Study on Venetoclax and Rituximab/Hyaluronidase for Treating Relapsed or Hard-to-Treat Chronic Lymphocytic Leukemia (CLL)

Inclusion Criteria

• Must sign an informed consent form and be willing to follow the study requirements.
• Must have a diagnosis of chronic lymphocytic leukemia (CLL) that meets specific medical criteria.
• The CLL must have returned or not responded to previous treatments and require further treatment.
• Must have a performance status score of 0 to 2, indicating full activity or some restriction in strenuous activities.
• Must have adequate blood cell counts and organ function, unless affected by the disease itself.
• Must have good kidney function, as shown by specific tests.
• Must have good liver function, as shown by specific tests.
• Female participants must not be able to become pregnant or must have a negative pregnancy test before starting treatment.
• Participants with controlled HIV infection may join the study, with precautions to adjust their medication if needed.
• Participants taking warfarin should consider switching to another blood thinner, but can still join the study with caution if they cannot switch.

Exclusion Criteria

• Known allergy to any of the study drugs.
• Have had a stem cell transplant from a donor within the past year.
• Have a type of CLL transformation known as Richter's transformation.
• Have another cancer that could interfere with the study or its results, except for certain skin cancers or early-stage cancers that have been treated.
• Have uncontrolled health conditions that could interfere with the study or increase risk.
• Have an active infection or recent major infection requiring hospitalization or IV antibiotics.
• Have taken certain medications or foods that interact with venetoclax within a week before starting the study.
• Have significant liver disease or active hepatitis infections.
• Have uncontrolled HIV infection.
• Have received live vaccines recently or need them during the study.
• Are pregnant, breastfeeding, or planning to become pregnant during the study.
• Have had major surgery recently, except for diagnostic purposes.
• Have a condition that affects the absorption of oral medications.
• Have known allergies to specific medications used to prevent side effects.