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Observational Study for Evaluation of Quality of Life in Patients Under Treatment for B-Chronic Lymphocytic Leukemia.


N/A
18 Years
N/A
Not Enrolling
Both
Leukemia, B-Cell, Chronic

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Trial Information

Observational Study for Evaluation of Quality of Life in Patients Under Treatment for B-Chronic Lymphocytic Leukemia.


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.


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
- 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
- Life expectancy
- 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

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Principal Investigator

Medical Monitor

Investigator Role:

Study Director

Investigator Affiliation:

Genzyme

Authority:

Italy: Ethics Committee

Study ID:

306003

NCT ID:

NCT00344825

Start Date:

January 2004

Completion Date:

November 2006

Related Keywords:

  • Leukemia, B-Cell, Chronic
  • B- Chronic Lymphocytic Leukemia
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid
  • Leukemia, B-Cell

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