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

  • Observational [Patient Registry]
  • Recruiting
  • NCT02582879
Eligibility Details Visit Clinicaltrials.gov

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).

InformCLL is a multicenter, prospective, observational registry of CLL patients designed to characterize and describe treatment patterns for those initiating treatment with approved oral kinase inhibitors, BCL-2 inhibitors and other approved anti-CLL therapies/regimens. The registry will provide information on regimens used to treat first-line and later lines of CLL/SLL as well as the sequencing of treatment regimens. The registry will also evaluate the association of these treatment patterns with patient characteristics, healthcare resource utilization, and functional outcomes including patient-reported HRQoL. These data will provide information to physicians that may help guide clinical practice and appropriate use of therapies, and will also provide information on HRQoL and healthcare resource utilization that will be of interest to healthcare decision makers.

Gender
All

Age Group
18 Years and up

Accepting Healthy Volunteers?
No

Inclusion Criteria:

         - 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

        Exclusion Criteria:

         - 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)

At a Glance

National Government IDNCT02582879

IRB#IRB17-1297

Lead SponsorPharmacyclics LLC.

Lead PhysicianMichael J. Thirman

Collaborator(s)N/A

EligibilityAll
18 Years and up
Recruiting