Phase IV Observational Study in Chronic Lymphocytic Leukemia Patients Receiving Ofatumumab in the European Union
N/A
N/A
N/A
N/A
N/A
Open (Enrolling)
Both
Leukaemia, Lymphocytic, Chronic
Both
Leukaemia, Lymphocytic, Chronic
Trial Information
Phase IV Observational Study in Chronic Lymphocytic Leukemia Patients Receiving Ofatumumab in the European Union
Inclusion Criteria:
- All CLL patients who have previously received Arzerra, whether alive or deceased
- Patients who have either completed the full course of Arzerra therapy or discontinued
treatment early
Exclusion Criteria:
- CLL patients newly initiating Arzerra
- Patients having been treated with Arzerra in phase II or phase III clinical trials
Type of Study:
Observational
Study Design:
Observational Model: Cohort, Time Perspective: Retrospective
Outcome Measure:
Physicians' assessment of response
Outcome Description:
Physicians' assessment of response to include one or more of the following: CR, MRD status, incomplete CR, PR nodular, Stable Disease, Refractory/Progressive disease
Outcome Time Frame:
Approximately one-year post-drug initiation or at the last available patient contact with the physician
Safety Issue:
No
Principal Investigator
GSK Clinical Trials
Investigator Role:
Study Director
Investigator Affiliation:
GlaxoSmithKline
Authority:
United States: No Health Authority
Study ID:
114429
NCT ID:
NCT01453062
Start Date:
September 2011
Completion Date:
September 2013
Related Keywords:
- Leukaemia, Lymphocytic, Chronic
- Ofatumumab
- Chronic lymphocytic leukemia (CLL)
- Arzerra
- Leukemia
- Leukemia, Lymphocytic, Chronic, B-Cell
- Leukemia, Lymphoid
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