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

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00344825
First received: June 26, 2006
Last updated: December 2, 2013
Last verified: December 2013

June 26, 2006
December 2, 2013
January 2004
November 2006   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00344825 on ClinicalTrials.gov Archive Site
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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.

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

Patients, aged >/= 18 years, either sex with B-CLL, who are starting a new pharmacological treatment for B-CLL (1st, 2nd, 3rd, 4th), duration of CLL therapy </= 6 months, WHO Performance Status &#8804; 2, life expectancy >/= 6 months

Leukemia, B-Cell, Chronic
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.

Group 1
Intervention: Drug: Alemtuzumab (MabCampath, BAY86-5045) and Fludarabine Phosphate (Fludara, BAY86-4864)
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
300
November 2006
November 2006   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT00344825
306003
No
Medical Monitor, Genzyme
Genzyme, a Sanofi Company
Not Provided
Study Director: Medical Monitor Genzyme, a Sanofi Company
Sanofi
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP