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NCT05197192 · ClinicalTrials.gov record · last posted 2026-08-20

A Phase-3-trial of Acalabrutinib, Obinutuzumab & Venetoclax Compared to Obinutuzumab and Venetoclax in Previously Untreated Patients With High Risk CLL

StatusRecruiting
PhasePhase 3
Started2022-04-19
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from the ClinicalTrials.gov record
This multicenter, prospective, open-label, randomized, superiority phase 3 study is designed to demonstrate that treatment with a triple combination of acalabrutinib, obinutuzumab and venetoclax (GAVe) prolong the progression-free survival (PFS) as compared to treatment with the combination of obinutuzumab and venetoclax (GVe) in pa-tients with high risk CLL (defined as having at least one of the follow-ing risk factors: 17p-deletion, TP53-mutation, complex karyotype or an unmutated IGHV-gene status).

Amendment record 6 amendments on the ClinicalTrials.gov record

This ClinicalTrials.gov record has been amended 6 times since 2022-01-04; most recent amendment 2025-08-13. DataLookout shows field-level changes from the day a trial enters its daily monitoring; earlier amendments are counted here from the ClinicalTrials.gov version history. See every version on ClinicalTrials.gov ↗

2022-05-04
Status change Not Yet Recruiting→Recruitingv1
Trial Details
NCT Number NCT05197192
Lead Sponsor German CLL Study Group
Collaborators: AstraZeneca
Conditions Chronic Lymphocytic Leukemia
Enrollment 202 participants
Start Date 2022-04-19
Primary Completion 2028-05 (estimated)
Study Completion 2028-05 (estimated)
Updated on ClinicalTrials.gov 2026-08-20