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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:
Genzyme
ClinicalTrials.gov Identifier:
NCT00344825
First received: June 26, 2006
Last updated: July 28, 2010
Last verified: July 2010
History of Changes
  Purpose

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 Intervention
Leukemia, B-Cell, Chronic
 Drug: Alemtuzumab (MabCampath, BAY86-5045) and Fludarabine Phosphate (Fludara, BAY86-4864)

Study Type: Observational
Study Design: 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.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Genzyme:

Enrollment: 300
Study Start Date: January 2004
Study Completion Date: November 2006
Primary Completion Date: November 2006 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

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 </= 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00344825

Locations
Italy
Many locations, Italy
Sponsors and Collaborators
Genzyme
Investigators
Study Director: Medical Monitor Genzyme
  More Information

Additional Information:
Click here and search for drug information provided by the FDA  This link exits the ClinicalTrials.gov site
Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Medical Monitor, Genzyme
ClinicalTrials.gov Identifier: NCT00344825     History of Changes
Other Study ID Numbers: 306003
Study First Received: June 26, 2006
Last Updated: July 28, 2010
Health Authority: Italy: Ethics Committee

Keywords provided by Genzyme:
B- Chronic Lymphocytic Leukemia

Additional relevant MeSH terms:
Leukemia
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, Lymphoid
Leukemia, B-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Fludarabine
Fludarabine monophosphate
Alemtuzumab
 Vidarabine
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on June 18, 2013