OncoMatch/Clinical Trials/NCT04908228
Fixed-duration Therapy With Ibrutinib and Obinutuzumab (GA-101) in Treatment-naïve Patients With CLL
Is NCT04908228 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Ibrutinib and obinutuzumab for chronic lymphocytic leukemia.
Treatment: Ibrutinib and obinutuzumab — This is a phase 2 multicenter national interventional pharmacological study aimed at determining the efficacy of a fixed duration treatment with ibrutinib and obinutuzumab in terms of uMRD in the BM at the end of treatment (+30 Days follow-up). Treatment with ibrutinib and obinutuzumab will be administered according to the following schedule: Ibrutinib 420 mg QD for 24 months (Cycles 1-24) Obinutuzumab starting from Cycle 13 Day 1 (100 mg Cycle 13 Day 1, 900 mg Cycle 13 Day 2, 1000 mg Cycle 13 Days 8 and 15, 1000 mg Cycles 14-18 Day 1). At the end of Cycle 24 all responding patients will discontinue ibrutinib and proceed with follow-up. If disease relapse occurs at any time after discontinuing treatment, ibrutinib therapy will be reintroduced at the standard dose of 420 mg QD and response to treatment monitored over time. Patients with stable (SD) or progressive disease (PD) at the end of Cycle 24, will continue ibrutinib as long as the treating physician deems they are benefiting from treatment and will be followed up in the study for survival and response to subsequent therapies.
Check if I qualifyExtracted eligibility criteria
Cancer type
Chronic Lymphocytic Leukemia
Biomarker criteria
Excluded: TP53 mutation
Patients carrying del(17p) and/or TP53 mutation as assessed by central laboratory
Excluded: TP53 deletion
Patients carrying del(17p) and/or TP53 mutation as assessed by central laboratory
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: any therapy for CLL or SLL
Any prior therapy (including but not limited to chemotherapy, targeted therapy, immunomodulating therapy, radiotherapy, and/or monoclonal antibody) used for treatment of CLL or SLL.
Lab requirements
Blood counts
anc >750 cells/μl; platelet count >30,000/μl; hemoglobin >8.0 g/dl
Kidney function
estimated creatinine clearance (crcl) ≥30 ml/min (cockcroft-gault)
Liver function
ast or alt ≤3.0 x uln; bilirubin ≤1.5 x uln (unless due to gilbert's syndrome or non-hepatic origin)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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