OncoMatch/Clinical Trials/NCT05197192
A Phase-3-trial of Acalabrutinib, Obinutuzumab & Venetoclax Compared to Obinutuzumab and Venetoclax in Previously Untreated Patients With High Risk CLL
Is NCT05197192 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments including Obinutuzumab and Venetoclax for chronic lymphocytic leukemia.
Treatment: Obinutuzumab · Venetoclax · Acalabrutinib — 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).
Check if I qualifyExtracted eligibility criteria
Cancer type
Chronic Lymphocytic Leukemia
Biomarker criteria
Required: TP53 mutation
At least one of the following risk factors: 17p-deletion, TP53-mutation, complex karyotype (defined as defined as the presence of 3 or more chromosomal aberrations in 2 or more metaphases) or an unmutated IGHV gene status.
Required: IGHV unmutated
At least one of the following risk factors: 17p-deletion, TP53-mutation, complex karyotype (defined as defined as the presence of 3 or more chromosomal aberrations in 2 or more metaphases) or an unmutated IGHV gene status.
Required: CHROMOSOME 17 17p-deletion
At least one of the following risk factors: 17p-deletion, TP53-mutation, complex karyotype (defined as defined as the presence of 3 or more chromosomal aberrations in 2 or more metaphases) or an unmutated IGHV gene status.
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: cll-specific therapy
Exception: corticosteroid treatment administered due to necessary immediate intervention; within the last 10 days before start of study treatment, only dose equivalents up to 20 mg prednisolone are permitted
Lab requirements
Blood counts
platelet count >30 x10^9/l
Kidney function
creatinine clearance ≥ 30ml/min
Liver function
total bilirubin ≤ 2 x, ast/ alt ≤ 2.5 x the institutional uln value, unless directly attributable to the patient's cll or to gilbert's syndrome
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify