Safety, Effectiveness and Patient Acceptance of the Treatment With MabCampath in Chronic Lymphocytic Leukemia
This study will collect data on safety, effectiveness and patient acceptance of MabCampath treatment under daily life conditions.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Safety, Effectiveness and Patient Acceptance of the Treatment With MabCampath in Chronic Lymphocytic Leukemia (CLL)|
- Efficacy related variables are patient's condition, physician's assessment of efficacy and tolerability, information whether application could be completed, clinical and laboratory findings. Safety Variables. [ Time Frame: After first cycle of treatment, e.g. 12 weeks, then after 9 months ] [ Designated as safety issue: Yes ]
|Study Start Date:||October 2008|
|Study Completion Date:||April 2009|
|Primary Completion Date:||April 2009 (Final data collection date for primary outcome measure)|
Drug: Alemtuzumab (MabCampath)
Intravenous therapy according to product information.
Other Name: BAY86-5045
As of 29 May 2009, the clinical trial sponsor is Genzyme Corporation. NOTE: This study was originally posted by sponsor Schering AG, Germany, which was subsequently renamed to Bayer Schering Pharma AG, Germany.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00836043
|Bosnia and Herzegovina|
|Many Locations, Bosnia and Herzegovina|
|Many Locations, Israel|
|Macedonia, The Former Yugoslav Republic of|
|Many Locations, Macedonia, The Former Yugoslav Republic of|
|Study Director:||Medical Monitor||Genzyme, a Sanofi Company|