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

Sponsor

Genzyme, a Sanofi Company (Industry)

Overall Status

Completed

CT.gov ID

NCT00344825

Collaborator

(none)

300

Enrollment

Location

Duration (Months)

8.8

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Leukemia, B-Cell, Chronic	Drug: Alemtuzumab (MabCampath, BAY86-5045) and Fludarabine Phosphate (Fludara, BAY86-4864)

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.

Study Design

Study Type:

Observational

Actual Enrollment :

300 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Observational Study for Evaluation of Quality of Life in Patients Under Treatment for B-Chronic Lymphocytic Leukemia.

Study Start Date :

Jan 1, 2004

Actual Primary Completion Date :

Nov 1, 2006

Actual Study Completion Date :

Nov 1, 2006

Arms and Interventions

Arm	Intervention/Treatment
Group 1	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.

Arm

Intervention/Treatment

Group 1

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.

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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 </= 6 months
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 </= 2
Life expectancy </= 6 months
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