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
Finalized
Finalized
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
Observational study model:
Cohort
Primary completion date:
Not applicable
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)

No location data available.

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
Finalized
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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