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
|
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Condition or disease | Intervention/treatment |
---|---|
Leukemia, B-Cell, Chronic | Drug: Alemtuzumab (MabCampath, BAY86-5045) and Fludarabine Phosphate (Fludara, BAY86-4864) |
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 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 |

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. |

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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 |
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

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
Italy | |
Many locations, Italy |
Study Director: | Medical Monitor | Genzyme, a Sanofi Company |
Additional Information:
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 |