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

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ClinicalTrials.gov Identifier: NCT00344825
Recruitment Status : Completed
First Posted : June 27, 2006
Last Update Posted : December 4, 2013
Sponsor:
Information provided by:
Sanofi

Study Description
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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
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
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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 : January 2004
Actual Primary Completion Date : November 2006
Actual Study Completion Date : November 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts
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Group/Cohort 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
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Eligibility Criteria
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00344825


Locations
Italy
Many locations, Italy
Sponsors and Collaborators
Genzyme, a Sanofi Company
Investigators
Study Director: Medical Monitor Genzyme, a Sanofi Company
More Information
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:
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Responsible Party: Medical Monitor, Genzyme
ClinicalTrials.gov Identifier: NCT00344825     History of Changes
Other Study ID Numbers: 306003
First Posted: June 27, 2006    Key Record Dates
Last Update Posted: December 4, 2013
Last Verified: December 2013

Keywords provided by Sanofi:
B- Chronic Lymphocytic Leukemia

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