Study of Acalabrutinib Versus Chlorambucil Plus Rituximab in Adult Subjects With Previously Untreated Chronic Lymphocytic Leukemia
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Phase
Phase 3
Status
Active, not recruiting
Study type
Interventional
Design
Randomized · None · Treatment
Enrollment
155actual
Sites
46
Countries
China, Philippines, Taiwan +2
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2020-01-20 | actual | When the study began enrolling |
| Primary completion | 2024-01-03 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2027-01-01 | estimated | The whole study's end, after follow-up |
| First posted | 2019-08-30 | actual | When this record first appeared on the registry |
| Results posted | 2025-01-30 | actual | When the sponsor posted results to the registry |
| Record updated | 2026-06-16 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Untreated Chronic Lymphocytic Leukemia
Interventions
- Drug: Acalabrutinib
- Drug: Rituximab
- Drug: Chlorambucil
Primary outcome
what the primary-completion date above is the date OFProgression Free Survival (PFS) Assessed by BICR
measured Response evaluations performed every 12 weeks from Cycle 4 Day 1 to Cycle 25, then every 24 weeks until PD or death, up to DCO date of 03 January 2024 (a maximum of approximately 47.5 months)
Posted documents
hosted by the registry — we link, never re-serveStudy Protocolposted 2024-04-03 · 10.7 MB · Prot_000.pdf
Statistical Analysis Planposted 2023-12-19 · 1.9 MB · SAP_001.pdf
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