informCLL™: A Disease Registry for Patients With Chronic Lymphocytic Leukemia

The purpose of the Inform CLL is to characterize and describe treatment patterns for those initiating treatment with approved oral kinase inhibitors and other approved anti-CLL therapies/regimens. This study also evaluates association of treatment patterns with patient characteristics, healthcare resource utilization and patient reported HRQoL.
Cancer (Oncology) - Leukemia, Cancer (Oncology)
John Pagel, MD, PhD
Swedish Cancer Institute
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with CLL/SLL from a total of 200 sites in the US over a 36-month enrollment period. Approximately 1000 patients will be initiating novel therapies including oral kinase inhibitors and approximately 500 patients initiating other approved anti-CLL therapies/regimens for the treatment of CLL/SLL. Approximately 85% of sites will include sites from the community hematology-oncology setting.
Criteria

Inclusion Criteria:

  • Age of at least 18 years
  • Clinical diagnosis of CLL/SLL that meets published diagnostic criteria (Hallek 2008)
  • Initiating treatment within ±30 days of enrollment with novel therapies including oral kinase inhibitors (e.g., inhibitors of BTK [e.g., ibrutinib], 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

Exclusion Criteria:

  • Diagnosis of B-cell malignancies other than CLL/SLL
  • Estimated life expectancy <6 months
  • Currently enrolled in any 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)
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