Last updated: 11/03/2018 21:34:18

Characterization of patients with Chronic Lymphocytic Leukemia in British Columbia, Canada using a province-wide CLL database

GSK study ID
201373
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: Characterization of patients with Chronic Lymphocytic Leukemia in British Columbia, Canada using a province-wide CLL database
Trial description: The aim of this study is to characterize current treatment patterns for Chronic Lymphocytic Leukemia (CLL) in first-line treatment setting and to compare the patient characteristics based on the type of regimens they received in this setting in British Columbia (BC) and to characterize the broader treatment patterns for CLL patients in BC including second line and further therapies in a well defined cohort of patients with diagnosis from 2003 to 2012. Currently there are few good therapies available for those who are not suitable for standard fludarabine-based treatment, however this situation is changing, and with the advent of newer therapies, including ofatumumab, the patient group who is fludarabine non-suitable, or others may benefit from these therapies. It will therefore be important to know the baseline proportions of patients treated with different first and subsequent therapy, and their outcomes, so that accurate predictions and comparisons will be possible once these newer therapies are available.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Demographic characteristics and treatment patterns

Timeframe: 1 year

Overall Survival (OS) and treatment-free survial

Timeframe: 9 year

Secondary outcomes:

Demographic characteristics and treatment patterns

Timeframe: 1 year

Interventions:
  • Other: Data Collection
  • Enrollment:
    600
    Primary completion date:
    Not applicable
    Observational study model:
    Cohort
    Time perspective:
    Retrospective
    Clinical publications:
    Not applicable
    Medical condition
    Cancer, Neoplasms
    Product
    ofatumumab
    Collaborators
    Not applicable
    Study date(s)
    January 2014 to May 2014
    Type
    Observational
    Phase
    Not applicable

    Participation criteria

    Sex
    Female & Male
    Age
    18+ years
    Accepts healthy volunteers
    none
    • Diagnosed with CLL by standard IWCLL (International Workshop on Chronic Lymphocytic Leukemia) criteria, and included in BC CLL Database as determined by availability of one or more FISH (fluorescence-in-situ-hybridization) tests
    • Information on status – treated vs. untreated
    • Incomplete therapy information in the database – i.e. unable to determine if the patient has / has not required therapy
    • Children (<18 years)

    Trial location(s)

    This study does not involve prospective enrollment of participants.

    Study documents

    Clinical study report
    Available language(s): English
    Scientific result summary
    Available language(s): English

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Refer to study documents

    Recruitment status
    Study complete
    Actual primary completion date
    Not applicable
    Actual study completion date
    2014-12-05

    Plain language summaries

    Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.

    Additional information about the trial

    Not applicable
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