Vitalis Study - Observational Study on the Quality of Life in Patients Under Treatment for B-Chronic Lymphocytic Leukemia (B-CLL)

• Status: Completed
• Trial end date: 2006-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Genzyme, a Sanofi Company
• Treatments: Alemtuzumab; Fludarabine; Fludarabine phosphate

Criteria

Inclusion Criteria:

• Aged >/=18 years

• Patients of either sex with B-CLL, who are starting a new pharmacological treatment for B-Chronic Lymphocytic Leukemia (1st, 2nd, 3rd, 4th)

• Foreseen duration of CLL therapy
• B-Chronic Lymphocytic Leukemia progressive stage A, stage B or C (according to Binet system), or II-IV (according to Rai system)

• WHO Performance Status
• Life expectancy
• Signed Informed consent for personal data's treatment and availability to fill in the QoL questionnaire

Exclusion Criteria:

• Patients with any other tumour disease

• Chronic Lymphocytic Leukemia therapy in the last 30 days before V0

• More than 3 previous CLL treatments (the therapy is defined by the drug and/or the treatment period)

• Previous stem cells transplantation

• Concurrent or in the last 30 days participation to any other clinical trial

• Any medical or psychological conditions that might compromise the capacity to sign the consent for personal data's treatment or to fill in the QoL questionnaire