OncoMatch/Clinical Trials/NCT06757647
Acalabrutinib for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Is NCT06757647 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Acalabrutinib for chronic lymphocytic leukemia/small lymphocytic lymphoma.
Treatment: Acalabrutinib — This phase II trial tests how well acalabrutinib works in treating patients with chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) and evaluates how treatment with acalabrutinib affects heart function. Acalabrutinib is in a class of medications called kinase inhibitors. It blocks a protein called BTK, which is present on B-cell (a type of white blood cells) cancers at abnormal levels. This may help keep cancer cells from growing and spreading. CLL/SLL patients treated with a different BTK inhibitor called ibrutinib often experience cardiac side effects, leading to discontinuation of life-saving therapy. Treatment with acalabrutinib after discontinuing, or even before starting, treatment with ibrutinib may reverse or prevent cardiac side effects and be an effective treatment option for patients with CLL/SLL.
Check if I qualifyExtracted eligibility criteria
Cancer type
Chronic Lymphocytic Leukemia
Non-Hodgkin Lymphoma
Biomarker criteria
Excluded: BTK C481S mutation
Presence of C481S mutation
Excluded: PLCG2 mutation
Presence of...PCLG2 mutation
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: BTK inhibitor (ibrutinib) — current treatment
CLL patients cardiac intolerant to current treatment with ibrutinib as defined by AF or other cardiac arrhythmias
Cannot have received: acalabrutinib (acalabrutinib)
Prior exposure to acalabrutinib for primary cohort
Cannot have received: BTK inhibitor
prior exposure to BTK inhibitor for pilot cohort
Cannot have received: ibrutinib (ibrutinib)
Disease progression on ibrutinib
Cannot have received: allogeneic stem cell transplantation
Prior allogeneic stem cell transplantation
Cannot have received: cardiac transplantation
Prior cardiac transplantation
Lab requirements
Blood counts
ANC >= 1000/mm^3 (unless due to marrow involvement by CLL/SLL and/or disease-related immune thrombocytopenia; if cytopenias are due to disease in the bone marrow any degree of cytopenias is allowed); Platelets >= 30,000/mm^3 (unless due to marrow involvement by CLL/SLL and/or disease-related immune thrombocytopenia; if cytopenias are due to disease in the bone marrow any degree of cytopenias is allowed)
Kidney function
Creatinine clearance >= 30 mL/min/1.73m^2
Liver function
Total bilirubin =< 1.5 x upper limit of normal (ULN) (excepting Gilbert's syndrome); AST and ALT =< 2.5 x ULN
ANC >= 1000/mm^3...Platelets >= 30,000/mm^3...Total bilirubin =< 1.5 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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