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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:
Genzyme, a Sanofi Company
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00344825
First received: June 26, 2006
Last updated: December 2, 2013
Last verified: December 2013
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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:
Genetic and Rare Diseases Information Center resources:
Chronic Lymphocytic Leukemia
Leukemia, B-cell, Chronic
U.S. FDA Resources
Further study details as provided by Sanofi:
| 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 (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 ≤ 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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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00344825
Please refer to this study by its ClinicalTrials.gov identifier: NCT00344825
Locations
| Italy | |
| Many locations, Italy | |
Sponsors and Collaborators
Genzyme, a Sanofi Company
Investigators
| Study Director: | Medical Monitor | Genzyme, a Sanofi Company |
More Information
Additional Information:
| 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: | December 2, 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 Fludarabine phosphate Alemtuzumab Antineoplastic Agents Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on June 23, 2017