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Title informCLL: A Disease Registry for Patients with Chronic Lymphocytic Leukemia

IRB PCYC1915

CC 17-420

Hospital Main Campus

Stage N/A

Phase N/A

Disease Leukemia - Chronic Lymphocytic (CLL)

Description

Primary Objective

• To describe current treatment patterns in the real-world setting among CLL patients who are initiating treatment with novel therapies including approved oral kinas inhibitors, BCL-2 inhibitors, or other approved anti-CLL therapies/regimens as first- or later-line therapy, and exlpore the associations with baseline patient characteristics, healthcare resource utilization, and clinical outcomes.

Secondary Objectives

• To characterize non-serious ADRs, that led to discontinuation/modification/interruption of therapy and all serious AEs, in CLL patients who are initiating treatment with novel therapies including approved oral kinase inhibitors or other approved anti-CLL therapies/regimens as first- or later-line therapy.
• To assess patient-reported HRQoL and its association with therapeutic treatment patterns and clinical outcomes in CLL patients who are initiating treatment with novel therapies including approved oral kinase inhibitors or other approved anti-CLL therapies/regimens as first- or later-line therapy.

Inclusion Criteria

• Age of at least 18 years
• Clinical diagnosis of CLL/SLL that meets published diagnostic criteria
• Initiating treatment within +/- 30 days of enrollment with novel therapies including oral kinase inhibitors (e.g., inhibitors of BTK [e.g., ibrutinib], BCL-2 inhibitors [e.g., venetoclax] or PI3Kd [e.g., idelalisib]), or with other anti-CLL therapies/regimens approved at the time of patient enrollment.
• Availability of documentation on previous CLL/SLL treatment and duration of response in the patient's medical records
• Willing and able to provide written informed consent
• Willing and able to complete PRO questionnaire
• Willing and able to provide information on patient survey questionnaire
• Willing to provide a blood sample at time of enrollment

Exclusion Criteria

• Diagnosed with any B-cell malignancy other than CLL/SLL
• Estimated life expectancy of < 6 months
• Currently receiving treatment in an interventional clinical trial at study entry (note: patients who enroll in an interventional clinical trial after enrollment may remain in the registry).