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

Chronic Lymphocytic Leukemia (CLL) Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03342144
• Other study ID #: P17-132
• Status: Active, not recruiting
• Start date: December 4, 2017
• Est. completion date: December 31, 2025

Study information

• Verified date: June 2024
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 350
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Lymphocytic Leukemia (CLL)
• Leukemia
• Leukemia, Lymphocytic, Chronic, B-Cell
• Leukemia, Lymphoid

Locations

Country	Name	City	State
Austria	Medizinische Universitaet Graz /ID# 221155	Graz	Steiermark
Austria	Landeskrankenhaus Salzburg-Universitaetsklinikum der PMU (LKH) /ID# 221153	Salzburg
Austria	Universitaetsklinikum St. Poelten /ID# 221152	Sankt Poelten	Niederoesterreich
Austria	Hanusch Krankenhaus /ID# 221151	Wien
Germany	MVZ am Klinikum Aschaffenburg Onkologie /ID# 201548	Aschaffenburg	Bayern
Germany	Studienzentrum Aschaffenburg /ID# 204125	Aschaffenburg	Bayern
Germany	Gemeinschaftspraxis Dr. Heinrich und Prof. Bangerter /ID# 200950	Augsburg	Bayern
Germany	Praxis Dr. Kreher /ID# 202604	Bad Liebenwerda	Brandenburg
Germany	Caritas-Krankenhaus gGmbH /ID# 243212	Bad Mergentheim
Germany	Onkologische Schwerpunktpraxis /ID# 200953	Berlin
Germany	Praxis für Hämatologie und Onkologie /ID# 241763	Berlin
Germany	Ambulantes Tumorzentrum Bremerhaven /ID# 224353	Bremerhaven	Bremen
Germany	Pioh Dres. Draube & Partner /ID# 239507	Cologne
Germany	BAG Freiberg-Richter, Jacobasch, Illmer, Wolf /ID# 201532	Dresden	Sachsen
Germany	Onkozentrum Dresden /ID# 202599	Dresden	Sachsen
Germany	Praxis Dres. Prange-Krex/Mohm /ID# 210049	Dresden
Germany	Internistische Schwerpunktpraxen, Erlangen /ID# 200949	Erlangen
Germany	Klinikum Frankfurt Hoechst /ID# 210048	Frankfurt
Germany	Centrum fuer Haematologie und Onkologie Bethanien /ID# 206701	Frankfurt am Main	Hessen
Germany	MVZ Dres. Cordes & Partner /ID# 202598	Frankfurt am Main	Hessen
Germany	Praxis fuer interdisziplinaere Onkolologie und Haematologie /ID# 206999	Freiburg im Breisgau
Germany	Onkologische Kooperation Harz /ID# 201550	Goslar	Niedersachsen
Germany	onkomedic GbR /ID# 218354	Halle (Saale)
Germany	OncoResearch Lerchenfeld GmbH /ID# 205237	Hamburg
Germany	Onkologische Gemeinschaftspraxis /ID# 205239	Hamburg
Germany	Evangelisches Krankenhaus Hamm /ID# 206703	Hamm
Germany	OAZ Hannover /ID# 201538	Hannover	Niedersachsen
Germany	Studienbüro Kamal und Dorn GBR /ID# 234105	Hanover
Germany	Studienzentrum am Raschplatz /ID# 250180	Hanover
Germany	Onkologie Hof /ID# 201531	Hof	Bayern
Germany	Klinikum Idar-Oberstein GmbH /ID# 210046	Idar-Oberstein
Germany	Hämatologie und Onkologie /ID# 205247	Kaiserslautern	Rheinland-Pfalz
Germany	Praxis Dres. Tebbe/Mayer /ID# 206730	Kassel	Hessen
Germany	Praxis Dr. Stauch /ID# 202611	Kronach	Bayern
Germany	VK&K Studien GbR /ID# 202614	Landshut	Bayern
Germany	Praxis Fuchs/Koehler /ID# 243215	Langen (Hessen)
Germany	Haemato-Onkologie /ID# 205236	Muenchen	Bayern
Germany	Stauferklinikum Schwaebisch Gmuend /ID# 201518	Mutlangen	Baden-Wuerttemberg
Germany	Friedrich-Ebert-Krankenhaus GmbH /ID# 206206	Neumuenster	Schleswig-Holstein
Germany	Praxis Dr. Klaproth/Cura /ID# 216413	Neunkirchen	Saarland
Germany	Praxis Dres. Plewe/Losem /ID# 202606	Neuss	Nordrhein-Westfalen
Germany	Onkolologische Praxis Oldenburg /ID# 202607	Oldenburg	Niedersachsen
Germany	Onkologische Praxis GbR /ID# 206705	Porta Westfalica
Germany	MVZ f. Blut- u.Krebserkrankungen /ID# 206704	Potsdam	Brandenburg
Germany	Praxis Dres. Krober/Stosiek /ID# 206729	Regensburg	Berlin
Germany	Praxis Dres. Decker/Lakner/Leithäuser /ID# 206208	Rostock
Germany	Diakonieklinikum Schwaebisch Hall /ID# 206205	Schwaebisch Hall
Germany	Onkologische Praxis /ID# 201545	Stuttgart	Baden-Wuerttemberg
Germany	Schwarzwald-Baar-Klinikum /ID# 208176	Villingen-Schwenningen	Baden-Wuerttemberg
Germany	Med. Studiengesellschaft Nord West GmbH /ID# 201535	Westerstede	Niedersachsen
Switzerland	Kantonsspital Aarau AG /ID# 210034	Aarau	Aargau
Switzerland	EOC Ospedale Regionale di Bellinzona e Valli /ID# 208782	Bellinzona	Ticino
Switzerland	Inselspital, Universitaetsspital Bern /ID# 210031	Bern
Switzerland	Luzerner Kantonsspital /ID# 210029	Luzern 16	Luzern
Switzerland	Kantonsspital Münsterlingen /ID# 210035	Münsterlingen	Thurgau
Switzerland	Réseau Hospitalier Neuchâtelois /ID# 227865	Neuchâtel	Neuchatel
Switzerland	Kantonsspital St. Gallen /ID# 223037	St. Gallen	Sankt Gallen
Switzerland	Spital Thun /ID# 233714	Thun	Bern
Switzerland	KSW Kantonsspital Winterthur /ID# 211068	Winterthur	Zuerich

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Countries where clinical trial is conducted

Austria,  Germany,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Percentage of Participants Still on Venetoclax Monotherapy	Percentage of participants still on venetoclax monotherapy throughout the study.	Up to 24 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Percentage of Participants Receiving Venetoclax Monotherapy and Achieving Complete Response (CR)	Complete Response as defined in the study protocol.	Up to 24 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Percentage of Participants Receiving Venetoclax Monotherapy and Achieving Partial Response (PR)	Partial response as defined in the study protocol.	Up to 24 months
Secondary	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
Secondary	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
Secondary	Percentage of Participants Receiving Venetoclax Monotherapy with Progressive Disease	Progressive disease as defined in the study protocol.	Up to 24 months
Secondary	Percentage of Participants Receiving Venetoclax Combination with Obinutuzumab with Progressive Disease	Progressive disease as defined in the study protocol.	Up to 24 months
Secondary	Percentage of Participants Receiving Venetoclax Combination with Rituximab with Progressive Disease	Progressive disease as defined in the study protocol.	Up to 36 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Health Resource Utilization (HRU) per year	Health Resource Utilization (HRU) per year will be assessed.	Up to 24 Months
Secondary	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
Secondary	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

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