Short-term combined acalabrutinib and venetoclax treatment of newly diagnosed patients with CLL at high risk of infection and/or early treatment, who do not fulfil IWCLL treatment criteria for treatment. A randomized study with extensive immune phenotyping.

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-511072-33-00

Acronym

PreVent-ACaLL

Enrollment

Registered

2024-06-12

Start date

Unknown

Completion date

Unknown

Last updated

2025-03-17

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

Grade ≥3-Infection-free survival in the treatment arm compared to the observation arm 12 weeks after finishing treatment (24 weeks after treatment initiation). This is a non-inferiority analysis as detailed in statistical analysis plan to assure safety of the combination treatment in this preemptive trial population.

Detailed description

Grade ≥3-infection free, CLL-treatment-free survival at end of treatment, 1 year and 2 years after enrollment, Overall survival and cause of death, Treatment free survival, Rate and CTCAE grade of infections, Response rate and duration according to IWCLL criteria, Treatment related adverse events, type, frequency and severity during and for 2 years after treatment, Immune function as assessed by immune phenotyping, functional TruCulture assays and measurements of cytokine levels

Interventions

DRUGVenclyxto 10 mg film-coated tablets

DRUGCalquence 100 mg hard capsules

DRUGVenclyxto 100 mg film-coated tablets

DRUGVenclyxto 50 mg film-coated tablets

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Grade ≥3-Infection-free survival in the treatment arm compared to the observation arm 12 weeks after finishing treatment (24 weeks after treatment initiation). This is a non-inferiority analysis as detailed in statistical analysis plan to assure safety of the combination treatment in this preemptive trial population.	—

Secondary

Measure	Time frame
Grade ≥3-infection free, CLL-treatment-free survival at end of treatment, 1 year and 2 years after enrollment, Overall survival and cause of death, Treatment free survival, Rate and CTCAE grade of infections, Response rate and duration according to IWCLL criteria, Treatment related adverse events, type, frequency and severity during and for 2 years after treatment, Immune function as assessed by immune phenotyping, functional TruCulture assays and measurements of cytokine levels	—

Measure

Time frame

—

Countries

Denmark, Netherlands, Sweden

Outcome results

None listed

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