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

Study Identifier
PCYC-1134M-CA
CT.gov Identifier
NCT02582879
EudraCT Identifier
Not available
EUCTIS ID
Not available
For general inquiries, please contact

844-663-3742 or [email protected]

Study Complete

Results Available

Scientific Result Summary
Available Language(s): English
Download document(s)

Study Details

Medical Condition
  • Blood Cancer - Chronic Lymphocytic Leukemia (CLL)
    • Study Drug
    N/A
    Phase
    N/A
    Sex
    Female & Male
    Age
    18+ years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    * Age of at least 18 years * Clinical diagnosis of CLL/SLL that meets published diagnostic criteria (Hallek 2008) * Initiating anti-CLL/SLL treatment regimen (excluding clinical trials) within ±45 days of enrollment * Availability of documentation of previous CLL/SLL treatment and duration of response in the patient's medical records if patient has received prior line(s) of treatment (i.e. NOT treatment naïve) * 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 prior to receiving treatment, as possible
    Exclusion Criteria:
    * Diagnosis of B-cell malignancies other than CLL/SLL * Estimated life expectancy \<6 months * Currently receiving treatment in an interventional clinical trial at time of entry into this study \* Note- Exceptions: 1) Patients may enroll in interventional clinical trials for indications other than CLL/SLL, 2) The interventional clinical trial treatment is not the treatment used for meeting Inclusion Criteria #2 (or "Index Treatment"), 3) Patients may enroll in an interventional clinical trial indicated for CLL/SLL as later line of treatment after discontinuing the Index Treatment

    Protocol Summary

    The study is designed as a multicenter, prospective, observational registry of CLL/SLL patients who are initiating approved oral kinase inhibitors, BCL-2 inhibitors or other approved anti-CLL therapies/regimens. The study will characterize treatment patterns and their association with patient characteristics, healthcare resource utilization, and clinical outcomes, as well as patient-reported outcome (PRO) measures.

    Study Locations

    Location
    Status
    Location
    OSF Saint Anthony Medical Center
    Rockford, Illinois, United States, 61108
    8.0 miles (12.8 km) away from your location
    Status
    Not applicable