Study Comparing Acalabrutinib and Ibrutinib for Previously Treated High-Risk Chronic Lymphocytic Leukemia (CLL)

Inclusion Criteria

• Men and women aged 18 years or older.
• Must be able to perform daily activities with minimal assistance (ECOG performance status of 0 to 2).
• Diagnosed with chronic lymphocytic leukemia (CLL).
• Must have at least one high-risk factor, such as:
  • A specific genetic deletion known as 17p del.
  • Another genetic deletion known as 11q del.
• Must have active CLL that requires treatment based on specific medical criteria.
• Must have received at least one prior treatment for CLL.
• Must meet certain blood test requirements:
  • Neutrophil count of at least 750 cells/μL, or 500 cells/μL if bone marrow is involved, without recent growth factor support.
  • Platelet count of at least 30,000 cells/μL without recent transfusion.
  • Liver enzymes (AST/ALT) within 3 times the normal limit.
  • Total bilirubin within 1.5 times the normal limit.
  • Kidney function with creatinine clearance of at least 30 mL/min.

Exclusion Criteria

• Have cancer affecting the central nervous system (CNS).
• Have a type of leukemia called prolymphocytic leukemia or a condition known as Richter's syndrome.
• Have uncontrolled autoimmune blood disorders.
• Have previously taken Ibrutinib or similar medications.
• Have received chemotherapy, radiation, or certain cancer treatments within 30 days before starting the study.
• Have had certain types of antibody therapy or stem cell transplants.
• Have had major surgery within 4 weeks before starting the study.
• Have had another cancer, unless it was treated and inactive for over 3 years.
• Have significant heart disease within 6 months before the study.
• Have a known HIV infection.
• Have had a stroke or brain bleeding within 6 months before the study.
• Have a history of bleeding disorders.
• Need to take blood thinners like warfarin within 7 days before starting the study.
• Need to take strong medications that affect liver enzymes (CYP3A).