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
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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
    Clearview Cancer Institute
    Huntsville, Alabama, United States, 35805
    Status
    Not applicable
    Location
    Northwest Alabama Cancer Center, PC
    Muscle Shoals, Alabama, United States, 35661
    Status
    Not applicable
    Location
    Arizona Oncology Associates, PC - HAL
    Glendale, Arizona, United States, 85308
    Status
    Not applicable
    Location
    Arizona Oncology Associates, PC - HAL
    Phoenix, Arizona, United States, 85016
    Status
    Not applicable
    Location
    Arizona Oncology Associates, PC - HAL
    Phoenix, Arizona, United States, 85027
    Status
    Not applicable
    Location
    Arizona Oncology Associates, PC - HAL-Scottsdale
    Tempe, Arizona, United States, 85284
    Status
    Not applicable
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