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Recruiting NCT03342144

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

Observational Chronic Lymphocytic Leukemia (CLL)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Chronic Lymphocytic Leukemia (CLL). Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Austria, Germany, Switzerland
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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

Overview

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.

Primary outcome measures

  • Percentage of Participants Achieving Best Overall Response Rate (ORR) [Time frame: Up to 12 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Germany · 57 centers
  • Stauferklinikum Schwaebisch Gmuend /ID# 201518 — Mutlangen
  • Onkologische Praxis /ID# 201545 — Stuttgart
  • Schwarzwald-Baar-Klinikum /ID# 208176 — Villingen-Schwenningen
  • MVZ am Klinikum Aschaffenburg Onkologie /ID# 201548 — Aschaffenburg
  • Studienzentrum Aschaffenburg /ID# 204125 — Aschaffenburg
  • Gemeinschaftspraxis Dr. Heinrich und Prof. Bangerter /ID# 200950 — Augsburg
  • Drs. Tanzer, Chirca, Stoeberl /ID# 202613 — Bad Reichenhall
  • Internistische Schwerpunktpraxen, Erlangen /ID# 200949 — Erlangen
  • … and 49 more centers
Switzerland · 9 centers
  • Kantonsspital Aarau AG /ID# 210034 — Aarau
  • Spital Thun /ID# 233714 — Thun
  • Luzerner Kantonsspital /ID# 210029 — Lucerne
  • Réseau Hospitalier Neuchâtelois /ID# 227865 — Neuchâtel
  • Kantonsspital St. Gallen /ID# 223037 — Sankt Gallen
  • KSW Kantonsspital Winterthur /ID# 211068 — Winterthur
  • EOC Ospedale Regionale di Bellinzona e Valli /ID# 208782 — Bellinzona
  • Kantonsspital Münsterlingen /ID# 210035 — Münsterlingen
  • … and 1 more center
Austria · 4 centers
  • Universitaetsklinikum St. Poelten /ID# 221152 — Sankt Pölten
  • Medizinische Universitaet Graz /ID# 221155 — Graz
  • Landeskrankenhaus Salzburg-Universitaetsklinikum der PMU (LKH) /ID# 221153 — Salzburg
  • Hanusch Krankenhaus /ID# 221151 — Vienna

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. PMID 38421404

Identifiers

NCT: NCT03342144 · P17-132

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗