Vitalis Study - Observational Study on the Quality of Life in Patients Under Treatment for B-Chronic Lymphocytic Leukemia (B-CLL)
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|ClinicalTrials.gov Identifier: NCT00344825|
Recruitment Status : Completed
First Posted : June 27, 2006
Last Update Posted : December 4, 2013
|Condition or disease||Intervention/treatment|
|Leukemia, B-Cell, Chronic||Drug: Alemtuzumab (MabCampath, BAY86-5045) and Fludarabine Phosphate (Fludara, BAY86-4864)|
The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany.
Bayer Schering Pharma AG, Germany is the sponsor of the trial.
|Study Type :||Observational|
|Actual Enrollment :||300 participants|
|Official Title:||Observational Study for Evaluation of Quality of Life in Patients Under Treatment for B-Chronic Lymphocytic Leukemia.|
|Study Start Date :||January 2004|
|Actual Primary Completion Date :||November 2006|
|Actual Study Completion Date :||November 2006|
Drug: Alemtuzumab (MabCampath, BAY86-5045) and Fludarabine Phosphate (Fludara, BAY86-4864)
Descriptive statistical methods applied for the whole study cohort and for subgroups according to QoL and the correlation of the following parameters: Age, Sex, Stage of disease, Time from first B-CLL diagnosis, number of previous B-CLL treatments, Reason of starting of the new B-CLL treatment (progression disease, relapse, no-response to the previous treatment, previous treatment toxicity), Therapeutic Regimen (Day Hospital, Hospital Admission, etc.), Type of Centre, B-CLL treatment lasting, Response to B-CLL treatment.
QoL at baseline, Change in QoL over time evaluated using an analysis of Variance.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00344825
|Many locations, Italy|
|Study Director:||Medical Monitor||Genzyme, a Sanofi Company|