- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00344825
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Many locations, Italy
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Group 1
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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. |
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Leukemia
- Leukemia, Lymphocytic, Chronic, B-Cell
- Leukemia, Lymphoid
- Leukemia, B-Cell
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Antineoplastic Agents, Immunological
- Fludarabine
- Fludarabine phosphate
- Alemtuzumab
Other Study ID Numbers
- 306003
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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