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
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
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:
Enrollment:
600
Primary completion date:
Not applicable
Observational study model:
Cohort
Time perspective:
Retrospective
Clinical publications:
Not applicable
- 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)
Inclusion and exclusion criteria
Inclusion criteria:
- 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
- If treated, therapies received are available in the database
- At least 1 entry in the BC CLL Database from January 1, 2003 and December 31 2012
- Adults (> 18 years)
Exclusion criteria:
- 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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