Leukemia, Chronic Lymphocytic (PCYC-1134M), Registry
informCLL™: A Disease Registry for Patients With Chronic Lymphocytic Leukemia
The purpose of the InformCLL Registry is to characterize and describe treatment patterns for those initiating treatment with approved oral kinase inhibitors, BCL-2 inhibitors, and other approved anti-CLL /SLL therapies/regimens. This study also evaluates association of treatment patterns with patient characteristics, healthcare resource utilization and patient-reported Health-related Quality of Life (HRQoL).
Key Inclusion Criteria
For a patient to be eligible for participation in this study, all of the following criteria must apply.
- Age of at least 18 years
- Clinical diagnosis of CLL/SLL that meets published diagnostic criteria (Hallek 2008)
- Initiating treatment within ±45 days of enrollment with novel therapies including oral kinase inhibitors (e.g., inhibitors of BTK [e.g., ibrutinib], inhibitors of BCL-2 pathway [ e.g venetoclax] or PI3K [e.g., idelalisib]), or with other anti-CLL therapies/regimens approved at the time of patient enrollment
- Availability of documentation of previous CLL/SLL treatment and duration of response in the patient's medical records
- Willing and able to provide informed consent
- Willing and able to complete PRO instrument
- Willing and able to provide information on patient survey questionnaire
- Willing and able to provide a blood sample at time of enrollment
Key Exclusion Criteria
A patient will not be eligible for participation in this study if any of the following criteria apply.
- Diagnosis of B-cell malignancies other than CLL/SLL
- Estimated life expectancy <6 months
- Currently receiving treatment in an interventional clinical trial with a non-approved, investigational agent for CLL/SLL at study entry (note: patients who enroll in an interventional clinical trial after enrollment may remain in the registry)
To learn more, visit ClinicalTrials.Gov
Observational (Patient Registry)
Asim Pati, MD