Trials / Completed
CompletedNCT00344825
Vitalis Study - Observational Study on the Quality of Life in Patients Under Treatment for B-Chronic Lymphocytic Leukemia (B-CLL)
Observational Study for Evaluation of Quality of Life in Patients Under Treatment for B-Chronic Lymphocytic Leukemia.
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 300 (actual)
- Sponsor
- Genzyme, a Sanofi Company · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
300 patients, starting a new pharmacological treatment for B-CLL, were enrolled by 36 Italian Centres for assessing the Quality of Life (QoL). A descriptive analysis of QoL and the correlation of the 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: therapeutic Regimen, type of Centre, B-CLL treatment lasting, response to B-CLL treatment.
Detailed description
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2004-01-01
- Primary completion
- 2006-11-01
- Completion
- 2006-11-01
- First posted
- 2006-06-27
- Last updated
- 2013-12-04
Locations
1 site across 1 country: Italy
Source: ClinicalTrials.gov record NCT00344825. Inclusion in this directory is not an endorsement.