VONKO-029: Description of patient- and tumor-related characteristics, treatment patterns and adverse events, and survival of adults with CLL overall and those receiving first-line therapy, specifically the fixed-duration regimens ventoclax + obinutuzumab (VenO) and venetoclax + ibrutinib (VenI)

VONKO-029: Description of patient- and tumor-related characteristics, treatment patterns and adverse events, and survival of adults with CLL overall and those receiving first-line therapy, specifically the fixed-duration regimens ventoclax + obinutuzumab (VenO) and venetoclax + ibrutinib (VenI) - VONKOdb CLL 2025

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00036877

Enrollment

21500

Registered

2025-05-19

Start date

2025-06-01

Completion date

Unknown

Last updated

2025-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

C91.1

Interventions

Group 1: Retrospective analysis of cases with CLL from the diagnosis years 2014-2024

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. ICD-10 C91.1 2. diagnosis years 2014-2024 3. if diagnosed, place of residence in the federal state of the requested registry (“residence-related cases”) 4. at least one day of survival / close observation time 5. at least 18 years old at diagnosis

Exclusion criteria

Exclusion criteria: 1. the case is known to the registry exclusively on the basis of a. a corpse certificate (DCO cases) b. a pathology report c. a progress report d. a report to the tumor conference e. a combination of the aforementioned notification types 2. unknown vital status at the end of the follow-up period 3. patients who have experienced another cancer up to 5 years before the diagnosis of CLL (except for non-melanotic skin tumors, ICD-10 C44)

Design outcomes

Primary

Measure	Time frame
Overall survival (OS) from date of diagnosis of a real-world cohort of patients with chronic lymphocytic leukemia (CLL) overall and of subgroups of patients with first-line therapy with fixed-duration administration of venetoclax plus obinutuzumab or venetoclax plus ibrutinib	—

Secondary

Measure	Time frame
a) Description of patient- and tumor-related characteristics b) Description of the patterns of use of systemic anti-neoplastic therapies (SACT), including treatment duration, treatment freedom and treatment intensity across multiple lines of therapy (LoT, 1st to 4th LoT) c) Description of overall survival (OS) from the start of each line of therapy (1st-4th LoT), including stratified evaluation according to VenO and VenI in the first line d) Description of real-world progression-free survival (rwPFS), time to next treatment from start (TTNT) and time to next treatment or death (TTTNTD) from the start of each line of therapy (1st-4th LoT) e) Description of the objective response rate (ORR) and the complete response rate (CRR) after the end of therapy. f) Analysis of the recorded safety-relevant events (including adverse events such as tumor lysis syndrome, infusion-related reactions) in connection with systemic therapies and radiotherapy h) Description of the results of biomarker testing	—

Measure

Time frame

a) Description of patient- and tumor-related characteristics b) Description of the patterns of use of systemic anti-neoplastic therapies (SACT), including treatment duration, treatment freedom and treatment intensity across multiple lines of therapy (LoT, 1st to 4th LoT) c) Description of overall survival (OS) from the start of each line of therapy (1st-4th LoT), including stratified evaluation according to VenO and VenI in the first line d) Description of real-world progression-free survival (rwPFS), time to next treatment from start (TTNT) and time to next treatment or death (TTTNTD) from the start of each line of therapy (1st-4th LoT) e) Description of the objective response rate (ORR) and the complete response rate (CRR) after the end of therapy. f) Analysis of the recorded safety-relevant events (including adverse events such as tumor lysis syndrome, infusion-related reactions) in connection with systemic therapies and radiotherapy h) Description of the results of biomarker testing

—

Countries

Germany

Contacts

Public ContactAnnika Waldmann

Universität zu Lübeck, Institut für Sozialmedizin und Epidemiologie

Annika.Waldmann@uksh.de+4945150051240

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026