OncoMatch/Clinical Trials/NCT05336812
Acalabrutinib in Combination With Venetoclax or Obinutuzumab for the Treatment of Treatment-naive Chronic Lymphocytic Leukemia
Is NCT05336812 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Obinutuzumab and Acalabrutinib for chronic lymphocytic leukemia.
Treatment: Acalabrutinib · Obinutuzumab · Venetoclax — This phase II trial tests whether acalabrutinib in combination with venetoclax or obinutuzumab works to shrink tumors in patients with treatment-naive chronic lymphocytic leukemia . Acalabrutinib is also an inhibitor that works in the body to block the activation of certain cells that lead to the growth of cancerous B cells. Venetoclax is in a class of medications called B-cell lymphoma-2 (BCL-2) inhibitors. It may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Obinutuzumab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Giving acalabrutinib in combination with venetoclax or obinutuzumab may help ease symptoms, decrease the amount of cancer suggestive of improvement, prolonged disease-free remission and/or survival, and increased knowledge about cancer treatment in patients with chronic lymphocytic leukemia. Patients will be treated with acalabrutinib for 12 cycles, and then randomized to receive 6 cycles of acalabrutinib plus obinutuzumab or acalabrutinib plus venetoclax.
Check if I qualifyExtracted eligibility criteria
Cancer type
Chronic Lymphocytic Leukemia
Non-Hodgkin Lymphoma
Biomarker criteria
Excluded: TP53 mutation
Presence of TP53 mutation on next generation sequencing
Excluded: CHROMOSOME 17P13 deletion
Presence of deletion 17p13 on cytogenetic analysis by fluorescent in situ hybridization (FISH)
Excluded: COMPLEX KARYOTYPE complex karyotype (>= 3 karyotypic abnormalities)
Presence of complex karyotype on cytogenetic evaluation (Defined as >= 3 karyotypic abnormalities)
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: chemotherapy
Exception: palliative loco-regional radiotherapy, rituximab for autoimmune conditions, or corticosteroids for symptoms control
Received no prior chemotherapy, immunotherapy, or targeted therapy for the treatment of CLL, with the exceptions of palliative loco-regional radiotherapy, rituximab for autoimmune conditions, or corticosteroids for symptoms control
Cannot have received: immunotherapy
Exception: palliative loco-regional radiotherapy, rituximab for autoimmune conditions, or corticosteroids for symptoms control
Received no prior chemotherapy, immunotherapy, or targeted therapy for the treatment of CLL, with the exceptions of palliative loco-regional radiotherapy, rituximab for autoimmune conditions, or corticosteroids for symptoms control
Cannot have received: targeted therapy
Exception: palliative loco-regional radiotherapy, rituximab for autoimmune conditions, or corticosteroids for symptoms control
Received no prior chemotherapy, immunotherapy, or targeted therapy for the treatment of CLL, with the exceptions of palliative loco-regional radiotherapy, rituximab for autoimmune conditions, or corticosteroids for symptoms control
Lab requirements
Blood counts
ANC >= 1000/mm^3; Platelets >= 30,000/mm^3; Hemoglobin >= 7 g/dL; Adequate bone marrow independent of growth factor support or infusion support at screening unless cytopenias are due to marrow involvement by CLL/SLL and/or disease-related immune thrombocytopenia or anemia
Kidney function
Creatinine clearance >= 30 mL/min/1.73m^2 (using 24-hour creatinine clearance or modified Cockcroft-Gault equation)
Liver function
Total bilirubin <= 2.0 x ULN (excepting Gilbert's syndrome); AST and ALT <= 2.5 x ULN
Adequate bone marrow independent of growth factor support or infusion support at screening unless evidence shows that the cytopenia(s) is due to marrow involvement by CLL/SLL and/or disease-related immune thrombocytopenia, or anemia. If cytopenias are due to disease in the bone marrow any degree of cytopenias are allowed. ANC >= 1000/mm^3; Platelets >= 30,000/mm^3; Hemoglobin >= 7 g/dL; Total bilirubin <= 2.0 x ULN (excepting Gilbert's syndrome); AST and ALT <= 2.5 x ULN; Creatinine clearance >= 30 mL/min/1.73m^2
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Ohio State University Comprehensive Cancer Center · Columbus, Ohio
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