Long-term follow-up after ibrutinib and venetoclax treatment

Who can take part

• You were part of the CAPTIVATE study before.
• You receive care at a center that is taking part in this follow-up study.
• You are willing and able to give your consent to join.
• You are not in this study if you cannot or will not give informed consent.
• You must have been treated with a combination of ibrutinib and venetoclax as part of your care.
• You are willing to share your medical records related to your CLL treatment for the study.
• You are able to travel to your treatment center for the required follow-up visits.
• You agree to follow the study schedule, which may include blood tests and physical exams.
• You are at least 18 years old.
• You are willing to comply with the study requirements and procedures.
• You understand that your participation is voluntary and you can leave at any time.
• You have been informed about the study and have had the chance to ask questions.
• You are willing to be contacted for future research.
• You will allow your medical information to be shared with the research team.
• You have a life expectancy of at least 24 weeks.
• You can swallow capsules and are willing to follow the medication schedule.
• You have not taken part in any other interventional study within the last 30 days.
• You have no other medical conditions that, in the opinion of the doctor, would make it unsafe for you to take part.
• You have not had major surgery within the last 4 weeks.
• You have not had any other cancer within the last 3 years.
• You are not pregnant or breastfeeding.
• You are using effective birth control if you are of childbearing potential.
• You have adequate liver and kidney function.
• You have no active bleeding or blood clotting disorder.
• You have not had a live vaccine within 4 weeks of starting the study.
• You are willing to avoid grapefruit and related products during the study.
• You have not used any investigational drug in the last 30 days.
• You are able to adhere to the study visit schedule.
• You are not taking any medications that could interfere with the study drugs.
• You have not been treated with certain blood thinners.
• You have not had an allergic reaction to the study drugs.
• You are willing to have your care team contact you for follow-up.
• You have a social insurance number and can provide it for administrative purposes.
• You agree not to participate in any other clinical trial during this study.
• You have not previously participated in this study.
• You are willing to be randomized to a treatment group if applicable.
• You are willing to fill out required questionnaires at each visit.
• You are willing to follow the study rules and procedures.
• You understand that you will not be paid for your participation.
• You have been given a copy of the informed consent form to keep.
• You have read and understood the information and agree to participate.
• You understand that you can ask for your participation to be discontinued at any time.
• You have no conflicts of interest with the study team.
• You are willing to comply with all study procedures and visits.
• You have no other medical condition that would interfere with the study.
• You have not had a transplant in the last 12 months.
• You have not had radiation therapy in the last 4 weeks.
• You have not had a stem cell transplant.
• You have no history of progressive multifocal leukoencephalopathy.
• You have no active infections.
• You have had no major cardiac events in the last 6 months.
• You have no history of stroke or bleeding in the brain.
• You have not had stomach surgery that affects absorption.
• You are willing to give a copy of your advance directive to the study team.
• You have a healthcare proxy or are willing to designate one.
• You are willing to have your records stored in a database.
• You have not been part of any other study in the last 30 days.
• You are willing to be followed for a total of 5 years.
• You are willing to have annual physical exams during follow-up.
• You are willing to have blood drawn at each visit and stored for future research.
• You understand that the study is not a treatment trial.
• You have been given the opportunity to ask questions about the study.
• You have had your questions answered to your satisfaction.
• You are making a free and informed decision to participate.
• You have been told about the risks and benefits of participating.
• You are aware that participation is voluntary and can be withdrawn at any time.
• You agree to inform your primary care physician about your participation.
• You consent to be contacted for future research studies that may be of interest.
• You have not been previously enrolled in this follow-up study.
• You are not in a prison or other institution.
• You are not involved in the planning of this study.
• You have not been employed by the sponsor or their representatives.
• You have no close family members who work for the sponsor that could create a conflict of interest.
• You have no legal incapacity to provide consent.
• You are not in a situation where your choices could be influenced by any third party.
• You have no other medical conditions that would make it unsafe for you to participate in this study.
• You have not participated in this study before.
• You have not been withdrawn from this study, as you are eligible to participate.
• You have read and understood the requirements of the study and are willing to give your informed consent.
• You are able to read and understand the study documents.
• You are willing to give a blood sample at each visit for routine laboratories.
• You have a platelet count of at least 30,000 per microliter.
• You have an absolute neutrophil count of at least 1,000 per microliter.
• You have a hemoglobin level of at least 10 grams per deciliter.
• You have normal kidney function, as defined by a creatinine clearance of at least 30 milliliters per minute.
• You have adequate liver function, defined as a bilirubin of less than 1.5 times the upper limit of normal and