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AVO-CLL: a phase III multicenter, randomized, open-label, clinical trial comparing efficacy and safety of acalabrutinib in combination with obinutuzumab versus venetoclax in combination with obinutuzumab in the first-line treatment of newly diagnosed patients with chronic lymphocytic leukemia

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-508423-13-00
Acronym
AVO CLL
Enrollment
72
Registered
2024-04-02
Start date
2024-07-01
Completion date
Unknown
Last updated
2025-07-18

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

Conditions

Chronic lymphocytic leukemia

Brief summary

Primary endpoint Progression-free survival (PFS), defined as the time from randomization to progression or death, a clinically important endpoint.

Detailed description

Secondary endpoints Response to treatment (including MRD), time to next line of treatment. The amount of change in quality of life. Treatment safety based on the assessment of adverse events. Overall survival is defined as the time from randomization to death from any cause.

Interventions

DRUGVenclyxto 50 mg film-coated tablets
DRUGVenclyxto 100 mg film-coated tablets
DRUGVenclyxto 10 mg film-coated tablets
DRUGGazyvaro 1
DRUG000 mg concentrate for solution for infusion.

Sponsors

Specjalistyczny Szpital Im. Dra Alfreda Sokolowskiego
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Primary endpoint Progression-free survival (PFS), defined as the time from randomization to progression or death, a clinically important endpoint.

Secondary

MeasureTime frame
Secondary endpoints Response to treatment (including MRD), time to next line of treatment. The amount of change in quality of life. Treatment safety based on the assessment of adverse events. Overall survival is defined as the time from randomization to death from any cause.

Countries

Poland

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026