: Graz
country: Austria
facility: Medizinische Universitaet Graz /ID# 221155
state: Steiermark
city: Salzburg
country: Austria
facility: Landeskrankenhaus Salzburg-Universitaetsklinikum der PMU (LKH) /ID# 221153
city: Wien
country: Austria
facility: Hanusch Krankenhaus /ID# 221151
city: Mutlangen
country: Germany
facility: Stauferklinikum Schwaebisch Gmuend /ID# 201518
state: Baden-Wuerttemberg
city: Stuttgart
country: Germany
facility: Onkologische Praxis /ID# 201545
state: Baden-Wuerttemberg
city: Villingen-Schwenningen
country: Germany
facility: Schwarzwald-Baar-Klinikum /ID# 208176
state: Baden-Wuerttemberg
city: Aschaffenburg
country: Germany
facility: MVZ am Klinikum Aschaffenburg Onkologie /ID# 201548
state: Bayern
city: Aschaffenburg
country: Germany
facility: Studienzentrum Aschaffenburg /ID# 204125
state: Bayern
city: Augsburg
country: Germany
facility: Gemeinschaftspraxis Dr. Heinrich und Prof. Bangerter /ID# 200950
state: Bayern
city: Hof
country: Germany
facility: Onkologie Hof /ID# 201531
state: Bayern
city: Kronach
country: Germany
facility: Praxis Dr. Stauch /ID# 202611
state: Bayern
city: Landshut
country: Germany
facility: VK&K Studien GbR /ID# 202614
state: Bayern
city: Muenchen
country: Germany
facility: Haemato-Onkologie /ID# 205236
state: Bayern
city: Regensburg
country: Germany
facility: Praxis Dres. Krober/Stosiek /ID# 206729
state: Berlin
city: Bad Liebenwerda
country: Germany
facility: Praxis Dr. Kreher /ID# 202604
state: Brandenburg
city: Potsdam
country: Germany
facility: MVZ f. Blut- u.Krebserkrankungen /ID# 206704
state: Brandenburg
city: Bremerhaven
country: Germany
facility: Ambulantes Tumorzentrum Bremerhaven /ID# 224353
state: Bremen
city: Frankfurt am Main
country: Germany
facility: Centrum fuer Haematologie und Onkologie Bethanien /ID# 206701
state: Hessen
city: Frankfurt am Main
country: Germany
facility: MVZ Dres. Cordes & Partner /ID# 202598
state: Hessen
city: Kassel
country: Germany
facility: Praxis Dres. Tebbe/Mayer /ID# 206730
state: Hessen
city: Goslar
country: Germany
facility: Onkologische Kooperation Harz /ID# 201550
state: Niedersachsen
city: Hannover
country: Germany
facility: OAZ Hannover /ID# 201538
state: Niedersachsen
city: Oldenburg
country: Germany
facility: Onkolologische Praxis Oldenburg /ID# 202607
state: Niedersachsen
city: Westerstede
country: Germany
facility: Med. Studiengesellschaft Nord West GmbH /ID# 201535
state: Niedersachsen
city: Neuss
country: Germany
facility: Praxis Dres. Plewe/Losem /ID# 202606
state: Nordrhein-Westfalen
city: Kaiserslautern
country: Germany
facility: Hämatologie und Onkologie /ID# 205247
state: Rheinland-Pfalz
city: Neunkirchen
country: Germany
facility: Praxis Dr. Klaproth/Cura /ID# 216413
state: Saarland
city: Dresden
country: Germany
facility: Onkozentrum Dresden /ID# 202599
state: Sachsen
city: Dresden
country: Germany
facility: BAG Freiberg-Richter, Jacobasch, Illmer, Wolf /ID# 201532
state: Sachsen
city: Neumuenster
country: Germany
facility: Friedrich-Ebert-Krankenhaus GmbH /ID# 206206
state: Schleswig-Holstein
city: Bad Mergentheim
country: Germany
facility: Caritas-Krankenhaus gGmbH /ID# 243212
city: Berlin
country: Germany
facility: Praxis für Hämatologie und Onkologie /ID# 241763
city: Berlin
country: Germany
facility: Onkologische Schwerpunktpraxis /ID# 200953
city: Cologne
country: Germany
facility: Pioh Dres. Draube & Partner /ID# 239507
city: Dresden
country: Germany
facility: Praxis Dres. Prange-Krex/Mohm /ID# 210049
city: Erlangen
country: Germany
facility: Internistische Schwerpunktpraxen, Erlangen /ID# 200949
city: Frankfurt
country: Germany
facility: Klinikum Frankfurt Hoechst /ID# 210048
city: Freiburg im Breisgau
country: Germany
facility: Praxis fuer interdisziplinaere Onkolologie und Haematologie /ID# 206999
city: Halle (Saale)
country: Germany
facility: onkomedic GbR /ID# 218354
city: Hamburg
country: Germany
facility: OncoResearch Lerchenfeld GmbH /ID# 205237
city: Hamburg
country: Germany
facility: Onkologische Gemeinschaftspraxis /ID# 205239
city: Hamm
country: Germany
facility: Evangelisches Krankenhaus Hamm /ID# 206703
city: Hanover
country: Germany
facility: Studienzentrum am Raschplatz /ID# 250180
city: Hanover
country: Germany
facility: Studienbüro Kamal und Dorn GBR /ID# 234105
city: Idar-Oberstein
country: Germany
facility: Klinikum Idar-Oberstein GmbH /ID# 210046
city: Langen (Hessen)
country: Germany
facility: Praxis Fuchs/Koehler /ID# 243215
city: Porta Westfalica
country: Germany
facility: Onkologische Praxis GbR /ID# 206705
city: Rostock
country: Germany
facility: Praxis Dres. Decker/Lakner/Leithäuser /ID# 206208
city: Schwaebisch Hall
country: Germany
facility: Diakonieklinikum Schwaebisch Hall /ID# 206205
city: Aarau
country: Switzerland
facility: Kantonsspital Aarau AG /ID# 210034
state: Aargau
city: Thun
country: Switzerland
facility: Spital Thun /ID# 233714
state: Bern
city: Luzern 16
country: Switzerland
facility: Luzerner Kantonsspital /ID# 210029
state: Luzern
city: Neuchâtel
country: Switzerland
facility: Réseau Hospitalier Neuchâtelois /ID# 227865
state: Neuchatel
city: St. Gallen
country: Switzerland
facility: Kantonsspital St. Gallen /ID# 223037
state: Sankt Gallen
city: Münsterlingen
country: Switzerland
facility: Kantonsspital Münsterlingen /ID# 210035
state: Thurgau
city: Bellinzona
country: Switzerland
facility: EOC Ospedale Regionale di Bellinzona e Valli /ID# 208782
state: Ticino
city: Winterthur
country: Switzerland
facility: KSW Kantonsspital Winterthur /ID# 211068
state: Zuerich
city: Bern
country: Switzerland
facility: Inselspital, Universitaetsspital Bern /ID# 210031
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: