Chronic Lymphocytic Leukemia
Conditions
Keywords
CLL, alemtuzumab
Brief summary
This study will collect data on safety, effectiveness and patient acceptance of MabCampath treatment under daily life conditions.
Detailed description
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.
Interventions
Intravenous therapy according to product information.
Sponsors
Genzyme, a Sanofi Company
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
In- and outpatients suffering from CLL, who are treated with Mab Campath, and are routinely monitored with PCR (Polymerase Chain Reaction) for CMV infection during MabCampath treatment and for at least 2 months following completion of treatment.
Exclusion criteria
In accordance with Summaries of Product Characteristics (SPC).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | After first cycle of treatment, e.g. 12 weeks, then after 9 months |
Countries
Bosnia and Herzegovina, Israel, North Macedonia
Outcome results
None listed