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 (Jun 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
Treatments studied
Immunotherapy
Targeted therapy
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)
Demographics
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.
Frequently asked questions
Is NCT05197192 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
Does this trial require TP53?
Yes, TP53 mutation is a required biomarker for enrollment.
Does this trial require IGHV?
Yes, IGHV unmutated is a required biomarker for enrollment.
Does this trial require CHROMOSOME 17?
Yes, CHROMOSOME 17 17p-deletion is a required biomarker for enrollment.
Is there an age limit?
Yes. Patients must be 120 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
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