OncoMatch/Clinical Trials/NCT06544785
Zanubrutinib With Obinutuzumab in Untreated Patients With Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
Is NCT06544785 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Zanubrutinib Oral Product and Obinutuzumab for chronic lymphocytic leukemia.
Treatment: Zanubrutinib Oral Product · Obinutuzumab — The goal of this phase II randomized open label study is to compare the rate of complete remission (CR) with undetectable minimal residual disease (uMRD) obtained with zanubrutinib in combination with obinutuzumab with two different schedules of administration of obinutuzumab (starting obinutuzumab at cycle 2 or 12 months) in patients with previously untreated Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL). There is scarce information about which is the most appropriate schedule of combining the BTKi and the anti-CD20 monoclonal antibody, and whether treatment can be safely stopped in those patients attaining deep responses (CR with uMRD) remains to be determined. Response will be assessed after 20 cycles of treatment for the primary objective of the study. Patients attaining uMRD will stop treatment with zanubrutinib, whereas the rest of patients will continue on treatment with zanubrutinib until progression, unacceptable toxicity, or trial completion, whichever comes first.
Check if I qualifyExtracted eligibility criteria
Cancer type
Chronic Lymphocytic Leukemia
Non-Hodgkin Lymphoma
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: any prior therapy for CLL
Prior treatment for CLL
Lab requirements
Blood counts
Absolute neutrophil count (ANC) < 1.0 X 10^9/L; Platelet count < 75 X 10^9/L, except for patients with bone marrow involvement by CLL in which case the platelet count must be ≥ 30 X 10^9/L
Kidney function
Estimated Glomerular Filtration Rate (Cockcroft-Gault) ≤30 mL/min/1.73m2
Liver function
Serum aspartate aminotransferase (AST)/serum glutamic-oxaloacetic transaminase (SGOT) or alanine transaminase (ALT)/serum glutamate pyruvate transaminase (SGPT) >2.5 x upper limit of normal (ULN); Serum total bilirubin > 1.5 x ULN, except in cases of Gilbert's syndrome
Cardiac function
Prothrombin time/INR or aPTT (in the absence of Lupus anticoagulant) > 2x ULN
Estimated Glomerular Filtration Rate (Cockcroft-Gault) ≤30 mL/min/1.73m2; Absolute neutrophil count (ANC) < 1.0 X 10^9/L; Platelet count < 75 X 10^9/L, except for patients with bone marrow involvement by CLL in which case the platelet count must be ≥ 30 X 10^9/L; Serum aspartate aminotransferase (AST)/serum glutamic-oxaloacetic transaminase (SGOT) or alanine transaminase (ALT)/serum glutamate pyruvate transaminase (SGPT) >2.5 x upper limit of normal (ULN); Serum total bilirubin > 1.5 x ULN, except in cases of Gilbert's syndrome; Prothrombin time/INR or aPTT (in the absence of Lupus anticoagulant) > 2x ULN
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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